Research Involving Human Subjects Review of Risk and Protection from Harm

What is human participants’ research?  Systematic investigation  Collection of new data  Use of existing data  Use of data  Contributing to knowledge  About live human beings

Mission of IRB  Facilitate ethical research  Review of proposals in assisting the research to ethically proceed  Collegial and supportive interactions with investigators  Evaluation of the benefits of research with no or minimal risk to participants.

The IRB Committee is composed of members who are:  Faculty from varying disciplines across the campus.  One faculty member who serves as IRB chair.  Representatives from the community.  A compliance officer (non-voting).  An IRB administrator (non-voting).

Why Must IRB Review? FFederal and state laws require the review. RReviewers must monitor the risk for human participants according to federal guidelines. CCollege policy requires rights and welfare of participants is adequately protected.

Collaborative Process  IRB is charged to review risk to participants.  Investigators develop research procedures that protect participants’ rights, while meeting research objectives.  Reviewers strive for flexibility and individuality in the review of each research project.

How is the proposal reviewed?  Risk vs. benefits  Equitable selection of participants  Equitable recruitment of participants  Soundness of research design vs. risk to participants  Informed consent process  Privacy and confidentiality  Special populations  Consistency throughout all aspects of the proposal

Project Categories  Category #1 Exempt – presents no possible risk to participants.  Category #2 Expedited – presents minimal risk to participants.  Category #3 Full Review – presents potential for harm to participants, violates rights, or requires special protections.

Resources   nt/guidelines.html nt/guidelines.html   Phone (585)  Fax (585)