LSA solicits ClinicalTrials.gov responses | Matt Goldrick on behalf of the Linguistic Society of America

[Below is a guest post by Matt Goldrick on behalf of the Linguistic Society of America]

Over the past decade the lack of transparency in research – and its implications for the reproducibility of research findings – has been a major focus of scientists and funding agencies (see previous discussions on LanguageLog here, here, here). This has led to many exciting developments in the social sciences including the founding of no-fee platforms for sharing and pre-registering studies (e.g., the Center for Open Science, AsPredicted) and new professional sciences promoting transparent, open research practices (e.g., the Society for the Improvement of Psychological Science). These positive developments have, unfortunately, lead to an overzealous reaction from the US National Institutes of Health (NIH) which is likely to hamper basic science (more info below). The LSA, in partnership with other research organizations, is asking for your help in pushing back against policies that could hamper the work of NIH-funded linguists.

Background: The NIH decided to address issues of transparency by expanding the use of ClinicalTrials.gov, a mechanism for reporting the design and results of medical research studies. The definition of a “clinical trial” was revised as follows:

“A research study in which one or more human subjects are prospectively assigned to one or more interventions … to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

These terms are so vague (“behavioral outcome”) as to potentially apply to most if not all basic science research. This overapplication of a medical model provoked strong pushback from individual scientists and professional societies fearing a greatly increased bureaucratic burden and, most critically, potential roadblocks to supporting basic science research (by restricting the types of funding opportunities these “clinical” studies can be supported by).

The feedback from basic scientists lead to a seemingly productive dialogue with the NIH and, importantly, a provision in the 2018 omnibus spending bill that directed the NIH to delay implementation of the new rule and consult with the research community. (The Federation of Behavioral and Brain Sciences [FABBS] has a comprehensive overview of the debate.)

Where the LSA needs your help: As directed by Congress, the NIH has delayed enforcement of the rule and is requesting input from the community. However, they have also made it clear that they are not backing down from their approach to these issues. We want to make sure the NIH hears from all the scientists that might be impacted. For example, you might want to review the interventional study protocol template to see what you’d be expected to enter when registering you basic science study.

To be clear, our community embraces transparent and open research practices, but there is real concern ClincalTrials.gov is not the proper mechanism for implementing these principles in basic science research. The window for such comments is relatively short (ends November 12), so please respond quickly. You can find information about how to do this here. Thanks for your help!

[Above is a guest post by Matt Goldrick on behalf of the Linguistic Society of America]