Update on the NIH Definition of Clinical Trials and New Resource Unveiled

April 12, 2019

FABBS members will recall a consequential decision that the National Institutes of Health (NIH) made in 2016, resulting in a new clinical trial definition capturing basic research that had not been previously considered clinical. If you need a refresher on the topic, or why this is a problem and what has happened over the past couple of years, there are some resources at the end of this article. You can also watch a new talk about the issue by FABBS Immediate-past-President, Jeremy Wolfe, ‘Changing the Definition of Clinical Trials.’

Enforcement of the new clinical trials policies and procedures has been delayed until September 24, 2019. This was the result of a congressional directive (pages 34-35) to NIH. Since this announcement last summer, NIH has been assessing “its approach to registration and results reporting for prospective basic science studies involving human participants, while delaying enforcement.”  To date, NIH has not announced a reaction to the comments from the community, which had a submission deadline in November 2018.  FABBS joined other scientific and academic organizations in urging the NIH to reconsider the underlying definition.  

FABBS has received numerous reports that this new definition is creating confusion and burden in the field. Accordingly, FABBS leadership and members regularly update policymakers on Capitol Hill and engage with NIH officials and stakeholders to share information and explore more suitable reporting requirements for basic research. FABBS will continue to work towards a solution that will meet our three goals:

  1. Promote responsible registering and reporting of all federally funded research, especially research involving human volunteers.
  2. Avoid confusion, misunderstanding, and unintended consequences arising from the overly broad definition of “clinical trials”.
  3. Support the development of reporting requirements and portals that are appropriate to the science being reported and that foster better science.

While the community awaits a response from the NIH, the agency is taking other steps to help scientists navigate the complicated, and in some cases, unfamiliar, process of developing a comprehensive clinical protocol.  On March 28, Dr. William Riley, Director of the NIH Office of Behavioral and Social Science Research, unveiled a new template to help scientists who are designing studies, particularly basic behavioral and social science research studies, in which one or more independent variable(s) are manipulated for the purpose of understanding some health-related aspect of functioning. While use of the template is not compulsory, the NIH believes there are several reasons why scientists should be motivated to use it.  Those reasons include facilitating the standardization of procedures and guiding replication of studies, reducing likelihood of inaccuracies in study procedures, fostering training and accountability of staff, and improving review by peers and oversight bodies. The template and its accompanying e-protocol writing tool will allow users to edit and submit their information directly to clinicaltrials.gov.

The NIH is very enthusiastic about the template’s potential, and Dr. Riley encourages users to share their feedback and also suggests the agency is amenable to refining the template and writing tool.

More information is available at: https://osp.od.nih.gov/2019/03/28/protocol-template-behavioral-social-sciences-research-involving-humans-new-community-resource/.

If you have questions or comments about the NIH Clinical Trial policy, FABBS continues to be a clearinghouse for those concerns. Please reach out to Juliane Baron at jbaron@fabbs.org.


Mike Lauer and William T. Riley, November 28, 2018. New Funding Opportunities for Basic Experimental Studies Involving Humans

Wolfe, J. M. (2018). In dialogue with the NIH on clinical trials policy. Nature Human Behaviour, 2(2), 100-102. doi: 10.1038/s41562-018-0303-x

Wolfe, J. M., & Kanwisher, N. G. (2017). Not your parent’s NIH clinical trial. Nature Human Behaviour. doi: 10.1038/s41562-017-0262-7

“NIH Outlines Plan to Address Basic Scientists’ Concerns” (June 29, 2018) http://www.fabbs.org/2018/06/29/nih-outlines-plan-to-address-basic-scientists-concerns/