RESEARCH ON ADHERENCE TO INTERVENTIONS FOR MENTAL DISORDERS RELEASE DATE: April 21, 2003 PA NUMBER: PA-03-111 (This PA has been reissued, see PA-06-324 for R01 applications) March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE: March 02, 2006 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.242 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA replaces PA-00-016. Maximal benefits from treatment or preventive interventions will not be achieved if individuals discontinue those interventions before completion. Even if a protocol is completed, less than full adherence to one or more of its components can also limit the benefits. An example of the consequences of nonadherence to treatment regimens may be seen in statistics relating to unipolar major depression. According to World Health Organization estimates, unipolar major depression will become the second leading cause of disability worldwide by the year 2020. Although effective treatments exist, large segments of those who suffer from depression do not receive treatment. The Agency for Healthcare Research and Quality estimates that, among those who do receive treatment with available antidepressant medications, forty percent do not complete the recommended 7-12 months regimen. Thus, the full benefit of antidepressant medication therapy is not realized. Similarly, substantial dropout rates from psychosocial and behavioral interventions for mental disorders limit their public health impact. In addition to unipolar major depression, bipolar disorder, schizophrenia, and anxiety disorders such as obsessive-compulsive disorders are among the leading causes of disability worldwide. Available interventions for these disorders could have greater impact and relieve more suffering if adherence to them were improved. This program announcement is intended to expand research on adherence and behavior change that leads to improved adherence and/or improved mental health outcomes. It should integrate findings from the basic behavioral sciences with interventions for mental disorders, symptoms, or related disability, and with findings from services research about the elements of care delivery systems that facilitate or create barriers to improved adherence. Included are studies of mechanisms and processes that enhance or interfere with adherence to preventive, treatment, and rehabilitative interventions. The interventions may be pharmacological, behavioral, or psychosocial. Emphasis is on the development of innovative approaches to adherence and behavior change, especially models of interventions to improve adherence. A well-articulated, empirically based conceptual framework is therefore essential in applications solicited under this announcement. Applications that also include a detailed plan for initial tests of a conceptual model, or which test the feasibility of implementing an efficacious intervention in an existing health care delivery system are especially encouraged. One commonly used definition of adherence is: The degree to which a patient or client's behavior is consistent with an agreed-upon mode of treatment. However, the definition of "adherence" or "behavior change" might well vary depending upon the nature and scope of the particular problems under study. Clear conceptual and operational definitions and psychometrically sound measures that are consistent with these definitions are essential in this research. Definitions of "adherence" or "behavior change" might address, for example, the completeness and frequency with which a client engages in behavioral or psychosocial components of an intervention protocol, or the extent to which a client takes medications at the dosage and frequency prescribed. Other definitions and measures could focus on provider behaviors, intervention strategies or on aspects of the patient provider relationship. Increased understanding of the mechanisms and processes underlying individuals' decisions to adhere or not to adhere to interventions for mental disorders, their symptoms, and related disability, would enhance our ability to develop models of interventions to modify those mechanisms and processes to increase adherence. Although many theoretical models have been developed to describe the processes of adherence and behavior change, their potential has not been fully exploited to guide the design of pharmacological, behavioral and psychosocial interventions. Progress in applied public mental health could be accelerated significantly by building on fundamental research in the behavioral and biomedical sciences related to motivation, persuasion, attitude change, decision-making, perception, self-efficacy, social cognition and other interpersonal processes, initiation and sustainment of behavior change, personality factors, family and community support, and the character of alliances between providers and clients. Therefore, investigation of the utility of such theoretical models remains an important challenge. Applications examining mechanisms and processes underlying provider strategies and behaviors that enhance recruitment, retention, and adherence are also encouraged. Other areas of interest under this program announcement include research on approaches to decreasing stigma related to mental disorders and increasing adherence to interventions; studies of ways in which various informed consent procedures and other issues related to research ethics can facilitate or hinder adherence to interventions; and the development of reliable and valid measures for all the above areas. The importance of adherence to the outcome of preventive, treatment, and rehabilitative interventions is well recognized, but it has often been treated simply as a nuisance variable in research. Adherence must be regarded as a central focus in all research that attempts to develop or test models of interventions for mental disorders, symptoms, and related disability. RESEARCH OBJECTIVES The need for research is urgent across a range of topics germane to adherence to interventions for mental disorders, symptoms, and related disability. This program announcement will encourage grant applications for research in a number of critical areas, including, but not limited to: o Cross-cutting principles of motivating adherence and behavior change in studies aimed at developing models of preventive, treatment, and rehabilitative interventions and innovative strategies to enhance adherence to them; o Methods of adherence and behavior change that promote incremental change over time to sustain the benefits of intervention; o The relationship of adherence to intervention response throughout the course of the intervention; o How competing theories of adherence and behavior change complement each other, such as studies simultaneously varying motivation source, degree of self-efficacy, stage of change, social reinforcement, or norms; o How differential patterns of adherence to various components of combined interventions influence outcomes; o Identifying the general principles of motivation (e.g., intrinsic or extrinsic motivation) most effective in encouraging adherence, and identifying the emotions, attitudes, states, or beliefs (e.g., negative emotions such as fear, or positive attitudes such as an enhanced self-image or an appeal to an ideal self) that are most centrally associated with adherence behaviors; o Studies of various theory-based interventions for improving adherence in various under-served or high-risk/special-need populations across the life-course; o Strategies containing sub-components that address different adherence- related behaviors separately, e.g., a project with multiple sub-studies that investigate different aspects of a theory for their relevance to different behaviors; o Studies of how factors underlying adherence or behavior change in one domain, for example, interventions aimed at HIV disease, other sexually transmitted diseases, Hepatitis C and tuberculosis, might inform adherence to interventions aimed at mental disorders; o Studies of factors underlying provider strategies and behaviors that enhance recruitment, retention, and adherence; o Developing and validating measurements of adherence to pharmacological, behavioral, or psychosocial interventions, including blood and urine levels, self-reports, clinicians' observations, pill counts, remote or automated sensing devices, etc.; o Clarifying the characteristics of study participants that may contribute to adherence and non-adherence, such as age, gender, ethnicity, level of education, occupation, marital status, parental status, socioeconomic status, sexual orientation, religion, personality traits, personal and/or cultural beliefs about health, the nature of their disorder, or their treatments, and the presence of co-morbid mental illness; o The health provider/client alliance and communication patterns, and how these processes affect adherence; o Studies of interventions and service models that aim to increase client involvement in preventive, treatment, and rehabilitative decisions as a way of improving adherence; o Studies that examine the impact of organizational, management, integration, or financial features of the mental health delivery system that may facilitate or create barriers to improved adherence and/or more productive health provider/client alliances; o Community and clinical epidemiological studies that assess the relative impact of the competing explanatory domains that are associated with adherence, such as the relative impact of intra-psychic phenomena, behavioral cues and reminders, the health provider/client alliance, or the features of the health care delivery system; o Research on approaches to decreasing stigma related to mental disorders and increasing adherence to interventions, including studies of self stigma, stigma among providers, families and significant others, the social context of stigma, as well as studies of individuals who are stigmatized; or o Research on the potential positive and/or negative impact of various informed-consent procedures and other issues related to research ethics on interventions aimed at mental disorders, including issues such as capacity to make informed consent, adequacy of informed consent content and procedures, efforts to identify and reduce therapeutic misconceptions, the impact of wash-out protocols, and the feasibility and adequacy of connect by proxies. MECHANISM(S) OF SUPPORT This PA will use the NIH Small Research Grant Program (R03), NIH Exploratory/Developmental Research Grant Award (R21), and Research Project Grant (R01) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The Small Grant (R03) provides two years of funding with a maximum of $50,000 direct costs for each year. Information on the requirements for the NIH Small Grant may be obtained at http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html. The Exploratory/Developmental Grant (R21) provides two years of funding with a maximum of $275,000 direct costs over the entire budget period; it is intended for pilot testing of interventions and other aspects of intervention development. The Research Plan may not exceed 15 pages. Information on the requirements for the NIH Exploratory/Developmental Grant may be obtained at http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. The Research Project Grant (R01) provides up to five years of funding that is commensurate with the science proposed. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: William Riley, Ph.D. Division of AIDS and Health and Behavior Research National Institute of Mental Health 6001 Executive Boulevard, Room 6226, MSC 9623 Bethesda, MD 20892-9623 Telephone: (301) 435-0301 FAX: (301) 480-2920 Email: wiriley@mail.nih.gov Junius Gonzales, M.D. Division of Services Research and Clinical Epidemiology Branch National Institute of Mental Health 6001 Executive Boulevard, Room 7141, MSC 9631 Bethesda, MD 20892 Telephone: (301) 443-3364 FAX: (301)443-4045 Email: jgonzale@mail.nih.gov o Direct your questions about financial or grants management matters to: Brian Albertini Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6135, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: ba18b@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants. nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02 -001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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