What are the responsibilities of the HSRB?
In accordance with Title 45 of the Code of Federal Regulations, Part 46.111, in order to approve research, the HSRB must determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the HSRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The HSRB should not consider possible long-range effects of applying knowledge gained in the research
