FSW Institutional Review Board (IRB)

The Institutional Review Board (IRB) of FSW reviews all human subject research activities conducted at FSW to ensure that the proper precautions are taken into consideration to ensure the safety and welfare of the subjects and preserve the rights of those subjects. Human subjects research may not be conducted at FSW without IRB approval.

To seek IRB approval, complete the IRB Application Form linked here. If you have any questions throughout the process you can contact FSW’s Human Subjects Administrator, the Director of Assessment & Effectiveness, Dr. Joseph van Gaalen (), the current IRB Chairperson, Professor of Anatomy & Physiology, Dr. Roy Hepner (), or any of the current IRB Members which are listed in the dropdown below.

Next IRB Meeting: March 21, 2018, 3:00pm

FSW IRB Procedures+

Upon completion of the IRB application (linked above), the IRB Human Subjects Administrator will review the application for completeness and present it to the IRB Chairperson. The IRB Chairperson will review within 10 business days of receipt from the Human Subjects Administrator. If the application can be exempted or expedited, a determination will be made within that time. If the application requires IRB review it will be placed on the agenda for the next available IRB convening and the PI will be notified. The FSW IRB convenes twice annually, once in the fall term and again in spring term. Upcoming meeting dates are posted above. The IRB will consider applicant requests to convene earlier than scheduled if aspects of planned research are time sensitive. To request an early convening, contact the Human Subjects Administrator, .

The principal investigator may not engage in research activities until approval from the IRB is granted. If there are multiple co-principal investigators it is up to the principal investigator to communicate approval to their collaborator(s). Additionally, the Chairperson will conduct an annual review of any continuing projects lasting longer than one year. The Chairperson may make the determination upon initial approval that review may take place at varying intervals so long as the timespan between review is not in excess of one year.

FSW IRB Members+

Joseph F. van Gaalen, Ph.D. Director of Assessment & Effectiveness Human Subjects Administrator
Roy Hepner, M.D. Professor of Anatomy & Physiology Chairperson
Leslie Bartley, Ph.D. Professor of Psychology Alternate
Frank Dowd, M.L.S. Faculty Librarian
Sindee Karpel, M.P.A. Professor of Respiratory Care
Mark Lupe, J.D. General Counsel
Susan Marcy, J.D. Director of Risk & Counsel
Lawrence Miller, Ph.D. Dean of Education
Matthew Vivyan, Ph.D. Professor of History
Brian Just, Ph.D. Monsanto
Howard T. Osment, M.S.M. Ret. VP of Planned Systems Int’l, Inc. Non-FSW Affiliate

FSW affiliated IRB members serve a 3-year term based on the recommendation of their respective Dean. A member can serve longer if no replacement has been recommended at the end of term. Non-FSW affiliated IRB members are appointed by the Human Subjects Administrator with approval from the current IRB and also serve a 3-yr term. The chairperson is selected by the current FSW IRB. The FSW IRB will always include an Academic Dean, a faculty representative from the School of Pure & Applied Sciences, one from the School of Arts, Humanities, and Social Sciences, one from the School of Health Professions, one non-FSW affiliated member, and one non-voting representative from the College’s General Counsel Office, and may at times include additional individuals with proper expertise in specific areas associated with a given research submission to convene with the IRB. IRB membership does not exceed 10 members and does maintain alternates in the event absences at a convening would alter the above representation.

Human Subjects Research (Resources & Information)+

A need for oversight with regard to human subjects research historically dates back to the 1930s, most notably, the Syphilis Study1,2 which began in 1932 and the Nazi Medical War Crimes3 during World War II. These and other cases led to the Nuremberg Code of 1947 which established an outline for voluntary consent and a need for the study (what would later become research towards generalizable knowledge). Shortly thereafter, the UN adopted a Universal Declaration of Human Rights in 1948 which firmly established such fundamental human rights on an international stage.

The first Federal Policy for Protection of Human Rights was established in 1953, and is generally considered to be the precursor to today’s current IRB system. The evolution into today’s IRB is grounded in the Belmont Rule of 1979 which focuses on three major principles required of ethical conduct of research with humans; (1) respect for persons, (2) beneficence, and (3) justice. By this standard, an IRB is reviewing research to ensure there is respect for the subjects, that the research should have the welfare of that subject included as a goal in the research, and that the research is conducted as fairly as possible. Today’s IRB follows the Federal Policy for the Protection of Human Subjects (a.k.a. the Common Rule) and is classified in the Department of Health and Human Services regulations 45 CFR part 46.

Human subjects research is classified into three categories: Exempt, Expedited, and Full Committee Review. Exempt research requires an IRB review, but does not require the convening of the full IRB. At FSW, this determination can be made solely by the IRB Chairperson. Low risk research such as anonymous surveys or anonymous non-invasive observation of public behavior would qualify as exempt. Expedited research also does not require the convening of the full IRB, and can also be made solely by the IRB Chairperson. If the IRB Chairperson cannot approve of the research under expedited review, it is set on the agenda for the upcoming IRB convening. Limited risk research such as surveys that are not anonymous or slightly invasive observations such as vocal or visual recordings of volunteers would qualify as expedited. Full committee review research requires the convening of the IRB. Some examples of research requiring full committee review include those in which subject identification or their results may cause risks in reputation, employability, financial status, or insurability.

1Brandt, AM. 1978. Racism and Research: The Case of Tuskegee Syphilis Study. Hastings Center Report 8(6): 21-29.
2Jones, JH. 1993. Bad Blood: Tuskegee Syphilis Experiment. Rev. ed. New York: Free Press.
3Annas, GJ, and Grodin, MA. 1992. The Nazi Doctors and the Nuremburg Code, Human Rights in Human Experimentation. New York: Oxford University Press.

Below are some additional helpful links for background into the purpose and structure of IRBs.

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