PA-04-115: RELIGIOUS ORGANIZATIONS AND HIV

Department of Health
and Human Services (HHS)

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RELIGIOUS ORGANIZATIONS AND HIV RELEASE DATE: June 22, 2004 PA NUMBER: PA-04-115 (August 17, 2006 - This PA has been Amended, see NOT-HD-06-008 -
R21s no longer accepted relating to this announcement) EXPIRATION DATE: September 02, 2006, unless reissued Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) APPLICATION RECEIPT DATES: September 01, 2004, September 01, 2005, September 01, 2006 CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements 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 Religion is a powerful force worldwide. Estimates suggest that over 80 percent of the world's population identifies with some established religion. Religious organizations exist in virtually all societies and play varying roles in setting moral and behavioral standards. Religious beliefs, religious practices, and religious organizations have clear relevance to sexual behaviors related to HIV risk as well as to the ways in which HIV-positive individuals are viewed and cared for. This PA calls for studies to examine the extent and nature of religious organizations' involvement in HIV-related activities, the factors that influence such involvement and its effectiveness. The focus is on religious organizations or congregations such as churches, synagogues or mosques. Faith-based organizations -- i.e., those supported by or tied to religious organizations, but not directly providing religious services -- may be involved in the research, but are not the focus of the research. RESEARCH OBJECTIVES Background Religious organizations have long engaged in HIV-related activities such as providing educational interventions and caring for the affected and infected. In many locations around the world, such organizations have been in the forefront or alone in the struggles to ameliorate the suffering of HIV- infected people and their families. However, little systematic knowledge exists concerning how religious organizations, in themselves, influence risk and prevention strategies and responses to HIV at the individual, community, and societal levels. Furthermore, little is known about what aspects of this influence may be unique to the "faith" dimension of such organizations. A scientifically-focused knowledge base will contribute not only to an improved understanding of the factors driving HIV risk, prevention, and care world- wide, but also to the development of innovative prevention and care strategies that build on the strengths and unique features of religious organizations. There are many ways in which religious organizations may contribute to HIV prevention and care. These include shaping family and community values around sexual behavior and other behaviors associated with HIV risk; supporting families and communities in the enforcement of norms and values; providing direct guidance or information to congregants regarding HIV risk behaviors; providing care to HIV-infected individuals and their families; connecting congregants to HIV-related services; creating networks and cooperating with other organizations involved in HIV-related services and/or conducting outreach to individuals and groups at high risk of HIV. Many factors may influence the extent and nature of a religious organization's involvement in HIV-related activities. Members' and leaders' views of the organization's mission are one potential factor. Doctrines that prescribe specific norms of sexual behavior may strongly affect the type of messages and activities promoted. The norms and characteristics of the local populations -- both those proximate to the organization and those served by it -- may have an effect, as may the scope of the organization's connections to community members and groups at risk of HIV. The size, structure, and function (e.g., priority- setting, selection of leaders) of the organization and its linkages to other community organizations may also be influential. Impact of HIV-related activities may be influenced by such factors as the strength of members' ties to the organization, the ability of the organization to retain its youth members, the influence of the organization in the community and culture, cultural consonance between the organization and the local population, networks with other organizations, and the personal strengths of organizational leaders. To have an impact, HIV prevention efforts must reach people at high risk for infection and those who are already infected to encourage them to avoid spreading infection. Successful efforts may work indirectly as well as directly. To the extent that at-risk individuals are disconnected from religious organizations yet connected to less formal social structures such as local bars or social clubs, there may be alternative routes to reaching high- risk populations. Alternatively, religious organizations can alter the conditions and norms of the community in ways that indirectly aid in the prevention of HIV, through altered norms regarding sex or drug use, safer streets, stronger families, or stronger neighborhood ties. Research Scope This announcement focuses specifically on the activities and impact of religious organizations. The term "religious organization" here refers to a body or organization the primary purpose of which is religious worship. Types of religious organizations include churches, mosques, or synagogues; some researchers use the term "congregation" to refer to such entities. Faith-based organizations include religious organizations, but may also include organizations that are supported by or tied to religious organizations, may include worship in their activities, but do not exist primarily for the purpose of religious worship. Examples include groups and organizations, affiliated with a particular denomination or set of denominations that provide social or educational services (e.g., Catholic Charities) or promote social change (e.g., Promise-Keepers). These types of faith-based organizations are not the central focus of the research. However, religious organizations' relationships with faith-based organizations may be appropriately studied in research responsive to this announcement. This initiative invites social science research directed toward building a knowledge base concerning the extent and nature of religious organizations' involvement in HIV-related activities, and the factors that influence such involvement and its effectiveness. Activities related to reducing HIV risk and prevalence, ameliorating the lives and care of HIV-infected individuals, and reducing the costs of HIV infection to communities are all considered relevant under this announcement. The research proposed must be informed by clearly articulated theory addressing HIV risk and prevention, religion and/or religious organizations, and organizations and their functions. Applicants are encouraged to think creatively and broadly in developing a theoretical framework. It is hoped that research carried out under this initiative will contribute to the further development of theory regarding the role of community institutions in HIV prevention. Researchers are encouraged to consider a full range of appropriate qualitative and quantitative methods in designing their research. Multidisciplinary approaches are encouraged, but not required. Applicants may consider the involvement of a wide range of scientists, in addition to those with expertise in the HIV/AIDS arena. Others may include, but are not limited to, those who study religion, institutional organization, service delivery, behavior change, persuasive communication, and community organization and dynamics. Anthropologists, demographers, geographers, economists, political scientists, psychologists, theologians, and sociologists all might have skills of use in developing these studies. We strongly encourage research teams to include significant, substantive involvement of individuals from the institution or institutions to be the focus of the study. Relevant research questions include, but are not limited to: Involvement o To what extent are religious organizations involved in activities related to HIV prevention and care? o How do the structures and function of individual religious organizations influence whether they become involved in HIV-related activities and the specific roles they play? o To what extent is a religious organization's involvement in HIV-related activities related to the personal experience, vision, or ability of specific leaders and to what extent does it result from organizational characteristics? o How is a religious organization's involvement in HIV-related activities influenced by specific elements in organizational missions and doctrines, and the flexibility with which these elements can be interpreted? o How do the characteristics of local communities and populations served by the religious organization influence involvement in HIV-related activities? o To what extent do religious organizations develop active networks with other organizations involved with HIV prevention and care? How are these networks used and sustained? Impact o To what extent are individuals who are HIV-positive or at high risk for HIV exposure connected to religious organizations? Do these connections help to strengthen people's abilities to avoid risk? o How can religious organizations effectively reach individuals who are HIV- positive or at high risk of HIV infection? Do efforts to reach out to such individuals have adverse effects on the participation or retention of not-at- risk populations in the organization? Conversely, what deters at-risk populations from participation in religious organizations? o What are the mechanisms through which religious organizations influence HIV risk and protective behaviors? o How do religious organizations shape and enforce community norms relevant to HIV risk, specifically sexual risk and injection drug use? How does this differ by type, structure of the organization, or community context? o How does a religious organization's ability to retain the involvement of youth and geographically mobile members affect its ability to influence HIV- related outcomes in the community? o How effective are "commuter" churches -- religious organizations located in poor inner-city neighborhoods, but attended by non-community residents -- in influencing HIV-related outcomes in the local community? o In what ways do local religious organizations impede effective HIV prevention or encourage risky behaviors? What factors are responsible and how can they be addressed? Does stigma play a role? o Do the teachings, norms, structure, and operation of religious organizations in particular communities influence community rates of HIV-related behavior? o Does the influence or dominance of a religious organization in a local community, or the cultural consonance between the organization and the local population, influence the impact of the organization's HIV-related activities on HIV-related outcomes in the community? o Does cooperation or conflict (e.g., over appropriate prevention messages) among religious organizations and between religious and other organizations in communities influence these outcomes? o How is a religious organization's capacity or ability to enforce norms, affect behavior or reduce stigma affected by its location within its broader local community? Are certain characteristics -- for instance, its membership composition, its theology, its resources -- more useful in some communities than in others? o How does the larger economic, political, and cultural context in which specific religious organizations are embedded relate to their effect on HIV- related outcomes in their communities? o What is the role of religious leaders and gatekeepers in creating and sustaining or deterring and avoiding prevention efforts? How does institutional involvement in HIV prevention that is initiated by an individual leader at one organization become "institutionalized? MECHANISM OF SUPPORT This PA will use the NIH Research Project Grant (R01) and Exploratory/Developmental Grant (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The R21 mechanism is intended to encourage new exploratory and developmental research projects and/or exploration of novel hypotheses and strategies. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system. These projects should be exploratory and novel, and distinct from the type of project supported through the traditional R01. Specific instructions for the use of the R21 mechanism may be found at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (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. Otherwise follow the instructions for non- modular research grant applications. 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 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 institutions/organizations 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 his/her 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. SPECIAL REQUIREMENTS Budget requests should include funding for one trip per year by the Principal Investigator to an annual meeting of grantees supported through this initiative. This PA has one receipt date per year: September 1. See the "Submitting an Application" section of this announcement for details. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Susan Newcomer, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6981 FAX: (301) 496-0962 Email: Snewcomer@nih.gov o Direct your questions about financial or grants management matters to: Annette Hanopole Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6975 FAX: (301) 402-0915 Email: hanopola@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. 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. The title and number of this program announcement must be typed on line 2 of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS: Applicants submitting R21 applications must follow the guidelines for the Exploratory/Developmental grant mechanism, available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html 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 six 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 submitted in response to this program announcement (PA) will be accepted ONLY on September 1, 2004, September 1, 2005, and September 1, 2006. If sufficient responsive applications are received at that time, a Special Emphasis Panel (SEP) will be organized to review them. If not, the applications will be reviewed in the regular AIDS expedited review panels. 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 unfunded version 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 eight 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 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 written critique 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 the 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 the application's overall score, weighting them as appropriate for each application. The 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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). (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.) ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. 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). 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 is 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. 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. 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 the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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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