The IRB Member Handbook deliniates the role of the Harvard Universtiy Area IRB Member.

In short, IRB members review research proposals in an electronic application system called ESTR.  The board discussion is focused on making sure the study design and procedures meet a set of eight regulatory criteria required for IRB approval.   In brief, those are:

• Research design is sound and study hypothesis is reasonable Risks to subjects are minimized
• Risks to subjects are reasonable in relation to anticipated benefits
• Selection of subjects is equitable.
• Informed consent is obtained or appropriately waived from all prospective subjects and documented
• The research protocol includes a plan for data and safety monitoring
• Subject’s privacy and confidentiality are protected
• Appropriate additional safeguards are incorporated for any vulnerable subjects