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

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.


  • 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 (ICH) E6 Good Clinical Practice guidelines.
  • Utilizing the template through the e-Protocol Writing Tool allows users to seamlessly send and edit protocol information through the e-Protocol Writing Tool allows users to seamlessly send and edit protocol information directly to

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 IRB or for an operations manual aimed at research staff.  This template can also be an important tool for preparing those documents.

While the template is a suggested format for clinical trials that are testing a behavioral or social intervention or manipulation it can be an effective tool to help anticipate decision-points and potential challenges before a study launches, thus helping avoid delays down the road.

We encourage all of our clinical behavioral and social sciences stakeholders to take a 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.

This blog was co-authored by Dr. William Riley, Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR). More information about OBSSR can be found at

William Riley
Director of the NIH Office of Behavioral and Social Sciences Research

GDPR: Crossing the Data Sharing Bridge, One Regulation at a Time

Like most of you, my personal email last summer was filled with fun invitations, the latest news….and tens to hundreds of emails from companies highlighting new privacy policies, notices, and updates. Behind the immense number of notifications that “we’ve updated our privacy policy” was a new regulation and one of the defining science policy issues of the last decade: the tension between participant privacy and open data sharing.

When it comes to data sharing and biomedical research, most of us have a horse in both races. We want to know and have some control over how our personal data is accessed and shared, and we understand that open science—where researchers share data as freely as possible with other researchers—can skyrocket our ability to find better treatments and cures for patients, which helps us all. Balancing and respecting these different values is complicated. NIH has spent a lot of time and resources staying attuned to participant interests in privacy and autonomy while charting a path that allows for responsible open science and data sharing.

The European General Data Protection Regulation (GDPR) enacted in May last year is the latest regulation on the privacy and data policy block, As Europe’s answer to navigating today’s data-filled, breach-full and not-always-regulated online and business world, GDPR mandates a high level of personal data protection and autonomy for people in the European Economic Area (EEA). GDPR defines personal data broadly—from name and email address to special categories such as health and genetic data—and provides people in the EEA with control over when and how their personal data is collected, retained, passed along, and used. So, given that GDPR was written to protect people in the EEA from data and privacy breaches, and not intended to target biomedical research—where significant protections for individual privacy and the concept of explicit consent already exist—why has the onset of GDPR created barriers for critical research collaborations between NIH grantees and their European research partners?

Not surprisingly, the answer has to do with both GDPR itself and with individual reactions to GDPR. GDPR is not directed at biomedical research, but it does regulate the use, processing, and transfer of personal data collected in the EEA for clinical and observational research. There are legal pathways under GDPR for data collected in the EEA to be transferred to, used and processed in other countries. Unfortunately, understanding how to translate the legalese of these pathways into practice has been confusing, and the costs for non-compliance are high—most recently €50 million for Google in France. As a result, risk-adverse interpretations of GDPR have dominated collaboration discussions between EEA and U.S. research partners and led to delays in EEA-U.S. collaboration. In the absence of an official recognition that U.S. laws ensure an adequate level of protection (an “adequacy decision”), and with the NIH unable to use standard, GDPR-approved data protection clauses (as they conflict with U.S. law for federal agencies), the NIH is exploring GDPR’s other legal options for data sharing. These include relying on explicit consent from participants, defining data transfer as being in the “public interest,” and adherence to an approved, sector-specific code of conduct (to date unwritten). A code of conduct is particularly compelling, as it should serve as an implementation manual, providing clear, concise guidance to EEA and non-EEA researchers and research institutions on how to ensure GDPR protections for personal data when collaborating.

Given the current uncertainty, and the likelihood that any “solutions” to GDPR for biomedical research will take time, what does all this mean for NIH-funded researchers now? Fundamentally, it means that it is never too early to begin the time-consuming but necessary data privacy and data sharing discussion with potential collaborators in the EEA. While such discussions are leading to glimmers of light at the end of tunnels for currently halted collaborations, it sure would be preferable to resolve issues before research is scheduled to begin. We are interested in hearing from you about any GDPR-related problems or resolved issues and will certainly keep you updated on our experiences. In the midst of all this work, I am reminded that GDPR presents us with great opportunities as well as challenges. If we can harmonize consent and data sharing between U.S. and EEA researchers, we will be able to pool analysis of genomic and other health data and tissue samples, powering new and innovative trials and advancing the science of the future.