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<p>Re Gary Rubin 's comment that I interpret to mean that perhaps we
all hope to do work that ultimately may have a “health-related
biomedical or behavioral outcome” on " biomedical or behavioral
status or quality of life”? <br>
</p>
<p> If one takes the broadest point of view, consider the following
studies that can have profound effect on both individual and on
societal health-related outcomes: Different interventions that
affect voting patterns--whether people will vote for or against
inclusive governmental health insurance, studies on educational
interventions that may affect how people can discriminate between
and respond to real and false news concerning climate change and
air pollution, and agricultural studies with farmers assigned to
groups that continue using their habitual fertilizers and
pesticides versus farmers that are induced not to. All can have
very important implications on "biomedical or behavioral status or
quality of life" of the individuals in the studies as well as on
the public. These studies do not fall under the category of
clinical trials as they are conventionally understood but might
under a broad interpretation of the above NIH definition of
Clinical Trial. While one may believe that all such studies as
well as those suggested by other writers require governmental
oversight, the NIH rules for clinical trials are not the
appropriate guidelines for these sorts of studies and therefore
should be reformulated to exclude them. The NIH definitions are a
legalistic matter in sense that what ultimately is important is
not what the rules intend but what the rules actually say. I
suggest that the most interested parties coordinate to consult
with lawyers and other experts on how to best reformulate and
clarify NIH rules as well as to incorporate specific exclusions,
and then send very specific suggestions to NIH. <br>
</p>
<div class="">George Sperling, University of California, Irvine,
Department of Cognitive Sciences<br class="">
</div>
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<div class="moz-cite-prefix">On 6/4/17 4:23 AM, Rubin, Gary wrote:<br>
</div>
<blockquote type="cite"
cite="mid:0D73F10A-829F-44FB-AD49-A1308756453A@ucl.ac.uk">
<meta http-equiv="Content-Type" content="text/html; charset=utf-8">
Can you argue that the results of your studies do not conform to
the definition of a “health-related biomedical or behavioral
outcome” in that they don’t have an effect on " biomedical or
behavioral status or quality of life”?
<div class=""><br class="">
</div>
<div class="">Gary Rubin</div>
<div class="">UCL Institute of Ophthalmology (London)</div>
<div class=""><br class="">
</div>
<div class=""><br class="">
<div>
<blockquote type="cite" class="">
<div class="">On 2 Jun 2017, at 19:19, Nancy Kanwisher <<a
href="mailto:ngk@mit.edu" class=""
moz-do-not-send="true">ngk@mit.edu</a>> wrote:</div>
<br class="Apple-interchange-newline">
<div class="">
<div style="word-wrap: break-word; -webkit-nbsp-mode:
space; -webkit-line-break: after-white-space;" class="">
<p class="MsoNormal"><span class="" style="font-family:
Arial;">Colleagues-</span></p>
<p class="MsoNormal"><span class="" style="font-family:
Arial;">The NIH is considering a new definition of
clinical trials that would wrongly classify the work
that many of us do as clinical trials.<o:p class=""></o:p></span></p>
<p class="MsoNormal"><span class="" style="font-family:
Arial;">The definition is found here <a
href="http://osp.od.nih.gov/sites/default/files/NIH%20Definition%20of%20Clinical%20Trial%2010-23-2014-UPDATED_0.pdf"
class="" moz-do-not-send="true">http://osp.od.nih.gov/sites/default/files/NIH%20Definition%20of%20Clinical%20Trial%2010-23-2014-UPDATED_0.pdf</a><o:p
class=""></o:p></span></p>
<p class="MsoNormal"><span class="" style="font-family:
Arial;">The broader issue is described here: </span><a
href="http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials"
class="" moz-do-not-send="true"><span class=""
style="font-family: Arial; color: rgb(17, 85,
204);">http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials</span></a></p>
<p class="MsoNormal"><span class="" style="font-family:
Arial;">This new rule has many adverse consequences
for NIH, for you as a researcher, and for the public
and their access to ‘real’ clinical trials. Bill
Riley, Director of the NIH Office of Behavioral and
Social Sciences Research, is working to modify this
definition. We urge you to send an email to Bill. He
is collecting information over the next few days. We
provide two models below. As you will see, these lay
out the problems that come with this new definition.
Your most important contribution will be a specific
example from your own work. Please modify one of
these letters or write your own describing the work
you do and how it would fit the new NIH definition
of clinical trials. This is a time-urgent issue as
Bill plans to speak to Francis Collins in the next
few days.</span></p>
<p class="MsoNormal"><span class="" style="font-family:
Arial;">Please disseminate widely (e.g. post to your
mailing lists, facebook page,<o:p class=""></o:p></span></p>
<p class="MsoNormal"><font class="" face="Arial"><span
class="">Thanks</span></font></p>
<div class="">Jeremy Wolfe & Nancy Kanwisher</div>
<div class=""><br class="">
</div>
<div class=""><br class="">
</div>
<div class="">================================</div>
<div class=""><br class="">
</div>
<div class="">
<p class="MsoNormal"><span class=""
style="font-family: Times;"><font class=""
size="4" color="#9a244f">June 2, 2017<o:p
class=""></o:p></font></span></p>
<div class=""><span class="" style="font-family:
Times;"><font class="" size="4" color="#9a244f"> </font></span><br
class="webkit-block-placeholder">
</div>
<p class="MsoNormal"><span class=""
style="font-family: Times;"><font class=""
size="4" color="#9a244f">William Riley <o:p
class=""></o:p></font></span></p>
<p class="MsoNormal"><span class=""
style="font-family: Times;"><font class=""
size="4" color="#9a244f">NIH OBSSR<o:p class=""></o:p></font></span></p>
<p class="MsoNormal"><span class=""
style="font-family: Times;"><font class=""
size="4" color="#9a244f"><a
href="mailto:william.riley@nih.gov" class=""
moz-do-not-send="true">william.riley@nih.gov</a></font></span></p>
<p class="MsoNormal"><span class=""
style="font-family: Times;"><font class=""
size="4" color="#9a244f">Dear Bill</font></span></p>
<p class="MsoNormal"><font class="" color="#9a244f"><span
class="" style="font-family: Times;"><font
class="" size="4">I am writing to express my
concern about the NIH Definition of Clinical
Trial. It seems likely to classify a large
body of research as ‘clinical trials’ that
should not be so classified. Let me give you
an example from my own work. I am interested
in the problem of “incidental finding errors”
in radiology. When radiologists examine an
image for one specific problem (e.g.
pneumonia), they also search for other
clinically significant findings (e.g. signs of
lung cancer). Unfortunately, these “incidental
findings” are missed at relatively high rates.
Radiologists are an expensive and limited
resource as experimental observers, so we have
developed a “hybrid search” analog of the
incidental finding problem that can be used
with non-experts. In hybrid search, observers
look for an instance of any several candidate
targets held in memory. Our observers search
for any of three specific (e.g. this picture
of this hat) and three categorical (e.g. any
animal) targets. Specific targets are the
analog of the radiologist’s primary task.
Categorical targets are the analog of
incidental findings. I will spare you the
details but I am happy to say this is a good
‘model system’ for the problem we are trying
to understand. It is not a clinical trial in
any meaningful sense of the word but it would
be classified as a clinical trial under the
new definition. It involves “a manipulation of
the subject or subject’s environment for the
purpose of modifying one or more
health-related biomedical or behavioral
processes”, especially if “behavioral process”
is defined as “positive or negative changes to
psychological … parameters”. In this case, we
are making manipulations that alter error
rates.</font></span><span class=""
style="font-size: large; font-family: Times;"> </span></font></p>
<p class="MsoNormal"><font class="" color="#9a244f"><span
class="" style="font-family: Times;"><font
class="" size="4">It seems obvious that this
work should not be classified as a ‘clinical
trial’ and this is just one of a huge body of
research in cognitive and sensory science that
would be reclassified. This reclassification
has many negative consequences:</font></span><span
class="" style="font-size: large; font-family:
Times;"> </span></font></p>
<p class="MsoListParagraphCxSpFirst"
style="text-indent: -0.25in;"><font class=""
size="4" color="#9a244f"><span class=""
style="font-family: Times;"><span class="Apple-tab-span" style="white-space: pre;"></span>1)<span
class="" style="font-family: 'Times New
Roman';"> </span></span><span class=""
style="font-family: Times;">By posting such
clinical trials on government websites, we will
confuse the public about the nature of the
clinical trials.<o:p class=""></o:p></span></font></p>
<p class="MsoListParagraphCxSpMiddle"
style="text-indent: -0.25in;"><font class=""
size="4" color="#9a244f"><span class=""
style="font-family: Times;"><span class="Apple-tab-span" style="white-space: pre;"></span>2)<span
class="" style="font-family: 'Times New
Roman';"> </span></span><span class=""
style="font-family: Times;">We will make it less
likely that members of the public will be able
to find and enroll in true clinical trials.<o:p
class=""></o:p></span></font></p>
<p class="MsoListParagraphCxSpMiddle"
style="text-indent: -0.25in;"><font class=""
size="4" color="#9a244f"><span class=""
style="font-family: Times;"><span class="Apple-tab-span" style="white-space: pre;"></span>3)<span
class="" style="font-family: 'Times New
Roman';"> </span></span><span class=""
style="font-family: Times;">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 (e.g. error rates in hybrid search
tasks.)<o:p class=""></o:p></span></font></p>
<p class="MsoListParagraphCxSpMiddle"
style="text-indent: -0.25in;"><font class=""
size="4" color="#9a244f"><span class=""
style="font-family: Times;"><span class="Apple-tab-span" style="white-space: pre;"></span>4)<span
class="" style="font-family: 'Times New
Roman';"> </span></span><span class=""
style="font-family: Times;">It will dilute NIH
oversight of real clinical trials that should be
monitored.<o:p class=""></o:p></span></font></p>
<p class="MsoListParagraphCxSpMiddle"
style="text-indent: -0.25in;"><font class=""
size="4" color="#9a244f"><span class=""
style="font-family: Times;"><span class="Apple-tab-span" style="white-space: pre;"></span>5)<span
class="" style="font-family: 'Times New
Roman';"> </span></span><span class=""
style="font-family: Times;">It will add to the
bureaucratic burden for researchers and their
institutions<o:p class=""></o:p></span></font></p>
<p class="MsoListParagraphCxSpLast"
style="text-indent: -0.25in;"><font class=""
size="4" color="#9a244f"><span class=""
style="font-family: Times;"><span class="Apple-tab-span" style="white-space: pre;"></span>6)<span
class="" style="font-family: 'Times New
Roman';"> </span></span><span class=""
style="font-family: Times;">This is likely to be
particularly true for researchers at smaller
schools.<o:p class=""></o:p></span></font></p>
<div class="" style="margin: 0in 0in 0.0001pt 0.5in;
text-indent: -0.25in;"><font class="" size="4"
color="#9a244f"><span class="" style="font-family:
Times;">7)<span class="" style="font-family:
'Times New Roman';"> </span></span><span
class="" style="font-family: Times;">An
undergraduate doing an honors thesis or a
graduate student doing something as simple as a
first-year project would have to register with <a
href="http://clinicaltrials.gov/" class=""
moz-do-not-send="true">clinicaltrials.gov</a>.</span><span
class="" style="font-family: Times;"><o:p
class=""></o:p></span></font></div>
<div class="" style="margin: 0in 0in 0.0001pt 0.5in;
text-indent: -0.25in;"><font class="" size="4"
color="#9a244f"><span class="" style="font-family:
Times;"><br class="">
</span></font></div>
<div class="" style="margin: 0in 0in 0.0001pt 0.5in;
text-indent: -0.25in;"><font class="" size="4"
color="#9a244f"><span class="" style="font-family:
Times;">8)<span class="" style="font-family:
'Times New Roman';"> </span></span><span
class="" style="font-family: Times;">Grant
review will be significantly disrupted by the
requirement that “clinical trial” grants must be
reviewed by study sections that review “clinical
trials”.</span><span class=""
style="font-family: Times;"><o:p class=""></o:p></span></font></div>
<div class="" style="margin: 0in 0in 0.0001pt 0.5in;"><span
class="" style="font-family: Times;"><font
class="" size="4" color="#9a244f">I would be
happy to elaborate on any of these points, but
let me conclude by noting that this policy seems
to be in strong contradiction with the
streamlining of the research process proposed in
the revised Common Rule.<o:p class=""></o:p></font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4" color="#9a244f"> </font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4" color="#9a244f">I strongly
urge you to support a more sensible definition
of “clinical trial” at the NIH.<o:p class=""></o:p></font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4" color="#9a244f"> </font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4" color="#9a244f">Thank-you for
your work on this topic to date.<o:p class=""></o:p></font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4" color="#9a244f"><br class="">
</font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4" color="#9a244f">Sincerely,</font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4" color="#9a244f"><span class="Apple-tab-span" style="white-space: pre;"></span>Jeremy
Wolfe</font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4"><br class="">
</font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4">==========================</font></span></div>
<div class="" style="margin: 0in 0in 0.0001pt;"><span
class="" style="font-family: Times;"><font
class="" size="4"><br class="">
</font></span></div>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">Dear Bill,<o:p
class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6"> I greatly
appreciate your informing us yesterday about the
proposed new NIH definition of “clinical trial”:
(<a
href="http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials"
class="" moz-do-not-send="true">http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials</a>).<o:p
class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6"> I am
writing to share my concern that broadening the
definition in this fashion will likely have many
negative consequences listed below. But I’ll be
concrete by first describing one (of many)
examples of studies from my own current
research, which as far as I can tell would be
classified as a clinical trial, to the detriment
of many: I am currently running an fMRI
experiment on normal adults characterizing a
region of the brain that responds to both human
faces and human voices (compared to numerous
other stimulus conditions). To understand this
brain region and its role in social cognition
(and perhaps autism) we are measuring its
response to many different stimulus types. So,
we scan many typical adults (sometimes assigned
to different groups), we show them different
kinds of visual and auditory stimuli (an
intervention) while we measure the magnitude of
the fMRI response of this region to these
stimuli (a “health-related biomedical or
behavioral outcome”). Thus this experiment (and
many others like it in my lab) would fit the
proposed new definition of a clinical trial,
even though it is in fact nothing of the kind.<o:p
class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">The negative
consequences of this new definition include:</font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">1) I would
be required to register my study as a clinical
trial, which would seriously mislead members of
the public who may be looking for an actual
clinical trial, wasting their time and causing
confusion. <o:p class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">2) It would
dilute the resources NIH has available for
oversight of real trials that actually should be
monitored as such.<o:p class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">3) Because
the public will not appreciate the subtleties of
the new definition of ‘clinical trial’, this
will hold the field and the NIH up to public
ridicule for claiming to be doing ‘clinical
trials’ of matters that are clearly not clinical
issues. <o:p class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">4) The new
definition will drastically increase the
bureaucratic burden to PIs and universities, and
disproportionately harm researchers at smaller
schools who have smaller bureaucratic
infrastructures. <o:p class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">5) An
undergraduate doing an honors thesis or a
graduate student doing something as simple as a
first-year project would have to register the
relevant research and do battle with <a
href="http://clinicaltrials.gov/" class=""
moz-do-not-send="true">clinicaltrials.gov</a>--so
we run the risk of massive red tape on very
simple and innocuous projects. It would serve as
a serious barrier to mentoring very early stage
investigators on anything involving
randomization. <o:p class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">Please let
me know if I can provide any </font></span><span
class="" style="color: rgb(0, 86, 214); font-size:
14px;">further information, and thank you in
advance for your help.</span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6"> <o:p
class=""></o:p></font></span></p>
<p class="MsoNormal"><span class="" style="font-size:
14px;"><font class="" color="#0056d6">Nancy
Kanwisher, MIT</font></span><o:p class=""></o:p></p>
<div class=""><span class="" style="font-size: 14px;"><font
class="" color="#0056d6"><br class="">
</font></span></div>
</div>
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