The Protocol Template for Behavioral and Social Sciences Research Involving Humans: A New Community Resource!

The Protocol Template for Behavioral and Social Sciences Research Involving Humans: A New Community Resource!

This blog was co-authored by Dr. Carrie D. Wolinetz, Director of the NIH Office of Science Policy (OSP). More information about OSP can be found here.

Dr. Carrie D. Wolinetz

Dr. Carrie D. Wolinetz

A few months ago, back in August 2018, we authored a blog letting the community know that we were working on a new resource for behavioral and social science researchers to prepare research protocols for human studies measuring a behavioral or social outcome or testing a behavioral or social science-based intervention. We are now happy to report back that the template has been finalized and is ready for researchers to utilize. Even better news is that the template has been fully integrated into the NIH’s Clinical e-Protocol Writing Tool!

As you may recall from our previous post, the Behavioral and Social Clinical Trials Template was derived from the successful NIH-FDA Phase 2/3 IND-IDE Clinical Trial Template but was adapted to include terminology and approaches used by behavioral and social scientists. While use of the template is not required, we would like to share a few of the reasons why we encourage investigators to take advantage of the benefits it affords.

TOP REASONS TO USE THE NEW BEHAVIORAL AND SOCIAL SCIENCES RESEARCH TEMPLATE

  • The template is an effective resource for communicating the science, methods, and operations of a clinical trial, thus allowing for standardization of procedures and guiding replication studies.
  • Consistent use of the template will reduce the chance for inaccuracies in study procedures that could potentially result in null or spurious findings.
  • It fosters training and accountability of study staff and allows for efficient review by peers and oversight bodies.
  • It assists investigators who are less familiar with the information and level of detail expected in a clinical protocol and fully adheres to the International Conference on Harmonisation E6 Good Clinical Practice guidelines.
  • Utilizing the template through the e-Protocol Writing Tool allows users to seamlessly send and edit protocol information directly to ClinicalTrials.gov.

These are just a few of the reasons that we are excited about this template and why we believe that it is such a valuable resource to the research community.

We also recognize that many researchers involved in clinical behavioral and social sciences research already prepare protocols, whether they be for submission to an Institutional Review Board or for an operations manual aimed at research staff. This template can also be an important tool for preparing those documents.

Finally, while the template is a suggested format for clinical trials that are testing a behavioral or social intervention or manipulation for which a stand-alone clinical protocol is required, the template can also be a useful tool for those trials funded by NIH Institutes or Centers that do not require stand-alone clinical protocols. Using the template to anticipate decision points and potential challenges before a study launches can help avoid delays down the road.

We encourage all our clinical behavioral and social sciences stakeholders to look at both the template document and the associated e-protocol writing tool. We think once you start using these resources you will see the value they offer. Also, we would appreciate any feedback users have on their experiences with the template and tool. These resources are meant to be "living" tools that will evolve based on feedback so that they are of maximum utility to the community.

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