You are here

Action Alert: NIH “Clinical Trials” Definition”

US capitol dome and words action alert on blue background

As Chair of SPSP’s new Government Relations Committee, I want to call your attention to an Action Alert issued by our advocacy partner, the Coalition of Social Science Associations. It’s pertinent that the social and behavioral sciences have a strong showing with providing input into the Request for Information seeking input specifically on registering and reporting of basic science studies involving human participants. Comments are due by November 12.

Please see the information below and provide input by the deadline date. COSSA provides an easy method and sample language to use, sot he whole process takes just a few minutes.

Thanks,

Yolanda Niemann

Chair, SPSP Government Relations Committee

PS… please sign up for COSSA’s Washington Update to stay abreast of pertinent issues affecting our field.

 

ACTION ALERT: Register Your Concerns About the Problematic NIH “Clinical Trials” Definition

October 17, 2018

As COSSA has been reporting, the National Institutes of Health (NIH) has been taking steps in recent years to enhance its stewardship of and increase transparency over the clinical trials it funds. This has included the development of a new, expanded definition of the term “clinical trial.” According to the NIH definition (released in 2014), a “clinical trial” is:

“A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

In other words, research that involves a prospective experimental manipulation of an independent variable would fall under the definition of a clinical trial and trigger the need for researchers to adhere to a number of new registering and reporting requirements using clinicaltrials.gov. Many basic behavioral and social science studies will be caught up in these new requirements.

COSSA and countless other advocates have been working for more than a year to convince NIH to reconsider the definitional change and develop registration and reporting procedures—separate from clinicaltrials.gov—that are more suitable for basic research studies involving human subjects. Although some marginal changes have been made in response to community pressure, we still have major concerns.

We need your help!

The latest development is the release of a Request for Information (RFI) seeking public input specifically on registering and reporting of basic science studies involving human participants. Comments are due by November 12.

However, COSSA’s concerns go well-beyond the issues of registration and reporting of research findings. We fundamentally object to the revised “clinical trials” definition and the impacts it can have on recasting basic science studies as clinical trials going forward.

Therefore, we are asking for your assistance in responding to the RFI to register your concern about the expanded definition. Scroll down for step-by-step guidance as well as sample language you can use in submitting your comments. Note that responses can only be submitted using an online form that limits entries into the comment boxes to 500 words.

Thank you in advance for taking action on this important issue. Should you require additional information, background, or guidance, do not hesitate to contact the COSSA team. You can also find additional information in COSSA’s coverage of the issue.

Remember, November 12 is the deadline for comments. Spread the word!

Click here to see COSSA’s 4 Easy Steps to Act

Announcement Categories: 
Sidebar Items: 
Sidebar: Convention