Information for Applicants to “Funding For Collaborative Clinical Research In Type 1 Diabetes: Living Biobank (R01 Clinical Trial Optional)”

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FAQ

RFA-DK-17-032: Funding For Collaborative Clinical Research In Type 1 Diabetes: Living Biobank (R01 Clinical Trial Optional)

The information in this document does not take the place of the published Funding Opportunity Announcement (FOA). The FOA is linked above; please read it carefully before submission. In case of conflict, the FOA takes precedence. Questions may have been edited for clarity.

1. How does “exploratory,” even with a hypothesis, tie in with R01s, which are heavy on preliminary data? My impression is that reviewers generally don’t like exploratory work for an R01, no matter what the RFA says.
   • Preliminary data that address the feasibility of the proposed project are very important to reviewers, and publications are always a plus. Exploratory projects might include those that seek to discover (as opposed to those that validate) a new biomarker, but the application should demonstrate that the project is doable within the time and resources requested.
2. Are there any restrictions on foreign collaborators (European)?
   • Please see the FOA. Foreign collaborators are allowed, but special restrictions apply. NIH makes a big distinction between grants to a domestic institution with foreign collaborators and grants to a foreign institution. The following text is an example of some of the policies that pertain to foreign collaborators. For the complete information, visit the NIH Grants Policy Statement.
     
     16.3 APPLICATION REVIEW
     Applications from foreign organizations or international organizations will be evaluated and scored during the initial review process using the standard review criteria. In addition, the following will be assessed as part of the review process and award decision:
     • Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
     • Whether the proposed project has specific relevance to the mission and objectives of the IC [Institute or Center] and has the potential for significantly advancing the health sciences in the United States.
     Note, these additional criteria are not applied to applications from domestic organizations with foreign components or applications in response to an FOA requesting applications from foreign organizations only.
     
     Research grant applications from foreign organizations or international organizations may not be funded unless approved by the IC National Advisory Council or Board.
3. Does the letter of collaboration need to be a part of the Letter of Intent (LOI)? Such letters typically take some time to obtain, especially if the Principal Investigator is not part of the original study.
   • No, the letter of collaboration need not be provided with the LOI, but it must be included with the application by the receipt date.
4. Do you know success rates for the ancillary study Program Announcement (PA)?
   • Success rates are not applicable across different FOAs. Although we have offered Living Biobank opportunities in the past, the specific intentions, requirements, review criteria, and review panels for the prior FOAs have been diverse, so comparisons are likely to be inaccurate.
5. How will the “add on test” be handled at the Institutional Review Board (IRB) level? Will a central IRB approval be required?
   • Multicenter clinical trials (those with two or more sites) are required to use a central IRB. In this case, the ancillary is not expected to add a new site to an existing consortium (it would be nonresponsive if it did). However, ancillary studies should take advantage of the central IRB, if feasible.
6. My experience is that getting collaborative letters can take months.
   • Formal collaborative work can be challenging and we regret that circumstances prevented us from having an active FOA until relatively late in the grant cycle. We prefer to give applicants more time to prepare. Other funding opportunities are available for projects that are not ready for submission by the receipt date. Please contact NIDDK staff for ongoing opportunities through the Parent Announcement and other PARs.
7. Our experience is that outsiders may not be as successful in trying to be involved in these ancillary studies.
   • The NIDDK encourages their ongoing clinical studies to leverage their resources through ancillary studies. Part of the purpose of this FOA is to create new opportunities for collaborative research. For example, it is required that participating clinical studies or networks have a process in place for responding to requests for collaboration and informing outside researchers about the opportunities, policies, and data sharing requirements. This requirement is intended to promote collaborative research among different scientific communities. We appreciate that these are challenging projects and NIDDK staff are ready to try to facilitate interactions; just call us!

Agenda

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