Human Research Information and Application/Registration Forms

(FORMS at end of this page)

Institutional Assurance Concerning Research
CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD (CUIRB)
Revised January 2000

I. GENERAL POLICIES AND RESPONSIBILITIES

I.a. UNIVERSITY COMMITMENTS

Chapman University is committed to safeguarding the rights and welfare of all people who participate in research conducted by Chapman faculty. It is also committed to insuring humane care and use of animals in teaching and research. Chapman University supports responsible experimentation which promises to increase knowledge and understanding, and encourages the highest ethical standards among Chapman researchers.

In addition to assuring compliance with Department of Health and Human Services (DHHS) regulations 45 CFR 46, as specified in the Office for Protection from Research Risks (OPRR) 1983 report on Protection of Human Subjects, Chapman accepts responsibility for complying with Food and Drug Administration (FDA) regulations (21 CFR 56) and all other applicable state and local laws as they may relate to research covered by the DHHS policy. Categories of research exempted from this policy are those specifically listed in 45 CFR 46.101 (2) (B) 1 through 5 (see CHAPMAN UNIVERSITY INSTITUTIONAL ASSURANCE Section II.f.).

Chapman University also abides by the provisions of the DHHS Guide to the Care and Use of Laboratory Animals and Principles for Use of Animals; the Animal Welfare Act PL 85-544; and the Standards for Accreditation by the American Association for the Accreditation of Laboratory Animal Care (AAALAC).

I.b. GENERAL AIMS OF THE CUIRB

The central aims of the CUIRB are:

I.b.1. To protect the rights of human participants in research studies, including their rights to give informed consent and to have their safety protected from undue risk.

I.b.2. To ensure the humane care and use of animals in research and teaching, and to approve only those experiments using animals which are justified by overriding benefits for teaching and new knowledge.

I.c. GENERAL CHARGE TO THE CUIRB

The CUIRB has the responsibility and authority to review and approve all research projects by Chapman faculty and students involving human or animal participants. It will approve only experiments that conform to the professional standards as understood within the relevant discipline.

I.d. RESPONSIBILITIES AND AUTHORITY OF THE CUIRB

I.d.1. Review all new and ongoing projects involving human participants at convened CUIRB meetings with the majority of the Board's membership constituting a quorum; a CUIRB member whose concerns are primarily in non-scientific areas must be included in the quorum. Voting on projects is limited to duly appointed Board members. Excluded from this process are those submissions which are participant to expedited review.

I.d.2. Review projects on an annual basis or more frequently as deemed appropriate.

I.d.3. Require written notification by investigators when changes in a research activity are proposed.

I.d.4. Require prompt reporting by investigators when unanticipated problems involving risks to participants occur.

I.d.5. Suspend or terminate approval of research that has been associated with unexpected serious harm to participants or that is not being conducted in accordance with the CUIRB's decisions.

I.d.6. Report to the Chancellor of the University and to the Faculty Research and Development Committee any suspension or termination of approved research.

I.d.7. Require that the informed consent procedure is in accordance with policy.

I.d.8. Notify investigators of the results of CUIRB review.

I.d.9. Observe or have a third party observe the consent process and the research, when appropriate.

I.d.10. Advise and consult with investigators regarding specific problems associated with protocols involving human participants.

I.d.11. Distribute campus guidelines to aid principal investigators in the preparation of their application for approval of research involving human and animal participants

I.d.12. Maintain complete records.

I.d.13. Interpret government and University policies pertaining to the protection of human and animal research participants.

I.d.14. Develop and publish campus policies and procedures governing review of research involving human or animal participants.

I.d.15. Provide consultation through its Chair to any participant or principal investigator.

I.d.16. Establish procedures for monitoring implementation of CUIRB action.

I.d.17. Maintain communication with Federal, State, and local agencies and institutions to insure that CUIRB procedures are current and consistent.

I.d.18. If the research activity is funded in whole or in part by a DHHS grant, contract, or fellowship, report to the Secretary of DHHS on serious or continuing noncompliance by investigators with the requirements and determinations of the CUIRB; suspension or termination of approved research that is not being conducted in accordance with the CUIRB's requirements; or any unexpected serious harm to participants associated with a research project.

I.d.19. Coordinate review of research carried out at non-university sites.

I.d.20. Through its Chair, report any changes in CUIRB membership to the Chancellor of the University

I.e. COMPOSITION OF THE CUIRB
All review of human participant involvement in research activities covered by this policy shall be carried out by the CUIRB following the procedures set forth in this policy. CUIRB members are appointed by the Chancellor of the University and reviewed by the Faculty Executive Committee. The CUIRB shall annually elect its own chairperson.

The CUIRB is sufficiently qualified through the experience, expertise, and diversity of its members, including sensitivity to community attitudes, to command respect for its advice and counsel in safeguarding the rights and welfare of research participants.

The CUIRB is composed of at least five members from the University, representing diverse backgrounds and possessing the professional competence necessary to review the specific research activities assigned to it. The CUIRB shall not consist entirely of men or women or entirely of persons in one profession.

CUIRB includes at least one member whose primary expertise is in a non-scientific area and one additional member with no formal affiliation with the University. At any time, consultants may be sought, but these persons may not participate by vote in CUIRB actions.

I.f. RESPONSIBILITY AND AUTHORITY OF CHAPMAN UNIVERSITY

I.f.1. Legal assistance. The University Legal Office is available to the CUIRB and investigators for legal consultation and assistance.

I.f.2. Liabilities. The University is legally responsible for the acts and omissions of its investigators while acting in the course and scope of their University duties. In the event of a suit against investigators or members of an CUIRB based on their actions in connection with a research activity involving human participants, the University would be obligated to assume their defense if the research project was approved by an CUIRB in accordance with this policy. If a principal investigator has, or should have, knowledge of the applicable University policy requiring that every research activity placing human participants at risk be reviewed by an CUIRB and fails to obtain such approval prior to involvement of human participants, the investigator would be acting outside the scope of his/her duties and the University would not be obligated to defend or indemnify the investigator if legal actions were initiated by a participant.

II. INFORMATION AND INSTRUCTIONS FOR FILING HUMAN RESEARCH PARTICIPANT PROTECTION PROTOCOLS WITH THE CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD

II.a. GENERAL INFORMATION

In accordance with Department of Health and Human Services regulations, Chapman University recognizes three categories of review for research involving human participants: full, exempt, and expedited. It is anticipated that most research activities carried out at Chapman will fall under the exempt and expedited review categories in that they involve relatively low-risk procedures. The guidelines that follow should guide the investigator in determining the appropriate application format.

The standard review criteria are used regardless of the risk level of the proposed study. It must be emphasized that CUIRB review concerns research and thus a project must be defined. The nature of the procedures in the study defines the level of review required.

The following definitions are used by the CUIRB when review research projects using human participants:

II.a.1. HUMAN PARTICIPANT is an individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or through identifiable private information.

II.a.2. RESEARCH is a systematic investigation explicitly designed to develop or contribute to generalizable knowledge. (Classroom activities are no longer automatically participant to CUIRB review unless they constitute "research" as herein described.)

II.a.3. RISK AND MINIMAL RISK. The term "minimal risk" means that risks for harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Using minimal risk as a goal, the CUIRB will use the reasonable person standard to compare the risks of research to those in the daily life of a typical person in the anticipated participant population.

II.a.4. BENEFIT. To a certain extent risk is evaluated relative to the potential benefit(s)of the research. The CUIRB applies two categories when considering risk/benefit relationships of proposed research:

II.a.4.a. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual.

II.a.4.b. Research involving greater than minimal risk and no prospect of direct benefit to individual participants but likely to yield generalizable knowledge about the participant's disorder or condition. This risk can be only a "minor increase over minimal risk." The experience should be reasonably commensurate with those the participant would ordinarily encounter.

II.a.5. EVALUATION OF RISKS IN RELATION TO BENEFITS. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the CUIRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapy subjects would receive even if not participating in the research). The CUIRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (45 CFR 46.111(a)(2).)

II.b. ACTIONS Applying the criteria for IRB research review set forth in 45 CFR 46.111, the CUIRB will review each proposal and take one of the following actions:

II.b.1. Determine the research as exempt from approval. Research in the exempt from approval category represents projects which involve minimum risk to the participants (refer to section II.f.).

II.b.2.Approves the research. Although the research may involve some risk to the participants, the CUIRB may find that the risk is minimum, and that the investigator has taken all practical steps to minimize the risk.

II.b.3.Conditionally approves the research. This action entitles the investigator to proceed with the project provided that certain conditions are fulfilled as specified by the CUIRB. Conditions may include items such as revising the consent form to explain the procedure more clearly, adding a foreign language version of the consent form or receiving clearance from the student health service.

II.b.4. Disapproves the research with a request for resubmission of the protocol.This occurs when the CUIRB believes that it has insufficient information to take action, or when it feels the research design contains flaws or characteristics that should be revised to reduce risks to participants. The CUIRB may ask the investigator to provide for emergency back-up medical care, to take further steps to protect the confidentiality of the participants, or to develop a substitute procedure.

II.c. INFORMED CONSENT

Except as provided in these documents, legally effective informed consent must be obtained from any research participant or the participant's legally authorized representative who, in the course of a research protocol, is exposed to the risk of physical, psychological, or social injury. Informed consent is defined as the knowing consent of an individual or their legally authorized representative so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. The term "participant" shall, where appropriate, mean the participant or the participant's legally authorized representative.

Legally effective informed consent, at least includes both the investigator's oral explanation to the participant of the research and the potential participant's expected participation therein as well as the investigator's response to any and all questions that the participant may have concerning the research protocol. In certain instances, this will require documentation of consent using an CUIRB-approved consent form which is signed by the participant or the participant's legally authorized representative and the investigator.

Informed consent is to be sought only under circumstances which provide the participant with sufficient opportunity to freely consider whether or not s/he wishes to participate in the research and minimizes any possibility of coercion or undue influence.

In those research settings in which risk to participants may be increased by written record of their names (e.g., studies of deviant populations), or in observational studies of naturally-occurring human interaction, the requirement of informed consent must nevertheless be met. The researcher must provide a written explanation to the CUIRB of how the participants' rights to privacy and anonymity will be protected. It is strongly recommended that in such instances, investigators develop an informational letter to be given to the participants. The informational letter should be submitted with the CUIRB application, and it will be subject to committee review.

Any or all of the requirements for obtaining consent may be waived by the CUIRB during its review of the study, but only under certain circumstances as specified in 45 CFR 46.101 (b).

The following guidelines are to be followed when preparing a Consent Form:

II.c.1. The consent form is to be written in narrative form and include all information the participant should know in making his/her decision of whether or not to participate.

II.c.2. Statements must be easily readable and understandable. Technical terminology and abbreviations are not to be used unless clearly defined.

II.c.3. The consent form must be in the fluent language of the participant. However, translations of consent forms should not be done until the English language version has been approved by the IRB. Furthermore, translations MUST either be done or verified by a qualified faculty member of the University or their designee.

II.c.4. THE PARTICIPANT IS TO BE GIVEN SUFFICIENT TIME TO CONSIDER WHETHER OR NOT THEY WISH TO PARTICIPATE BEFORE SIGNING THE CONSENT FORM.

II.c.5. The investigator is reminded that the consent form is simply the written documentation of the consent process. Oral explanations are to be given to each prospective participant and the participant encouraged to ask questions.

II.c.6. In reviewing research protocols and consent forms, CUIRB is particularly cognizant of research involving minors. All research involving minors must conform to Department of Health and Human Services regulations stated in "Additional Protection for Children involved as Subjects in Research" (45 CFR 46.401-409). The specific requirements are specified in Section II.d., below.

II.d. RESEARCH INVOLVING MINOR PARTICIPANTS

The Department of Health and Human Services issued regulations, effective June 6, 1983, giving additional protection for children involved as participants in research. The regulations contained in "Additional Protection for Children Involved as Subjects in Research" (45 CFR 46.401-409) must be applied to all research involving minors which is reviewed by the IRB.

A minor is a person under age 18 who does not have the legal authority to consent. Emancipated minors, whom the state gives the right to consent and contract as adults, are to be treated as adults. The regulations governing children in research decree that investigators need to consider the age, maturity, and psychological state of the participating children and include them in the consent process. The older and more mature children should be allowed to sign the consent form, while "assent" must be obtained from all children. Regulations define "assent" as the child's affirmative agreement to participate. Further, "Mere failure to object should not, in the absence of affirmative agreement, be construed as assent".

The assent procedure may be represented by an assent form, or by a prepared script of the explanation to by tendered by the investigator. The following areas must be addressed in the assent procedure, utilizing language appropriate to the child's age and/or developmental level:

II.d.1. Why is the child asked to participate.

II.d.2. What is going to occur from the child's point of view.

II.d.3. The risk to the child.

II.d.4. The benefit to the child.

II.d.5. Identification of the researcher by name and telephone number in case questions should arise before and after participation.

II.d.6. In non-therapeutic research, a statement that the child has a choice to participate in or to withdraw from the research at any time without any negative consequences.

II.d.7. A statement that the child can retain a copy of the assent form.

II.d.8. Date and signature lines for the investigator and, if appropriate, for the child.

II.e. PROCEDURE FOR FULL REVIEW

Unless expedited or exempt review is specifically requested, all research proposals will undergo full review by the CUIRB. The investigator will complete the Application to the Institutional Review Board for Approval of Research with Human Participants (CUIRB FORM IV). For full review, the investigator should submit 10 copies of the application, with any applicable supporting material, to the Chair of the CUIRB. All members of the CUIRB will review the proposal and supply written recommendations. When necessary, the opinions of an outside consultant expert (i.e., medical, legal, etc.) may be sought. At any time during the review process, the CUIRB may request further information. By a majority vote of all its members, the CUIRB will take one of the three actions specified in Section II.b., subparts b.2.-b.4.

A written decision, with explanation where necessary, will be sent to the investigator and to the Chancellor of the University. The review process typically will require two weeks.

II.f. CATEGORIES OF HUMAN RESEARCH EXEMPT FROM CUIRB REVIEW:

In accordance with 45 CFR 46.101, the following research activities may be exempt from review by the CUIRB:

II.f.1. Research conducted at established or commonly accepted educational settings, involving normal educational practices, such as:

II.f.1.a. research on regular and special education instructional strategies or

II.f.1.b. research on the effectiveness or of the comparison among instructional techniques, curricula or classroom management methods.

II.f.2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) if information taken from these sources is recorded in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

II.f.3. Research involving survey or interview procedures with adults age 18 or over except where all of the conditions below* apply. All research, involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.

II.f.4. Research involving the observation (including observation by participants) of public behavior except where all of the conditions below* apply.

II.f.4.a. Conditions for #3 and #4 above:

II.f.4.a.1. Responses/observations are recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants, and,

II.f.4.a.2. The participant's responses (or observations recorded about the participant) if they become known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing or employability, and,

II.f.4.a.3. The research deals with sensitive aspects of the participant's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.

II.f.5. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator on such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

PROCEDURE FOR APPLYING FOR EXEMPT REVIEW

Investigators seeking the exempt from review category will complete a Registration of Research Exempt From Review (CUIRB FORM V). This form will assist researchers and Department Chairs in certifying that proposed research qualifies for expedited review and specifying which of the five categories of exempt research listed in 46 CFR 46.101 is/are representative of the proposed research. In questionable cases, investigators and Department Chairs are strongly urged to consult the CUIRB. Annually, originals or copies of this form are to be forwarded to the Chair of the CUIRB to be kept on file by the board.

II.g. CATEGORIES OF RESEARCH SUBJECT TO EXPEDITED REVIEW

In accordance with DHHS guidelines (63 FR 60364), research activities with human participants involving no more than minimal risk and involving one or more of the following categories (carried out through standard methods) may be reviewed through an expedited review procedure:

11.g.1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met:

11.g.1.a. Research on drugs for which an investigation new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

11.g.1.b. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required or (ii) the medical device is cleared/ approved for marketing an the medical device is being used in accordance with its cleared/approved labeling.

11.g.2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

11.g.2.a. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amount drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

11.g.2.b. From other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

11.g.3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingical dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (I) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight and health of the individual.

11.g.4. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

11.g.5. Collection of data from voice, video, digital, or image recordings made for research purposes.

11.g.6. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

11.g.7. Continuing review of research previously approved by the convened IRB as follows :

11.g.7.a. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or

11.g.7.b. Where no subjects have been enrolled and no additional risks have been identified; or

11.g.7.c. Where the remaining research activities are limited to data analysis.

11.g.8. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no great than minimal risk and no additional risks have been identified.

PROCEDURE:

Those investigators seeking the expedited review should submit three copies of the Registration of Research for Expedited Review (CUIRB FORM VI). The CUIRB will appoint a three-person subcommittee to review the registration form. When two members have read and approved the application, it is referred to the Chair of the CUIRB who reviews and, if in agreement, signs an approval letter. The approval letter is then sent to the investigator and the action is reported to the full committee at the next scheduled meeting. The full committee is likely to approve but has the option of requesting more information or disapproving.

Any of the three reviewers may object to expedited review or may have further questions and has the option of referring the application to the full CUIRB.

Investigators should be aware that though applications for expedited review are simpler and involve less paper and duplication then involved in full review, the review and evaluation process may be no faster than that of the full review procedure. To be safe, allow 3 weeks for the process (before the time planned to commence research).

PROJECT SUBMISSION INFORMATION

---

 FORMS

• Application for Research with Human Research Subjects (Word) (PDF)
• Instructor's Application for Course Assignments involving Human Research Subjects* (Word) (PDF)
       *Question to Instructor - Does the research in your course assignment qualify for this project category? Review the "Guidelines for Course-Related Student Research Projects." (PDF only)
• Application for Registration of Research Exempt From Review (Word) (PDF)
• Application for Registration of Research for Expedited Review (Word) (PDF)
• Written Informed Consent Guidelines and Requirements w/ Sample (Word) (PDF)
• Research Participant's Bill of Rights (Word) (PDF)
• Children's Assent to Participate in Research (Word) (PDF)
• Information Letter Sample for Research Subjects (Word) (PDF)
• Notice of Adverse Event or Complication (PDF)
• Request for Modification (Word) (PDF)
• Project Continuation/Termination Request and Completion Report (Word) (PDF)

 These PDF forms require Adobe Acrobat Reader. Click here for free download.