Science of Behavior Change
- What is the Common Fund?
- What is the Science of Behavior Change Program?
- What is the experimental medicine approach?
- What scientific expertise is required for the experimental medicine approach to behavior change?
- What are putative intervention targets?
- Why do these announcements have a specific focus on adherence to medical regimens?
- What is meant by medical regimen adherence?
- Who are appropriate subjects, and what is an appropriate setting for this research? Does the work on medical regimen adherence need to be conducted in individuals for whom specific medical regimens have been prescribed or recommended?
- What are cooperative agreements?
- What is the SOBC Research Network Steering Committee?
- How are Program Officers assigned for Common Fund Programs?
- Can applications from the same institution be submitted for a UH2/UH3 project and the U24 Resource and Coordinating Center?
- Can an institution/ research team submit more than one application to an RFA or submit an application to more than one of these companion RFAs (i.e., one interpersonal and social processes project and one self-regulation project)?
- The UH2/UH3 RFAs mention the need to focus on targets relevant to two (or more) health behaviors relevant to two (or more) clinical endpoints or conditions. How are these targets, behaviors and endpoints supposed to be related?
- Can a project be funded as a UH2 for the 5-year award period?
- Does adherence to medical regimens have to be included in my application?
- What type of expertise is necessary for the UH2/UH3 investigator team?
- Are the studies of preclinical nonhuman primates responsive to these RFAs?
- Can these projects support the conduct of a large scale clinical trial?
- If clinical trials are not permitted, is this announcement just calling for basic science?
- What sorts of experimental manipulation or intervention techniques are permitted for testing target engagement?
- Can research teams span institutions?
- Can an institution or research team submit more than one application to a given RFA (or submit one interpersonal processes project and one stress project?
- How will the transition from UH2 to UH3 be determined?
FAQs Specific to the U01 Resource and Coordinating Center (RCC) RFA (RFA-RM-14-017)
- What is the role of the Resource and Coordinating Center (RCC) and how will it relate to the UH2/UH3 projects?
- What type of expertise is necessary for the RCC investigator team?
The NIH Common Fund, managed by the Office of Strategic Coordination in the Office of the Director, supports cross-cutting trans-NIH programs that require participation by multiple Institutes and Centers. Common Fund programs are intended to be transformative, catalytic, synergistic, cross-cutting, and unique. More information can be found at http://www.commonfund.nih.gov.
The Science of Behavior Change (SOBC) is a Common Fund Program that began in 2009 with a focus on studying mechanisms of behavior change in the laboratory and the field. The overall goal of the SOBC Program is to implement a mechanisms-focused, experimental medicine approach to behavior change research and to develop the tools required to implement such an approach. These announcements are the first to be issued under the second 5-year period of the SOBC Program. More information about past and current SOBC Program activities can be found at http://www.commonfund.nih.gov/behaviorchange.
The experimental medicine approach, as applied to behavior change research, involves identifying an intervention target, developing assays (i.e., measures) to permit verification of target engagement, engaging the target through experimentation or intervention, and testing the degree to which target engagement produces the desired behavior change.
Teams consisting of both basic and intervention scientists are needed to advance this agenda. Basic researchers in the behavioral sciences are needed to identify candidate measures of processes that are thought to be causally linked to health behaviors and conduct tests to verify that these processes can be manipulated. Intervention scientists are needed to conduct the theory testing and experimentation that constitutes Stage 0-1 research in the behavioral intervention development pipeline.
For the purpose of these Requests for Applications (RFA) (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020), putative intervention targets represent mechanisms or processes that are hypothesized to be measurable, malleable, and to play a causal role in producing behavior change. It has been hypothesized that self-regulatory functions, processes involved in stress reactivity and stress resilience, and a range of interpersonal and social processes play causal roles in motivating, initiating and maintaining behavior change, including adherence to medical regimens. If this is the case, then intervening to alter these processes could result in behavior change. The UH2/UH3 funding opportunities (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020) call for applicants to identify intervention targets in these three broad domains that they believe can be manipulated and measured to test whether they indeed play such a causal role.
Well-documented non-adherence to medical regimens serves as an exemplar of the challenges in initiating and sustaining healthful behavior change. Recognizing this challenge, NIH has determined that all projects must include a focus on adherence to medical regimens. It is important to underscore that a unifying principle of the SOBC Program is that common mechanisms underlie successful and unsuccessful behavior change across a range of behaviors and clinical conditions. Hence, aspects of self-regulation (for example) applicable to medical regimen adherence may be relevant to a number of other health behaviors. That principle can be formally tested in the proposed projects.
Reference: Haynes, R.B., Ackloo, E., Sahota, N., McDonald, H.P., & Yao, X. (2008). Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews, Issue 2. Art. No.: CD000011. DOI: 10.1002/14651858.CD000011.pub3. Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000011.pub4/pdf.
For the purposes of these RFAs (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020), medical regimen adherence includes, but is not limited to, the following: adherence to prescribed medications, adherence to prescribed screening and immunizations, adherence to behavioral regimens prescribed by a physician or health professional, including follow-up tests, dietary modifications, etc.
8. Who are appropriate subjects, and what is an appropriate setting, for this research? Does the work on medical regimen adherence need to be conducted in individuals for whom specific medical regimens have been prescribed or recommended?
Medical regimen adherence is one of the behavior change outcomes that must be examined and applicants must justify the selection of research participants for investigating the questions posed for any health behaviors of study. For the purposes of these RFAs (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020) work may be conducted in experimental contexts or in clinical contexts, with subjects who do or do not have disease, disorders, or health conditions. Thus, subjects may be healthy individuals or those engaged in prevention or treatment protocols, in laboratory or field experiments, or in a clinical context, as long as the goals of the RFA are met. The ultimate goal for the UH2/UH3 projects will be to demonstrate short-term behavior change under controlled conditions. Regardless of whether the work is conducted in a specific disease context, a clinical population, or in non-clinical contexts, the outcomes of interest are health behaviors relevant to multiple clinical endpoints, not the specific clinical endpoints themselves.
A cooperative agreement funding mechanism supports discrete, specified, circumscribed projects to be performed by investigators in an area representing their specific interest and competencies and is used when substantial NIH programmatic involvement is anticipated. In addition to a Program Officer from the administering Institute, each award will be assigned a Project Scientist from NIH who will participate with the Principal Investigators on a Steering Committee.
The SOBC Research Network Steering Committee will be the main governing board of the SOBC Research Network, which will be comprised of all the funded UH2/UH3 projects (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020) and the U24 Resource and Coordinating Center (RFA-RM-14-017). Voting members of the Steering Committee include the Principal Investigators of the awards and the NIH Project Scientists assigned to each project. The Steering Committee will meet in person at a kick-off meeting before the end of calendar year 2015 and then annually thereafter in each award year. Key project collaborators and other NIH staff as appointed by the SOBC Working Group co-chairs can participate in the annual meetings. The Principal Investigator of the Resource and Coordinating Center will serve as chair of the Steering Committee for the first award year. Thereafter, the group will select its chair from among the members. Applications must include budgets to support the travel of Principal Investigators and key collaborators to these annual meetings. Please see the Cooperative Agreement Terms and Conditions of Award section in the RFAs (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020) for additional information.
Applications will be assigned to Program Officers from various Institutes and Centers that participate in the SOBC Program. After scientific review, the SOBC Working Group will make funding recommendations to the Common Fund and applications will be reviewed by the administering Institute’s advisory board. The administering Institute will function as the award administrator; however, the awards will be funded by the Common Fund.
Yes, applications for more than one of the SOBC RFAs can be submitted from the same institution. However, awards for a UH2/UH3 project (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020) and the Resource and Coordinating Center (RFA-RM-14-017) will not be given to the same institution due to potential conflicts of interest. Applicants may consult with NIH staff to ensure that any potential conflicts of interest are eliminated prior to the award.
13. Can an institution/research team submit more than one application to a one RFA or submit an application to more than one of these companion RFAs (i.e., one interpersonal and social processes project and one self-regulation project)?
Yes, there is no prohibition on the number of applications an institution may submit, provided the applications are scientifically distinct.
14. The UH2/UH3 RFAs mention the need to focus on targets relevant to two (or more) health behaviors relevant to two (or more) clinical endpoints or conditions. How are these targets, behaviors and endpoints supposed to be related?
The limits on the two health behaviors and two clinical endpoints represent the lower bound for what applicants should propose. All of the targets selected should be relevant to both of the selected health behaviors. In addition, any health behavior studied should be relevant to at least two clinical endpoints.
For example, a team may choose to focus on the health behaviors of smoking and adherence. Both are relevant to the clinical endpoints of cardiovascular disease and cancer. Adherence is also relevant to diabetes. A team might propose to examine two targets in the domain of self-regulation that are hypothesized to impact both smoking and adherence (e.g., an aspect of cognitive control and an aspect of emotion regulation). The team may also elect to focus on other targets in that domain that are relevant to other health behaviors.
The SOBC Program, with input from experts in the field of behavior change, have proposed that targets in the three domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes that are the focus of these three UH2/UH3 RFAs, are relevant to multiple health behaviors involved in multiple clinical endpoints, and thus relevant to the missions of several NIH Institutes and Centers. Applications with a narrow focus on one clinical endpoint would be inconsistent with the broad goal to develop tools for a unified science of behavior change that addresses multiple and often co-occurring clinical problems. Applicants must make the case for the relevance of the selected targets and health behaviors to clinical endpoints. However, applicants are not required to demonstrate change in clinical endpoints. The outcomes of interest in the later stages of these projects are changes in health behaviors. There is no requirement to measure clinical endpoints.
No. UH2 awards provide three years of funding. The subsequent two years of UH3 funding depends upon completion of objectives and NIH administrative review at the end of the UH2. UH2 projects that do not meet the awardee-specified milestones by the end of the third award year, as determined by NIH administrative review, will not continue to receive support.
Yes. Applications without at least one component focused on adherence to medical regimens will be deemed unresponsive to these RFAs. For the purposes of these RFAs (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020), medical regimen adherence includes, but is not limited to, the following: adherence to prescribed medications, adherence to prescribed screening and immunizations, adherence to behavioral regimens prescribed by a physician or health professional, including follow-up tests, dietary modifications, etc.
These projects require expertise from basic behavioral scientists working to understand the basic processes involved in either self-regulation, stress reactivity and stress resilience, or interpersonal and social processes relevant to health behaviors. It also requires individuals with expertise in mechanistically-informed behavioral intervention research. It is anticipated that teams will include individuals from a range of disciplines, some of whom may have not previously collaborated across the full basic to applied spectrum envisioned here.
No. These RFAs (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020) will support early stage behavior change intervention activities in humans related to developing and testing specific experimental manipulations or controlled interventions that engage a specified behavioral or social target. These RFAs will not support assay development in animal models, although a team may include expertise in animal models relevant to behavior change.
No. These RFAs will not support the development of diffuse or multi-component interventions, or full scale clinical trials as defined by the NIH (e.g., Phase III or IV, or Stage 2-4). Applications involving large-scale clinical trials will be deemed nonresponsive. These RFAs will support Stage 0 and Stage I work. As with all the stages of intervention development, Stage 1 research is an iterative, recursive process. Stage I involves the creation of a new intervention, or the modification, adaptation, or refinement of an existing intervention. Feasibility and pilot testing are also considered to be part of Stage I (“Stage 1B”). One goal of a Stage I project is to produce the essential materials and information to proceed to another stage of intervention development (e.g., Stage II or Stage III). Another essential goal is to obtain basic scientific knowledge of the behavioral, cognitive, social or biological mechanism of behavior change mechanisms of behavior change (Stage 0). This involves, like all the Stages of intervention development, testing the theory upon which an intervention is based. Small scale pilot Stage 1 clinical trials may be supported by this RFA. In addition, some of the work supported under these RFAs may be conducted within the context of an existing clinical trial. However, the primary goal of the UH2/UH3 is to conduct a range of studies to determine whether specific behavior change targets in the domains of self-regulation, stress reactivity and stress resilience, and interpersonal and social processes, can indeed be manipulated, whether measures exist (or can be developed) to demonstrate that this manipulation has occurred, and to establish whether manipulation of these targets leads to measureable change in two or more health behaviors under controlled conditions.
Reference: Onken, L., Carroll, K., Shoham, V., Cuthbert, B., & Riddle, M. (2014). Re-envisioning clinical science: Unifying the discipline to improve the public health, Clinical Psychological Science, 2, 22-34.
No. To be precise, these announcements (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020) are calling for an integration of approaches and principles from basic behavioral science and mechanistically informed behavioral intervention science. In the course of the proposed work, teams may conduct basic behavioral experiments, typical of those often conducted within the fields of social psychology, cognitive neuroscience or affective science, and may perform manipulations—either experiments, novel intervention approaches or new manipulations, or measurement activities within the context of ongoing intervention studies—to test mechanisms of action. Teams may conduct measurement development activities. They may develop novel or refine existing intervention (i.e., target manipulation) techniques.
There is no limit on approaches here. Applicants proposing specific techniques should make the case that the manipulation/intervention has potential to engage the target. However, note that these RFAs will not support the development of diffuse or multi-component interventions, or full scale clinical trials as defined by NIH (see above).
Yes. Team members may span multiple institutions, and it is possible that the full range of expertise needed for a single proposal may not exist at one institution. Teams are expected to assemble the expertise across labs, disciplines, institutions needed to achieve the target validation aims proposed. Collaborative research teams must include basic and clinical science expertise as well as expertise in the relevant target areas (self-regulation, interpersonal and social processes, and stress reactivity and stress resilience) across multiple levels of analysis (e.g., neurobiological, psychological, behavioral, social), and expertise in behavior change research relevant to one or more health behaviors, including adherence to medical regimens. It is expected that the assay validation work conducted under these initiatives will require the combined expertise of both basic behavioral scientists and intervention scientists. The collaborative nature of the work will require that there are procedures in place to for regular communication, developing protocols and sharing results. An application could involve several labs working on common problems.
There is no prohibition on the number of applications an institution may submit, provided the applications are scientifically distinct.
Teams must meet the objectives listed in the RFAs (RFA-RM-014-018, RFA-RM-014-019, RFA-RM-014-020), according to procedures established after awards are made. Based on successful completion of objectives, program priorities, and availability of funds, decisions will be made by NIH regarding advancement to the UH3 phase.
The RCC will facilitate communication and coordination among the UH2/UH3 projects. Applications should describe a strategy for how the RCC would fulfill its primary functions: establishing, maintaining, and disseminating a publicly available registry of validated assays and experimental methods for inducing and measuring specified behavior change targets; developing and disseminating technical guidelines and best practices for the validation of assays of behavior change targets; conducting systematic reviews of the behavior change literature, and specifically the medical adherence literature, to identify additional potential targets for future validation research; coordinate activities among the UH2/UH3 awardees, particularly those working on the same classes of targets (i.e., self-regulation); and organize the annual meetings and teleconferences of the Steering Committee, External Scientific Panel, and related subcommittees.
The RCC team requires content, methods, and coordination expertise. The RCC is expected to have significant experience and knowledge in the following areas:
- Conducting systematic reviews and meta-analyses of existing clinical trial reports and archived data sets, and using these sources to generate testable hypotheses concerning potential putative intervention targets, differential response of individuals to treatment, and estimates of intervention efficacy and effectiveness.
- All aspects of behavior change research and NIH-approved Good Clinical Practices (see http://www.nhlbi.nih.gov/research/funding/research-support/crg/management/comply-gcp.htm for more information) as well as ethical issues related to clinical research.
- Facilitating cooperation between basic and clinical scientists and in behavioral intervention development.
- Helping to take research questions from hypothesis to implementation and the ability to document these processes.
- Study design and statistics, particularly with novel designs and methods that could enhance the efficiency of validation studies and behavioral trial designs.
- Creativity and innovation in solving technical and project challenges, as well as coordinating efforts among disparate research communities.
- The three target domains (self-regulation; stress reactivity and stress resilience; interpersonal and social processes) sufficient to participate as a member of the subcommittee for that target domain and ensure that products produced by target domain subcommittees will be suitable for the first three objectives of the RCC.