Megan Columbus:      Welcome to All about Grants.  This is Megan Columbus from NIH’s Office of Extramural Research here with Dr. Sally Amero, NIH’s Peer Review Policy Officer, amongst other things, to talk about what grant application information can be updated after submission of that application, but before peer review.  So, Sally, why does NIH allow post-submission materials at all?  Shouldn’t the application be self-contained?
Sally Amero:                Well, thank you for the opportunity to describe this policy.  So, to your question about why have post-submission materials at all; the policy is intended to allow for certain unforeseen events that might happen to an investigator, to their institution, to the project that would not have been anticipated or known at the time of submission. 
Megan Columbus:      Can you give me some examples of the types of materials that are allowed?
Sally Amero:                Sure.  So, we would allow biographical sketches for say a new investigator who would be brought onto a project if another investigator were lost.  Let’s say they were ill; they retired; they left the institution.  We would allow adjustments resulting from natural disasters, such as floods, hurricanes, what have you, maybe loss of an animal colony.  Change of institution: If the PDPI leaves the institution and they need to find a new PDPI that would be another example.  One that’s often talked about is when a publication is accepted after submission of the application, and we do allow the investigator to notify the study section if a publication has been accepted, but we don’t allow the full publication.
Megan Columbus:      Okay, and those are some examples, and the notice provides the full list.  Who on the applicant side should be providing this information to NIH, and who should they be providing it to?
Sally Amero:                So, the information can come from either the PDPI or from the signing official, the authorized organization representative at the applicant institution.  If the PDPI sends the information in, they must provide evidence or documentation that the AOR is aware of the submission.  They can’t just cc the AR.  There has to be some previous e-mail or agreement from the AOR on behalf of the applicant institution, or the AOR can submit it and let the PDPI know.  That information is sent to the Scientific Review Officer, the SRO, who is managing the review of that application. 
Megan Columbus:      Great, and they would be able to find the information on the SRO through their eRA Commons account.
Sally Amero:                Correct.
Megan Columbus:      You had mentioned previously about articles that had been accepted for publication.  I think there’s a 30-day cut off for notification that a paid approval is accepted.  Can you talk a little bit more about that and why that exists?
Sally Amero:                So, the 30-day deadline was put in place to try to normalize the process across the agency to allow enough time for reviewers to have the same amount of information and not be disrupted in their evaluations coming up to the study section meeting.  One has to keep in mind that reviewers need to prepare their critiques and preliminary scores often a week in advance of the study section meeting.  So, there’s not a whole lot of time here for them to do their work after the 30-day deadline.
Megan Columbus:      Okay, and so that’s 30 days before the review meeting.
Sally Amero:                Right.
Megan Columbus:      And they should be corresponding then with the SRO, the Scientific Review Officer, at NIH to determine the timing then.  So, what happens if I have multiple papers if I’m that lucky, right?  Can I be submitting multiple items?
Sally Amero:                Absolutely.  So, it might happen that unfortunately there’s been a natural disaster and somebody has left the institution.  So, we would allow that kind of material to come in 30 days before the study section.  I will say though it gets a little awkward if the PDPI leaves the institution and takes the application with them.  Then that’s a lot of updating and they might—the new institution might think about withdrawing the application and submitting a clean one.
Megan Columbus:      But they’re not required to do that.
Sally Amero:                Correct.
Megan Columbus:      I know one of the questions that we get all the time is about late-breaking research findings, and people really want to get that in to make the strongest application possible.  Can you talk a little bit about why we don’t allow that?
Sally Amero:                Well, it’s hard to argue that a late-breaking research finding was not anticipated when the application was submitted.  So, it would have to be sort of a eureka moment to make that argument.  And again, it’s about fairness.  So, the reviewers need to have a set amount of information to consider doing their work. 
Megan Columbus:      As we think about NIH accommodating these kinds of changes, we need to remember the volume of applications that we’re handling at any given time, right?  So, we’re dealing with a lot and any additional churn jeopardizes our ability to get things done in time, right?
Sally Amero:                And adds burden to the reviewers.
Megan Columbus:      Which is a big consideration because a reviewer is not always easy to find, right, in the volumes that we need them.  Can you think of other common situations where applicants might have misconceptions about what’s allowed?
Sally Amero:                So, we get a lot of questions about submitting videos as part of application materials.  And in the technological age, videos are more and more important to demonstrate things that have a time element or how something functions.  So, we do allow videos as post-submission materials, but one has to follow the rules that are specified in the guide notice for submitting videos.
Megan Columbus:      Okay, and one of those rules are really that you have to make note of that video in the application itself, in the cover letter, in the research strategy.  It has to be very clear that it’s coming in in order for you to be able to submit it as post-submission materials.
Sally Amero:                Correct and there are only certain types of videos that we will accept.  We’re not looking to allow tours of laboratories or copies of presentations, posters, that sort of thing. 
Megan Columbus:      Yeah.
Sally Amero:                We’re really looking for something that pertains to the science.
Megan Columbus:      And so, as with every other one of NIH’s policies, following the rules I think is really important.  Note that NIH has a page on our Grants and Funding website that is devoted to application submission policies.  The co-submission materials policy is listed on that page as should be the video submission policy.  And so, we’ll give you the URL for that in just a few minutes, but thank you for joining us today.  For NIH and OER, this is Megan Columbus.

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