What is the IRB’s policy on human subjects training for investigators and research staff?

Question:  

What is the IRB’s policy on human subjects training for investigators and research staff?

- Research coordinator, medical practice

Response: 

In order to approve research, the IRB needs to determine that the risks to subjects are minimized by using procedures consistent with sound research design, consent will be obtained in accordance with the regulations, and that selection of subjects will be equitable. With greater than minimal risk research, involving investigators and research staff who are qualified by specific training and experience generally minimizes risk in a manner that does not affect the soundness of the research design. Training and experience is also generally required for legally effective informed consent, and generally required for equitable selection.

Although many institutions have baseline training requirements, there is no "one-size-fits-all" training that meets the needs of all research. Baseline requirements may be unnecessarily burdensome for some research, such as minimal risk community-based participatory research. Baseline requirements are rarely sufficient for all research, because they do not take into account specialized training that may be required and ignore the important aspect of experience.

In all cases, the IRB will evaluate the training and experience of the investigator in the context of the research being reviewed and determine whether that is sufficient to meet the regulatory criteria for approval.

About the Author

Jeffrey Cooper, MD, MMM | Process & Strategic Improvement

Dr. Cooper is a physician trained in pediatrics, pediatric pulmonary disease, and nuclear medicine. During his academic career, Dr. Cooper was a basic science investigator, clinical investigator, IRB chair, and hospital administrator. He left medical practice in 2002 to help start the Association for Accreditation of Human Research Protection Programs, Inc. (AAHRPP) where he was responsible for the development and operation of the accreditation process. Prior to that, Dr. Cooper was associate medical director at Albany Medical Center where he was responsible for utilization management and quality improvement. At WCG, Dr. Cooper specializes in combining his management and regulatory experience to create systems that promote clinical research while meeting regulatory requirements and high ethical standards.

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