[CogSci] Fwd: NIH's Plans Relating to Clinical Trial Policies Affecting Basic Science: New Developments

[Terry Regier]

The following announcement is forwarded from Paula Skedsvold of FABBS.


FABBS Member Societies and Affiliates:



For almost a year now, FABBS has led an effort to express the concerns of
basic scientists in our communities about their research being subjected to
a number of clinical trial policies at NIH. On May 2nd, a small group of
organizations and scientists were invited to meet with NIH's Deputy
Director, Larry Tabak, to discuss these concerns. The following
participated in the meeting and laid out the concerns of our respective
communities:



Paula Skedsvold – Federation of Associations in Behavioral & Brain Sciences
(FABBS)

Lisa Nichols – Council of Government Relations

Sarah Brookhart –  Association for Psychological Science (APS)

Mike Hall – Consultant for APS

James J. Pekar - Kennedy Krieger Institute & Johns Hopkins University

Jennifer Dreyfus – Consultant for American Society for Investigative
Pathology



*Call in:*

Jeremy Wolfe – FABBS / Harvard Medical School

Jennifer Lodge – Washington University in St. Louis

Laura L. Namy - Society for Research in Child Development

Judith Siuciak -  American Society for Pharmacology and Experimental
Therapeutics

Alyson Lewis – Consultant for APS

Howard Kurtzman—American Psychological Association

Patricia Kobor – American Psychological Association



Yesterday, we received word from Larry Tabak that NIH had developed a plan
to “address the shared interests of involved stakeholders” and that NIH was
“prepared to move forward so that [they] can widely communicate the delayed
enforcement and lenient implementation described in the plan.”



NIH’s plan to address the concerns about the reach of the clinical trials
policies is attached. It looks very promising, but of course, the devil is
in the details, and many of those details are not yet known. Here’s what we
know:



(1)  NIH will delay enforcement of a registration and reporting system for
basic science involving humans until July 1, 2019.


(2)  NIH will allow scientists to register and report their basic science
research involving humans through other portals such as Open Science.
Eventually, NIH will pull data elements from these portals in order to
track what they fund and comply with their own reporting requirements to
Congress.


(3)  A Request for Information (RFI) will be released soon so that NIH can
get feedback on what reporting standards are appropriate for the range of
basic science research involving humans. *FABBS will respond, and we
welcome input from our member societies and affiliates. Once the RFI is
released, we will share it with you and seek your input. *


*(4)  *NIH will be “flexible” and “lenient” with regard to enforcement of
other clinical trial policies for basic science. Although NIH’s plan is not
specific, presumably this applies to the requirements that basic scientists
whose research was defined as a clinical trial respond only to clinical
trial FOAs and take good clinical practice training. NIH had previously
told us that Review would not change for basic scientists responding to a
clinical trial FOA. *We would welcome feedback from our community about the
last two review cycles, although NIH’s new plan may also alleviate the
concerns.*


(5)  NIH will issue a Basic Science Parent FOA by October 30, 2018. *We
will interact with NIH over the coming months regarding this since it will
be important to our sciences as the policies evolve. *



What is still uncertain is how NIH will define basic science vs. a clinical
trial. The plan itself references “basic science trials,” “public health
trials,” and “prospective interventional human trials.” *We will continue
to interact with NIH to ensure that the definition of a clinical trial does
not continue to capture basic science research involving humans. *



For now, we consider NIH’s plan and engagement with us to be a very
promising step. In addition, NIH’s plan (to be described in a NIH Guide
Notice, which we will circulate to you) to be flexible and lenient in its
implementation of the clinical trial policies as they relate to basic
science studies should provide some reassurance to the basic science
communities that FABBS represents.



If you have any comments or questions at this time, please let us know. And
feel free to share the news with your membership!



Best,

Paula Skedsvold, JD PhD

FABBS Executive Director

pskedsvold at fabbs.org



and



Jeremy Wolfe, PhD

FABBS Past-President

jwolfe at partners.org
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