The National Institutes of Health (NIH) has launched a new protocol template to help behavioral and social science researchers prepare research protocols for human studies measuring social or behavioral outcomes.
The protocol template is an effective resource for communicating the science, methods, and operations of a clinical trial, to allow for efficient review by peers and oversight bodies, to facilitate reporting of information into ClinicalTrials.gov, and to guide replication of studies. Use of the template will also help ensure adherence to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines. The template will be especially helpful for investigators less familiar with the information and level of detail expected in a clinical protocol. While use of the template is encouraged, it is not required.
This template was based upon the NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template but is tailored specifically for clinical trials with a behavioral or social intervention or manipulation. As with the Phase 2 and 3 template, the behavioral and social template has been fully integrated in the NIH Clinical E-Protocol Writing Tool. The Clinical E-Protocol tool allows multiple collaborators to author protocol documents and then submit them to ClinicalTrials.gov or the NIH IC(s) funding the study.
To learn more about the importance of this new resource please see the latest “Under the Poliscope” blog authored by Dr. Carrie D. Wolinetz, Acting NIH Chief of Staff and Associate Director for Science Policy and Dr. William Riley, Associate Director for Behavioral and Social Sciences Research.
Questions may be sent to the NIH Office of Science Policy at SciencePolicy@od.nih.gov