SOCRA- IRB

What is the IRB

A committee whose primary purpose is to protect the rights and welfare of human research participants.

At least how many members on IRB?

5

Responsibility of the IRB

Protect research participants and to evaluate whether a research project has met the regulatory and ethical requirements for the conduct of research.

3 people that must be on IRB

1 non-scientific, one scientific, one non-affiliated

Criteria for IRB Approval for Research

1) Risks minimized
2) Risks are reasonable in relation to beenefits
3) Equal selection of subjects
4) Informed consent sought
5) Informed consent documented
6) Plan in placed for monitoring data collection
7) Appropriate measures to maintain privacy
8) Protection for vulnerable subjects

SR / NSR

significant risk
non-significant risk
associated with medical devices

Can a device study begin without an IDE?

Yes, if initial assumption of NSR from sponsor is determined by IRB to be true

IDE

investigational device exemption

How log should IRB records be held on to? (They document everything from list of members to meting minutes, research proposals, etc.)

3years after completion of research