http://www.brockport.edu/irb/
Research Involving Human Subjects
Review of Risk and Protection from Harm
http://www.brockport.edu/irb/
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
http://www.brockport.edu/irb/
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.
http://www.brockport.edu/irb/
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).
http://www.brockport.edu/irb/
Why Must IRB Review?
Federal and state laws require the review.
Reviewers must monitor the risk for human participants according to federal guidelines.
College policy requires rights and welfare of participants is adequately protected.
http://www.brockport.edu/irb/
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.
http://www.brockport.edu/irb/
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
http://www.brockport.edu/irb/
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.
http://www.brockport.edu/irb/
Resources
http://www.brockport.edu/irb/ http://www.brockport.edu/forms/grant
/guidelines.html Email: [email protected] Phone (585) 395-2524 Fax (585) 395-2006