nih-gov/www.grants.nih.gov/podcasts/All_About_Grants/episodes/changes-to-NIH-appendix-2018.htm

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<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
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Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>Welcome to another episode
of All About Grants. This is Megan Columbus with NIH's Office of Extramural
Research, here today to talk with Dr. Cathleen Cooper, who's the director of
the Division of Receipt and Referral and NIH's Center for Scientific Review.
Welcome, Cathie.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Dr.
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having me.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>We are here today to talk
about NIH's appendix policy. The latest policy <span
style='mso-spacerun:yes'><EFBFBD></span>goes into effect for applications submitted
January 25<sup>th</sup>, 2018 only allows for a few select items to be
submitted as appendix materials. Could you tell us what's actually allowed
under that policy.<o:p></o:p></span></p>
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don't specify appendix materials, so the standard NIH appendix policy applies
to most applicants. The standard policy only allows for blank data collection
forms, which are usually things like blank questionnaires or blank surveys, and
also informed consent or assent forms. And that<61>s it.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>So why do we limit the
amount of appendix materials applicants are allowed to submit? <o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Dr.
Cathleen Cooper: <span style='mso-tab-count:1'> </span>Its really all about
fairness and consistency for the applicants and also about reviewer burden. By
fairness and consistency, I mean that everyone competing for funding has the
opportunity to submit the same amount of information and the same type of
information to the reviewers for evaluation and scoring. And then the reviewer burden
issue is to ensure the reviewers will know what they're getting when they've
agreed to review. They need to know how much material they will be expected
review to make their commitment to review.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>We didn<64>t used to limit the
material as much as we will be as of January 2018.<span
style='mso-spacerun:yes'><EFBFBD> </span>What changed?<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Dr.
Cathleen Cooper:<span style='mso-spacerun:yes'><EFBFBD> </span>In January 2018 we are
implementing a new Human Subject and Clinical Trial Information form in our
application package. Some of the information that used to be allowed in the
appendix we're now collecting with a new Human Subjects and Clinical Trial
Information form.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;line-height:200%;mso-pagination:
none'><span style='font-family:"Arial",sans-serif'>For example, we used to
allow the clinical trial protocol to be part of the appendix, but now the
information contained in the protocol is captured within the new Human Subjects
Form itself and so the protocol attachment is likely redundant and we would
only allow it to be included if the FOA specifically requires it. <o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>What are the most common
mistakes that people make when submitting appendix material to NIH?<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Dr.
Cathleen Cooper: <span style='mso-tab-count:1'> </span>So a lot of people will
put additional material in the appendix for reasons that they tell me, <20>I want
it there in case the reviewers want to see it, it's not essential for the
review but they might want to look at it,<2C> or that they really would like to
put it in the application but there's no place for it, and so they just put it
in the appendix. That is not the right approach. Applicants should carefully
read the FOA and the application instructions and provide the information that
is requested.<span style='mso-spacerun:yes'><EFBFBD> </span>We try to warn people
ahead of time that they should check to be sure the appendix material submitted
with the application is allowed by including a warning through our application
submission systems that reminds applicants of the rules about appendix.
Unfortunately, too often people ignore the warning and lose their chance to fix
their application. <o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>And the consequences are
dire.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Dr.
Cathleen Cooper: <span style='mso-tab-count:1'> </span>The consequences are
dire. Since we can<61>t let what we call an <20>overstuffed<65> application go to
review, and we currently have no way to remove noncompliant appendix material
or redact pieces of an application in any way, noncompliant applications are
withdrawn and the applicant will likely have to submit for a different due date.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>So it's really important
that people follow this policy. Do you have any other pieces of advice that
could help people in case they make a mistake?<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Dr.
Cathleen Cooper: <span style='mso-tab-count:1'> </span>I always tell applicants
to submit early because that gives them time to put their application together,
address any errors or warnings like this one that arise during the submission
process, follow the application through to eRA Commons and view it to make sure
that it has all the parts you think it should have.<span
style='mso-spacerun:yes'><EFBFBD> </span>And if they submit early, they have time to
fix things. If they submit at 4:57 on the deadline date, they do not. <o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>So we say this a lot, but by
early, we're talking days, not minutes.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Dr.
Cathleen Cooper: <span style='mso-tab-count:1'> </span>Days and not minutes.
Not even hours. Not even hours.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>Good advice. Thank you,
Cathie.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Dr.
Cathleen Cooper: <span style='mso-tab-count:1'> </span>Most welcome.<o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'>Megan
Columbus: <span style='mso-tab-count:1'><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>For NIH and OER, this is
Megan Columbus.<o:p></o:p></span></p>
<p class=MsoNormal style='line-height:150%'><span style='font-family:"Arial",sans-serif'>Announcer:<span
style='mso-spacerun:yes'><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>The guide notice outlining
NIH<EFBFBD>s changes to the appendix policy <span style='mso-spacerun:yes'><EFBFBD><EFBFBD></span><o:p></o:p></span></p>
<p class=MsoNormal style='line-height:150%'><span style='font-family:"Arial",sans-serif'><span
style='mso-spacerun:yes'><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>can be found
by googling NOT-OD- 17-098. Appendix instructions <o:p></o:p></span></p>
<p class=MsoNormal style='line-height:150%'><span style='font-family:"Arial",sans-serif'><span
style='mso-spacerun:yes'><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD><EFBFBD> </span>can be found
in the Application Form guides. </span><span style='font-size:11.0pt;
line-height:150%;font-family:"Arial",sans-serif;mso-fareast-language:EN-US'><o:p></o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'><o:p>&nbsp;</o:p></span></p>
<p class=MsoNormal style='margin-left:117.35pt;text-indent:-117.35pt;
line-height:200%;mso-pagination:none'><span style='font-family:"Arial",sans-serif'><o:p>&nbsp;</o:p></span></p>
<p class=MsoNormal align=center style='margin-left:117.35pt;text-align:center;
text-indent:-117.35pt;line-height:200%;mso-pagination:none'><span
style='font-family:"Arial",sans-serif'>[END FILE]</span></p>
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