» Frequently Asked Questions (FAQs)

Researchers often interpret the word exempt to mean there is no IRB review needed. At Chapman University, a study must be reviewed by an IRB in order to be designated as exempt from needing further review.

Learn more about exempt review.

Learn more about types of exemptions in human subject research.

The 2018 Common Rule states that all “research” involving “human subjects” (as specifically defined by the Office of Human Research Protections - OHRP) requires IRB approval.  See Section 46.102(e) and (l) respectively for the complete definitions of “human subjects” and “research.”

The OHRP, the definition of “research,” excludes the following activities for purposes of IRB review:

Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

Therefore, the most common reason for humanities projects not requiring IRB review is that they do not fit the federal definition of “research.”  

For the study to require IRB review, it must be developed using a systematic approach to generate generalizable knowledge that can be applied in or be predictive of similar circumstances.

Further, if the proposed project will involve collecting identifiable information about a living individual and will be used to reach conclusions, inform policy, or generalize findings, then the project must be submitted to the IRB for review. 

Indicators that IRB review is required:

• The study is funded by an agency that seeks to support projects designed to create generalizable knowledge, such as the U.S. Department of Health and Human Services, the National Science Foundation, or the U.S. Department of Education (including the Fulbright program).
• The study will involve multiple individuals’ perspectives on the issue of interest, AND these perspectives will be analyzed to reach generalized conclusions predictive of similar circumstances.
  

When IRB review is not required:

• The goals of the project are to document a specific issue, event or the experiences of individuals and will not be used for further analysis for commonalities predictive of future instances.
• The project will compare and contrast policies, procedures, or events to identify general commonalities or inform policy decisions without collecting information about identified individuals.

References:

Office of Human Research Protections Common Rule definitions  https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102 

OHRP guidance on Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements

https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-scholarly-and-journalistic-activities-deemed-not-to-be-research/index.html

All research studies are submitted electronically via Cayuse IRB. Detailed information that explains how to submit for IRB review is available on the Chapman University Cayuse IRB page. For quick reference to learn how to submit in Cayuse IRB, view the two powerpoints below.

• How to sign in, navigate, and submit new applications
• How to create and submit additional submissions (renewals, modifications, incidents, withdrawal)

Documents to be submitted include but are not limited to the following:

• Collaborative Institutional Training Initiative (CITI) completions by all investigators
• Surveys
• Questionnaires
• Pre and post assessment tools
• Debriefing scripts for studies that will involve deception
• Recruitment material (e.g., flyers, letters, verbal scripts, telephone scripts, email samples)
• Letters of support for off-campus activities (e.g., schools, community centers, hospitals) 
• IRBs approval from other institutions (i.e., may be required for multi-site or joint research)
• Data use agreements
• Letter to verify accurate translations of non-English forms

*Additional documents may be required based on the nature of the research.

While the IRB appreciates that you would include a full research proposal or thesis (that includes literature review, background, etc.), it is not required to include with your research submission. It is much more important to provide complete answers to all of the specific questions in the submission. A complete submission provides consistency and clarity during the committee's review process.

Non-Chapman-affiliated researchers must also complete CITI training. Chapman University's IRB requires that all researchers satisfy the CITI training requirement and submit proof of completion.

No, expedited is a level of review named and defined by federal regulation. It does not indicate speediness. The speed of an IRB review depends on thoroughness of the application and speed of responses from the applicant regarding information and edits requested by the IRB.

Learn more about expedited review.

Consent to participate in a research study can only be given by competent individuals who have reached the legal age of consent (typically 18 years old in the U.S.) and have been given sufficient information of the nature, benefits and risks of participation to form a reasoned decision.

Assent in general, is the agreement or expression of willingness of a minor (or individual who is not able to give legal consent) to participate in a research study. Assent given by a minor must be accompanied by informed consent obtained from the subject's parent(s) or legal guardian(s).

• Writing short, simple, and direct sentences
• Keeping paragraphs short and limited to one idea
• Using active verbs
• Using the second person (you) not third person (the participant) to increase personal identification
• Highlighting important points by using underline and bold font
• Avoiding repetition
• Avoiding large blocks of printed text
• Spelling out acronyms when first used

Obtaining a witness signature is required when a short form consent is used, or (in alignment with FDA’s requirements) when the subject (or his/her Legally Authorized Representative) is unable to read due to any reason (e.g., illiteracy, blindness, diminished vision, dyslexia).The IRB has the authority to require a witness signature for other types of studies as an additional measure to protect human subjects. 

Multi-site research refers to research involving two or more investigators at different institutions. Chapman makes extensive use of reliance or IRB authorization agreements (IAAs) which enable one institution to be the IRB of record, and other collaborators may rely on a single IRB approval. Chapman must agree to serve as the IRB of record for any non-exempt research study in which outside researchers will be engaged in the study. Chapman may also rely on another institution’s IRB approval if that arrangement is more appropriate.

It may also be possible for non-Chapman investigators who are not affiliated with any institution, to obtain an affiliation with Chapman through an Individual Investigator Agreement (IIA).

See the Single IRB Review website for more information, or contact irb@chapman.edu.

Students who wish to obtain IRB review can complete and submit a study submission in Cayuse IRB. Students who are directing the research should be listed as Student Investigators, while faculty and staff advisors should be listed as Principal Investigators.

The IRB requires each student to identify a faculty or staff advisor(s) who will provide direct supervision when developing and submitting IRB submissions. Faculty and staff advisors are required to review each student's IRB submission for clarity and completeness.

Each student and advisor must complete the Collaborative Institutional Training Initiative (CITI) course modules mentioned on the Chapman University Training and Continuing Education page.

No, modifications to the study do not change the study's expiration date. Studies are approved between the approval and expiration dates shown on the study's initial approval letter. Please refer to the study's initial approval letter to see the approval and expiration dates of your study.

The Chapman IRB must approve all research procedures conducted on Chapman students or employees. The unaffiliated researchers must have a Chapman department or school sponsor to support the study. The Chapman sponsor should submit the final protocol (including consents, surveys, flyers, etc.) with the approval memo from the home institution via email to irb@chapman.edu. The determination of engagement is at the discretion of the IRB.

Anonymous means that you will not be receiving or collecting any identifying information about or from the subject(s) and you will have no means to contact the subject and no follow-up will be initiated. Subjects consenting to participate in anonymous research will be provided with consenting information but DO NOT sign the consent document. The subject's agreement to participate is considered passive consent.

When subject research data is collected in a confidential manner, the subject's identifying information may be used to correlate specific serial or grouped data or to contact the subject for follow-up procedures or interviews. To protect the subject's confidential information, all identifying data should be coded so as not to be linked with the subject's individual responses in the final analysis.

There is much nuance as to what is technically "human subject research" as defined by federal regulations. Please see the flowchart for an overview per the 2018 Requirements. 

The Food and Drug Administration (FDA) defines "clinical investigation" as 'any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects'. All human subject research, including clinical investigations, require IRB review, per Chapman's Human Research Protection Program (HRPP).

Data are de-identified when:

•  any individual identifiers are removed from the data (see below), or
•  codes linking the data to the individual participant's identity are destroyed such that the information about an individual cannot be traced back to the participant, or
•  identifiers will be shared, and a data provider can access codes, but the data sharing agreement states that the Chapman researchers will not be provided any access to the codes or identifiers, or
• the PI can describe, and the IRB agrees with the PI that there is very little/no potential for deductive disclosure.  

See the full list of identifiers below.  

(i) The following identifiers of the individual or of relatives, employers, or household members of the individual must be removed in order for the data to be considered de-identified:

(A) Names;

(B) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census:

(1) The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and

(2) The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.

(C) All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;

(D) Telephone numbers;

(E) Fax numbers;

(F) Electronic mail addresses;

(G) Social security numbers;

(H) Medical record numbers;

(I) Health plan beneficiary numbers;

(J) Account numbers;

(K) Certificate/license numbers;

(L) Vehicle identifiers and serial numbers, including license plate numbers;

(M) Device identifiers and serial numbers;

(N) Web Universal Resource Locators (URLs);

(O) Internet Protocol (IP) address numbers;

(P) Biometric identifiers, including finger and voice prints;

(Q) Full face photographic images and any comparable images; and

(R) Any other unique identifying number, characteristic, or code; and

(ii) The covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.

Compensation for participation and benefits of participation in a research study are not the same thing. Compensation is payment or reimbursement for the participant's time and expenses (or even class credit) rather than a benefit of the research. Benefits from the research might include an increased self-awareness of health issues, or improved test scores; something that can be directly related to or resulting from the research efforts.

The IRB requires a Chapman University faculty advisor to assume a primary role in completing and submitting a research submission for IRB review. While students may serve as the student investigator for student-directed research, the faculty advisor is responsible for the following:

1. Determine whether projects require IRB review, and assist students during the process.
2. Ensure that all elements of the IRB submission are completed thoroughly and accurately.
3. Ensure that all documents (e.g., informed consent/assent documents, recruitment documents, data collection documents) are clearly written (i.e., grammatically correct, written at for the appropriate reading levels of the intended participants) and include all necessary information, which will allow participants to be fully informed of all elements of the research.
4. Serve as the primary contact for the IRB (unless the student meets PI eligibility criteria and is listed as PI).

Faculty advisors must also ensure students' understandings of research ethics principles. The Collaborative Institutional Training Initiative (CITI) course modules describe faculty advisors as responsible for the protection of human subjects, and for the following:

1. Complete the required CITI modules.
2. Be familiar with ethical and regulatory requirements of human subjects research, and discuss research ethics with students.
3. Monitor student research, while ensuring the maintenance of confidentiality, privacy, risk reduction, voluntary participation and withdrawal, and informed consent.
4. Ensure that any unexpected or adverse events are reported to the IRB.