Implementation of shared decision making for HLBS diseases and conditions (R01 Clinical Trial Optional)

Released Date
Expiration Date
Activity Code
Full Announcement

Frequently Asked Questions for PA-19-166

Q1. When are applications due?

A1. This program announcement supports the R01 grant mechanism. The due dates follow the standard non-AIDS dates, and standard AIDS dates for R01 new, resubmission, renewal, and revision submissions.

Q2. How should I submit my application?

A2. Applications must be submitted electronically. Applicants should follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Q3. Am I required to submit a letter of intent?

A3. A letter of intent is not required and it does not enter into the review process. Applicants are encouraged to communicate with the NIH scientific contact persons listed at the bottom of the FOA to discuss their research ideas and specific aims prior to submitting applications.

Q4. Does the application have a page limit?

A4. Yes. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Q5. What types of research designs that are appropriate for this program announcement?

A5. Several research designs may be appropriate for this program announcement, depending primarily on the research question. For intervention research it will also depend on whether randomization is possible. Randomized controlled trials are not a required component of applications submitted in response to this announcement but they are allowed. In some cases, a randomized design may not be possible or feasible, or would raise ethical concerns that are difficult to address. In such instances, investigators could propose and justify alternative, high-quality study designs. Such designs include, but are not limited to, quasi-experimental designs such as multiple baseline or interrupted time series, pre-to-post intervention with external comparison; qualitative methods, quantitative and mixed-method approaches; natural experiments, or others. The use of a variety of novel implementation research study designs, including adaptive designs, is encouraged where appropriate. For proposals involving interventions, applicants should describe the strongest study design that can evaluate the effects of an intervention program with high internal validity, taking into account external validity and generalizability. In the case of secondary data analyses, the data must be well described and appropriate for this funding initiative.

Q6. Who needs to be included in the multidisciplinary teams mentioned in the announcement?

A6. Project team composition will be determined in large part by the research question and proposed approach. Disease/condition-specific area experts, implementation researchers, and stakeholders should comprise the core team. Clinical trials, ethics, organizational management, information technology, and behavioral economics are examples of other types of expertise that might be represented in multidisciplinary teams. Teams also may include patient and community-based organizations.

Q7. Who qualifies as an implementation research expert?

A7. While there is no uniform definition of an implementation research expert, it is expected that the 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.

Q8. How many awards does NHLBI intend to Fund?

A8. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Q9. On what basis are applications selected for funding?

A9. Applications will be selected for funding based on scientific merit, current NIH program research priorities, and availability of funds. Applicants are highly encouraged to discuss potential research aims with program officials to determine fit with programmatic research priorities. Applications which do not align with NHLBI research priorities may be rejected without review.

Q10. Where will my application be reviewed?

A10. Applications to this announcement will be received and reviewed in the NIH’s Center for Scientific Review.

Q11. Where can I find more information about implementation research frameworks?

A11. Resources related to Dissemination and Implementation Frameworks, Theories, and Models can be found here.

Q12. Are foreign institutions eligible to apply?

A12. Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.