FREQUENTLY ASKED QUESTIONS: PAR-16-037
Program Officials listed in the FOA can address any questions not listed here.
Q1: Are first in human studies, early safety studies, phase I studies or other feasibility studies responsive to this Funding Opportunity Announcement (FOA)?
A1: Probably not. The intent of this NHLBI R34 FOA is to provide support to collect information needed to finish the design of a clinical trial with public health importance. A review consideration specific to this FOA is “Is acquisition of pilot study data critical to address the objectives of a full-scale trial?” In general, first in human studies, early safety studies, studies to define dose-response or other Phase I or I-II type studies will not meet the criterion of both “necessary and sufficient” to design the planned full-scale trial with large public health impact.
Q2: What should be included in the “Clinical Trial Description” if the design of full-scale trial is not final?
A2: The purpose of this attachment is to provide context for the goals of the R34 award. The reviewers will use this information to evaluate how the pilot study contributes to the full scale trial’s goals and how the results of the pilot study will inform its design. Specifically, the application should contain enough information for the reviewers to evaluate: 1) the hypothesis of the trial; 2) the public health impact of the trial; 3) whether the planned design of the trial will address the hypothesis; 4) how the information gathered through an R34 grant will contribute to the design of the trial; and 5) whether the information gathered with the R34 is both necessary and sufficient for you to make the final decisions about the trial design.
Q3: I have developed a clinical trial and need support to identify clinical sites, finalize the protocol and write the manual of procedures. Is the NHLBI R34 mechanism appropriate?
A3: No, it is not. Some R34 FOAs sponsored by other NIH institutes permit this, but the NHLBI PAR-16-037 is specifically tailored to support research addressing gaps in knowledge necessary to complete the design of a trial with large public health impact.
Q4: If I am an Early Stage Investigator (ESI) and am awarded an R34, will I lose the ESI status?
A4: No, an R34 does not count against the ESI status. However, other factors could. Please see the NHLBI Funding and Operating Guidelines, subheading on Early Stage Investigators.
Q5: If I qualify as an Early Stage Investigator (ESI), will I be given special funding consideration?
A5: No, the R34 is not eligible for ESI special funding consideration.
Q6: Where is my R34 application reviewed?
A6: The R34 applications are reviewed by a committee that is convened by the NHLBI Office of Scientific Review. The review criteria and process is similar to CSR with the standard scoring system.
Q7: Can I submit an R34 and an R01 for the same trial simultaneously?
A7: This is not advisable. An R01 application for a clinical trial that lacks sufficient information to justify its design would not be competitive. On the other hand, reviewers are likely to look unfavorably on an R34 application if you already have sufficient information to design a competitive full-scale trial. In this case, you should submit an R01 application directly.
Q8: Can I submit two R34s for the same planned follow-up trial?
A8: No. If you need two R34s, neither one will meet the criterion of “both necessary and sufficient” to design the follow-up trial.
Q9: If I submitted an R01 application for a clinical trial and the reviewers said that I needed more data to justify or show feasibility of one aspect, may I apply for an R34 for that trial?
A9: Yes, if the questions you are asking meet the criteria of PAR-16-NNN, you may apply, even if you have already applied unsuccessfully for an R01 for the same trial. The R34 will be a new application; however, following completion of the R34, the follow-up R01 application will be considered a resubmission (A1).
Q10: How do I decide whether to submit an R34 or an R01 for a small multi-site intervention trial?
A10: If you have all the information that you need to design the trial, you should use the R01 mechanism. The NHLBI R34 mechanism is specifically designed to allow investigators to collect information needed to enhance the quality of the trial design and the likelihood of successful implementation.
Q11: Are studies involving vertebrate animals appropriate to be conducted under this FOA?
A11: Although not specifically prohibited by the PAR, it is very unlikely that studies involving vertebrate animals can be conducted to contribute to the completion of aims that are necessary and sufficient to commence a definitive trial of public health impact and is discouraged.
Q12: I serve on study section and am eligible for continuous submission. May I submit my application late?
A12: Yes, see the NIH Continuous Submission page for full details including how to check your eligibility, and the associated Frequently Asked Questions. If you have further questions about this, please contact the Scientific Review Officer, listed in the FOA.
Q13: Are there any additional instructions for the application?
A13: Follow the instructions in the SF424 Application Guide as modified by the instructions in the FOA. Note that the FOA requires additional attachments, such as the “subsequent clinical trial description”, any contracts, memorandums of understanding or agreements, and any FDA approval. Detailed information is contained in Section IV.2. Applications may not be reviewed if they do not contain the required information. Please read the entire FOA for all the requirements, many of which have changed from previous issuances of this PAR.
Q14: Are appendices permitted?
A.14: No, appendices are not permitted. NIH issued NOT-OD-16-129 on August 12, 2016 eliminating most appendix materials. The required file, “Clinical Trial Description.pdf”, should be included as an attachment. It should be included under the “Other Project Information” section of the application, should be bookmarked for easy access by reviewers, and may not exceed 3 pages. The description of the subsequent trial is intended to provide context for the reviewers to see how the information collected in the R34 award would inform the decisions about the trial.
Q.15: Should the required clinical trial description file be submitted as an appendix?
A. 15: No, the R-34 FOA does not allow appendices (see related question Q.14). The R-34 required file, “Clinical Trial Description.pdf”, is not considered a protocol and should be included under “Other Project Information” section of the application, should be bookmarked for easy access by reviewers, and may not exceed 3 pages.
Q.16: May I include the description of the subsequent clinical trial in the main body of the application?
A.16: No, the “Clinical Trial Description.pdf” file is required and should be included as an attachment, not an appendix.