Frequently Asked Questions: Increasing Use of Cardiovascular and Pulmonary Rehabilitation in Traditional and Community Settings (RFA-HL-18-019)

Although not required, we suggest that the applicant send a Letter of Intent to NHLBI as well as scheduling a conference call to discuss the planned application submission.  

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide  for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

In general, the instructions for the parent R61/R33 FOA apply to this RFA, which uses the same mechanism. That includes required additional Other Attachments:

1. Clinical Protocol Synopsis
2. Study Organization Plan
3. Clinical Trial Experience
4. FDA or Other Applicable Regulatory Agency Strategy and Communications Plan
5. Project Management Plan
6. Data Management Plan
7. Statistical Analysis Plan
8. Single Site Justification Plan

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NHLBI intends to commit total costs of $3,750,000 per year in fiscal years 2018 through 2022 to support up to 5 awards.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

There is no strict definition of an implementation research expert. However, it is expected that this investigator (or investigators) will have the appropriate knowledge, skills, and experience in implementation research to carry out the proposed project in collaboration with a multi-disciplinary team of investigators that also includes cardiology, pulmonary, behavioral, and rehabilitation research expertise.

A multi-site clinical trial involves the implementation of the same clinical protocol at two or more independent investigational sites where participants are seen for an intervention and/or outcomes assessment. In a multi-site trial, investigational sites are typically administratively or corporately distinct from each other.

A single-site clinical trial, on the other hand, utilizes one investigational site to conduct and coordinate the protocol. While a single-site clinical trial may enroll participants from multiple locations, those participants will receive an intervention and/or undergo outcome assessments under the direction and oversight of one research team located at one investigational site.

Yes they are permitted. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Although there is no formal policy for special consideration of ESIs for non-percentiled applications, NHLBI will consider ESI status in making funding decisions for this RFA.

No, only randomized trial designs will be considered responsive to the RFA.

The intent of this RFA is to study different approaches to cardiac and pulmonary rehabilitation. While exercise training is generally considered to be the central feature of a rehabilitation program, other components are important, including guidance on diet, stress, smoking, and other cardiac risk factors. 

Yes, the control arm can be the local standard of care in such a setting.

Yes, medical costs that are normally covered by insurance are covered if they occur as part of a clinical trial.

Applications to this RFA will be reviewed by a Special Emphasis Panel (SEP) convened by the NHLBI for the exclusive purpose of this RFA. The SEP will include reviewers with respective expertise in all areas relevant to the RFA and to the individual applications.

Please refer to Section V (Application Review Information) in the funding opportunity announcement (https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-18-019.html). Review criteria are specified in that section.