[visionlist] Proposed NIH Clinical Trials Definition To Affect Human Behavioral Studies

Vision Sciences Society vss at visionsciences.org
Mon Jun 5 12:10:48 -05 2017

Dear VSS Colleagues,   


The following message is relevant for our members in the US who work with
NIH funding. This concerns the implementation of a definition of clinical
trials by NIH that we believe would wrongly classify the work that many of
us do as clinical trials. Implementation of this new rule has many adverse
consequences for NIH, for you as a researcher, and for the public and their
access to actual clinical trials.   


Below we summarize the issue and then invite you to take action as an
individual investigator.   


Here is the definition: "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." (from
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). The
major concern revolves around the interpretation of "intervention", which is
stated as follows, "An intervention is defined as a manipulation of the
subject or subject's environment for the purpose of modifying one or more
health-related biomedical or behavioral processes and/or endpoints.
Examples include:  drugs/small molecules/compounds; biologics; devices;
procedures (e.g., surgical techniques); delivery systems (e.g.,
telemedicine, face-to-face interviews); strategies to change health-related
behavior (e.g., diet, cognitive therapy, exercise, development of new
habits); treatment strategies; prevention strategies; and, diagnostic
strategies." Psychophysical studies could seem to qualify.   


Here is the NIH website:
-research-policy/clinical-trials. If you think that these new guidelines do
not apply to your research, then please refer to the statement from the
Office of Behavioral and Social Sciences Research
ehavioral-and-social-science-researchers/.   It certainly indicates that the
definitions apply to the kind of human behavioral research that many of us


The definition of clinical trials is from 2014. People did not pay much
attention to it (certainly to what constitutes an "intervention" and other
terms in the definition) until the new clinical trials policies came out
this year, implementing the 2014 definition. Clearly this new policy has
far-reaching consequences. Members of the Board know of colleagues who are
already affected by this new rule.   


Dr. William Riley, Director of the NIH Office of Behavioral and Social
Sciences Research, is working to modify this definition by collecting
information over the next few days. We urge you to send a personalized email
to him ( <mailto:william.riley at nih.gov> william.riley at nih.gov). This is
urgent. Dr. Riley plans to speak to Francis Collins, the Director of NIH, in
the next few days.   


We want you to know that the VSS Board of Directors will be sending a letter
on behalf of the membership, and we encourage each of you who are supported
by NIH funding to email a letter as well.  Numbers count. Below is
representative text that spells out the problems entailed by this new
definition. We encourage you to revise the text with examples of how this
new policy will affect your research.   




Eli Brenner, David Brainard, Lynne Kiorpes, Jeff Schall, Preeti Verghese,
Andrew Watson, Mike Webster, Laurie Wilcox, Jeremy Wolfe           






William Riley  


 <mailto:william.riley at nih.gov> william.riley at nih.gov   


Dear Dr. Riley; 


As an NIH sponsored investigator, I would like to register my concern about
the NIH Definition of Clinical Trials. My research encompasses the breadth
of topics in modern vision science, from visual coding to perception,
recognition and the visual control of action, as well as the recent
development of new methodologies from cognitive psychology, computer vision
and neuroimaging. Most of this work is basic research, using humans as
experimental observers. My research provides fundamental data that can be
applied to health-related issues from diagnosis and treatment of ocular and
nervous system disorders to driving safety and medical image perception.
These studies are not 'clinical trials' in the normal understanding of that
term but the new NIH definition could put that label on a substantial body
of my work. I believe that this would produce multiple negative effects


1)   There is important clinical work in vision science. Some of this work
leads to clinical trials of the sort listed on public-facing sites such as
clinicaltrials.gov. Classifying basic human research as clinical trials can
confuse the public about the nature of the clinical trials. Note that we are
not opposed to scientific openness. The public has a right to know what the
NIH is funding, but defining clinical trials too broadly does not advance
that goal. 

2)   Diluting the clinical trials databases with studies that are not
clinical trial will make it less likely that members of the public will be
able to find and enroll in true clinical trials. 

3)   Because the public will not appreciate the subtleties of the new
definition of 'clinical trial', this will hold the researchers and the NIH
up to public ridicule for claiming to be doing 'clinical trials' of matters
that are clearly not clinical issues. 

4)   This will dilute NIH oversight of real clinical trials that should be

5)   This will add to the bureaucratic burden for researchers and their

6)   We have a particular interest in researchers at smaller institutions
that may not have administrative support to guide researchers through the
increased burden. 

7)   Grant review will be significantly disrupted by the requirement that
"clinical trial" grants must be reviewed by study sections that review
"clinical trials".   


Therefore, I urge you to seek clarification of the definition. We trust that
a clarification would limit the definition of clinical trials to the
appropriate and sensible subset of NIH research.   







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