POLICY STATEMENT

The IRB will determine that the following requirements are satisfied in order to approve research for initial and continuing review and review of modifications to research:

• Risks to subjects are minimized by using procedures that:
  • Are consistent with sound research design and which do not unnecessarily expose subjects to risks;
  • Are already being performed on the subjects for diagnostic or treatment purposes.
• Risks to subjects are reasonable in relationship to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.

When making the above determination the IRB should consider physical, psychological, social, legal, and economic sources of risk. For risk-benefit determinations the IRB should consider only those risks that may result from the research itself and not risks from procedures subjects would receive if not enrolled in the research. The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. Investigators are responsible for supplying requested information to the IRB for the IRB to make this determination. (See PRO127 Procedure for Determination that Research Risks to Subjects Are Minimized.)

Investigators, in accordance with relevant standards of their discipline, will conduct studies using sound research design, which includes minimizing risks to subjects under the requirements of this policy. Study designs should monitor subjects sufficiently to detect harm promptly. An investigator will not implement a change in the IRB-approved research protocol without prior IRB approval, except to eliminate an apparent immediate hazard to a research subject. Such changes must be reported to the IRB and FDA, if applicable, within 5 working days.