All of the University’s human subject activities and all activities of the IRB are guided by the basic ethical principles that underlie the conduct of biomedical and behavioral research involving human participants set forth in the report of the National Commission for the Protection of Human Participants of Biomedical and Behavioral Research, The Belmont Report:  Ethical Principles and Guidelines for the Protection of Human Participants of Research, regardless of funding source.  The three basic principles contained in The Belmont Report central to the ethics of research involving human participants and guiding the IRB in assuring that the rights and welfare of participants are protected include: respect for persons, beneficence and justice.

Respect for persons requires that potential participants be given the opportunity to choose what will or will not happen to them and is the principle upon which obtaining informed consent and the consent process (including information, comprehension and voluntariness) is based.    Respect for persons also provides additional protections for potentially vulnerable participants.

Beneficence is exemplified in the expressions of “do no harm” and “maximize possible benefits and minimize possible harms”, both on the individual investigator and societal levels, as they extend both to particular research projects and to the research enterprise as a whole, respectively.

Justice requires that there be fair procedures and outcomes in the selection of participants, both individually (by offering potentially beneficial research to all who might benefit) and socially (based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons).

While not explicitly stated in the Belmont Report, an additional principle of Scientific Integrity also guides the IRB in its actions.  This principle requires clarity around research processes sufficient to allow for an adequate evaluation of the impact the research may have on human participants and right conduct on the part of those implementing the research to assure ethical behavior.

General Information on the IRB:

Principal Investigators (PIs) are responsible for the preparation of applications and for the content therein.  Applications are reviewed by (a) a faculty member’s department head and two IRB representatives (in the case of an expedited or exempt application), or by the entire board if deemed necessary to the IRB reviewers.  If approved, the OSRP will notify the PI of the Board’s disposition.  Approvals are for a one year period, unless a shorter interval is specified by the Board.  Projects requiring full Board review are required to submit quarterly project progress reports.  Once projects are completed, PIs submit a Completion of Research Activities report to the OSRP .

Previously approved projects may be modified by the PI by submitting a new application cover sheet and a detailed description of the modifications/changes being made to the IRB Chair.  If the Chair determines that the changes to the application significantly impact the risk/benefit ratio, he/she may require the PI to submit an entirely new application for review.  If the risk/benefit ratio remains relatively unchanged, the IRB Chair can approve such changes without other review

Reports of adverse events must be reported immediately via phone, email, or in person to the IRB Chair and to the Office of Sponsored Research and Programs.  A written report of the adverse event must then be submitted to the IRB Chair and OSRP, within 5 working days after first awareness of the problem.

The IRB is responsible for the following activities:

• Conduct initial and continuing review of research with human participants and report the findings and actions to the PI in writing;
• Determine whether any given project requires more than an annual review. Considerations used in making these determinations include the absolute risk to the subject, whether the risks outweigh the benefits, and prior conduct of the investigator(s) regarding the protection of human research participants.
• Review proposed significant changes in research activities to ensure that the protection of human research participants is maintained.
• Collaborate with the OSRP to investigate any actual or suspected adverse event or incident of noncompliance.
• Observe project activities at any point to ascertain whether human subject protections are implemented so as to reduce the likelihood of an adverse event or noncompliance.