Megan 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. Welcome, Cathie.

Dr. Cathleen Cooper: Well, thank you for having me.

Megan 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.

Dr. 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.

Megan Columbus:      So why do we limit the amount of appendix materials applicants are allowed to submit?

Dr. 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.

Megan Columbus:      We didn’t used to limit the material as much as we will be as of January 2018.  What changed?

Dr. 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 Information form.

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.

Megan Columbus:      What are the most common mistakes that people make when submitting appendix material to NIH?

Dr. 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 their application.

Megan Columbus:      And the consequences are dire.

Dr. 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.

Megan 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?

Dr. 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.

Megan Columbus:      So we say this a lot, but by early, we're talking days, not minutes.

Dr. Cathleen Cooper: Days and not minutes. Not even hours. Not even hours.

Megan Columbus:      Good advice. Thank you, Cathie.

Dr. Cathleen Cooper: Most welcome.

Megan Columbus:      For NIH and OER, this is Megan Columbus.

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.

 

 

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