3.16 Human Participants in Research Scripps College Institutional Review Board

1. The Scripps College Institutional Review Board (IRB) shall be responsible for the protection of the rights and welfare of participants in research activities carried out by persons acting under the auspices of Scripps College. All such research activities involving human participants shall be reviewed to determine whether the participants are at risk, and, if risk is involved, whether:
   1. The risks to the participant (or to groups with which s/he may be identified) are minimized,
   2. The risks are reasonable in relation to anticipated benefits,
   3. The selection of participants is equitable, or
   4. Informed consent is sought from each participate and is appropriately documented.
   5. Privacy and confidentiality of participants are protected.

Where risk is involved, the Committee shall be responsible for continuing, regular review of the conduct of the research. Where necessary, the Committee shall be responsible for certifying the acceptability of proposed research to the President in order that s/he may convey this to agencies requiring such assurances.

2. Composition of IRB
   The President of the College shall appoint the Scripps College Human Protections Administrator who will staff the Institutional Review Board. The Dean of the Faculty shall appoint the Institutional Review Board members. The Human Protections Administrator has administrative responsibility for administering the College’s human participants review program and serves as the College’s primary contact to federal agencies requiring IRB review of human participants research.
   
   To be eligible to review federally funded research grants involving human participants, the IRB must be registered with the Office for Human Research Protections (OHRP) and the College must have on file with the Office for Human Research Protections an approved Federal-Wide Assurance (FWA). (Please contact the President’s Office for further information about IRB certification and the College’s approved FWA.) Moreover, the Institutional Signatory Official, the IRB Chair, the Human Protections Administrator and all the Human Participants Research Investigators must complete appropriate education and training before reviewing or conducting human subject research. Further information can be obtained from the website for the Office of Human Research Protections (OHRP) http://ohrp.osophs.dhhs.gov. Educational and training modules are also available at this website.
   
   IRB shall consist of two Chairs, one for assessing quantitative and one for assessing qualitative research proposals, and at least five additional members: two faculty, one student and two individuals from outside the College. The IRB Chair-Quantitative and all IRB members shall constitute the IRB Quantitative Subcommittee. The IRB Chair-Qualitative and all IRB members shall constitute the IRB Qualitative Subcommittee. The IRB Chair-Quantitative and the IRB Chair-Qualitative will receive 1 course release for every 3 years of service. Course replacements for an IRB chair course release will follow the same process as sabbatical course replacements and will be granted when crucial for the integrity of the curriculum.
   
   The IRB shall be sufficiently qualified through experience, expertise and diversity of its members to promote complete and adequate review of research activities commonly conducted at Scripps. In accordance with OHRP policies, every effort should be made to ensure that the IRB does not consist entirely of women or men or representatives of one discipline/profession.
   
   The Committee shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
   
   The IRB may not have a member participate in its initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
    
3. Guidelines for IRB Review:
   All IRB reviews related to research with human participants at Scripps College should be guided by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
   
   The IRB should ensure that all federally supported research with human participants for which the IRB provides review and oversight complies with the Federal Policy (Common Rule) for the Protection of Human Subjects. All research with human participants that is supported by the Department of Health and Human Services (DHHS) should comply with all subparts of HHS regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46). All federally supported research with human participants should also comply with any additional related regulations and policies of the supporting department or agency or any relevant regulatory department or agency. In reviewing research that is both federally-supported and FDA-regulated, the IRB should satisfy all of the responsibilities that are applicable to each. Further information can be obtained from the website for the Office of Human Research Protections (OHRP) http://ohrp.osophs.dhhs.gov.

Implementation/Recordkeeping

1. The IRB shall establish written procedures for:
   1. conducting IRB initial and continuing review, approving research, and reporting IRB findings to the investigator and Scripps;
   2. determining which projects require review more often than annually, and which projects need verification from sources other than the investigator that no material changes have occurred;
   3. ensuring that changes in approved research are reported promptly and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; and
   4. ensuring prompt reporting to Scripps, the relevant Federal Department or Agency Head, any applicable regulatory body, and OHRP of any (i) unanticipated problems involving risks to subjects or others in any covered research; (ii) serious or continuing noncompliance with Federal, institutional, or IRB requirements; and (iii) suspension or termination of IRB approval for federally-supported research.
2. Proposals for IRB review are to be submitted to the IRB Administrator.
3. A majority vote of the complete membership of the IRB shall be required for approval of a proposal. Discussion of proposals and voting shall be carried out in a meeting where no fewer than one-half of the membership plus one is present.
4. Expedited reviews procedures may be used for
   research in the categories listed in the published OHRP list of eligible research and found to involve no more than minimal risk may be reviewed through an expedited review procedure.
   
   minor changes in previously approved research during the authorized approval period.
   
   Expedited reviews may be carried out by the IRB Chair. All of the requirements for IRB approval of research apply equally to expedited reviews, which should not be viewed as a less rigorous review process.