Columbus: ���� 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.
Cathleen Cooper: Well, thank you for
Columbus: ���� We are here today to talk
about NIH's appendix policy. The latest policy �goes into effect for applications submitted
January 25th, 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.
Cathleen Cooper: Sure. So first of all, before
I get into the policy itself, its important to remember that anything that is
specified in the funding opportunity announcement to which you are applying �will be allowed. You would find that
information in Section 4 of the FOA under the heading �Appendix,� But most FOAs
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�s it.
Columbus: ���� So why do we limit the
amount of appendix materials applicants are allowed to submit?
Cathleen Cooper: 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.
Columbus: ���� We didn�t used to limit the
material as much as we will be as of January 2018.� What changed?
Cathleen Cooper:� 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
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.
Columbus: ���� What are the most common
mistakes that people make when submitting appendix material to NIH?
Cathleen Cooper: So a lot of people will
put additional material in the appendix for reasons that they tell me, �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,� 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.� 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
Columbus: ���� And the consequences are
Cathleen Cooper: The consequences are
dire. Since we can�t let what we call an �overstuffed� 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.
Columbus: ���� 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?
Cathleen Cooper: 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.� And if they submit early, they have time to
fix things. If they submit at 4:57 on the deadline date, they do not.
Columbus: ���� So we say this a lot, but by
early, we're talking days, not minutes.
Cathleen Cooper: Days and not minutes.
Not even hours. Not even hours.
Columbus: ���� Good advice. Thank you,
Cathleen Cooper: Most welcome.
Columbus: ���� For NIH and OER, this is
Announcer:���������������� The guide notice outlining
NIH�s changes to the appendix policy ��
���������������������������������� can be found
by googling NOT-OD- 17-098. Appendix instructions
���������������������������������� can be found
in the Application Form guides.