Announcer: From the National Institutes of Health in Bethesda, Maryland, this is All About Grants.

Megan Columbus: Welcome to another edition of All About Grants. This is Megan Columbus from the NIH Office of Extramural Research. We’ve all seen it. Investigators working right up to the application due date, hoping to incorporate that last bit of late-breaking data into their application. Sometimes those research findings are not available until just after the deadline. Then what happens, or what do you do when there’s a mistake in your application that you do not discover until after the due date? Can you fix it? We often receive questions about what kinds of material NIH will accept after the due date, but before the actual review happens. Today we have with us Sally Amero, NIH’s Peer Review Policy Officer, to join us again to talk about NIH’s post-submission materials policy. Sally, could you tell us what types of materials NIH will accept after the deadline?

Sally Amero: Sure. So, in broad terms, we will accept materials that arise from an unforeseen administrative issue or event. So let’s say that there was a loss of an investigator, perhaps that investigator moved to another institution and has to be replaced. That could be an unforeseen administrative issue that has a big effect on the review and on the project. Let’s also think about many of the natural disasters that have happened in recent years. Those are unforeseen events that might involve loss of an animal colony or replacement of certain facilities. So that’s the type of thing that will be accepted.

Megan: Those would be fairly unusual events.

Sally: Fairly unusual. Now there is another spoke in the wheel there of the policy which will allow news of a publication that has been accepted. So we will not accept the actual manuscript, but one can inform the reviewers that manuscript has been accepted for publication.

Megan: What about in the case of a single receipt date funding opportunity announcement, so a request for applications, for example. If there’s late-breaking data and this is somebody’s one shot to get this application in, what happens in those cases?

Sally: Well, in those cases we will accept updated specific aims or research strategy pages, late-breaking research findings, or new letters of support or collaboration.

Megan: Okay, so those are handled a little bit differently. Are there exceptions to this policy?

Sally: There are a few. So, one involves certain funding opportunity announcements, which will specify the types of materials that they will accept. So it’s not unusual to see in particular RFAs or PARs statement of the types of materials that will be accepted after the deadline. There’s almost a separate policy for institutional training grants and fellowship applications. And the final exception would be things like videos and devices, which one cannot submit electronically and obviously have to come in after the deadline. Those are accepted at the discretion of the scientific review officer.

Megan: In terms of the timing, so how far before the review takes place would somebody need to contact the scientific review officer to see about submitting these types of materials?

Sally: So there is a cut-off for accepting these materials, which is thirty days before the review panel meets.

Megan: Does the scientific review officer automatically have to accept any of these materials or is that a conversation or a negotiation that’s had?

Sally: No, if they fall under one of these acceptable categories, then it is no longer at the discretion of the scientific review officer.

Megan: So it’s often times the investigator that is interfacing with NIH on these questions, but again this application is coming from an institution. So when these post-submission materials are submitted who submits them?

Sally: They can come either from the investigator or from the authorized organization representative, the AOR. If they come from the investigator, however, they must carry the active concurrence from the authorized organization representative. So, simply a CC to that AOR person is insufficient. Either the AOR can submit them on behalf of the PI or the PI can submit an email from the AOR confirming that they’re aware of this material.

Megan: You know, Sally, one of the interesting things about doing podcasts is being able to see a little bit behind the scenes of the some of the policies. I wonder if you could give us some insight into the rationale behind this policy. I could imagine people out there saying, “Well doesn’t NIH want to know everything so they can give me a fair review?”

Sally: So part of the rationale comes from our long-standing policy that incomplete applications are not accepted. So it becomes a fuzzy area here where people find that pages are missing or they really meant to say x, y and z when it says a, b and c. So to sort of firm up that policy and make it easier to decide when an application is complete, we had to cut off things that dribble in after the receipt date.

Megan: Well NIH has also been moving in other ways towards making sure an application is complete by the due date. So they’ve gotten rid of the error correction window that used to apply for electronic applications. Increasingly, what you submit by the due date needs to be a complete application.

Sally:  So another aspect of the policy has to do with fairness. So when things are in the discretion of the SRO one would think that all of the applications going through one study section would be held to the same standards and expectations. But we were finding that across the agency different SROs had different views of what would be acceptable and that could be problematic. So in order to increase fairness, everyone should be treated to the same standard. We also wanted to implement the thirty day deadline so that SROs and reviewers could have a clean window in which what they were provided is what they were to evaluate without changes at the last minute. So there were many reasons for the policy.

Megan: It does lead me to realize -- I didn’t ask this directly so I just want to confirm -- so that means if I had a mistake in my application that is not something that I’m going to be able to correct after the fact?

Sally: That’s right.

Megan: And so the appropriate time for me to do that would be once I submit my application before the deadline, I look at my application before the deadline in the eRA Commons and I look at my image.  At that point, as long as I’m still before the deadline, I could submit a corrected application and that’s the only time?

Sally: Yes. Or let’s say in the paper world it does happen sometimes where the master copy, if you will, with the ink signature comes in intact, but in the duplicating process some pages get lost, they stick together in the Xerox machine and that’s hard to find. So in those cases we would probably just run off new copies from the master. But if the master is deficient we will not allow you to replace them, unless it’s one of these RFA exceptions.

Megan: Alright. I think that helps. Thank you very much for joining us today. For NIH and OER this is Megan Columbus.

Announcer: You can find frequently asked questions and answers about the post submission materials policy on our website at grants.nih.gov. Click on the yellow question mark and look under “application/progress report information.”