The Institutional Review Board (IRB) is an official committee of Kessler Foundation, made up of scientists and nonscientists, whose function is to protect participants in research studies at Kessler Foundation and Kessler Institute for Rehabilitation (KIR). The IRB provides an independent review of all research studies involving patients and healthy volunteers at Kessler Foundation and KIR to assure 1) that potential risks to the research subjects are minimized and acceptable in relation to potential benefits and 2) that the subjects are given understandable information about the study so their decision to participate in the study is truly informed.
Since 1974, local IRB review and approval of a research study on humans has been required before the Federal Government will fund an institution to carryout the study. The FDA also requires IRB approval of any study that will be used by a manufacturer to support an application for approval to market a new drug or device. Kessler Foundation and KIR require IRB review and approval of all of their human research studies regardless of funding source.
Before a research study can be initiated at Kessler Foundation and KIR, it must first be submitted to the IRB for its review and approval. Only IRB members who are not involved in the study are allowed to vote on its approval. If the risks to participants are minimal in comparison to potential benefits and if the informed consent document is written in clear, non technical language, the study is approved. Many studies are conditionally approved pending changes requested by the IRB to clarify the language of the consent form so that potential research subjects can provide truly informed consent. Studies are approved for one year and must be re-evaluated by the IRB annually. Any changes to the study procedures must be reviewed and approved by the IRB before they are implemented. And any adverse events that occur to research subjects must be submitted to the IRB for its assessment of whether the event reflects a potential risk to other study participants.
The IRB is a crucial part of a system that protects participants in research studies. The leaders of Kessler Foundation and KIR have provided written assurances to the secretary of Health and Human Services that all human research carried out at these institutions will be performed with the highest ethical standards. The IRB’s role is to implement these assurances.