<div dir="ltr">The following announcement is forwarded from <b class="gmail_sendername">Paula Skedsvold </b><span class="gmail_sendername">of</span><b class="gmail_sendername"> FABBS.</b><br><div class="gmail_quote"><br></div><div class="gmail_quote"><br><div dir="ltr">
<p class="MsoNormal" style="margin:0in 0in 0.0001pt;font-size:12pt;font-family:Cambria">
</p><p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34);background:white">FABBS Member
Societies and Affiliates:</span><span style="font-size:11pt"><span></span></span></p>
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<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">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:<span></span></span></p>
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<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Paula Skedsvold – Federation of
Associations in Behavioral & Brain Sciences (FABBS)<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Lisa Nichols – Council of Government
Relations<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Sarah Brookhart – <span> </span>Association for Psychological Science (APS)<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Mike Hall – Consultant for APS <span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:black">James J. Pekar - Kennedy
Krieger Institute & Johns Hopkins University</span><span style="font-size:11pt;color:rgb(34,34,34)"><span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Jennifer Dreyfus – Consultant for
American Society for Investigative Pathology <span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"> <span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><u><span style="font-size:11pt;color:rgb(34,34,34)">Call in:</span></u><span style="font-size:11pt;color:rgb(34,34,34)"><span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Jeremy Wolfe – FABBS / Harvard
Medical School<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Jennifer Lodge – Washington
University in St. Louis<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Laura L. Namy - Society for Research
in Child Development<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Judith Siuciak - American
Society for Pharmacology and Experimental Therapeutics<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Alyson Lewis – Consultant for APS<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Howard Kurtzman—American
Psychological Association<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)">Patricia Kobor – American
Psychological Association<span></span></span></p>
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<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">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.”<span></span></span></p>
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<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">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:<span></span></span></p>
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<p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpFirst" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"><span>(1)<span style="font:7pt "Times New Roman"">
</span></span></span><span style="font-size:11pt;color:rgb(34,34,34)">NIH will delay
enforcement of a registration and reporting system for basic science involving
humans until July 1, 2019. <span></span></span></p><p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpFirst" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"><br></span></p>
<p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpMiddle" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"><span>(2)<span style="font:7pt "Times New Roman"">
</span></span></span><span style="font-size:11pt;color:rgb(34,34,34)">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. <span></span></span></p><p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpMiddle" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"><br></span></p>
<p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpMiddle" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"><span>(3)<span style="font:7pt "Times New Roman"">
</span></span></span><span style="font-size:11pt;color:rgb(34,34,34)">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. <b>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. </b><span></span></span></p><p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpMiddle" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"><b><br></b></span></p>
<p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpMiddle" style="margin:0in 0in 0.0001pt 0.5in"><b><span style="font-size:11pt;color:rgb(34,34,34)"><span>(4)<span style="font:7pt "Times New Roman""> </span></span></span></b><span style="font-size:11pt;color:rgb(34,34,34)">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. <b>We would welcome feedback
from our community about the last two review cycles, although NIH’s new plan
may also alleviate the concerns.<span></span></b></span></p><p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpMiddle" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"><b><br></b></span></p>
<p class="m_-5008439748892760262m_-3783629266389899630m_-1256136947006716348gmail-MsoListParagraphCxSpLast" style="margin:0in 0in 0.0001pt 0.5in"><span style="font-size:11pt;color:rgb(34,34,34)"><span>(5)<span style="font:7pt "Times New Roman"">
</span></span></span><span style="font-size:11pt;color:rgb(34,34,34)">NIH will issue a
Basic Science Parent FOA by October 30, 2018. <b>We will interact with NIH over the coming months regarding this since
it will be important to our sciences as the policies evolve. </b><span></span></span></p>
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<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">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.” <b>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. <span></span></b></span></p>
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<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">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. <span></span></span></p>
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<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">If you have any comments or questions
at this time, please let us know. And feel free to share the news with your membership!<span></span></span></p>
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<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">Best,<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">Paula Skedsvold, JD PhD<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">FABBS Executive Director<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)"><a href="mailto:pskedsvold@fabbs.org" target="_blank">pskedsvold@fabbs.org</a><span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)"><span> </span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">and<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)"><span> </span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">Jeremy Wolfe, PhD<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt;color:rgb(34,34,34)">FABBS Past-President<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span style="font-size:11pt"><a href="mailto:jwolfe@partners.org" target="_blank">jwolfe@partners.org</a><span class="m_-5008439748892760262m_-3783629266389899630HOEnZb"><font color="#888888"><span></span></font></span></span></p><span class="m_-5008439748892760262m_-3783629266389899630HOEnZb"><font color="#888888"><div><br></div></font></span></div></div></div>