and Human Services (HHS)
EXPIRED
REDUCING MENTAL ILLNESS STIGMA AND DISCRIMINATION RELEASE DATE: June 18, 2004 PA NUMBER: PAR-04-112 This funding opportunity has been replaced by PAR-07-156, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. Expiration Date for R01 Non-AIDS Applications: November 2, 2006 Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) Substance Abuse and Mental Health Services Administration (SAMHSA) (http://www.samhsa.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) Center for Mental Health Services (CMHS) (http://www.mentalhealth.samhsa.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 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 Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Mental Health (NIMH) invites applications for research to reduce mental illness stigma and discrimination. This initiative was conceived in collaboration with the Center for Mental Health Services (CMHS), within the Substance Abuse and Mental Health Services Administration (SAMHSA), and is in response to The President’s New Freedom Commission on Mental Health’s call for a national campaign to reduce mental illness stigma. The CMHS, which has a long history of providing support for innovative anti-stigma programs and strategies, recently launched the Elimination of Barriers Initiative (EBI). The EBI is a major undertaking to identify effective approaches in addressing mental illness stigma and discrimination. In a parallel effort, the NIMH is taking several new steps to encourage research applications to substantially increase our knowledge about how to effectively reduce stigma and discrimination and their consequences. This program announcement represents one of these steps and its purpose is to provide funding for partnerships between (1) consumer and/or advocate organizations, communities, or state and local agencies with hands-on expertise in developing and implementing stigma reduction programs and strategies, and (2) social, behavioral, and/or communication scientists with expertise in stigma research design and methodology. These partnerships would undertake studies that will: assess the effectiveness of existing stigma and discrimination reduction programs and approaches, including media-oriented approaches such as public service announcements; examine how, why, and for whom existing programs or approaches work; develop innovative new programs and approaches; and provide a better understanding of the impact of varied media (e.g., television, newspapers, magazines, cinema, direct-to-consumer advertising, internet), both positive and negative, on attitudes and beliefs about mental illness, and in perpetuating and changing mental illness stigma and discrimination. RESEARCH OBJECTIVES Background When the President launched his New Freedom Commission on Mental Health on April 29, 2002, he declared, Americans with mental illness deserve our understanding, and they deserve excellent care. He identified the stigma that surrounds mental illnesses as a major obstacle to Americans getting the quality mental health care they deserve. The President’s observation echoes findings of the Report of the Surgeon General on Mental Health (http://www.surgeongeneral.gov/library/mentalhealth/home.html) and the White House Conference on Mental Health (http://www.nimh.nih.gov/whitehouse/accomplish.asp), both issued in 1999, that the stigma and discrimination associated with mental illness and its treatment have substantial negative impact on the lives of individuals, families, and communities. The Surgeon General’s report concluded that despite the existence of effective treatments for mental disorders, the fear of stigmatization often deters individuals from acknowledging their illness, seeking help, and remaining in treatment. One of the aims of the Surgeon General’s report was to encourage the development and evaluation of fresh approaches to changing stigmatizing attitudes and behaviors. The final report of The President’s New Freedom Commission on Mental Health (http://www.mentalhealthcommission.gov) gives new impetus to stigma reduction efforts by calling for a national campaign to reduce the stigma of seeking care. Parallel efforts by the NIMH and the CMHS to respond to the call for innovative approaches to changing attitudes about mental illness and its treatment first issued in the Surgeon General’s report, and compellingly reiterated by the President and the final report of The President’s New Freedom Commission on Mental Health, provide both an urgency and an exciting opportunity for partnering to reduce mental illness stigma and discrimination. The NIMH established the Stigma Working Group in November 1999. The charge to the working group, comprised of outside experts, was to assist the Institute in developing a research agenda aimed at addressing the most pressing issues in changing mental illness stigma and discrimination. The working group identified two areas of research in urgent need of further investigation. The first area is research to better understand which strategies and approaches to reduce stigma and discrimination are the most effective, for whom, and why. Models that are found to be particularly effective could then be disseminated to other communities or tailored to other target groups. The second area is research to examine media influences, both positive and negative, on attitudes and knowledge about mental illness and its treatment. The CMHS launched its Elimination of Barriers Initiative (EBI) in June 2003. The EBI, aimed at identifying effective public education approaches to combat mental illness stigma and discrimination, is the most recent in a series of initiatives developed by CMHS to encourage and support the development by consumer and community groups of demonstration programs to reduce stigma and discrimination including, for example, educational programs and materials, contact-based approaches, and public service announcements. The EBI, as well as other CMHS- supported programs, provides a natural laboratory for better understanding what constitutes effective and transportable models and approaches for changing mental illness stigma and discrimination. (Additional information about the Eliminating Barriers Initiative and other CMHS anti-stigma activities can be found at the website of the CMHS-supported Resource Center to Address Discrimination and Stigma, http://www.adscenter.org.) These parallel efforts by the NIMH and CMHS provide a platform for identifying effective programs and approaches, and building a better understanding of how to reduce, or even eliminate, the stigma and discrimination associated with mental illness and its treatment. Although there are many programs and many approaches to changing attitudes and behaviors toward mental illness in existence and use, there has been little research to assess the effectiveness of these efforts or research to understand the mechanisms and processes through which they work. Research on these issues is necessary to provide the critical basis for knowing what works, and developing new programs and approaches where needed. This program announcement reflects the opportunity to build the needed research base. To fully capitalize on this opportunity requires the knowledge and expertise of individuals, groups, or organizations with hands-on experience in developing anti-stigma and discrimination campaigns and researchers with expertise in research design and implementation. For this reason, in order to be considered responsive to this program announcement, the establishment of a formal collaboration between these two groups of experts is required. It is expected that consumer and/or advocate organizations as a group have the most expertise and prior hands-on experience in anti-stigma and discrimination programs, and therefore they would be included as collaborating partners or they would have substantial roles in all applications submitted for this program announcement. Research Scope The types of research falling within the purview of this program announcement range from full-scale effectiveness studies that are grounded in requisite preliminary research, to small-scale pilot, exploratory, and/or developmental studies to, for example, develop and test new measures to assess program outcome. Also of interest are public education strategies, personal contact approaches, targeted public education, and media-oriented and other types of mental health awareness campaigns, and multifaceted campaigns that combine several types of approaches, as well as other innovative approaches. The programs and approaches might also target the general public, specific demographic groups (e.g., older adults, children and adolescents, racial and ethnic minority groups, and rural Americans), or specific stakeholder groups (e.g., mental health service providers, law enforcement officers, and employers). Multi-method studies combining qualitative and quantitative approaches are encouraged. Some illustrative examples of research topics that may be addressed under this program announcement are (but are not limited to): Studies to assess the effectiveness of existing stigma and discrimination reduction programs and approaches, including media-oriented approaches such as public service announcements: o Studies using existing measures and/or to develop pilot test measures to assess knowledge, attitudinal, and behavioral outcomes; o Studies of the differential effectiveness of programs or approaches across gender, age, regional, and/or cultural/ethnic groups; o Studies to assess durability of program effects; o Studies to examine the extent to which programs and approaches generalize across demographic and stakeholder groups versus the need for programs and approaches tailored to specific target groups; o Studies to examine the contribution of individual components of multifaceted programs to the overall program’s effectiveness. Studies to examine how and why existing programs or approaches work: o Studies to identify the critical elements and/or the conceptual elements of effective stigma change strategies targeted at specific groups of individuals (e.g., healthcare providers) and to the general public; o Studies to identify the operational elements of effective programs and approaches targeted at specific groups of individuals (e.g., healthcare providers) and to the general public; o Studies to examine the social, cognitive, psychological, and/or behavioral processes through which effective programs and approaches work to bring about reductions in stigma and discrimination. Studies to develop innovative new programs and approaches: o Studies to develop and pilot test program message content and style, and/or program format; o Studies to adapt existing programs or approaches to another demographic or stakeholder group; o Studies to develop training protocols for program delivery or implementation. Studies to examine the role of media (e.g., television, newspapers, magazines, cinema, direct-to-consumer advertising, internet) in perpetuating and changing mental illness stigma and discrimination: o Studies to examine the impact of media content and images on knowledge, attitudes, and beliefs about mental illness; o Studies of the influence of the media, both positive and negative, on the experience and self-beliefs of individuals with mental illness; o Studies comparing mediums of message delivery in changing knowledge, attitudes, and behaviors towards mental illness; o Studies to develop age-appropriate messages to change children’s negative attitudes and behaviors toward mental illness. MECHANISM OF SUPPORT This PA will use the NIMH collaborative R01 award mechanism (http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html) and requires a formal collaboration between individuals, groups, or organizations with hands-on experience in developing anti-stigma and discrimination campaigns, and researchers with expertise in research design and implementation. As an applicant, you, in collaboration with your collaborating partner(s), will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting 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 budget format. Otherwise follow the instructions for non-modular budget 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_2003/NIHGPS_Part2.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 Foreign institutions are not eligible to apply 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: Emeline Otey, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6186 Bethesda, MD 20892-9625 Telephone: (301) 443-1636 FAX: (301) 443-4611 Email: [email protected] o Direct your questions about the EBI and other CMHS/SAMHSA anti-stigma activities to: Paolo DelVecchio Office of External Liaison Substance Abuse and Mental Health Services Administration 5600 Fishers Lane, Room 15-99 Rockville, MD 20857 Telephone: (301) 443-2619 FAX: (301) 443-5163 Email: [email protected] o Direct your questions about the NIMH Outreach Partnership Program to: Timothy Hays, Ph.D. Office of Constituency Relations and Public Liaison National Institute of Mental Health 6001 Executive Blvd, Room 7111 Bethesda, MD 20892 Telephone: (301) 443-3673 FAX: (301) 443-2578 Email: [email protected] http://www.nimh.nih.gov/outreach/partners/ o Direct your questions about financial or grants management matters to: Brian Albertini Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6134, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: [email protected] 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: [email protected]. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS: This program announcement requires the knowledge and expertise of (1) individuals, groups, or organizations with hands-on experience in developing anti-stigma and discrimination campaigns, and (2) researchers with expertise in research design and implementation; and it requires that a formal collaboration between two (or more) groups of experts be established. Each of the collaborating partner sites must submit a separate application. The applications must contain an identical ABSTRACT, which identifies the collaborating partner(s) site(s) by the name of the Principal Investigator and the name of the applicant organization or institution, an identical OVERVIEW, an identical RESEARCH PLAN, Section 2 A-D, and an identical Section H, CONSORTIUM/CONTRACTUAL ARRANGEMENTS. The OVERVIEW must be no longer than 2 pages and must provide an overall rationale for applying as collaborative partner sites, the role of each partner site in the overall project. It is expected that consumer and/or advocate organizations as a group have the most expertise and prior hands-on experience in anti-stigma and discrimination programs, and would therefore, be included as a collaborating partner or have a substantial role in all applications submitted under this PA. If none of the collaborating sites is a consumer or advocate organization, the role of representatives of the consumer and/or advocate community in developing the application and in conducting the research must be explicitly laid out in the overview. The RESEARCH PLAN - Section 2 A-D, must describe the study design, the research procedures or protocol, the study population, resources, data analyses, and the special expertise and role of each of the collaborating partners in implementing each aspect of the research plan. Since the unique aspects of each site are described in both/all collaborating applications, the Collaborative R01 requirement of a specific section entitled ELEMENTS UNIQUE TO THIS SITE does not apply to this PA. Section H, CONSORTIUM/CONTRACTUAL ARRANGEMENTS, must describe a feasible mechanism for scientific integration of research procedures, overall managerial and administrative responsibilities, and cross-site comparability of training to assure reliability and quality control. The PIs may or may not wish to designate a Steering Committee or other decision making body, or identify one individual as the contact person for the group as a whole, for purposes of NIMH correspondence. Plans for ensuring access to data by all sites, analytic resources, publication and authorship rights, the possibility of public use research materials and data, or other means of distributing research materials to the wider scientific community, and a means of arbitrating disagreements on publication and other issues should be discussed in this section of the application. 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 BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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: Collaborating partners requesting $500,000 or more in direct costs (both/all sites combined for any year) must include a cover letter from the NIMH staff member who has agreed to accept assignment of the application. Collaborating partners requesting more than $500,000 for both/all sites combined must carry out the following steps: 1) Contact 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 IC staff member 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 an application (each site should submit their individual 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 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 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 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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 National Advisory Mental Health Council. 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 evaluate application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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: COLLABORATION: Is there a feasible mechanism for collaboration to achieve scientific integration of research procedures, overall managerial and administrative responsibilities, appropriate quality control and reliability assurance, and planning for data management, analysis and reporting of results? 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).http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 REVIEW CONSIDERATIONS 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 ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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 SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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. 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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). 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.healthypeople.gov/. 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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