ABA Family Legal Guide

Health-Care Law

Regulating Health-Care Professionals

Research on Humans

How does an IRB make its decision?

It is the job of the IRB to assess the "danger" and merit of the research. The IRB must make seven findings in order to approve a research program:

1. The risk to subjects must be minimized as much as possible.

2. The risk to subjects must be reasonable compared to the benefits.

3. The selection of the subjects must be unbiased.

4. Each potential subject must be given adequate information to determine whether he or she wishes to participate.

5. The informed consent must be documented.

6. The data must be adequately monitored.

7. Subjects' privacy must be protected and their personal data must be kept confidential.