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

Vision Sciences Society vss at visionsciences.org
Mon Jun 5 13:10:48 -04 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
<http://r20.rs6.net/tn.jsp?f=001_hbD42GADR2PAjAazUQZy_imHEga2551rrhDRvTmYDoi
DSySOM2YIPOHOAaHHQWXeVWfewI7s9cifIWbEjTXde450nW7EzTH5WQskvO54bM0RQudEWop9uF3
_0vLriBH1OgYClLcck_Jd7ywqk5VlKgc0WFe4emfetCVJNXpcdn8EwMr6wsfd2opT_IZpL3wrI5s
85tg3sW6E98QbLdrYA==&c=ApkhVKSwbst-lybLHqMFWBoxyh76GxksROV9pJOQ0xhrpeFb6Hef3
g==&ch=x02HLuqQy4j0dwKKb6JIVUsE8Tan9veBGh-A9NhiC---4a2GbzsHQQ==>
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:
<http://r20.rs6.net/tn.jsp?f=001_hbD42GADR2PAjAazUQZy_imHEga2551rrhDRvTmYDoi
DSySOM2YIPOHOAaHHQWXYLZFVTBV6D5G_dTYC4OfOtO106dkzXRnH30DMitU10rEMkbc07a2HT6d
JBpVPbJ2dbGOZVIf65AvjOy3ZlXy8m2eik73fyITcOUW4mgo7vVqnNXof2Qh3Fnp_vim8dyJysVG
Wpj-UzjLshs8S2-LtL5Y-FYItm3Uh97LUUEhX6js2kmtXeha5VdrlVjhcnGuepuXm8Zz8aY=&c=A
pkhVKSwbst-lybLHqMFWBoxyh76GxksROV9pJOQ0xhrpeFb6Hef3g==&ch=x02HLuqQy4j0dwKKb
6JIVUsE8Tan9veBGh-A9NhiC---4a2GbzsHQQ==>
http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical
-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
<http://r20.rs6.net/tn.jsp?f=001_hbD42GADR2PAjAazUQZy_imHEga2551rrhDRvTmYDoi
DSySOM2YIPOHOAaHHQWXo74af9tUqmy395kWGqHZB2QaD1FzYmq2VpIRnBiFfmWWfzbOoy1r3yHd
eehXlXoaZY0rsGpllni8MyRWWIUOeC-nbZQPObbgcKU5reCq9Uss71R_JIU3oKBHjox8jx35gjq5
8QJAeSxlOgFMqSgJuxoEwyoIZ7OoOizHIRyveP5xjVyCtWIq5NAbIbuMQGSGVT6xR3S9G2YRa4bp
1PFQWQ==&c=ApkhVKSwbst-lybLHqMFWBoxyh76GxksROV9pJOQ0xhrpeFb6Hef3g==&ch=x02HL
uqQy4j0dwKKb6JIVUsE8Tan9veBGh-A9NhiC---4a2GbzsHQQ==>
https://obssr.od.nih.gov/new-nih-clinical-trials-policies-implications-for-b
ehavioral-and-social-science-researchers/.   It certainly indicates that the
definitions apply to the kind of human behavioral research that many of us
do.   

 

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.   

 

Respectfully,   

 

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

 

 

 

PROPOSED TEXT TO CUSTOMIZE FOR INDIVIDUAL LETTERS   

 

William Riley  

NIH OBSSR 

 <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
including:   

 

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
<http://r20.rs6.net/tn.jsp?f=001_hbD42GADR2PAjAazUQZy_imHEga2551rrhDRvTmYDoi
DSySOM2YIPOHOAaHHQWXTuJmPytjV136bFb4v03OJV7WRmevvhkBxPnKM3A_UEOW2jY1fPrkUr2G
4dj_9Knm9Dsu8pv5rIrAdlLZtJ07JQ==&c=ApkhVKSwbst-lybLHqMFWBoxyh76GxksROV9pJOQ0
xhrpeFb6Hef3g==&ch=x02HLuqQy4j0dwKKb6JIVUsE8Tan9veBGh-A9NhiC---4a2GbzsHQQ==>
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
monitored. 

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

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.   

 

Sincerely,   

 

VSS MEMBER NAME HERE 

 

 



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