NIH Issues Best Practices for Clinical Trials in Social and Behavioral Sciences

NIH Issues Best Practices for Clinical Trials in Social and Behavioral Sciences

The National Institutes of Health (NIH) has expanded the required training for NIH-funded investigators involved in clinical research. In September 2016, a notice titled “Good Clinical Practice Training for NIH Awardees Involved in NIH-funded clinical trials,” was published, outlining new educational requirements for clinical researchers, including behavioral scientists. This new policy emphasizes the importance that practicing good clinical techniques has had and will continue to have on the social and behavioral sciences.

NIH’s expanded policy became effective January 1, 2017, and requires that all clinical trial investigators and staff involved in the design, conduct, oversight, or management of clinical trials funded by NIH grants and/or contracts be trained in the principles of Good Clinical Practice (GCP). It is expected that this training is renewed every three years.

The NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

Up until this point, many of NIH’s efforts to police clinical trials were largely associated with traditional biomedical clinical trials. While ample training exists for drug, device-, or biological-related studies, researchers have found that training for GCP in clinical trials using behavioral and social science research has been lacking in comparison. The new policy stresses the application of GCP principles to clinical trials involving social and behavioral science.

The NIH developed its own online course after initiating a project in 2014 through the Clinical and Translational Science Awards (CTSA) Program in recognition of the need for training that applies GCP to social and behavioral research. To address this concern, the CTSA Program developed the Best Practices in Social and Behavioral Research e-Learning Course with the goal to enable learners to apply GCP principles to clinical trials that specifically relate to social and behavioral research.

The e-Learning course consists of nine easily accessible video course modules. The Society of Behavioral Medicine made the course available online to both members and nonmembers, though it can also be accessed through an institution’s learning management system. After completion of all nine modules, knowledge tests, and exercises, the system will produce a certificate of completion to print or save. This certificate fulfills the NIH requirements and is good for the three years before training is required again.

The NIH’s e-Learning Course provides social and behavioral researchers a way to learn and maintain the standards of psychology. By becoming competent in the principles of GCP, investigators can continue conducting clinical trials with integrity, assuring the safety of the subjects and the solidity of the science.

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