Information about Human Volunteers in Research
Assessment of Risks and Benefits
All parties in human subjects research make an assessment of risks and benefits. For the Principal Investigator, it is a means of determining the proper protocol for protection of human subjects. For the IRB, it is a method for determining whether the risks are minimized and justified. For potential study subjects, this assessment will assist in them determine whether or not to participate in the research.
The most likely harms to research subjects are usually physical or psychological, such as injury or pain.
Risks and benefits of research may affect individual subjects, their families, or groups of society at large. It is required that the IRB will determine that the benefit to the subjects and/or to society as a whole will outweigh the risks before it will provide its approval.
A systematic, non-arbitrary analysis of risks and benefits must be made. This means that there must be an assessment of all aspects of the research, as well as a systematic consideration of alternatives. There should be a determination of the validity of the presuppositions of the research, followed by an assessment of the probability and magnitude of the risks. The IRB must determine that the risks are reasonable in relation to the benefits that may accrue from the research before its approval.
There are other considerations that should be assessed when determining risk and benefits.
June 1, 2010