NIH Request For Public Comment (NOT-OD-18-167)


Draft Protocol Template for Behavioral and Social Sciences

The National Institutes of Health (NIH) developed a template for NIH funded investigators to use in writing protocols for behavioral and social sciences clinical trials

The protocol template was developed for these purposes:

§to use as a tool for communicating the science, methods and operations of a clinical trial

§to guide training and accountability of study staff

§to allow for efficient review by peers and oversight bodies

§to ensure adherence to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice (GCP) guidelines

§to guide replication studies

Given the variations of intervention approaches and designs in the behavioral and social sciences, the NIH wants to encourage comments from a broad and diverse range of investigators on this draft protocol template.

Note: The template is a suggested format for clinical trials that are testing a behavioral or social intervention or experimental manipulation.  Use of the final version of this standardized protocol template will be encouraged but will not be required.

The deadline for submission of comments is October 11, 2018

§comments must be submitted electronically at:

For additional details, please review the August 27, 2018 NIH Notice (NOT-OD-18-167).

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