Social/Behavioral Research and Good Clinical Practice
In September 2016, the NIH expanded its definition of clinical trials to include social/behavioral research: “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.” The new definition may mean that studies not previously considered clinical trials will now meet the definition.
International Conference on Harmonisation Good Clinical Practice (ICH-GCP or just GCP) is the international gold standard for clinical trials. These are not federal regulations but best practice guidance. Due to the expanded definition of a clinical trial, we expect more social/behavioral research will be required to follow GCP. Many researchers at CHR are not familiar with GCP, so in 2017, Research Compliance established a work group to create materials for social/behavioral research that will help study teams navigate the standards.
The materials are posted on the Research Compliance website under Quality Improvement and Monitoring. They include an Investigator Guidance document, protocol deviation log, and training and delegation log. We updated our consent form template to comply with the new federal regulations and GCP. The consent form can be found on our website on the Forms and Templates page, as well as in the IRBNet, under the Forms and Templates tab.
The Investigator Guidance document covers GCP requirements, so if you are on a grant or have a protocol that requires the research to follow GCP, please use these tools. The Research Compliance Team (Melinda Allie and Andrea Seykora) is always available for consultation or to answer any questions.
Many thanks to the Social/Behavioral GCP Workgroup for helping create the materials: Andrea Seykora, Kaija Maggard, Mica Werner, Cheryl McGinley, Greg Clarke, Bobbi Jo Yarborough, Stefan Massimino, Michelle Henninger, Jen Rivelli, and Sara Gille.