» Policies and Guidelines

The Chapman University Institutional Review Board (IRB) operates under policies and procedures mandated by the U.S. Department of Health and Human Services and the Office for Human Research Protections. These policies are available for review at www.hhs.gov/ohrp/. The following documents are meant to serve both as policy statements for the Chapman University IRB and as guidelines for investigators involving human subjects in their research.

Policies


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+ - Principal Investigator (PI) Eligibility Policy

Purpose

This policy is intended to set forth the eligibility requirements of a Principal Investigator (PI) at Chapman University (CU). This Policy also describes the processes for requesting and approving exceptions to the PI eligibility requirements.

Definition of Principal Investigator

A Principal Investigator is responsible for the intellectual direction, design, scientific or technical conduct, administrative conduct, and reporting of a research, training, or public service project. As such, the University recognizes one individual as the Principal Investigator and he/she must personally participate in the project to a significant degree and provide oversight on project activities. Proposals submitted for extramural funding or to the University regulatory oversight committees must name an eligible employee of the University to serve as Principal Investigator. In order to be designated as the PI on a proposal, sponsored project, or Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC) protocol, an individual must be PI eligible. 

The majority of funding agencies recognize only one Principal Investigator. In those instances where several names are listed in the proposal, the agency assumes that the first name listed is primus inter pares (first between equals).

Other collaborating researchers who carry out portions of the project are considered to be Co-Principal Investigators (Co-PI) or Co-Investigators (Co-I). In order to serve as Co-PI or Co-I, an individual must be PI eligible. Although the PI may delegate fiscal or administrative aspects of the project to a Co-PI or Co-I, the PI still bears primary responsibility for the project.

In the event of an apparent conflict between policies of the University and the funding agency, the more restrictive policy shall be followed.

 Appointments Eligible for Principal Investigator Status

  • Faculty with Full-time (>30 hours) status including, tenure track, tenured, research, and clinical.
  • Administrators
  • Librarians, Associate Librarians, Assistant Librarians
  • Faculty with Emeritus status
  • Provost and Presidential Fellows
  • Academic Professionals in the Research Scientist series (Sr. Research Scientist, Research Scientist)

Appointments That Require Prior Approval for Principal Investigator Status

Anyone who wishes to serve as Principal Investigator, but does not meet the eligibility criteria set forth above, must receive approval from the Vice President for Research upon the recommendation of their Dean, Director or Vice President in order to serve in the Principal Investigator Role. The individual must have the necessary experience and independence to compete for his or her own sponsored program and/or to administer the project. They must have previous experience with similar types of research projects and the ability to comply with all the requirements of the award or project. These individuals include, but are not limited to:

  • Faculty with visiting appointments of less than the term of the grant if awarded
  • Affiliated Scholars with non-employee status on courtesy appointments
  • Faculty with full-time status who are identified as instructional faculty
  • Appointees salaried at less than full time status including adjunct faculty or lecturers
  • Postdoctoral scholars or trainees
  • Research Associates

Appointments That Are Non-Eligible for PI Status

  • Graduate Students. Faculty advisors or mentors will be designated as Principal Investigators for graduate student fellowships or traineeships awarded as grants to the university.
  • Research Assistants
  • Undergraduate Students

Requesting an Exception

To request an exception to the PI policy, a formal request must be made to the Vice President for Research via email to include the following:

  1. Current Curriculum Vitae
  2. A copy of their Appointment Term or Faculty Contract
  3. Summary Statement of the proposed project
  4. Recommendation of Dean, Director or Vice President. Recommenders should carefully consider whether the PI requesting exception has the ability and experience necessary to administer the project if the exception is approved. If department or college resources are needed, assurance must be given that the necessary space or other resources will be provided or made available for the entire length of the project.

(Research Office PI Eligibility Policy, Version: December 9, 2016)

+ - General Policies and Procedures

Policy Overview:

  • Applicable Regulations and Laws
  • Institutional Review Board
    • Purpose
    • Designation and Authority
    • Composition and Appointment of the IRB
  • Term of Appointment
  • Committee Officers
  • Meetings
  • IRB Meeting Minutes
  • Confidentiality of the Review Process
  • Conflict of Interest
    • IRB Members - Convened Meeting
    • Designated Reviewers for Expedited Review
    • Examples of IRB Member COI
    • Principal Investigator
  • Interaction with Other University Components and Commencement of Research Activities
  • Types of Research Conducted at the University
  • Categories of Research Subjects
  • Determining if IRB Review is Required
    • Determination of Human Subjects Research
    • Class Projects
    • Use of De-identified Secondary Data
  • Coded Private Information as Related to Human Subjects Research
  • Cooperative Activities
  • Reliance Agreements
  • Undue Influence of the IRB or Research Integrity Staff
  • Training Requirements
    • Researchers and Research Staff
    • IRB Members and Chairs
    • Research Integrity & Education Staff
  • Roles and Responsibilities
    • Principal Investigators
    • Faculty Sponsors
    • Departmental Review Committees
    • Institutional Official
    • Institutional Review Board
    • IRB Chair(s)
    • IRB Members
  • Monitoring/Verification of Compliance from Sources Other than the Pl
  • Contacts for Questions, Concerns, Complaints or Input
  • Record Retention

Applicable Regulations and Laws

The purpose and responsibility of the Institutional Review Board (IRB) is to protect the rights and welfare of human research subjects. The IRB reviews and oversees research activities involving human subjects and requires that the research complies, as applicable, with Federal regulations at 45 CFR 46, Subparts A, B, C, and D, (or equivalent policies and procedures), the FDA 21 CFR Parts 50, 56, 312, and 812, California law, and all other pertinent regulations and guidelines.

Institutional Review Board

Purpose

Safeguarding the rights and welfare of subjects at risk in any research activity, whether financially supported or not, and irrespective of the source of any supporting funds, is primarily the responsibility of the University. In order to provide for the adequate discharge of the institutional responsibility, no non-exempt research activity involving human subjects may be undertaken by any faculty, staff, employee, or student unless an IRB has reviewed and approved the research prior to commencing the research activity.

Designation and Authority

The University has designated the Chapman IRB responsible for conducting initial and continuing reviews and providing oversight for all research activities involving the use of human subjects performed by agents or employees of the University. The scope of research reviewed by the IRB is not limited and the IRB reviews all types of research submitted.

The Institutional Official (IO) formally grants the IRB the following authority relative to the protection of human subjects:
  1. To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted by the agents of the organization and involving human subjects, based on its consideration of the risks and potential benefits of the research and whether the rights and welfare of the subjects are adequately protected;
  2. To require reports for protocol continuing review;
  3. To continuously monitor the conduct of research with human subjects;
  4. To suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious risk to subjects;
  5. To place restrictions on a study, if necessary to protect human research subjects;
  6. To observe, or have a third party observe, the consent process;
  7. To observe, or have a third party observe, the conduct of the research.

No official within the organization may approve a protocol or human subjects research activity that has not been approved by the IRB. However, the IO or any other University executive administrative official may disapprove a protocol or research activity that has been approved by the IRB.

Composition and Appointment of the IRB

The IRB is composed of full board members, alternate members, and a community member, who represent Chapman University and the community. With backgrounds in the physical, medical, and social sciences, IRB board members are guided by regulations and standards of practice formulated and enforced by various government departments, including the Department of Health and Human Services.

The IRB is formally appointed by the IO, with input and membership nominations coming from the IRB Chair(s) and IRB members, University department chairs, directors, and deans, and is composed of a sufficient number of members to assure complete and adequate review of activities commonly conducted at the University.

Scientific members of the IRB generally will have experience in research involving human subjects, and will be recruited from among active research members of the University.

Nonscientific members will be recruited from the faculty at large and will reflect professional expertise in a non-scientific area, such as law, ethics, human or patient rights, etc. The appointment of non-affiliated (community) members and a prisoner representative will also be done by the IO but the IRB Chair(s), Director of Research Integrity, and IRB Administrator are responsible for determining whether or not the nominees are truly unaffiliated and/or have appropriate expertise to serve as prisoner representative.

Alternates are appointed and function in the same manner as the primary IRB members. The alternate's expertise is comparable to those of the primary member. The role of the alternate member is to serve as a voting member of the IRB when the regular member is unable to attend a convened meeting. When an alternate member substitutes for a primary member, the alternate member will receive and review the same materials prior to the IRB meeting that the primary member received or would have received. The alternate member will not be counted as a voting member unless the primary member is absent. The IRB minutes will document when an alternate member replaces a primary member.
 
At times, the IRB may not have the necessary expertise to judge the scientific soundness of a research protocol and may be unable to make a fair and accurate determination of the risk-benefit ratio. For these protocols the IRB Chair, or the primary reviewer after consultation with the IRB Chair, may call upon ad hoc consultants for assistance in review of scientific merit or to perform an in-depth review of the study. The ad hoc consultants are not considered to be members of the IRB, are utilized only for expert scientific review, have no voting rights, and must disclose whether or not they have any conflicts of interest with the protocol. The consultants will submit a written report and copies of the report will be distributed to all IRB members. The report and recommendations will be documented in the IRB minutes for the meeting. It is expected that because of the wide diversity of IRB members, the use of ad hoc consultants will be a rare occurrence.
 

The IO may appoint administrative staff and/or faculty (e.g., legal counsel) at the University to serve as non-voting members of the IRB should the IO, the IRB Chair, or the Director of Research Integrity decide that such persons would be of assistance to the IRB in conducting its duties. Individuals involved in the business function or in research development do not serve in any capacity on the IRB and have no involvement in the day-to-day operations of the review process. A non-voting member cannot be counted in the quorum and cannot vote, but can participate in discussions. In addition, funding agencies may have additional IRB membership requirements.
 
The Director of Research Integrity or designee will report changes in IRB membership to Office for Human Research Protections (OHRP) as required.

Term of Appointment

IRB members are appointed to 3-year, renewable terms. The IRB Chair(s) are expected to hold the position for several years. Upon appointment and again at time of reappointment, each IRB member is queried to determine roster information such as affiliation status, relationship of the member to the University, indications of experience and other relevant information. IRB member's performance will be reviewed annually by the IRB Chair with assistance from the IRB Administrator. IRB members who are not performing in accordance with the IRB's mission or policies and procedures or who have an undue number of absences will not be reappointed. Feedback will be provided to the members, as needed, by the IRB Chair and/or by the Director of Research Integrity.

IRB Chair(s)

The IRB has Co-Chairs chosen from IRB members who will typically be members of the faculty of the University, knowledgeable in human subjects research, including the federal and state regulations, University policies, and ethics relevant to such research. The IRB Chairs shall preside over and be authorized to speak for the IRB.

Meetings

In order to conduct IRB business, there must be a quorum of members present at a convened meeting. If quorum is lost, votes are not taken until it is restored. To be approved, a protocol must receive a majority of votes of members present at the meeting. The IRB shall hold regular meetings at a time and place to be determined by the IRB and posted electronically. Researchers may be invited to attend the meetings to address specific concerns regarding research protocols but will be asked to leave the meeting during all deliberations and votes. Other members of the University community are permitted to attend meetings but must request attendance through the IRB Administrator, the Director of Research Integrity, or IRB Chair. Guests will be asked to sign a confidentially agreement.

Prior to each full board meeting the IRB Administrator or other designee will assign primary reviewer(s) knowledgeable about or experienced in working with these types of studies. The IRB Administrator ensures that either the Primary or Secondary Reviewer is present at the meeting or available by teleconference during the convened meeting.

IRB Meeting Minutes

IRB meeting minutes are recorded in writing in sufficient detail to allow an outside observer to reconstruct protocol specific discussions and determinations. The IRB Administrator monitors quorum at each meeting and records IRB discussion points for the minutes. Meeting minutes are distributed each month to those IRB members who attended the given meeting. The IRB Administrator will provide a draft of the minutes for the Director of Research Integrity and the IRB Chairs to review for comments and/or suggested changes regarding the document's accuracy. After all comments are reviewed and addressed, a pending version of the minutes are available for review by the IRB members who attended the given meeting, prior to and for discussion at the next IRB meeting. A vote for approval of the final version of the minutes occurs at the next convened meeting. Once approved, a copy of the approved minutes will be posted in the Cayuse IRB system in order to document all actions taken by the IRB.

Minutes shall include:

  1. A protocol summary and the deliberations for each protocol and the resulting IRB action.
  2. The approval period for each initial review, continuing review, and amendment.
  3. A record of attendance for each protocol including the names of members who left the meeting due to a conflict of interest and a notation of such.
  4. The voting record for each protocol and the previous meeting's minutes reflecting the number of members for, against or abstaining from the vote and when alternate members replaced a primary member.
  5. The basis for requiring changes to a protocol, tabling, or disapproving research.
  6. A written summary of the discussion and resolution of controverted issues.
  7. Justification of deletions or substantive modifications of information concerning risks or alternative procedures contained in a consent form.
  8. If applicable, summaries of deliberations of protocols for inclusion of vulnerable populations.
  9. If applicable, the rationale for significant risk/non-significant risk device determinations.
  10. If applicable, protocol specific justifications for waivers of consent and research involving vulnerable populations.
  11. A list of all actions that were taken administratively during the previous month.

Confidentiality of the Review Process

During the process of initial, continuing review, or amendment of research activity, material provided to the IRB shall be considered privileged information and the IRB shall assure the confidentiality of the data contained therein.

Conflict of Interest (COI)

IRB Members - Convened Meeting

Prior to discussion of protocols at a convened meeting, the IRB Chair will ask if any member has a COI with any protocol being discussed at that meeting. Should an IRB member declare any level of involvement in a research protocol under review by the IRB, or state a COI with the research protocol the following is required:
  1. IRB member is excluded from discussion and voting except to provide information requested by the IRB.
  2. IRB member leaves the meeting room during discussion and voting.
  3. IRB member is not counted towards quorum.

Designated Reviewers for Expedited Review

IRB members (including experienced IRB staff members) who have been designated by the IRB Chair as reviewers for initial or continuing review of research protocols, reports of noncompliance, protocol deviations, unanticipated problems, and amendment requests that qualify for expedited review will self-identify any COI that they may have with the research or principal investigator (Pl). In such cases, the review responsibility will be reassigned to another experienced IRB member.

Examples of IRB Member COI

IRB members are considered to have a conflict of interest if they:

  1. Are involved in the design, conduct, or reporting of the research study.
  2. Have direct administrative powers over the investigators or the study.
  3. Are reviewing a proposal from a position who may determine promotion or merit (e.g., reviewing a protocol by the chair of your department or dean of your school).
  4. Have a financial and/or ownership interest of any amount in or related to the research and the value can be readily determined.
  5. Have a financial and/or ownership interest in or related to the research but the value cannot be readily determined.
  6. Received or will receive compensation and/or have ownership interest of any amount with value that may be affected by the outcome of the study.
  7. Have received in the past year, currently are receiving, or will receive from the sponsor of the study honoraria, payments, or compensation of any amount.
  8. Have a proprietary interest in the research, including but not limited to a patent, trademark, copyright, or licensing agreement.
  9. Serve as directors, board members, scientific advisors, or hold other decision-making positions in the entity sponsoring the research.
  10. Are not an investigator, co-investigator, or consultant on a study, but are closely associated with the investigators on the study being reviewed, or other studies.
  11. Have personal, familial, or intimate relationships with the principal investigator.
  12. For any reason, believe they cannot be objective concerning a study.

Principal Investigator

All PIs and their research staff are required to disclose any financial COI according to the University COI policy. Disclosed COIs that might affect the protection of subjects must have a management plan in place. Management plans may include: partial or complete divestment, limiting involvement of the conflicted individual, additional oversight, or disclosure. Disclosure alone cannot be used to manage conflicts of interests that might affect the protection of subjects.

When made aware of a possible researcher conflict, the IRB formally refers cases to the Conflict of Interest Officer (Director of Research Integrity), which in turn determines if formal COI management strategies are required.  If required, a draft COI Management Plan will be prepared by the Director of Research Integrity in consultation with the COI Committee. The COI Committee Chair and Director of Research Integrity will work with the researcher to develop and finalize a COI Management Plan. When finalized, the COI Management Plan will be submitted to the IRB for review and final approval. Under no circumstances will research be approved until the IRB has reviewed and approved the COI Management Plan.

Institutional COIs are handled through the Office Institutional Compliance according to the Institutional Conflict of Interest policy.

Interaction with Other University Components and Commencement of Research Activities

The University is comprised of multiple types of research review and some reviews are accomplished by standing committees, e.g., Institutional Biosafety Committee (IBC). The successful fulfillment of the University's intent to protect human research subjects is dependent upon open communication among these various institutional components. Committees and offices exchange information, when necessary, to assure that, in addition to IRB review, human subjects research receives all appropriate review prior to implementation of the research activities. Human subjects research is not allowed to commence until all applicable reviews are complete and notification of approval is received by the IRB.

Types of Research Conducted at the University

The majority of research at the University is social-behavioral in nature. The University does not participate in planned emergency research described in and covered under 21 CFR 50.54 and OHRP Guidance 97-01.

Categories of Research Subjects

Human subjects research at the University generally includes normal healthy individuals; adults, and/or children. The IRB reviews and approves research proposing inclusion of vulnerable populations. The vulnerable populations most commonly included in research activities are children, prisoners, pregnant women, cognitively impaired adults, and economically or educationally disadvantaged individuals.

Determining if IRB Review is Required

Determination of Human Subjects Research

The federal regulations include a very specific definition for what constitutes “research” (see 45 CFR 46.102(d)) and for what is meant by a “human subject” (see 45 CFR 46.102(f)). A formal determination from the IRB can be made if a project either is not research and/or does not involve human subjects (e.g., as may be required by a student’s doctoral dissertation committee, a funding agency, or a journal editor). The IRB will not provide a formal written determination after the project has been initiated.
 
If a researcher is unsure whether a project meets this criteria, they should contact the IRB staff before submitting their application for review.

The federal research regulations (45 CFR 46) do not require the IRB to make a formal determination that projects are not research, or do not involve human subjects. Thus, a Non-Research Determination Form should be used only if a formal determination is required by a university entity (e.g., dissertation committee) or by an external agency.

According to HHS regulations, the University becomes engaged in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes, or (ii) obtain individually identifiable private information about those individuals for research purposes. Under FDA regulations, the institution becomes engaged in human subjects research when it undertakes a clinical investigation on individuals who are or become subjects in the investigation, either as recipients of a test article or as controls and may be either patients or healthy non-patients.

PIs are automatically considered to be "engaged" in human subjects research whenever they apply for or receive a direct award to support research that includes human subjects, even if all the activities involving human subjects will be carried out by a subcontractor or collaborator. In all cases the institution to which the grant has been awarded bears the responsibility for protecting human subjects under the award.

Classroom-Based Projects

Classroom-based research projects typically do not meet the definition of human subjects research. As such, IRB review may not be required. For guidance regarding institutional policy for the review of classroom-based projects see Chapman University IRB Guidelines for Student Classroom Projects and Research Involving Human Subjects.

Use of De-Identified Secondary Data

By federal regulation, existing (or secondary) data are defined as data that existed "before the research is proposed" to an institutional official or the IRB. This provision is frequently interpreted as data that were "on the shelf" at the time the protocol was written. Existing data include both those provided to the investigator from any source; and those already in the possession of the investigator.

Secondary data analysis that does not require review by the IRB

Using the following types of public data does not constitute federally-regulated human subjects research and requires no further action with the IRB.

  1. Data that is not about living individuals (e.g., historical records of deceased individuals, death records, historical archives)
  2. Publicly available data; i.e. data with identifiable but not private information. (e.g., individual public records such as address, phone number, property value; data found on an unrestricted website, in publications, phone books, political campaign contributions, or obtained through a Freedom of Information Act request).
  3. A project that merges public datasets with other datasets containing private information may enable the identification of individuals and requires IRB review.

Secondary data analysis that may require IRB review

  1. Non-public, de-identified, or anonymous data
  2. Use of the following types of non-publicly available datasets does not constitute federally regulated human subjects research, if the provider of the data is NOT involved in the design, conduct or reporting of the research, including sharing any authorship rights:
    1. Datasets that are anonymized or
    2. Datasets that include coded private information, such that the investigator has no access to identifiable information. In such cases, no further action with the IRB is required
      • Investigators are advised to have on file a confidentiality statement from the data provider stating that identifiers were not included in the dataset that they received (e.g., de-identified data given by a colleague or provided by a data provider where no collaboration is expected).
  3. Non-public, identifiable data, but where research does not record, retain, or use identifiers.
  4. Use of datasets that contain private, identifiable data, but from which no identifiable information will be recorded, retained or used by any member of the research team in a manner that allows the direct or indirect identification of individuals, may be eligible for exemption from IRB review. Investigators are required to submit an Exemption application to the IRB. 
    • Investigators should include a data security plan that clearly describes measures to ensure that individuals cannot be identified, including the process for de-identifying information.
  5. 5. Non-public, identifiable data where research has access to and records private identifiable information.
  6. 6. Use of non-publicly available data when members of the research team or their collaborators have access to and plan to use private identifiable information about living individuals, is considered human subjects research and requires review by the IRB. Investigations using such data are required to submit an application to the IRB.

Written Agreement for Restricted Access or Licensed Data

An investigator planning to obtain data under contractual terms, such as a restricted access data agreement or licensed data agreement, must contact the Office of Research Sponsored Projects Services (SPS). SPS will negotiate the terms of that agreement with the data provider on behalf of the University. Chapman investigators are not authorized to sign data use agreements themselves.

Coded Private Information as Relates to Human Subjects Research

The OHRP does not consider an institution or Pl to be engaged in human subjects research if the Pl consults or collaborates on human subjects research by obtaining coded private information or human biological specimens from another institution, engaged in the research, which retains the code. However, one of the following four conditions must be met:

  1. The key to decipher the code is destroyed before the investigator receives the coded information.
  2. The consulting or collaborating Pl and the holder of the key enter into an agreement prohibiting release of the key under any circumstances.
  3. The releasing institution has Internal Revenue Service-approved written policies and procedures applicable to the research project that prohibit release of the key to consultants or collaborators under any circumstances.
  4. There are other legal requirements prohibiting release of the key to consultants or collaborators.
OHRP also does not necessarily consider authorship as a factor in determining whether or not an institution is engaged in human subjects research. It is possible that the authors of a paper or presentation were not involved in obtaining "data about subjects of the research through intervention or interaction with them" or "identifiable private information about the subjects of the research." If a Pl simply receives unidentifiable or coded information about human subjects, OHRP has determined that analysis of the information and/or publication of conclusions based on analysis of the information does not constitute being engaged in human subjects research.

Cooperative Activities

The IRB shall have special responsibilities in the review and approval of proposals involving cooperative activities. Cooperative activities are those in which the University faculty, students, or staff obtain access to human subjects involved through one or more cooperating institutions, or when PIs from cooperating institutions obtain access to human subjects at the University.

When a Pl plans to conduct research at a site external to the University, the Pl must respond to questions in a protocol application that informs the IRB of:

  1. The contact information of the site(s);
  2. Whether the site(s) has an IRB;
  3. Whether the site(s) has granted permission for the research to be conducted and;
  4. If the site has an IRB, has the IRB approved the research or does the site plan to defer to Chapman’s IRB.
For research that will be conducted off-site, the IRB requires a letter from an appropriate official from that site (e.g., schools, prisons, non-profit service organizations) when they are partners in a research project. If the research will be conducted outside the U.S., it is required that the Pl obtain appropriate authorization and observe any local laws and regulations established in the foreign country. Depending on the location, identifying a local partner when conducting international research may also be required.

Reliance Agreements

Reliance agreements are arrangements between institutions allowing the IRB of one institution to rely on the IRB of another institution for review of human subjects research.   A reliance agreement can take many different forms, but Chapman primarily uses the Institutional Authorization Agreements (IAA) template.

Investigators working at multiple institutions, each having an IRB, may choose to have one IRB become the IRB of record over some or all participating sites (commonly referred to as ceded review, reliance agreements, or deferral of IRB oversight.) This means that the Chapman IRB is either the reviewing IRB (IRB of Record) or is ceding (Relying) oversight of the research activity to another equally-qualified IRB.

The Office of Research Integrity, in coordination with the Institutional Official, determines whether ceding IRB review is appropriate on a case-by-case basis.

If an external site defers, or cedes to the Chapman IRB, the site must submit an update to their federal wide assurance (FWA) that designates the Chapman IRB as an IRB that the site relies upon for review of human subjects research. Additionally, an IAA will need to be created and approved between Chapman and the site before a research project can be initiated.

For PIs performing research in which Chapman is the lead or coordinating institution, the Pl should note in the initial IRB application that the University is the lead or coordinating institution of a multi-site study. The Pl should also provide the following information:

  1. The name(s) of each participating institution that will be engaged in human subjects research.
  2. Confirmation that each participating institution has an FWA.
  3. The contact name and information for the Pl at each institution.
  4. The contact name and information for the IRB of record at each institution.
  5. The method of multilateral communication between institutions/IRBs of any unanticipated problems involving risks to subjects or others and other study related information.
When Chapman cedes review to another IRB, the Chapman PI is responsible for obtaining all regulatory protocol information (e.g., approved protocol, approved consent documents) from the ‘overall PI’ at the collaborating institution. Any questions or required reporting will need to go through the PI at the reviewing IRB site. PI’s will no longer interact with the Chapman IRB for protocol issues related to that research, but PI’s are responsible for providing information of any unanticipated problems or adverse events.

The final IAA will dictate any additional responsibilities the Chapman PI will have.

Undue Influence of the IRB or Research Integrity Staff

It is the policy of the University that the human subjects research review process and implementation of IRB policies and procedures are conducted objectively and without undue influence over deliberations or processes. Individual members of the IRB, whether employed by the institution or community members, have the right and obligation to report any undue pressure upon them to make decisions that would favor an individual Pl over subject protections, during the initial and continuing review processes or when conducting or participating in other IRB-related business. IRB members or staff are asked to document the issues related to the case in writing to both the Director of Research Integrity and the IO in order to open a formal report. The IO will formally review the information and may convene a meeting and/or otherwise obtain additional information as necessary. The Director of Research Integrity will subsequently inform the IRB of the findings. The IO has the authority to take corrective action in consultation with the IRB.

Upon resolution, the IRB will determine if the attempted, inappropriate influence represents an unanticipated problem involving risks to subjects or others and will determine if reporting to OHRP is appropriate.

Training Requirements

Researchers and Research Staff

The University requires training for all faculty, faculty mentors, researchers, and students, including researchers from other institutions who wish to conduct human subjects research at the University. All key personnel (Pl, Co-Pl, faculty sponsor), originally listed or later added to a study through an amendment, must complete the required human subjects training. In order to comply with the policy, researchers are required to complete the University's training through the Collaborative Institutional Training Initiative (CITI). CITI is comprised of modules relating to ethics, regulations, risk assessment, informed consent, and privacy and confidentiality. Based on the type of research conducted, additional training modules may be required. Completion of this training must be accomplished every three years. Protocol submissions (initial, continuing, amendments) are checked to assure all researchers and research staff have completed training.

Student investigators and their faculty sponsor/advisor must both complete and maintain valid training per the IRB policy. Protocol actions are not approved until training is completed by all listed on the protocol.

IRB Members and Chairs

IRB members and their alternates and the IRB chair(s) must complete the required human subjects training upon being appointed to the IRB and every three years for the duration of their membership. Initial training consists of completion of the identical CITI modules required for IRB members. At the time of initial appointment, IRB staff will also provide IRB orientation information (meeting schedules, locations, etc.)

As a part of annual evaluation of members, the IRB staff provides the Chair with the training status for all members. Members in need of completing their training are reminded by the IRB Administrator of this requirement. Failure to complete the training may result in removal from the IRB. Continuing educational materials are distributed at IRB meetings in the form of relevant periodicals or articles. Webinars and local conferences are made available to the members to attend.

Research Integrity Staff

IRB staff must document that they have completed the CITI training. Attendance at regional and national meetings, (e.g., PRIM&R) is encouraged and supported for IRB staff. Research Integrity staff are encouraged to attend any additional training, such as webinars, that are offered.

Roles and Responsibilities

Chapman’s Human Subjects Protection Program Policy outlines the general responsibilities for researchers and staff involved in the Human Research Protection Program (HRPP).  Below are additional considerations.

Principal Investigators

Chapman has a separate Principal Investigator (PI) Eligibility Policy. The following are the Pl responsibilities and are not all inclusive:

  1. Assure that all faculty and staff personnel listed on the research protocol have completed the human subjects research training and submitted an annual Financial Conflicts of Interest Disclosure.
  2. Submit protocols for IRB review and approval of proposed research activities prior to commencing research activities.
  3. Employ sound study design in accordance with standards of the Pl's discipline.
  4. Assure that adequate time and resources are present before conducting a research study to assure participant protections.
  5. Maintain appropriate oversight of each research study, as well as research staff, and appropriately delegate research responsibilities and functions.
  6. Ensure that the research is conducted according to the protocol, any signed agreements, and in compliance with all applicable laws, regulations, and organizational policies and procedures with the highest of ethical standards.
  7. Submit for review and approval all proposed protocol and consent form changes prior to implementing the changes in the protocol except where necessary to eliminate immediate hazards to human subjects.
  8. Obtain legally effective informed consent from subjects prior to commencement of research activities, unless the requirement is waived by the IRB.
  9.  Ensure the rights, safety, and welfare of the research subjects are upheld; honor all commitments that were agreed to as part of the approved research (e.g., providing information about the study results to research subjects or honoring commitments for reimbursements to subjects).
  10. Upon completion of a study, submit a Closure Report on Cayuse IRB.
  11. Disclose all COIs.
  12. Retain records as required by the regulations, the sponsoring entity, and local policy for the appropriate time period.
  13. When a Pl is the lead researcher for a multi-site study, applications must include information about the management of information that is relevant to the protection of research participants (e.g., interim results, protocol modifications, how unanticipated problems involving risks to participants or other unanticipated
  14. problems will be managed, how communication of unanticipated problems to all sites will occur, how protocol modifications will be managed, formal agreements delineating each site's roles and responsibilities).
  15. If the Pl holds an investigational new drug (IND)/investigational device exemption (IDE), adhere to sponsor responsibilities in addition to investigator responsibilities as per 21 CFR Parts 312/812.
  16. If appropriate, assure that applicable clinical trials (including some National Institutes of Health [NIH] funded trials) are registered on the governmental database at http://www.ClinicalTrials.gov. (Contact the Director of Research Integrity for more information on clinical trial registration)
  17. Address research participant's concerns, complaints, or requests for information.
  18. Follow reporting requirements for problems that require prompt reporting.
  19. Submit requested data at specified times for continuing review of ongoing research activities.

Institutional Official (IO)

The IO is designated by the President to have responsibility for the IRB with the authority to delegate activities as may be necessary to fulfill the following responsibilities:

  1. Assures compliance with institutional policies and all applicable regulations for the protection of human research subjects.
  2. Is legally authorized to represent the institution in matters regarding human subjects research and is the signatory authority for all the FWA to the OHRP.
  3. Is responsible for review and evaluation of reports on HRPP performance and Quality Improvement activities.
  4. Is responsible for further institutional review and approval or disapproval of research approved by the University IRB (neither the IO nor any other University official can approve research that was disapproved by the IRB).
  5. Reviews copies of all IRB meeting minutes containing the results of Quality Improvement audits, and noncompliance findings and other issues as needed.
  6. Signs all correspondence and reports sent to federal regulatory agencies regarding Pl or institutional noncompliance.

Institutional Review Board

The IRB’s main responsibilities in safeguarding the rights and welfare of subjects are as follows and are not all inclusive:

  1. Conduct review of initial protocol submissions, continuing reviews, and all revisions to protocols of human subjects research conducted by the University researchers.
  2. Approve, require modifications to secure approval, defer (table), or disapprove research activities overseen and conducted under the auspices of the University, regardless of location of the research activities.
  3. Systematically analyze protocols for benefits to subjects and importance of knowledge to be expected and assess the potential benefits in relation to the potential risks involved in the research.
  4. Report in writing the findings and actions of the IRB to the PIs, IO, and, when applicable, to federal regulatory agencies or departments.
  5. Determine the interval at which ongoing studies need to be reviewed by the IRB.
  6. Determine which studies need verification from sources other than the researchers that no material changes have occurred since the previous IRB review.
  7. Observe, or have a third party observe, consent processes and/or the conduct of research.
  8. Ensure prompt reporting of any changes in research activities to the IRB by researchers.
  9. Ensure prompt reporting, by PIs, to the IRB and/or federal agencies or departments (where applicable) of:Unanticipated problems involving risks to subjects or others.
  10. Serious or continuing noncompliance with regulations.
  11. Suspension or termination of IRB approval.
  12. Determine if studies involving drugs need an investigational new drug (IND) number designated by the FDA.
  13. Determine if studies involving investigational devices pose significant or non-significant risk and whether an IDE is required.
  14. Suspend or terminate approval of research not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to subjects.

IRB Chair(s)

IRB Chair(s) main responsibilities are as follows and are not all inclusive:
  1. Serve as public spokesperson for the IRB.
  2. Lead convened meetings of the IRB.
  3. Ensure adequate expertise for review and determinations.
  4. Review protocols, continuing review reports, unanticipated problem and deviation reports, and other documentation submitted to the IRB.
  5. Obtain an individual vote on all IRB actions (For, Against, Abstain).
  6. Vote on each IRB action.
  7. Delegate review responsibilities as necessary and applicable.
  8. Maintain up-to-date knowledge of human subjects regulations and pertinent events.
  9. Consult with investigators as necessary.
  10. Suspend the conduct of research when individuals are placed at an unacceptable level of risk.
  11. Collaborate with the Director of Research Integrity and the IRB Administrator to provide continuing education for IRB members.
  12. Collaborate with the Director of Research Integrity to resolve IRB-related issues with researchers or subjects.
  13. Recognize and support partnership with the office of Research Integrity to assure IRB efficiency and effectiveness.

IRB Members

IRB members responsibilities are as follows and are not all inclusive:
  1. Be familiar with IRB policies and procedure, as well as federal, state, and local regulations, policies, or guidelines relating to human subjects research.
  2. Review submitted proposals as assigned in a timely manner.
  3. Review documents in advance of IRB meetings and be prepared for discussion of submitted protocols.
  4. Act as a primary or secondary reviewer of protocols when assigned.
  5. Maintain confidentiality of IRB proceedings.
  6. Disclose conflicts of interest, if applicable.

Monitoring/Verification of Compliance from Sources Other than the Pl

In accordance with 21 CFR 56.108(a)(2) (FDA) and 45 CFR 46.103(b)(4)(ii) (OHRP), it is incumbent upon the IRB to assure itself, by whatever method it deems appropriate, that the rights and welfare of human subjects are being protected. This applies to international research and research taking place in other states and in California.  In doing so, the IRB may determine that it is appropriate to use sources other than reports from the investigator to verify that no material changes in the protocols have occurred since their most recent review, and that investigators are conducting the research in compliance with all regulations, laws (domestic and international), policies, and guidelines. Also, the IRB may determine that the consent process for some higher risk protocols should be observed.

To assess whether there have been no material changes in the protocols as stated above, the IRB may request that members of the IRB and/or IRB staff conduct an observational visit for a specific protocol. This review will help ensure that investigators are not implementing protocol changes prior to IRB review and approval, except when necessary to eliminate immediate hazards to subjects.

Contacts for Questions, Concerns, Complaints or Input

Faculty, research staff, students, and research subjects or any other person who has a question, concern, complaint, suggestion, or input regarding the HRPP or feels that they have been subjected to coercion or undue influence regarding aspects of human subjects research, or feels that they have observed issues of concern regarding human subjects research, may contact:

Office of Research Integrity
Phone: (714) 628-2805
E-mail: irb@chapman.edu
Website: https://www.chapman.edu/research/integrity/index.aspx

Any and all concerns, complaints, input or suggestions regarding the HRPP and all allegations of coercion, undue influence or noncompliance are thoroughly investigated and, if applicable, corrective actions taken to rectify the situation. Ultimately, the Director of Research Integrity is responsible to assure that all concerns, complaints, and allegations have been addressed appropriately and that input and suggestions related to the HRPP are considered when reviewing the program.

IRB Record Retention (See University’s Policy on Record Retention)

In order to allow a reconstruction of a complete history of IRB actions related to the review and approval of protocols, the IRB records include copies of:

  1. Protocol applications, research protocols, consent documents and all other documents submitted for review of proposed human subject research
  2. Scientific evaluations, when provided by an entity other than the IRB
  3. Progress reports submitted by researchers
  4. Reports of injuries to participants
  5. Data and safety monitoring reports, if any
  6.  Modifications to previously approved research
  7. Unanticipated problems involving risks to subjects or others
  8. Documentation of noncompliance
  9. Significant new findings
Records related to IRB operations (as well as research related records) are retained for at least three years. Acceptable storage for research records must be maintained as outlined in the study protocol describing data security (i.e., on a password-protected computer or in a secured, locked cabinet).

+ - Initial IRB Review of Research Activities

Policy Overview:

  • Cayuse IRB
  • Exempt Research
    • Criteria to Determine that Subjects of Exempt Research are Protected
    • Length of Approval Period
    • Modifications to Exempt Research
  • Research Appropriate for Expedited Review
    • Submission and Review Schedule
    • Submission Requirements/Materials Reviewed
    • Assignment of Expedited Reviewer
    • Reviewer Considerations
    • Applicability Criteria
    • Criteria for IRB Approval of Research
    • Scientific/Scholarly Review
    • Length of Approval Period
    • Reporting of Expedited Review to the IRB
  • Full Committee IRB Review at a Convened Meeting
    • Submission and Review Schedule
    • Assignment of Primary and Secondary Reviewers
    • Distribution of Submitted Materials to IRB Members
    • IRB Meeting Schedule
    • Presentation and Discussion of Protocols
    • Criteria for IRB Approval of Research
    • Scientific/Scholarly Review
    • Length of Approval Period
  • Possible IRB Protocol Determinations
  • Notification of Determinations
  • Final Approval and Expiration Dates

Cayuse IRB

Chapman uses Cayuse IRB for submission and review of human subject research studies in accordance with institutional, federal, ethical, and regulatory standards. Cayuse IRB is an enterprise software program for preparing, submitting, and reviewing studies for IRB approval. All information is stored in the online Cayuse IRB system and can be accessed securely from any location. Multiple users can simultaneously view and access study documents. Additionally, study submissions can smoothly proceed from study creation to IRB approval, as users receive electronic notifications whenever they need to complete required tasks.

Exempt Review

For research to qualify as "Exempt" from the Code of Federal Regulations pertaining to the Protection of Human Subjects (45 CFR 46 full text), the research must be considered minimal risk. Additionally, human subject involvement must fall within one of eight categories listed in 45 CFR 46.104.

Research qualifying for exempt status must be in accordance with the University's ethical standards and training requirements.

The Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations define some research as exempt from IRB review. However, depending on the potential risks subjects may experience, the IRB may require a higher level of review either through the expedited process or by the IRB at a convened meeting. PIs who feel their research exactly fits one of the categories for exemption may submit an Exemption application. Upon receipt, the IRB Administrator, in consultation with the IRB Chair, if needed, will evaluate all requests for exemption and determine whether or not the research is eligible for exempt status. PIs will be informed of the results of the evaluation by letter. PIs are not allowed to make the final determination of exemption. PIs are not authorized to begin until this letter is received.

Modifications that affect the exempt category or the criteria for exempt determination must be submitted as an amendment.

Formal continuing review will not be required, but investigators will be contacted at least every three years to determine whether the research is still ongoing.

Criteria to Determine that Subjects of Exempt Research are Protected

Although exempt research is not covered by the federal regulations, it is not exempt from institutional ethical considerations. The individual making the exempt determination will assure the research meets the criteria of one of the categories for exemption and that ethical standards are met regarding risks, equitable selection of subjects, privacy and confidentiality, and informed consent.
 
More details about each of the categories is available in the U.S. Department of Health & Human Services website.
 
The Principal Investigator is responsible for assuring the following during the conduct of the research:
  1. All research personnel are trained in ethical principles, relevant federal regulations, and institutional policies governing human subjects research.
  2. All subjects are provided pertinent information (e.g., risks and benefits, contact information for investigators and IRB), are selected equitably, and voluntarily consent to participate.
  3. Information or unanticipated problems that may increase the risk to the subjects and cause the category of review to be reclassified as expedited or full committee review are immediately reported to the IRB.
  4. Complaints from subjects regarding their risks and benefits are immediately reported to the IRB.
  5. The privacy of the subjects and confidentiality of the research data will be maintained appropriately to ensure minimal risks to subjects.
  6. Reporting, by submission of an amendment request, any changes in the research study that alter the level of risk to subjects.

Length of Approval Period

Since protocols that are exempt from IRB review are not approved by the IRB, there is no approval period. However, PIs will be contacted every 2 years to verify that the research is ongoing and remains exempt. If the research is completed prior to the 2-year period, investigators are requested to notify the IRB of the study's closure.

Expedited Review

For research to qualify for "Expedited" review, the research must present no more than minimal privacy, psychological, and/or physical risk to human subjects, and involve only procedures listed in one or more of the nine expedited categories. 

NOTE: The expedited categories describe research that is eligible for expedited review. However, full committee review may be required if determined by the IRB.

If a protocol has been determined to be minimal risk it may be considered for expedited review provided that it fits one of the categories authorized by 45 CFR 46.110 for expedited review.

More details about each of the categories is available in the U.S. Department of Health & Human Services website.

The expedited review proposal may be reviewed and approved by the IRB Chair, IRB Administrator, or IRB designated reviewer.

Submission and Review Schedule

Protocols submitted for expedited review may be submitted at any time. There is no timeframe or submission deadlines. At least one IRB member or chair reviews the complete protocol, including any protocol modifications previously approved by the IRB.

Submission Requirements/Materials Reviewed

If the protocol meets all requirements for expedited review, the following must be electronically submitted:

  1. A completed IRB application, with an electronic signature of the Pl.
  2. A research proposal describing the rationale for the study, research questions to be answered, methods, procedures, data analysis plan, and other required information.
  3. An informed consent document.
  4. Verification of training in human subjects research.
  5. Recruitment materials (e.g., flyers, posters, web-pages, email messages).If applicable:
  6. Copies of all instruments if the study involves the use of interviews, questionnaires, surveys, or similar instruments.
  7. Letters of support for external sites.
  8. Institutional Biosafety Committee (IBC) approval documentation, if required.
  9. Sponsor protocol.
  10. Copy of the HHS grant application - Human subject section.

Assignment of Expedited Reviewer

Upon processing, the IRB Administrator(s) will verify the protocol is appropriate for expedited review. They will work with the Pl to assure that all required documentation has been uploaded and the application is complete. The research protocols are then presented to the IRB Chair, or other IRB designated reviewer. Designated reviewers will be experienced IRB members, defined as having served on the IRB for at least one year. The IRB Administrator will assure that reviewers do not have a conflict of interest.

Reviewer Considerations

Protocols undergoing expedited review are reviewed to assure:

  1. The research meets all applicability criteria and falls into one or more categories of research eligible for review using the expedited procedure. 45 CFR 46.110
  2. The regulatory criteria for approval are met.
  3. Investigators and their research staff have appropriate and sufficient qualifications, expertise, and training. 

Applicability Criteria

The following criteria should be considered for research undergoing expedited review:

  1. The research procedures present no more than minimal risk to subjects.
  2. The identification of subjects or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation or be stigmatizing, unless reasonable and appropriate protections will be implemented so that the risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
  3. The research is not classified.

Criteria for IRB Approval of Research

In order to approve research, the IRB will provide ethical and scientific/scholarly review of all human subjects research to determine that all of the requirements of 45 CFR 46.111 criteria for IRB approval of research are satisfied.
Protocols that may be minimal risk but are not included on the list of activities that may undergo expedited review are reviewed at a convened meeting of the IRB. The IRB may then designate that a protocol is minimal risk and determine that the protocol may undergo an expedited review process during its subsequent reviews for continuation.

Scientific/Scholarly Review

The IRB relies upon the IRB Administrator to assure that submissions contain appropriate information to facilitate IRB review. The IRB is ultimately responsible for the scientific/scholarly and ethical review of the research. The IRB may evaluate methods to the extent that the research design impinges upon the consideration of risk and benefit to the participants and may provide advice or make recommendations on methods even in instances where an evaluation of methods does not affect approvability.

Length of Approval Period for Full Review

The interval for continuing review will be at least once per year (not to exceed 365 days; 366 days during a leap year) but may be shorter. If the protocol was approved or approved with explicit conditions, the expiration date is calculated from the date of review and approval by the IRB Chair or designated reviewer. Protocols that have not undergone continuing review will expire at midnight on the expiration date. Research activities may not continue after midnight of the expiration date. A new submission will be required if the research need to continue.

Formal continuing review will not be required of non-federally funded expedited review protocols but the IRB has the authority to require continuing review if certain circumstances are identified to require an annual report. Only protocols reviewed and approved by the full committee or are federally-funded and approved through expedited review, must submit a continuing review.

Reporting of Expedited Review to the IRB

The protocol number, title, Pl name, and the category of research for which each protocol that was approved using an expedited review procedure is reported to the IRB at the next scheduled meeting.

Full Committee Review

If the research does not qualify as Exempt or Expedited based on the above research category descriptions, the research will require full committee review.

The following is required to be electronically submitted and included in the submission package:

  1. A completed IRB application with an electronic signature of the PI.
  2. A research narrative describing the rationale for the study, research questions to be answered, information that allows the IRB to determine whether selection of participants will be equitable, methods, procedures, data analysis plan, and other required information that will allow the IRB reviewer(s) to conduct an analysis of the risks and potential benefits.
  3. An informed consent document.
  4. Verification of training in human subjects research.
  5. Recruitment materials (e.g., flyers, posters, web-pages, email messages).
  6. Copies of all instruments if the study involves the use of interviews, questionnaires, surveys, or similar instruments. If applicable:
  7. Letters of support for external sites.
  8. Review/confirmation from the Institutional Biosafety Committee (IBC) or other committee as needed.
  9. Sponsor protocol (and the Investigator's Brochure, when one exists).
  10. Data use agreements.
  11. Letter to verify accurate translations of non-English forms.
  12. Copy of the Health & Human Services (HHS) grant application - Human subjects section.

Assignment of Primary and Secondary Reviewers

The IRB Administrator will assign each protocol to IRB members who, as primary and secondary reviewers, will review the protocol in detail and act as a liaison between the IRB and the Pl. Primary and secondary reviewers are assigned, as closely as possible, according to their expertise with the research being proposed and/or the subject population(s) being enrolled and their appropriate scientific or scholarly expertise to review the protocol. Protocols are not assigned to reviewers who have a conflict of interest (COI) or who have academic appointments in the same administrative unit as the Pl. The primary and secondary reviewers may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to ensure a thorough evaluation of risks and benefits of the proposed research.

At times, the IRB may not have the appropriate expertise to review the study for scientific or scholarly validity. In those cases, the IRB Chair will consider who in the University faculty or community has the appropriate scientific expertise to serve as an expert consultant to perform an in-depth review of the study. Consultants will disclose any COI prior to performing the review and those with a COI will not be used for protocol review.

Distribution of Submitted Materials to IRB Members

Meeting documents will be accessible to the IRB members 5-10 days prior to the scheduled meeting. The primary and secondary reviewers are expected to review all materials for their assigned protocol(s). IRB members who are not assigned as primary or secondary reviewers are expected to review at least the application, protocol, and consent forms for research studies being considered at the meeting but, of course, may review all submitted materials as follows:

  1. IRB application.
  2. Informed consent document
  3. Request to include vulnerable populations as subjects (e.g., pregnant women, fetuses, children, prisoners, cognitively impaired adults).
  4. Recruitment material.
  5. Copies of all instruments if the study involves the use of interviews, questionnaires, surveys, or similar instruments. If applicable:
  6. HHS grant application, Human subject section.
  7. Sponsor protocol.

IRB Meeting Schedule

The IRB is generally scheduled to meet on the second Monday of each month but may be adjusted as necessary to accommodate member schedules, quarter breaks, and other factors that affect member availability.

Presentation and Discussion of Protocols

Protocols undergoing initial and continuing review at the convened meeting are presented individually to the IRB by the Primary and Secondary Reviewers. At the invitation of the IRB, PIs may attend meetings to address specific concerns regarding research protocols, but will be asked to leave the meeting during all deliberations and votes. IRB Administrators will assure members with appropriate scientific expertise, local knowledge, and other expertise specific to the protocols are present at the IRB meeting, along with at least one member who is knowledgeable about or experienced in working with vulnerable subjects, when research involving subjects who are vulnerable to coercion are reviewed. If a member with the appropriate expertise, knowledge, or experience in working with the specific vulnerable population cannot be present, the IRB Administrators will notify the IRB Chair or Director of Integrity to obtain a consultant, if needed, to provide a written report of their evaluation of the protocol.

To be properly presented and discussed, a quorum of the members, which must include a non­scientist, an unaffiliated member, and a prisoner representative (if research including prisoners is discussed) must be present for the entire presentation, discussion, and deliberation. The IRB Administrator (or designee) will determine if a quorum of members is present and inform the Chair when quorum is met. Members not present for a substantial part of the discussion and deliberations should abstain from voting. The presence of a quorum of members is documented in the meeting minutes. For those protocols undergoing initial review, the following are discussed in detail (list is not all-inclusive):

  1. The regulatory criteria for approval at 45 CFR 46.111 are met.
  2. The setting in which the research occurs (i.e., investigators have adequate time, staff, and facilities to safely conduct and complete the research).
  3. The scientific and ethical justification for including vulnerable populations (e.g., children, prisoners, pregnant women, fetuses, and cognitively impaired adults), if applicable.
  4. Analysis of the procedures to minimize risk.
  5. The procedures to be used to ensure protection of subject privacy and data confidentiality.
  6. The scientific qualifications and experience of the investigators and their research staff.
  7. The human subjects protection training of the investigators and their research staff.
  8. Potential or disclosed investigator conflict of interest. If applicable:
  9. The scientific and ethical justification for excluding classes of persons from the research.
  10. Written consultant reports. (If the protocol was reviewed by a consultant, the consultant will not be present for deliberation and the voting on the protocol.)

Criteria for IRB Approval of Research

In order to approve research, the IRB will provide ethical and scientific review of all human subjects research to the extent necessary to determine that all of the requirements of 45 CFR46.111 Criteria for IRB approval of research are satisfied. Visit the HHS website.

To ensure that all regulatory requirements for review have been met, a reviewer checklist may be utilized.

Scientific/Scholarly Review

The IRB relies upon the IRB administrative staff to assure that submissions contain appropriate information to facilitate IRB review. The IRB is ultimately responsible for the scientific/scholarly and ethical review of the research. The IRB may evaluate methods to the extent that the research design impinges upon the consideration of risk and benefit to the participants and may provide advice or make recommendations on methods even in instances where an evaluation of methods does not affect approvability.

Length of Approval Period

The IRB will also determine the interval for the continuing review of the research, appropriate to the degree of risks that will be experienced by subjects. The following conditions are likely to require review more often than annually:

  1. There is a high degree of risk to subjects.
  2. The stage of research is such that many of the risks are unknown.
  3. The proposed procedures have not been used in humans.
  4. There have been confirmed instances of serious or continuing noncompliance.
  5. An IRB member believes more frequent review is required.
  6. Other reasons for which the IRB requests closer monitoring.

Possible IRB Protocol Determinations

Either the IRB at a convened meeting or a designated reviewer (for expedited protocols) will render one of the following determinations for each protocol:

  1. Approved: Approved by the IRB as written with no explicit conditions.
  2. Minor Stipulations: Approved with requirements for minor changes or pending letters of intent from schools or other research sites.  These will be identified to the Pl and must be completed and documented prior to beginning the research. For these conditions, the IRB Administrators, in consultation with IRB Chairs designated as reviewers, may approve the research on behalf of the IRB upon reviewing the Pl's adequate response(s) to the conditions.
  3. Return to PI: Generally, the protocol or consent form has deficiencies that prevent accurate determination of risks and benefits or requires significant clarifications, modifications, or conditions that, when met or addressed, require full IRB review and approval of the Pl's responses and revisions. The deficiencies will be specified to the Pl, and on occasion the Pl is asked to attend the full committee meeting in order to clarify the points in question. The Pl must revise the protocol, consent forms, or other documents as specified by the IRB and re-submit the entire protocol for full review at a convened meeting. The Pl may request reconsideration of determination by submitting a written response to the IRB. The IRB will invite the Pl to the IRB meeting if the IRB has additional questions. The IRB will reconsider its original decision in light of new information presented by the Pl. The second decision is final.
  4. Disapproved: This determination may only be made at a convened IRB meeting. The protocol describes a research activity that is deemed to have risks which outweigh potential benefits or the protocol is significantly deficient in several major areas. The protocol and/or other documents will need to be completely re-written and re-submitted as a new submission. PIs may request reconsideration of disapproved studies by submitting a written response to the IRB. The IRB will invite the Pl to the IRB meeting if the IRB has additional questions. The IRB will reconsider its original decision in light of new information presented by the Pl. For those protocols reviewed using the expedited review process, the designated reviewer may render decisions of approved, approved with explicit conditions, or deferred to full committee. The designated reviewer may not render a decision of disapproved. A decision of protocol disapproval may only be rendered.by the IRB at a convened meeting.
  5. Not Expedited/Not Exempt: This determination may be made by an Expedited Reviewer if the reviewer determines that the Full Committee is more appropriate or necessary to review due to concerns about the protocol design or insufficient human subjects protections.

Notifications of Determinations

Exempt Research

If the research study is determined to meet the criteria for exempt status, the IRB Administrator or a designated member will send an Exempt Determination letter to the Pl. The exempt determination will be recognized for three years.

By agreeing to the Pl Attestation outlined in the IRB Application, the investigator assures that all investigators and co-investigators are trained in the ethical principles, relevant Federal Regulations and institutional policies governing human subjects research. The investigator assures that:

  1. Human subjects will voluntarily consent to participate in the research when appropriate (e.g., surveys, interviews) and investigators will provide subjects with pertinent information such as risks and benefits of participation, contact information for investigators and the IRB office, etc.
  2. Human subjects will be selected equitably, so that the risks and benefits of the research are justly distributed.
  3. The IRB will be immediately informed of any information or unanticipated problems that would increase the risk to the human subjects and cause the category of review to be upgraded to Expedited or Full Committee Review.
  4. The IRB will be immediately informed of any complaints from participants regarding their risks and benefits.
  5. Confidentiality and privacy of the subjects and the research data will be maintained appropriately to ensure minimal risk to subjects.

Expedited Review

Within five working days after the protocol is reviewed by a designated reviewer, the Pl will receive a letter of the IRB determination. An approval letter requires no further action and the Pl can begin research. Letters giving approval with stipulations will contain a list of required conditions and PIs will not receive final approval until all conditions have been met. When the Pl has responded appropriately and completely in a letter to the IRB office addressing all conditions, then final approval is granted. The Pl will be notified by an approval letter that research can begin and when the protocol will require continuing review.

For deferred protocols, the Pl will be notified by letter of the reasons the protocol was deferred. In order to have the protocol reviewed again, the Pl must respond to all the tabled reasons by adjusting the submission documents or attaching additional supportive documentation.

Full Committee Review

Within five working days after each IRB meeting a letter is prepared and sent to the Pl of each reviewed protocol notifying them of the IRB determination for the protocol. An approval letter requires no further action and the Pl can begin research.

Letters giving approval with conditions will contain a list of required conditions and PIs will not receive final approval until all required stipulations have been met. Along with the determination, the IRB will determine whether the Pl's responses to the stipulations will need to be reviewed for appropriateness and completeness at another IRB convened meeting or by the IRB Chair or designated reviewer. Responses to clarifications that are directly relevant to regulatory criteria must be reviewed by the convened IRB. When the Pl has responded to all conditions appropriately and completely through Cayuse IRB then final approval is granted. The Pl will be notified by an approval letter that research can begin and when the protocol will require continuing review.

For deferred protocols, the Pl will be notified by letter the reasons the protocol was deferred. The entire protocol, with all supporting documents, must be revised as needed and resubmitted.

The Pl of protocols that are disapproved will receive a letter that delineates the reasons for disapproval.

Final Approval and Expiration Dates

If a study is approved with no conditions, the final approval is effective the day the study is approved, i.e., the date of the convened IRB meeting for full committee protocols. For federally funded expedited protocols, the final approval is the date of reviewer's approval for expedited protocols.

If a study is approved with explicit conditions, the final approval is effective on the day the protocol was reviewed and conditions were imposed by the IRB at a convened meeting (full committee protocols) or the date that the reviewer approved the expedited protocol. This determination will be documented in the IRB meeting minutes. Or, for expedited protocols, in the monthly IRB report. The expiration date for the approval is based on the date it was approved at a convened meeting or approved by a designated reviewer and will be no longer than 365 days (366 days if during a leap year) from the approval date, but may be sooner if more frequent review is stipulated by the IRB.

+ - Informed Consent

Policy Overview:

  • General Policy
  • Elements of Informed Consent
  • Other Requirements for Obtaining Informed Consent
  • Documenting Informed Consent
  • Non-English Language Informed Consent and other Study Documents
  • Use of a Short Form Written Consent Document
  • Informed Consent Process for Online Survey-Based Research
  • Third Party/Surrogate Consent
  • Parental Permission/Child Assent
  • Waiver of Informed Consent and Waiver of Documentation of Consent
  • Waiver of Informed Consent
  • Waiver of Documentation of Consent
  • Authorization to Use or Disclose Protected Health Information
  • Required Elements
  • Waiver of Authorization for Use and Disclosure of PHI
  • Re-Consenting Subjects
  • Record Retention Requirements for Subject Consent Forms

General Policy

Researchers must describe in the research protocol how the informed consent process will be conducted, the setting in which it will occur, a description of the waiting period between informing the prospective participant and obtaining consent, and methods to prevent undue influence on a potential participant to enroll in a study. The following are points to consider when conducting the consent process.
  • Researchers should consider obtaining informed consent as a process, not just a consent form, by which the research study is thoroughly explained to the potential subject. The requirement to obtain informed consent should be seen as not only a legal obligation, but also as an ethical obligation. Documentation of informed consent is accomplished through the use of a consent form. Prior to enrolling subjects in a research activity, researchers are required to obtain legally effective informed consent from a potential subject or their legally authorized representative (LAR) and, if the research involves children, a parent's consent and child's assent.
  • As part of the informed consent process, researchers are responsible for ensuring subjects (or LARs) are given sufficient opportunity to consider whether or not to participate in the study and must seek to avoid coercion or undue influence. Information given to potential subjects (or LARs) must be in language that is understandable to the subject or representative. Non-English speaking subjects musts have information presented in a language they understand. In addition, for all studies that pose a real or foreseeable risk of biomedical harm, California state law (Health and Safety Code section 24172) requires that the Experimental Subject's Bill of Rights be provided to all subjects "written in a language in which the subject is fluent."
  • No process or consent form used to obtain and document consent may include exculpatory language through which the subject waives any of their legal rights or releases, or appears to release, the researcher, sponsor, or institution or its agents from liability for negligence. Any consent form used to enroll subjects in a research protocol must be reviewed and approved by an IRB prior to enrollment. In addition, the IRB may request to observe the informed consent process to ensure adequate consent when the research involves particularly vulnerable populations.
  • Researchers should be aware that the setting in which consent is sought may introduce a feeling of undue influence. For example, students in an educational setting may feel that refusal to participate will affect their grades. Prevention of these sorts of pressures should be addressed in the research design as the process must always preserve the right to refuse participation.
  • In all cases, consent forms must be consistent with state laws and federal regulations regarding content. The informed consent requirements stated in this manual are not intended to preempt any applicable federal, state, or local laws that require additional information be disclosed in order for informed consent to be legally effective.
  • The Revised Common Rule allows the use of broad consent (e.g., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens.
    • Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
    • Whether or not identities are removed, the consent must state:
      • unspecified future research may occur without additional consent;
      • or that the information or biospecimens will not be used for future research

Elements of Informed Consent

The IRB will determine that the required disclosures will be provided to each subject or a LAR in accordance with legal and regulatory requirements listed below as required elements of informed consent. The IRB will also consider whether additional disclosures are required for inclusion in the consent process.

It is expected that researchers will use the informed consent form template with required sections and verbiage for preparing consent forms. Other formats may be considered providing that all required elements and applicable additional elements are present. Research-related consent forms must contain all the basic elements of informed consent regardless of the risk level of the study unless a request for waiver or alteration of some or all of the elements is requested by the researcher and the waiver is approved by the IRB. The consent form template contains all the required elements of consent. In addition, the IRB requires that all consent forms be written at a level appropriate to a minimum expected educational level of the target population and in the second person (e.g., "You will be asked to..."). The following are the basic required elements (extracted from 45 CFR Part 46.116):

  1. A statement that the study involves research.
  2. An explanation of the purpose of the proposed research.
  3. The expected duration of the subject's participation.
  4. A description of the procedures to be followed.
  5. Identification of which procedures are experimental. For studies that are not greater than minimal risk and are not HHS-funded, this element may be omitted.
  6. A description of reasonably foreseeable risks or discomforts that subjects may encounter and, if appropriate, a statement that some risks are currently unforeseeable.
  7. A description of possible benefits, if any, to the subject and others that may be reasonably expected. It should be stated that no benefits can be guaranteed for experimental treatments or procedures.
  8. A disclosure of appropriate alternative procedures or treatments, if any, which are available and might be advantageous to the subject. One alternative might be to choose not to participate in the research. For studies that are not greater than minimal risk and are not HHS-funded, this element may be omitted.
  9. A statement describing the manner and extent, if any, to which confidentiality of records identifying the subject will be maintained, a statement that the IRB and other entities may inspect the records, and, if the research is Food and Drug Administration (FDA)-regulated, FDA may inspect the records.
  10. For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained. For studies that are not greater than minimal risk and are not HHS-funded, this element may be omitted.
  11. A description of whether or not compensation for time, inconvenience, etc. will be given, including the schedule of payments.
  12. Information regarding who to contact for answers about the research in the event there is a research-related injury (this is generally the principal investigator (Pl) or another staff member closely associated with the study). A separate contact, typically this is the IRB, must be named for questions concerning the subject's rights to provide input, comments, or complaints.
  13. A statement that the subjects' participation is voluntary, that refusal to participate will not involve penalty or loss of benefits to which the subject is entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is entitled.
Note: for FDA regulated applicable clinical trials the following statement must be included:
"A description of this clinical trial will be available on https://www.ClinicalTrials.gov as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time."
The following additional elements of informed consent must be added to the consent form when appropriate:
  1. A statement that the particular treatment and/or procedure may involve risks to the subject (or to the embryo or fetus, if the subject becomes pregnant) that are currently unforeseeable. This element should be included when the research involves an investigational drug or device or involves procedures for which the risk profile is not well known.
  2. Anticipated circumstances under which the subject's participation may be terminated by the Pl, with or without the subject's consent. Include when there are known circumstances under which the subject's participation may be terminated by the Pl or sponsor.
  3. A description of additional costs for which the subject will be responsible, that may result from participation in the research study. Include when there are additional costs to subjects, over and above standard of care (e.g., additional MRls, radiographs, DEXA scans, visits that may not be covered by insurance/Medicare/Medicaid).
  4. A description of the consequences of a subject's decision to withdraw from the research and procedures for orderly and safe termination of participation by the subject. This element should be included when there is a likelihood that abrupt termination from the research is likely to result in adverse events to the subject.
  5. A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject. Include when there is likelihood that interim findings might indicate increased risk and a reasonable person would wish to reconsider participation.
  6. The approximate number of subjects that will be involved with the study, totally and at the University. Or other research sites. Include when such information might affect a subject's willingness to participate.
  7. One of the following statements about any identifiable private information or identifiable biospecimens:
    • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR;
    • or a statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
8.     Other additional information may be required by the IRB.

Other Requirements for Obtaining Informed Consent

  1. The IRB must be made aware of the person(s) who will be conducting the informed consent process. These researchers should be listed in the application and are the only personnel allowed to obtain consent. The IRB requires that the person obtaining consent be appropriately trained in human subjects research and fully knowledgeable about the project and be able to answer questions that potential subjects may ask regarding the project and/or procedures performed as a part of the project.
  2. If potential subjects are deemed as cognitively impaired, informed consent must be obtained from a LAR. They should be told that their obligation is to try to determine what the subject would do if they were competent, or if the subject's wishes cannot be determined, what they think is in the best interest of the cognitively impaired subject. The IRB must approve the inclusion of cognitively impaired subjects.
  3. The consent form is only part of the total consent process in which the researcher conducting the informed consent process, perhaps using the written consent form as an outline, describes all facets of the study and answers the subject's questions. The person obtaining consent is responsible for insuring that research subjects understand the research procedures and risks. Each subject (or LAR) must be provided adequate time to read and review the consent form, in addition to being advised of the procedures, risks, potential benefit, alternatives to participation, etc. Failure of the subjects to ask questions should not be construed as understanding on the part of the subject.
  4. The IRB has the authority to observe the consent process at any time. Depending on the perceived risk of the research procedures, the IRB may wish to observe the consent process for that protocol. In these cases, the Pl will be contacted and the time and place for observing the process will be scheduled.
  5. Obtaining informed consent from subjects must be accomplished prior to performing the research activity and using only an IRB-approved consent form. Written requests for amendments to an existing consent form must be approved prior to implementation, at which time the revised consent form will be stamped with an approval date by the IRB Administrator and be accompanied by a formal approval notification.
  6. Upon receipt of an IRB approved consent form, copies of all old versions should be discarded to prevent inadvertent use of an outdated consent form. Copies of the most recently approved consent form may be made and should be used until superseded by an amended consent form. The consent form must be reviewed at least annually as part of the continuing review process. It is advised the researchers retain a copy of the original, expired consent form(s) for their records.
  7. For long-term studies, researchers are reminded that the informed consent process is ongoing and that it does not end with the signing of the consent form. Subjects should be kept apprised of events that might affect their willingness to participate.

Documenting Informed Consent

Federal regulations governing the use of human subjects in research activities require written documentation of informed consent (handwritten signature of the subject) unless the research meets the criteria for waiver of documentation. The subject and research staff member administering the consent process should sign and date the IRB approved consent form.

  1. After completing the consent process and assuring that the subject (or LAR) has no further questions and agrees to participate in the research activity, the person obtaining informed consent should instruct the subject (or LAR) to sign and date the consent form in the appropriate spaces.
  2. The researcher or designee conducting the consent process must then sign and date the consent form in the appropriate space. It is assumed that in most cases, all persons signing the consent form will do so at the conclusion of the consent process.
  3. Each subject (or LAR) must be given a copy of the signed consent form. The original consent form should be filed in such a manner as to insure immediate retrieval when required by auditing entities, e.g., OHRP, FDA, IRB.

Non-English Language Informed Consent and other Study Documents

It is neither ethically justifiable to exclude potential subjects in a research study solely on the basis of language spoken nor ethically justifiable to obtain consent of subjects who do not have a clear understanding of the consent document or who do not have the opportunity to freely ask and receive answers to their questions. Without this understanding and opportunity, consent may not be truly informed and may not be legally effective. In order to address these considerations, when enrolling subjects who do not speak English in research, the subject must be provided with:
  1. A written consent document in a language understandable to them.
  2. An interpreter fluent in both English and the subject's spoken language.
A consent form translated into the appropriate language should be submitted to the IRB.

Translation Requirements:

  • Greater than minimal risk studies: a professional or certified translation of the consent/assent form(s) and recruitment material(s) is required for studies that pose more than minimal risk to subjects (i.e., studies that require full committee review), unless the IRB has granted a waiver of documentation of informed consent.
    • For a professional translation the PI must provide the qualifications of the individual who translated the informed consent documents and recruitment materials. Include any credentials, certifications, education, native language fluency, etc. For a certified translation, a copy of the certification from the translator or translation service should be attached to the translation of any informed consent documents and recruitment materials.
  • Minimal risk studies: Studies that are eligible for expedited review also require translation of the consent/assent forms; however, certified translation is not required. The IRB will accept documents translated by an individual fluent (i.e., can speak, read and write) in a given language. The qualifications of the individual performing the translation will be assessed by the IRB. A letter from the translator describing their qualifications must be provided with the translation documents. As noted above, include any credentials, certifications, education, native language fluency, etc.

Use of a Short Form Written Consent Document

A short form is a written document stating that the elements of informed consent required by 45 CFR 46.116 have been presented to and understood by the subject or the subject's LAR. A short form may be used when the majority of subjects in a study are English speakers, but there are a portion of the subjects who will not be able to understand the consent form written in English.

However, if the majority of the anticipated subjects to be enrolled do not speak English or will be unable to understand the consent form written in English, the consent form must be translated into a language understandable to the subjects.

When following regulations from the Department of Health & Human Services the IRB must determine

  1. The consent document states that the elements of disclosure required by regulations have been presented orally to the participants or the participant's LAR.
  2. A written summary embodies the basic and required additional elements of disclosure.
  3. There will be a witness to the oral presentation. For participants who do not speak English, the witness is conversant in both English and the language of the participant.
  4. The participant or the participant's LAR will sign the consent document.
  5. The witness will sign both the short form and a copy of the summary.
  6. The person actually obtaining consent will sign a copy of the summary.
  7. A copy of the signed short form will be given to the participant or the LAR.
  8. A copy of the signed summary will be given to the participant or the LAR.

When following regulations from the Food and Drug Administration the IRB must determine

  1. The consent document states that the elements of disclosure required by regulations have been presented orally to the participant or the participant's LAR.
  2. A written summary embodies the basic and required additional elements of disclosure.
  3. There will be a witness to the oral presentation.
  4. For participants who do not speak English, the witness is conversant in both English and the language of the participant.
  5. The participant or the participant's LAR will sign the consent document.
  6. The witness will sign both the short form and a copy of the summary.
  7. The person actually obtaining consent will sign a copy of the summary.
  8. A copy of the signed short form will be given to the participant or the legally authorized representative.
  9. A copy of the signed summary will be given to the participant or the legally authorized representative.

Informed Consent Process for Online Survey-Based Research

  1. Online consent documents should include all the elements of a regular signed consent form.
  2. Researchers should maintain the format of the template consent document, with study specific information added, as much as possible.

 Third Party/Surrogate Consent

  1. The regulations are clear that written documentation of informed consent (or consent of the parents if the subject is a child) of the subject (or LAR) is required.
  2. When a Pl proposes to conduct a research project utilizing adult subjects who by virtue of age, physical impairment, mental impairment, or any other reason may not be able to personally execute legally effective informed consent, the IRB shall review the project on the basis of risk and benefit. This policy is not meant to imply that the requirement for written documentation of consent is waived. Rather, it applies to those studies in which third party/surrogate consent is obtained from a LAR.

Parental Permission/Assent

If the research involves minors under the age of 18 years or individuals over the age of 18 who are cognitively impaired, federal regulations require the assent of the child or minor or cognitively  impaired adult and the consent of the parent(s) or guardian(s) (45 CFR 46.408). While children and some adults may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent. The assent process should involve taking the time to explain to a child or adult, at whatever age they can begin to understand, what is going on in the proposed study, why the study is being done, what will be done to them, and that if they object, the research will be terminated. Assent means the potential subject's affirmative agreement to participate in the research. Mere failure to object should not, in the absence of affirmative agreement, be construed as assent.
 
To obtain informed consent for children under the age of 18 years or for adults over the age of 18 who may be cognitively  impaired, submit the appropriate adult consent form. 

Waiver of Informed Consent and Waiver of Documentation of Consent

Waivers cannot be granted for FDA-regulated research and the IRB does not approve requests for "Planned Emergency Research" or exceptions to the requirement to obtain consent for "Planned Emergency Research."

Waiver of Informed Consent

Federal regulations include provisions for approval of a waiver or alteration of part or all of the consent process. There are two general instances when an IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth in 45 CFR 46.116, or waives the requirement to obtain informed consent. In the first general instance (45 CFR 46.116(c)) the IRB must find and document that:
  1. The research is to be conducted by or subject to approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) Possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
  2. The research could not be practicably carried out without the waiver or alteration.
In the second general instance (45 CFR 46.116(d)) an IRB may approve a consent procedure that does not include, or that alters some or all of the elements of informed consent or that waives the requirement to obtain informed consent provided that the IRB finds and documents that:
  1. The research involves no more than minimal risk to the subjects.
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alteration (it is impracticable to perform the research if obtaining informed consent is required and not just impracticable to obtain consent); and
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Waiver of Documentation of  Consent

Documentation of consent cannot be waived if the research is FDA regulated.

The IRB has the authority to waive the requirement for written documentation of informed consent. When waiving the requirement for a consent form, the IRB must review a written description of the information that will be provided to subjects and consider whether to require the researcher to provide subjects with a written statement regarding the research. If required, the IRB encourages researchers to use the consent template, or a reformatted version, with the signature sections removed. The IRB may waive the requirement for the researcher to obtain a signed consent form for some or all subjects if it finds that (45 CFR 46.117 (c)):

  1. The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality and the research is not FDA-regulated. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern or;
  2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
The IRB will also consider granting a waiver of documentation in special circumstances involving international research if the research meets the other regulatory requirements.

The determination of the applicability for waiver of the consent process must be documented in the IRB minutes as to the specific paragraph and subparagraph{s) under which the waiver was approved.

Authorization to Use or Disclose Protected Health Information

In the course of conducting research and/or seeing patients within the University’s programs, Chapman personnel may create or obtain medical information. Please note Chapman University is not a HIPAA Covered Entity. PI’s shall consider the following when handling of protected health information:

  • Medical information, along with other personally identifying information, may only be collected and stored in accordance with applicable laws.  If you work with or expect to begin working with this kind of data, please contact the Information Security Officer to establish a data security plan that will satisfy the university’s legal obligations.  Once a data security plan is implemented, it is important to make sure that you and all of your colleagues working with the data comply with the plan.
  • Although the university has numerous legal obligations it must meet in terms of protecting medical information, and even though this data may be referred to as “PHI” (protected health information), a defined term in the Health Insurance Portability and Accountability Act (HIPAA), Chapman is not subject to HIPAA and does not have the systems in place to comply with HIPAA’s requirements.
  • Researchers who wish to use HIPAA-protected PHI from a third party in their research should first consult with the Office of Research.  That office will consult with Legal Affairs and the Information Security Officer to establish appropriate parameters regarding the types of data that the University can properly accept responsibility for and what written agreements can be entered into governing use and safekeeping of the data.
To use or disclose PHI, researchers must obtain an authorization signed by the subjects.  Authorization to use or disclosure PHI shall consist of the following required elements:
  1. A description of the information to be used or disclosed presented in a specific and meaningful fashion.
  2. The name or other specific identification of the person(s), or class of persons, to whom the use or disclosure will be made.
  3. A description of each purpose of the requested use or disclosure.
  4. An expiration date or event that relates to the individual or the purpose of the useor disclosure.
  5. A statement of the individual's right to revoke the authorization in writing and the exceptions to the right to revoke, together with a description of how the individual may revoke the authorization.
  6. A statement indicating when the authorization for use and disclosure occurs (e.g., at the end of the research).
  7. Signature of the individual and date. If the authorization is signed by a personal representative of the individual, a description of such representative's authority to act for the individual must also be provided.

In addition to the core elements, the authorization is required to contain statements adequate to place the individual on notice of all of the following:

  1. The individual's right to revoke the authorization in writing, and either:
    1. The exceptions to the right to revoke and a description of how the individual may revoke the authorization; or
    2. To the extent that the Waiver of Informed Consent and Waiver of Documentation of Consent information is included in the notice required by 45 CFR 164.520, a reference to the covered entity's notice.
  2. The potential for information disclosed pursuant to the authorization to be subject to re-disclosure by the recipient and no longer be protected.
  3. The authorization must be written in plain language.
  4. The individual must be provided with a copy of the signed authorization

Waiver of Authorization for Use and Disclosure of PHI

In order to use or disclose PHI without an authorization signed by the research subject, the researcher must obtain one of the following:

  1. Documentation that an amendment or waiver of the research subjects' authorizations, for use/disclosure of PHI has been approved by the IRB. This provision of the rule might be used, for example, to conduct records research when researchers are unable to use de-identified information; or
  2. Where researchers represent:
    1. That the research is only for purposes of preparing a research protocol or similar uses preparatory to research.
    2. That he or she will not remove any PHI from the covered entity and
    3. That PHI is necessary for the research purpose; or
  3. To disclose PHI of decedents, where the researcher represents that the use or disclosure of PHI is:
    1. Solely for research on the PHI of decedents,
    2. Necessary for the research, and
    3. Documentation of the death of the individuals about whom PHI is sought and provided.

Re-Consenting Subjects

Researchers have the responsibility to inform subjects of any new information that might affect subjects' willingness to continue participation in the research. In these cases, an amended consent form, delineating the findings and the changes to the risks or benefits of the research, must be reviewed and approved by the IRB. Subjects should then be briefed on the changes, asked if they wish to continue participation and signify their willingness to continue participation by signing the amended consent form. For minor changes to the consent form that will not change risks or benefits, re-consenting is generally not required.

Record Retention Requirements for Subject Consent Forms

The Pl shall maintain, in a designated location, the original copy of all executed subject consent forms. The signed consent forms, along with all research-related files, are to be available for inspection by authorized officials of the University administration, the IRB, regulatory agencies, sponsors and, if applicable, the FDA or HHS. For non-FDA regulated studies, forms should be retained for at least three years after completion of the study. For FDA-regulated studies, all signed subject consent forms shall be retained by the Pl for the appropriate period(s) specified below:

  1. Drugs: 2 years following the date a marketing application is approved or the study is discontinued.
  2. Devices: 2 years after a study is terminated or completed and the records are needed to support FDA approval.
Should a Pl or project director depart the University prior to the completion of an activity or less than the time specified above, the Pl is responsible for initiating mutually satisfactory arrangements with their department and the University administration as to the disposition of executed subject consent documents.

+ - Continuing Review of Human Subjects Research Activities

Policy Overview:

  • Requirement for Continuing Review for Full Review
  • Submission Requirements
  • Continuing Review at an IRB Convened Meeting
    • Assignment of Primary and Secondary Reviewers
    • Distribution of Submitted Documents
    • Presentation and Discussion of Protocols
    • Possible IRB Determinations
    • Length of Approval Period
    • Third Party Observation
  • Criteria for IRB Approval of Research Continuation
  • Notification of IRB Determinations
  • Failure to Comply with Continuing Review Requirements - Lapsed Protocols

Requirement for Continuing Review

Any research activity involving the use of human subjects that has received initial review and approval by the Institutional Review Board (IRB) is subject to continuing review and approval. Time intervals for such reviews shall be made at the discretion of the IRB based on the anticipated risks to subjects but shall occur no less than once per year.
As a courtesy, the IRB will send three reminders to PIs 60 days before the study expires.  Additional notices will be sent at one-month intervals.  The Pl will not be able to continue with the research after submission has expired. Research activities may not continue after midnight of the expiration date. A new submission will be required if the research need to continue. It is ultimately the Pl's responsibility to complete and submit a continuing review application in time for IRB review prior to the study's expiration of approval.
 
Generally, if a protocol was approved at a convened meeting of the IRB at initial review, it must be reviewed at a convened meeting of the IRB for its continuing review. However, if the research initially did not qualify for expedited review the IRB may designate the protocol as minimal risk and determine that the protocol may undergo an expedited review process for continuing review under Category 9.  The project will not require continuing review going forward. This determination can be made at the time of initial review or at a subsequent continuing review.
 
Annual Continuing review is no longer required for studies that qualify for or have been approved through Expedited Review. However, the IRB has the authority to require continuing review if circumstances warrant additional oversight.

Principal Investigators (PIs) will be asked to submit administrative research updates via Cayuse IRB. However, researchers must submit to the IRB any modifications to the research protocol (e.g., changes to personnel, protocol amendments, or recruitment materials) and report any adverse events as often as necessary.

No federally-funded research protocol may continue after approval has expired until final approval for continuation is granted.

Submission Requirements

Continuing reviews must be submitted through Cayuse IRB. Full committee studies require the following be submitted for continuing review:
  1. Completed continuing review application including:
    1. Number of participants accrued.
    2. A summary since the last IRB review of:
      1. Adverse events, untoward events, and adverse outcomes experienced by participants.
      2. Unanticipated problems involving risks to participants or others.
      3. Participant withdrawals.
      4. The reasons for withdrawals.
      5. Complaints about the research.
      6. Amendments or modifications.
      7. Any relevant recent literature.
      8. Any interim or significant findings that might affect participants' willingness to continue.
      9. Any relevant multi-center trial reports.
      10. The researcher's current risk-potential benefit assessment based on study results.
  2. Completed research protocol.
  3. Consent form, if applicable:
    1. Current version being used with IRB stamp and date.
    2. If no changes are made in the consent form a new copy must be submitted so it can be stamped with a new approval date.
    3. If changes are being made the Pl must submit an amendment.
  4. If the protocol is being amended, submit a copy that highlights the changes being made (e.g., use Track Changes in Word).
  5. Other documents relating to the research activities that have not been reviewed by the IRB during initial review or by an amendment to the protocol.
  6. Renewal letters from cooperating IRBs as relevant (e.g., site still operational). If the site(s) in question did not have an IRB of record and thus submitted an official letter granting permission for the researcher to conduct the research, then a second letter is not required.
  7. Data and Safety Monitoring Plan (if applicable).
If a protocol receives a status of "Deferred - Modifications Required" and the required documents are not submitted within 30 days, or no communication has been received from the Pl, the protocol will be administratively closed and receive a status of "Closed - Expired." PIs requesting re-review/re-consideration of their protocols are required to complete the initial submission process.

Continuing Review at an IRB Convened Meeting

Assignment of Primary and Secondary Reviewers

Upon receipt, the IRB Administrator will assign each protocol to IRB members who, as primary, and in some cases secondary reviewers, will review the protocol in detail and act as a liaison between the IRB and the Pl. Primary and secondary reviewers are assigned, as closely as possible, according to their expertise with the research being proposed and/or the subject population(s) being enrolled and their appropriate scientific or scholarly expertise to review the protocol. Protocols are not assigned to reviewers who have a conflict of interest or who have academic appointments in the same administrative unit as the Pl. The primary and secondary reviewers may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to ensure a thorough evaluation of risks and benefits of the proposed research.

At times, the IRB may not have the appropriate expertise to review the study for scientific or scholarly validity. In those cases, the IRB Chair will consider who in the University faculty or community has the appropriate scientific expertise to serve as an expert consultant to perform an in-depth review of the study. Consultants will disclose any conflict of interest (COI) prior to performing the review and those with a COI will not be used for protocol review.

Distribution of Submitted Documents

The following continuing review documents are provided to all IRB members (including alternate members, if attending) and consultants for review:
  1. IRB continuing review application (status report) containing the following information:
    1. The number of participants accrued;
    2. Adverse events and outcomes experienced by participants;
    3. Unanticipated problems involving risks to participants and others;
    4. Participant withdrawals and reasons for withdrawal;
    5. Complaints about the research;
    6. Amendments or modifications;
    7. Any relevant recent literature;
    8. Any interim findings;
    9. Any relevant multi-center trial reports, if applicable;
    10. The researchers current risk-potential benefit assessment based on study results
  2. Research protocol.
  3. New informed consent form.
  4. Data and Safety Monitoring Plan (if applicable).

Presentation and Discussion of Protocols

Protocols undergoing continuing review are presented individually to the IRB by the assigned primary reviewer. IRB staff will assure that appropriate scientific expertise, local knowledge, and other expertise specific to the protocol(s) is present at the IRB meeting. Moreover, when research involving subjects who are vulnerable to coercion are reviewed, at least one member who is knowledgeable about or experienced in working with such subjects will be present at the IRB meeting. If a member with the appropriate expertise, knowledge, or experience in working with the specific vulnerable population cannot be present, the IRB staff will notify the IRB Chair to obtain a consultant if needed. For a protocol to be properly reviewed, a quorum of the members must be present for the meeting. Members not present for a substantial part of the discussion and deliberations should abstain from voting. For those protocols undergoing continuing review, the following are discussed in detail (list is not all­ inclusive):
  1. The regulatory criteria for approval at 45 CFR 46.111 are met.
  2. The new consent form to be used for the next approval period and the adequacy of the consent process.
  3. Demographics of recruited/enrolled subjects.
  4. Reports of protocol deviations, unanticipated problems, amendments, multi-center/Data and Safety Monitoring Board reports, and audit reports.

Possible IRB Determinations

After presentation by the primary and secondary reviewers and complete discussion by the IRB, each protocol is voted upon for one of four possible dispositions:

  1. Approved: It is approved as written with no explicit conditions.
  2. Approved with Modifications Required: Approval with conditions is not a final approval. The protocol was approved with minor changes or simple concurrence of the Pl. These will be identified to the Pl and must be completed and documented prior to beginning the research. For these conditions, the IRB Chair's designated reviewer (e.g., IRB member, IRB Administrator) may approve the research on behalf of the IRB upon reviewing the Pl's response(s) to the conditions. Pl responses to conditions deemed to be significant or that are directly relevant to regulatory criteria must be reviewed at a convened meeting.
  3. Deferred: The information in the submitted documents has deficiencies that prevent accurate determination of risks and benefits or requires significant clarifications, modifications, or conditions that, when met or addressed, require full IRB review and approval of the Pl's responses and revisions. The deficiencies will be specified to the Pl, who must address all IRB concerns in a written response. On occasion the Pl is asked to attend the full committee meeting in order to clarify the points in question. PIs may respond to a "deferred" decision with a written request. The IRB will review the appeal and invite the Pl to the IRB meeting if the IRB has additional questions. The IRB will reconsider its original decision in light of new information presented by the Pl. The second decision is final.
  4. Disapproved: The submitted materials describe events or situations that indicate that research risks now outweigh potential benefits. PIs may appeal a determination for disapproval in writing or by attending an IRB meeting and presenting reasons for reconsideration. Upon appeal, the IRB will reconsider its original decision in light of new information presented by the Pl. The second decision is final.
Researchers may be invited to attend the meetings to address specific concerns regarding research protocols but will be asked to leave the meeting during all deliberations and votes.

Length of Approval Period

The IRB will determine the interval for the continuing review of the research that is appropriate to the degree of risks experienced by subjects. The IRB can approve with Administrative Check-In at least once per year and may be longer. When the IRB grants approval it may also select a Mandatory review with an expiration date and justification for the expiration. Protocols that were reviewed Pre-Rule will expire at midnight on the expiration date. Research activities may not continue after midnight of the expiration date.

Third Party Observation

The IRB has the authority to observe or appoint a third-party to monitor research conduct, including consent procedures. The IRB may also consider whether a study requires independent verification from sources other than the Pl to ensure that no material changes have occurred since the last IRB approval. The IRB will require verification of the information provided for continuing review when:

  1. Continuing review materials appear inconsistent or inaccurate compared to prior applications or records and discrepancies cannot be resolved via communication with the Pl; or
  2. The IRB determines that such actions are useful as part of a corrective action plan for any unanticipated problem or event.
If the findings of such investigations during the continuing review process warrant corrective actions, the IRB may suspend or terminate a research project to ensure the quality of research and protection of research subjects.

Criteria for IRB Approval of Research Continuation

In order to approve research for continuation, the IRB must consider the Pl's continuing review report and assure that the requirements of 45 CFR 46.111 remain satisfied as follows:

  1. Risks to subjects are minimized:
    1. By using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk; and
    2. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  2. Risks to subjects continue to be reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result from the research. In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research, as distinguished from risks and benefits of therapy the subjects would receive even if not participating in the research.
  3. Selection of subjects is equitable and considers the purpose of the research and the setting in which the research will be conducted. Special attention is paid to problems of research involving vulnerable populations.
  4. Unless waived by the IRB, informed consent will be appropriately sought from each prospective subject or the subject's legally authorized representative in accordance with and to the extent required by appropriate local, state, and federal laws or regulations. The IRB is responsible for the review and approval of the informed consent form submitted by the Pl.
  5. Informed consent will be approriately documented according to local, state, and federal laws or regulations.
  6. Where appropriate, there are adequate provisions to protect the privacy of the subjects and to maintain the confidentiality of their identifiable data.
  7. When appropriate, the research plan continues to make adequate provision for monitoring the data collected to ensure the safety of subjects.
  8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study and in the IRB review process, to protect the rights and welfare of the subjects.

Notification of IRB Determinations

Within five working days after the IRB meeting at which the protocol was reviewed for continuation, the Pl will be notified of the IRB determination for their protocol. Approved protocols require no further action. Protocols that are approved with modifications required will have a list of conditions provided and PIs are notified that final approval will not be granted until all conditions have been met. For protocols reviewed at a convened meeting, the IRB will determine, at the convened meeting, whether the Pl's responses to modifications must be reviewed by the entire IRB or may be reviewed for appropriateness and completeness by the Chair or the Chair's designee. Responses to clarifications that are directly relevant to regulatory criteria must be reviewed by the convened IRB. When the Pl has responded appropriately and completely to all conditions via Cayuse IRB, a final approval is granted. The Pl will be issued an approval letter that research can resume and when the protocol will require future continuing review.
 
For deferred protocols, the Pl will be notified by letter posted in Cayuse IRB of the reasons the protocol was deferred. The entire submission, with all required documents, will need to be resubmitted after revision for IRB review.
 
For protocols that are disapproved for continuation, the Pl will receive a letter that delineates the reasons for disapproval. PIs may appeal the determination in writing to the IRB Chair.

Failure to Comply with Continuing Review Requirements - Lapsed Protocols

IRB approval can be for no longer than a one-year period of time and there is no grace period beyond the expiration date of IRB approval. Extensions of approval beyond the expiration date cannot be granted. Failure to submit the required documents and receive IRB approval for the protocol before the end of the approval period will result in a status of "Closed - Expired." This will occur even if the Pl has provided the required documents but IRB review and approval is not completed before the expiration date. If a protocol is placed in this status, the Pl will be notified that they must cease all research activities (e.g., recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection and analysis of private identifiable information) until the required documents are submitted, reviewed, and approved by the IRB.
 
During the "Closed - Expired" period, subjects currently enrolled and for which continuation would be in the best interest of their health or well-being, may continue to participate if the Pl requests and justifies, in writing, the need for continuation. The request will be considered by the IRB Chair. If the IRB Chair is of the opinion that stopping participation could result in increased risk or potential injury or hardship to subjects, the IRB Chair may approve continued participation for a reasonable time beyond the expiration date. Therefore, to prevent expiration of IRB approval and stopping research, it is of vital importance to ensure timely completion and submission of the continuing review documents to allow sufficient time for IRB review prior to the expiration date. No research protocol may continue activities after the expiration date of the protocol until final approval for continuation is granted.

+ - Vulnerable Populations

Policy Overview:

  • Inclusion of Vulnerable Populations in Research Activities
  • Vulnerable Populations and Exempt Research
  • Special Consideration for Projects Involving Vulnerable Populations

Inclusion of Vulnerable Populations in Research Activities

When some or all of the subjects that will be enrolled in a research study are likely to be vulnerable to coercion or undue influence, such as pregnant women, prisoners, children, and cognitively impaired adults, additional safeguards must be included in the study to protect the rights and welfare of these subjects.

In addition to the responsibilities prescribed for the IRB under 45 CFR Part 46, Subpart A, the IRB shall follow special procedures with respect to prisoners, and children as specified in Subparts C and D. Inclusion of other vulnerable populations as research subjects is considered by the IRB.

There are a number of research populations described in the Federal regulations as "vulnerable" or that require additional consideration or protection. "Vulnerable" or "special" classes of subjects include:

  1. pregnant women, human fetuses and neonates,
  2. prisoners,
  3. children,
  4. cognitively impaired persons
  5. students and employees
  6. minorities
  7. economically and/or educationally disadvantaged
  8. AIDS/HIV+ subjects
  9. terminally ill subjects.
In addition, the regulations outline specific provisions for research involving:
  • fetuses,
  • pregnant women, and in vitro fertilization
  • prisoners, and
  • children.

Vulnerable Populations and Exempt Research

Due to the vulnerable nature of the population, the exemptions in 45 CFR 46.101(b) do not apply to certain types of research involving children and prisoners, Subparts C and D.

Specifically, the exemption in 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

In addition, exemption from IRB review should be utilized conservatively when applied to research involving special classes of subjects who are not be defined by regulation as vulnerable.

Special Consideration for Projects Involving Vulnerable Populations

In reviewing these research projects, the IRB determines if the inclusion of the vulnerable population is adequately justified and that safeguards are implemented to minimize risks unique to each population.

During its review, the IRB must determine which of the following categories the research would involve:
  • the research does not involve more than minimal risk to the subject;
  • the research is likely to benefit the subject directly, even if the risks are considered to be more than minimal;
  • the research involves greater than minimal risk with no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition; or
  • research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of the subject.
Requests for approval of any research that exposes vulnerable populations to risks that do not meet one of the above criteria must be submitted to the United States Secretary of Health and Human Services for review and approval.

Special protections are essential to guide research involving vulnerable persons. In order to review projects involving the use of vulnerable populations as specified in 45 CFR 46, an IRB must have present at its meeting an advocate for these subjects.

The mere presence of the appearance of vulnerability should not lead to a presumption that a person is incapable of making a decision regarding participation in research and of giving valid informed consent. Yet sometimes these conditions do impair the decision-making capacity required to give a valid informed consent, raising ethical concerns about the vulnerability of persons in such conditions in research.

+ - Suspensions and Terminations

Policy Overview:

  • Reasons for Suspension or Termination
  • Authority to Suspend or Terminate Research Activities
    • Principal Investigator
    • IRB Chair
  • IRB
    • Institutional Official and Departmental Review Committee
  • Notification of Suspension or Termination
  • Lifting a Suspension or Termination

Reasons for Suspension or Termination

Common reasons for suspending or terminating a research protocol or research activities include, but are not limited to, instances when the research:

  1. Has led to or is associated with an unexpected increase in risks of harm to subjects.
  2. Is associated with subject injuries.
  3. Is not being conducted in accordance with IRB requirements (i.e., researcher noncompliance).
The IRB may suspend or terminate research based on information received during its continuing review, from the findings of post-approval monitoring visit, or from complaints made to the IRB.

Authority to Suspend or Terminate Research Activities

Principal Investigator (PI)

As the “front line” in human subject protections, a PI should always be aware of subject safety issues and should suspend research activities on a study in order to remove immediate hazards to subjects. If it is apparent that hazards cannot be eliminated by modification of various aspects of the study (e.g., the study design or inclusion/exclusion criteria), the study should be terminated. PIs must notify the IRB immediately after suspending research activities or terminating a study. The notification should contain information regarding the facts leading to the decision for the action. There should also be a plan for notifying and safely withdrawing current subjects, if applicable, that considers subjects’ rights and welfare and, if applicable, a plan for notifying former subjects of the suspension/termination and any follow-up that may be required to assure their ongoing safety. The IRB will review reports of suspensions or terminations, determine what, if any, further actions are required on the part of the Pl, and report the suspension/termination to the Institutional Official (IO) and others as required.

IRB Chair

An IRB Chair can suspend or terminate IRB approval of a study, prior to discussion by the IRB, in order to remove immediate hazards to subjects or in the event there is sufficient evidence of noncompliance by the research team and that the noncompliance results in increased risk for subjects. An IRB Chair must consider protection of the rights and welfare of currently enrolled subjects (e.g., making arrangements for medical or other care of subjects). The Pl will be notified of the decision immediately and be required to submit a response to the IRB Chair's concerns. At a convened meeting of the IRB, the IRB Chair will report the suspension/termination, discuss the reasons for the decision, review the Pl's response to the suspension/termination and lead an IRB discussion of the action, response, and possible further required actions. Possible further actions imposed by the IRB may include requiring the Pl to submit a plan for notifying and safely withdrawing current subjects, a plan for notifying former subjects of the suspension/termination and any follow-up that may be required to assure their ongoing safety, if applicable, and a requirement that all adverse events or outcomes resulting from the research or the suspension/termination are reported to the IRB. A report of the suspension/termination will be submitted to the IO and others as required.

IRB

The IRB, at a convened meeting, may suspend research activities or terminate as a result of the following:

  1. Reports of unanticipated problems involving risks to subjects and others (including adverse events).
  2. Other reports that relate to subject safety in a particular protocol.
  3. Reports of serious or ongoing noncompliance by the Pl and/or research team.
The Pl will be notified of the decision immediately and be required to submit a response to the IRB's concerns. At a subsequent convened meeting of the IRB, the IRB will review the Pl's response to the suspension/termination, discuss the response and possible further actions required to lift the suspension or rescind the decision to terminate the research. Possible further actions imposed by the IRB might include requiring the Pl to submit a plan for notifying and safely withdrawing current subjects and a plan for notifying former subjects of the suspension/termination and any follow-up that may be required to assure their ongoing safety, if applicable, and a requirement that all adverse events or outcomes resulting from the research or the suspension/termination are reported to the IRB. A report of the suspension/termination will be submitted to the IO and others as required.

Institutional Official

The Institutional Official may suspend a research activity or study.

Notification of Suspension or Termination

In the event of a suspension or termination of approval, the IRB or person directing the suspension or termination will inform the investigator in writing. If immediate action is required, the person imposing the suspension or termination may give the directive verbally to the Pl and the letter will follow. If the IRB did not suspend or terminate the research, members will be notified at the next convened meeting. Letters to the Pl will be sent within five working days of the effective date of suspension or termination. Such letters will include:

  1. The effective date of suspension or termination.
  2. If notification was initially done verbally the letter will reference the date of verbal notification.
  3. The reason for the suspension or termination.
  4. Identification of the research activity, in whole or in part that is being suspended or terminated.
  5. Any corrective action or clarification that must occur.
  6. If the reason for suspension may bear on the participant's decision to continue participation, a directive that currently enrolled participants will be informed of the suspension.
  7. For terminations, a directive that all currently enrolled participants will be informed of the termination.
  8. If applicable, a directive of how to deal with any currently enrolled participants.
  9. A direction to the Pl regarding to whom to submit responses.

Lifting a Suspension or Termination

Only the IRB can lift a suspension using either the expedited review process or full board review. If the IO imposed the suspension, that person is responsible for notifying the IRB Chair in writing, via email or in hard-copy format, when they are satisfied that all concerns leading to the suspension have been satisfied and they recommend lifting the suspension. That person must attach a copy of the responses from the Pl to the IRB’s letter. The IRB Chair may use the expedited review process to lift a suspension that was made under the following conditions:
  1. That was directed by the IRB Chair.
  2. That was directed by the IO, providing the documentation noted above is received.
  3. That was directed by the convened board when the board specifically delegates to the IRB Chair the authority to lift the suspension.
Otherwise, the convened IRB will determine whether to lift a suspension.

The IRB will send notification to the Pl via Cayuse IRB when the suspension is lifted. The letter will be prepared by the IRB Administrator, reviewed and approved by the IRB Chair, and posted in Cayuse IRB. The IRB Administrator will also forward a copy of the letter lifting the suspension to all entities who received a copy of the notification of suspension.

+ - Post-Approval Monitoring

Policy Overview:

  • Objective
  • Roles
  • Protocol Selection
  • Monitoring Process
  • Information Sharing Process and Follow-Up
  • Appeal Process
  • Recordkeeping

Objective

The goal of post-approval monitoring of studies involving human subject research is to confirm by observation and documentation comparison, an accurate and consistent protocol performance, conducted in accordance with an Institutional Review Board (IRB)-approved protocol. An additional goal of the program is to provide education to the investigators on best practices for conducting their human subject research study in compliance with their IRB-approved protocol, Chapman IRB policies and guidance, and federal regulations. The program is also designed to help investigators, their teams, and the University prepare for external audits by granting, regulatory, and accreditation agencies.

Roles

The purpose of the IRB is to help researchers ensure that the rights and safety of human participants in research are protected and that research is conducted in compliance with relevant regulations. To achieve this, the IRB (1) advises investigators in the design of research projects that minimize potential harm to participants, (2) reviews all planned research involving human participants prior to initiation of the research, (3) approves research that meets established criteria for protection of human participants, and (4) monitors approved research to ascertain that participants are being protected. The IRB has the authority to approve, require modifications, disapprove, suspend, or terminate all human subject research activities at Chapman. The IRB may determine whether a post-approval monitoring visit is needed.

The Director of Research Integrity provides oversight and management of the post-approval monitoring program and assures that the IRB and the Institutional Official receive reports or updates on items of concern.

As part of the post-approval monitoring program, the IRB Chair(s), in consultation with the Director of Research Integrity, may determine if a post-approval monitoring visit is needed. This is considered a “directed” visit. Additionally, the IRB Chair(s) review post-approval monitor reports in consultation with the Director of Research Integrity and/or the IRB Administrator to determine if additional follow-up is needed.

Post-approval monitoring will be conducted by designated Research Integrity staff.  The designated monitor will meet with investigators and/or their teams and confirm by observation and documentation comparison that research activity is performed in accordance with approved IRB protocols. The monitor reviews study records, observes research activity, prepares reports, provides recommendations for maintaining compliance, provides training or information on training options when needed, and assists in execution of corrective and preventative actions.

Protocol Selection

All studies, even those determined to qualify for exempt status, are subject to monitoring. Studies chosen for monitoring visits are primarily randomly selected. However, emphasis may be placed on monitoring studies involving greater than minimal risk, vulnerable populations, deception, confidentiality concerns, waivers granted by the IRB (e.g., waiver of informed consent or waiver of documentation of informed consent), or studies conducted by investigators with past IRB concerns.

Monitoring visits may also be “directed” by the IRB, the Director of Research Integrity, or the IRB Chair(s) as needed (e.g., to assist in verification of findings in cases of potential noncompliance, to provide verification of implementation of corrective actions implemented in response to noncompliance, to assist the IRB in monitoring studies requiring more frequent review, etc.).

A principal investigator (PI) may also request an on-site review to help keep records and procedures in compliance with federal regulations and institutional policies or to prepare for an external audit by a sponsor or federal agency. Visits of this nature are encouraged, as the goal of post-approval monitoring is to assist investigators in conducting compliant research. During these PI-requested visits, the monitor focuses on areas of improvement and, if protocol deviations are found, counsels the PI on self-reporting the issue to the IRB, along with submitting a protocol modification if needed.

Monitoring Process

The monitor schedules the visit with PI(s) and their staff, making every attempt to accommodate schedules. “Directed” monitoring may or may not be scheduled.
 
During the post-approval monitoring visit, the monitor compares procedures being conducted in the laboratory or study area with those listed in the IRB-approved protocol and any approved modifications. This may include reviewing study records, visiting with the PI to review procedures being followed, observation of the consent process, etc. Documented discrepancies between observed and approved activities are brought to the attention of the PI.

The monitor reviews and assesses areas such as, but not limited to the following:
  • Research team composition and training
  • Recruitment procedures
  • Screening procedures
  • Consent process
  • Study procedures
  • Publications from the study
  • Current enrollment and verification of informed consent
  • Reports of adverse events
  • Storage of study documents and data
  • Privacy and confidentiality issues
  • Subject payment
  • Questions and concerns from the PI and research team

One of the primary goals of the post-approval monitoring program is education. The monitor is able to explain the IRB process, the importance of following the approved IRB protocol, and what is expected from investigators and their team. Additionally, the monitor is a resource for investigators, providing best practice ideas for conducting their human subjects research in compliance with IRB polices and educating the research team on IRB guidance documents, policies, and federal regulations.
The monitor also assists the principal investigator in identifying any protocol deviations and/or unanticipated problems, provides guidance for self-reporting any deviations or unapproved changes to the IRB protocol, and implementing any necessary actions, such as submitting a protocol modification.

In many cases, minor discrepancies observed during post-approval monitoring visits can be addressed through modification of an existing protocol or reverting to procedures that were originally approved; however, protocol deviations and/or unanticipated problems are reported to the IRB.

Information Sharing Process and Follow-Up

Following completion of the post-approval monitoring visit, the monitor discusses observations with the PI and/or their staff prior to leaving the office/laboratory. If the PI is unavailable, a time is scheduled to discuss the results of the visit. Issues that pose an immediate threat to research participants or that may constitute serious noncompliance are brought to the immediate attention of the Director of Research Integrity and IRB Chair(s).
 
A written report of the post-approval monitoring visit is prepared by the monitor. The goal of this report is to outline any discrepancies from the IRB-approved protocol and offer suggestions or recommendations for areas of improvement, including any suggested protocol modifications identified during the visit. A draft copy of the report will be shared with the PI for their comments and review. Following review by the PI, the report is finalized and a copy is shared with the PI for their records. The final report is then shared with the Director of Research Integrity and the IRB Chair(s) who review the report to determine whether additional follow-up is needed.

The Research Integrity staff assists investigators, if needed, in completion of required actions resulting from the post-approval monitoring visit or IRB-determined corrective actions. Assistance may include providing guidance with protocol modifications and/or direction to appropriate training.

Appeal Process

If a PI disagrees with the findings of the post-approval monitoring visit or required actions, they are invited to address these concerns with the monitor during the discussion at the end of the visit. If a satisfactory resolution has not been determined, the PI may then contact the Director of Research Integrity to discuss these issues within 30 days. Again, if no satisfactory resolution is agreed upon, the PI may address the IRB in writing within a second 30-day period.

Recordkeeping

A copy of the final post-approval monitoring visit report is kept with study files.