Is my “basic” research really a clinical trial?

Many of you may be following this through your professional societies, but if not this is an important change in federal policy that could potentially impact even “basic” research. The policy went into effect January 1 and is currently active. The following summary is from FABBS:

The new NIH policy on clinical trials┬ápotentially includes a good bit of basic science research. According to the policy, 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.” The policy requires registration of the research and results as well as good clinical practice training for investigators. It also affects funding opportunities and review of grant applications. There are criminal and civil penalties for noncompliance. Additional information can be found on the NIH blog here.

FABBS and other scientific societies are expressing their concerns over this broad definition/policy, but their objections do not seem to have gained much traction. They have created this site to compile information and resources. I will provide updates as I hear of them through FABBS; Robin Thomas is also her society’s FABBS contact and may have more information. Josh Magee also points out that the NIH provides examples to help one determine whether their research is included.