At the Fall 2009 Plenary Session, the body adopted the following resolution concerning institutional review boards (IRB):
Resolved, That the Academic Senate for California Community Colleges strongly encourage local senates to consider the development of local college and district Institutional Review Board (IRB) Committees as a preventive measure to litigation and for the protection of the students and community that they serve; and
Resolved, That the Academic Senate for California Community Colleges recommend that development of IRB Committees be a faculty driven collegial consultation process through each local senate in an effort to establish a culture of compliance regarding protection of human subjects when conducting research and writing grants.
Our article in the October 2009 Rostrum provided basic information about Institutional Review Boards (IRB) and their relation to academic and professional responsibilities. This companion article details the form and function of an IRB.
What is an IRB?
To repeat information from our previous article, an Institutional Review Board (IRB) is part of a review process to ensure ethical standards in conducting research that is derived from classroom experiences involving human subjects and when such projects and presentations become public (i.e., presentations at professional conferences, sabbatical reports distributed throughout the college).
The purpose of the IRB is to review a proposed research project to determine whether participants in the study will be placed at physical or mental risk and, if risk is involved, to certify that the following conditions have been met: (a) risks to participants are minimized; (b) participants in the study (and their guardians) are fully aware of the risks and that individuals may withdraw from the study at any time without any form of penalty; (c) risks to the participants are so outweighed by the sum of the benefits to the participants and the importance of the knowledge to be gained as to warrant a decision to allow the participants to voluntarily accept these risks; (d) rights and welfare of any such participants will be adequately protected; (e) legally effective, informed consent will be obtained by adequate and appropriate methods in accordance with the provisions delineated in Title 45 of the Code of Federal Regulations; and (f) conduct of the activity will be reviewed at intervals determined by the IRB, but not less than annually (Lincoln, 2005).
The Composition and Functioning of an IRB
The membership of an IRB is normally made up of at least five members, with varying backgrounds, who review research activities commonly conducted by the institution. The IRB shall be sufficiently qualified, through the experience, expertise, and diversity of the members, to promote respect for its advice and counsel in safeguarding the rights and welfare of human participants. The composition of the IRB should reflect the college’s commitment to diversity. Local campuses may use a variety of procedures to identify members for an IRB. The composition of the IRB membership should be determined in consultation with the local senate.
In general, IRBs are self-governing. No other group or individual should be able to interfere with its decision-making process or overrule its decisions. Each IRB designates a chairperson using a locally-determined process. With the approval of the full IRB, the chairperson typically (a) conducts the meetings of the IRB; (b) assigns certification authority to the members; (c) maintains a record of the proceedings of the IRB meetings, including agendas, actions of the IRB and the certification logs of the members; (d) maintains a record of all IRB members for that campus, including current curriculum vitae for each member; and (e) invites new board members.
The IRB reviews all research projects to determine compliance with Federal and State laws. Also, colleges need to work with their respective offices of Institutional Research to iron out the processes and procedures to be used in an IRB review. These processes and procedures may include approved consent forms and assurance that both faculty and students as well as the college are not at risk of federal sanction or litigation.
The Three Categories for IRB Review
There are three categories for IRB review: Exempt (Level 1), Expedited (Level 2), and Full (Level 3). These levels are based on a risk/benefit ratio to the participants. The investigator must assess the level of risk, or exposure to sensitive or harmful experiences, due to participation in the study and assign a category status to an IRB application (IRB applications can also be developed by faculty in consultation with the college/district researcher).
Exempt Review (Level 1) is performed for research projects using archived data and research projects for which there is no human participant interaction. Research projects on sensitive topics and vulnerable populations, such as children or minors, pregnant women and prisoners, do not qualify for exempt review. International studies also do not qualify for exempt review. The IRB makes the final determination about whether a proposal qualifies for exempt review.
Expedited Review (Level 2) is applicable to certain categories of research involving no more than moderate risk to human participants. Any research in which human participant interaction is anticipated falls in this category unless the risk to participants is considered more than moderate. Most projects and studies fall into this category. In addition to meeting the general eligibility criteria for Level 2, the research must also meet the certification criteria that assure (a) risks to participants for participating in the research are reasonable in relation to the anticipated benefits, if any, and the importance of the knowledge that may be gained; (b) participant selection must be fair; (c) informed consent is sought and documented unless a waiver of consent and/or documentation of consent have met the waiver criteria; (d) the plan to collect and monitor data assures participant safety; (e) procedures provide for the privacy of participants and for maintenance and disposal of confidential data; and (f) where necessary, additional safeguards are included to protect vulnerable participants.
Finally, research projects requiring a Full IRB Review (Level 3) entail sensitive or risky research topics or methodologies. The application for a Level 3 project must contain extensive details describing procedures designed to protect vulnerable participants.
For any application, a majority of IRB members must approve the proposal and sign the cover page of the research proposal. The investigator must obtain this certification of compliance before any data is gathered or else he/she opens the college up to liability under federal law.
Sources
Lincoln, Y. S. (2005). Institutional review boards and conservatism: The challenge to and from phenomenological paradigms. In N. K. Denzin & Y. S. Lincoln (Eds.), The sage handbook of qualitative research (pp. 165-181)
O’Brien, R. (2001). An overview of the methodological approach of action research. Retrieved February 18, 2008 from: http://www.web.net/~robrien/papers/ arfinal.html#_edn11
Stringer, E.T. (2007). Action research (3rd Ed.). Los Angeles: SAGE Publications