Yes, more measures will be added before the December 5, 2017 application deadline. Please visit www.scienceofbehaviorchange.org/measures and click on “Coming Soon Measures.” There are measures listed in the pop-up that should be available after November 15, 2017, and a second list of measures that should be available after December 1, 2017. You can contact the SOBC Resource and Coordinating Center (RCC) at [email protected] if you have questions about the domains the Coming Soon Measures will cover. Please note that there are some measures that might be tagged as being in the self-regulation domain that might also be applicable to stress reactivity and stress resilience or interpersonal and social processes domains.

Yes, proposed projects can include measures that are not provided in the SOBC Measures Repository. The FOAs require the use of at least one measure from the SOBC Measures Repository but do not limit the use of additional measures.

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Revision applications may propose an additional intervention arm. Please discuss your ideas with the parent award Program Official and one of the scientific contacts listed in the FOA.

Yes, the competing revision FOAs are open to R01, U01, and R34 parent clinical trial awards from any NIH Institute or Center. However, the SOBC Program strongly encourages applicants to discuss the opportunity with their parent award Program Official and Grants Management Specialist to determine whether the administering Institute or Center agrees that this opportunity would be a good fit for the parent award.

Yes, clinical trials is defined in accordance with NOT-OD-15-015, which has been in effect since October 2014.

No. The PI for the competing revision application must be the PI of the parent award. It is possible to add a multiple PI to the parent award and competing revision application, but this would require strong justification related to the parent award and prior approval of the parent award Grants Management Officer in consultation with the parent award Program Official. See https://grants.nih.gov/grants/multi_pi/faq.htm#2984 and https://grants.nih.gov/grants/multi_pi/faq.htm#2985.

The SOBC competing revision application will be awarded in July or August 2018 regardless of the recycle date of the parent award. However, in the second year the administering Institute or Center may choose to move the recycle date of the competing revision to be the same as for the parent award. The end of the competing revision project period cannot extend beyond the project period of the parent award.

No. Only current awardees at the time of application submission (December 5, 2017) may apply for a competing revision.

No, both types of activities are acceptable.

Both patient-oriented and provider behaviors are acceptable.

The R21 must focus on at least one health behavior. Medication adherence is considered a health behavior; see FAQ #7 and #30 at https://commonfund.nih.gov/behaviorchange/faq.

You may contact one of the scientific contact with broad questions about the opportunity. However, for NIH staff to be maximally helpful to you, it is suggested that you have specific aims or other proposed study details ready if there is a follow up conversation with the scientific contact.

The R21 Request for Applications (RFA-RM-17-028) is open to applications that might be applicable to any NIH Institute or Center. The SOBC Common Fund Program is a trans-NIH program that involves multiple Institutes and Centers. The scientific contacts on the FOAs represent the members of the SOBC Working Group who led the development of these FOAs, but their Institute affiliation does not mean the applications are limited to their Institutes. Please reach out to one of the scientific contacts listed in the FOAs, and if it would be helpful for you to discuss your idea with an SOBC Working Group member from a different Institute, the scientific contact can connect you.

RFA-RM-17-028 states that the NIH expects to award 10 to 20 R21s. However, this is an estimate contingent upon receiving scientifically meritorious applications and availability of funds. Also noted in the FOA, the SOBC Common Fund Program intends to commit $5.25 million in FY18 and in FY19 for all four FOAs combined.

Any design that would allow evaluation of a mechanisms-focused, experimental medicine approach to behavior change research is acceptable. The R21 project should engage a selected putative target or verify engagement of a putative target and test the degree to which engaging the putative target produces a short-term desired change in a health behavior. Insofar as the design of your project falls within the NIH clinical trial definition as outlined in NOT-OD-15-015, then a clinical trial that can be completed within a two-year project period is allowed but not required. Further, the scope of proposed project should determine the project period. The maximum project period is 2 years for the R21 activity code.

Standard due dates apply to open funding opportunity announcements without a specific focus, review, or dedicated funding, such as Parent Announcements and Program Announcements. (see Understanding Funding Opportunities for more information). Standard due dates do not typically apply to Requests for Applications (RFAs). All of the SOBC FOAs are RFAs. RFAs typically identify a narrowly defined area for which there are set-aside funds and have a single unique receipt date. Please see the NIH Guide for more information on the different types of FOAs.

Absolutely. Irrespective of the type of intervention, it is important for the application to clearly articulate which putative target/mechanism of action is believed to be part of the causal chain for the behavior of interest and clearly delineate how the intervention will engage that target to produce a short-term desired change in a health behavior.

See RFA-RM-17-022, RFA-RM-17-023, RFA-RM-17-024, and RFA-RM-17-028 for examples of activities relevant to the purpose of the competing revision and exploratory/developmental RFAs. Note the description of activities is illustrative not exhaustive. The SOBC Program has not prioritized one type of activity over another.

No. The Letters of Intent will assist the SOBC Program and the Center for Scientific Review in planning for the review.

No. However, we encourage you to submit a Letter of Intent only if you do intend to submit an application.

Please include:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Send it to Dr. Will M. Aklin (National Institute on Drug Abuse) at [email protected].

A summary of the proposed activity or specific aims are not needed in the Letter of Intent.

Non-domestic (non-US) entities (foreign institutions) are eligible to apply. Non-domestic (non-US) components of US organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. Parent awards to US-based institutions with field work in non-US locations are eligible to apply.

Awards will be made in July or August of 2018.

Note that the use of the word “target” in these FOAs is being used in the sense of the experimental medicine approach to intervention design, where it refers to a specific process you are attempting to influence in order to achieve a health-related behavior change. A few example targets for medical regimen adherence (see FAQ #7 and #30 at https://commonfund.nih.gov/behaviorchange/faq for the definition of medical regimen adherence adopted by the SOBC Program) are delay discounting, executive control, and response inhibition.

The SOBC notion of targets should not be confused with the specific area of medical regimen adherence. Some specific examples of treatment/medical regimen adherence that might be an outcome include but are not limited to adherence to prevention or treatment protocols that have broad health implications across a wide range of functional and clinical outcomes and disease conditions. Specifically, adherence to prescriptions, screenings, immunizations, behavioral regimens, and the like, as prescribed by a health professional or as an evidence-based recommendation of an authorized entity, such the Centers for Disease Control and Prevention or the U.S. Preventive Services Task Force, is a highly-desired health behavior outcome.

No. Many institutions have sample applications from their investigators that might be useful to you in understanding (e.g.) aspects of grantsmanship. But it should be noted that with respect to the specific science, we have released these FOAs precisely because there is a dearth of projects or applications using the experimental medicine approach.