IRB Risk Versus Benefit Analysis
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Minimal Risk
The probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in everyday life or during performance of routine physical or psychological examinations or tests.
Risk
The probability of harm (physical, psychological, social or economic) occurs as a result of participation in the research study.
Benefit
A valued or desired outcome; an advantage.
The HSRB must:
1. identify risks associated with the research, as distinguished from the therapies the subjects would receive if not participating in the research.
2. determine that risks will be minimized to the extent possible.
3. identify probably benefits derived from the research.
4. determine that risks are reasonable in relation to the benefits to the subject and the importance of knowledge gained.
5. assure that potential subjects are provided with fair and accurate descriptions of risks and discomforts and the anticipated benefits.