Notice Number: NOT-OD-18-167

Key Dates
Release Date: August 27, 2018
Response Date: October 11, 2018

Issued by
National Institutes of Health (NIH)

Purpose

Background

The National Institutes of Health (NIH) is developing a template with instructional and example text for NIH funded investigators to use in writing protocols for behavioral and social sciences clinical trials.

The protocol is meant to be 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, and to ensure adherence to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines, and to guide replication studies. It was created to guide investigators through the systematic development of a comprehensive protocol, especially for investigators less familiar with the information and level of detail expected in a protocol. This protocol 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. NIH Institutes and Centers (ICs) have tailored, risk-based procedures for ensuring rigorous and ethical conduct of NIH-funded clinical trials which may include development of a stand-alone protocol in a specific format for some studies. Even for clinical trials for which a stand-alone protocol is not required, this protocol template may be a useful tool for considering decision-points and potential challenges before a study launches, so that comprehensive planning can ensure smooth and systematic study operations.

Information Requested

The NIH is seeking public comment on the draft protocol template available at: https://osp.od.nih.gov/rfc-behavioral-social-sciences-studies/. We welcome feedback from investigators, investigator-sponsors, institutional review board members, and any other stakeholders who are involved in the conduct or oversight of behavioral and social sciences research. We particularly welcome perspectives on how to maximize the utility of the protocol template, where the instructional and example text could be clearer, and how to be sure that the template accommodates the full range of behavioral and social intervention studies (including experimental manipulation studies). The NIH will include the final version of this template when it becomes available, in the NIH electronic Protocol Writing Tool, to dynamically guide users through steps to write protocols for behavioral and social sciences clinical trials.

How to Submit a Response

Comments may be submitted at https://osp.od.nih.gov/rfc-behavioral-social-sciences-studies/. Responses will be accepted through October 11, 2018. The NIH will consider public comments before taking next steps.

This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the government. The government will not pay for the preparation of any information submitted or for the government’s use of that information.

The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. The information provided will be analyzed, may appear in reports, and may be shared publicly on an NIH website. Respondents are advised that the government is under no obligation to acknowledge receipt of the information or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s), policies or procedures.

Inquiries

Please direct all inquiries to:

NIH Office of Science Policy
SciencePolicy@od.nih.gov