Evaluating Scientific Validity
Many IRB members have asked whether or not they are to review the science in a proposed project.  IRBs must determine whether the risks are reasonable in relation to the importance of the knowledge that may be expected to result from the project.  If the science is not good, the corresponding expectations of important knowledge are slight.  The research design (i.e., the science) must be reviewed in order to determine that the risks are minimized and reasonable in relation to the anticipated benefits.  If a study is assigned to you and there are questions about the scientific design of the study which you feel need additional input, please contact the IRB office so that a consultant in the area being researched may be requested to assist you with the review.  Scientific review, to meet the IRB’s regulatory obligations, requires looking for procedures consistent with sound design, making sure that the scientific methods proposed in the project will yield knowledge, and then weighing the importance of that knowledge against the risk.

Jennifer Sharp, J.D.
March 30, 2005