Megan Columbus: Welcome to All About Grants. This is Megan Columbus from NIH’s Office of Extramural Research here today to talk about NIH’s Appendix Policy with Dr. Cathleen Cooper, who’s the Director of the Center of Scientific Reviews, Division of Receipt and Referral.
Cathie Cooper: Thank you for having me.
Megan Columbus: Thank you. So, let’s start with just what’s the idea behind having an appendix to a grant application?
Cathie Cooper: Right. So, the appendix really plays a limited role in the application. For the most part, you can think of it as a kind of swing space where certain funding opportunity announcements with specific needs can direct applicants to upload unique or additional documents that don’t have a place in the application itself.
Megan Columbus: Mm-hmm.
Cathie Cooper: That said, NIH has always allowed a few defined items to be placed there as appropriate for the study described in the application. However “few” and “defined” are the critical words here. Reviewers are not required to consider appendix materials as part of their review unless those appendix materials are stated as required in the funding opportunity announcement.
Megan Columbus: Okay. So, I think that’s a really important point for people who are thinking about what they can stick in the appendix, that reviewers are not required to look at it unless it’s requested by NIH.
Cathie Cooper: Exactly. So, if it’s needed for the review, it really does need to be in the research strategy and not put into the appendix instead. However, it does create a problem because some reviewers will review the appendix anyway, particularly when an applicant refers to the appendix material repeatedly and oftentimes they’re referring them out for data or other information that really needed to be in the research strategy itself. And because appendices can be significantly abused, we’re watching them very closely.
Megan Columbus: And the reality is when we say if the appendices are abused, your office actually can turn back an application and have us not consider it for funding because people have violated the rules.
Cathie Cooper: Absolutely, and it’s really very unfortunate, but we’re not able to modify the applications in any way that are submitted to us. So, it’s not a simple matter of saying Appendix A is not compliant; let’s just get rid of it and send the application forward to review. Our choice is to send it to review as non-compliant, which we can’t do based on our policy, or withdraw that application, in which case the applicant misses a council round and has to start over again.
Megan Columbus: So, make note that—listen to this podcast carefully. The appendix policy matters and you need to understand it.
Cathie Cooper: Well, I would say so.
Megan Columbus: As of January 2017, NIH tightened our policy about what we’ll allow in that appendix. Can you explain the new policy?
Cathie Cooper: Sure. So, if you are proposing a clinical trial in the application itself, you can include a clinical trial protocol. And when it’s appropriate, you can include the investigator’s brochure from an FDA IND application. In addition to that and for all applications, you include blank data collection instruments, which are questionnaires or surveys or something like that, and informed consent or assent forms as appropriate.
Megan Columbus: So, going back to the fact that we allow the blank data collection instruments, that’s been a sore point for you, right?
Cathie Cooper: Well, it has been a little problem lately because the interpretation of “blank” and the interpretation of “data collection instrument” have been somewhat fuzzy for applicants. By “blank” we mean blank; a questionnaire or a survey you’re going to use in your research that has tick boxes that you will tick or options you will circle or text boxes where you’ll enter information, but they’re blank. They’re just a sample of the form you’re going to use. And a data collection instrument is just that form you’re going to use. It’s not the equipment you’re going to use to collect the data. It’s not a series of screenshots from a website showing what your data will look like once you collect it. It is literally a blank tool used to collect the data.
Megan Columbus: So, in addition to the information that’s allowed for clinical trial application and this data collection instrument, if the funding opportunity announcement says something specific should be included in the appendix, that’s what’s allowed.
Cathie Cooper: Right. That is correct and some funding opportunity announcements will list additional items that are supposed to be in the appendix. And when that is in the funding opportunity announcement, it’s perfectly allowed and in that case, the reviewers are required to review them. So, it does become part of the review. So, that’s what makes it very different.
Megan Columbus: So, what I’m hearing you say is that publications, manuscripts, abstracts are not allowed.
Cathie Cooper: Not any more. Those are shifting to be covered by our post-submission materials policy, but they’re not to be put into the appendix any more.
Megan Columbus: So, what do I do? So, if I’m putting together an application and I have materials that don’t fit in other places, if I can’t stick them in the appendix, what can I do with them?
Cathie Cooper: Well, you can put them in the application. I mean we do get this question all the time. We had a gentleman just the other day who had a 19-page table that belonged in a 6-page research strategy and he goes, “But, I can’t fit it in the research strategy.” And I said, “Well, I’m sorry,” because I was, but it does not belong in the application.
Megan Columbus: And so, what you would do in that case is summarize the contents of that table.
Cathie Cooper: Yes, and that’s what he planned to do when he submitted it again.
Megan Columbus: Great. What about hyperlinks?
Cathie Cooper: No. Hyperlinks are only allowed in very limited parts of the application and only when they’re specified either in the funding opportunity announcement or the form field instructions. So basically, hyperlinks are allowed in the bio-sketch and the references section and no place else; certainly not in the research strategy or the appendix.
Megan Columbus: What if the reviewers in a previous review asked for additional information that’ll not fit into that research strategy section?
Cathie Cooper: Right. Well, we have this conversation also periodically and it’s very difficult because it has to fit into the research strategy. I advise applicants to have a conversation with their program officer to maybe triage the comments from the reviewers and decide which ones really are the most important and should be addressed in the research strategy and then unfortunately the rest of them have to be left out.
Megan Columbus: So, we’ve been living with this policy for a little over a month now. What are the common issues you’ve been seeing with applications? Where are people falling down?
Cathie Cooper: Right. So, we’re not seeing too many non-compliant appendices, which is really good. I’m very happy about that, and over half of the appendices we’re seeing non-compliant would have been non-compliant under our old 2007 policy. So, I’m also very happy about that. The most common new problems I’m seeing are clinical trial protocols put into appendices when the application is not proposing a clinical trial protocol, or publications and copies of patents which were allowed under the old policy.
Megan Columbus: Great. And so, people should follow the rules and otherwise, they’re at risk of having their application withdrawn, and nobody wants that. We’re looking to review your application; not to turn it away.
Cathie Cooper: Absolutely and, you know, I’m hoping that everyone gets this message and sends us nice compliant appendices so that those applications can go forward to review and be considered for funding.
Megan Columbus: And this just goes, again, to stressing we need to read the application instructions and read them carefully as we’re putting together an application.
Cathie Cooper: Absolutely.
Megan Columbus: Hey, Cathie, thank you for joining us today. That’s really helpful.
Cathie Cooper: You’re welcome.
Megan Columbus: For NIH and OER, this is Megan Columbus.
Announcer: The appendix policy is covered within the SF 424 application instructions. You can also view frequently asked questions by going to grants.nih.gov/grants/frequent_questions.htm. Once again that’s grants.nih.gov/grants/frequent_questions.htm