#  IRB Member Handbook 

 



The [IRB Member Handbook](/file_url/138) deliniates the role of the Harvard Universtiy Area IRB Member.

In short, IRB members review research proposals in an electronic application system called [ESTR](https://irb.harvard.edu/). The board discussion is focused on making sure the study design and procedures meet a set of [eight regulatory criteria required for IRB approval.](http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.111) 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