and Human Services (HHS)
EXPIRED
INTERNATIONAL BIOETHICS EDUCATION AND CAREER DEVELOPMENT AWARD RELEASE DATE: August 5, 2003 RFA Number: RFA-TW-04-001 (This RFA has been modified, see RFA-TW-06-003) Fogarty International Center (FIC) (http://www.fic.nih.gov) National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov) National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.989, 93.213, 93.233, 93.837, 93.838, 93.839, 93.172, 93.856, 93.121, 93.277, 93.894, 93.862 LETTER OF INTENT RECEIPT DATE: November 17, 2003 APPLICATION RECEIPT DATE: December 16, 2003 EXPIRATION DATE: December 17, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Training Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Fogarty International Center (FIC), in partnership with the National Center for Complementary and Alternative Medicine (NCCAM), the National Heart Lung and Blood Institute (NHLBI), the National Human Genome Research Institute (NHGRI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute on Drug Abuse (NIDA), the National Institute of Environmental Health Sciences (NIEHS), and the National Institute of General Medical Sciences (NIGMS), invites applications to develop or expand current graduate level curricula and training opportunities in international bioethics related to performing research involving human subjects in low- and middle-income nations. Since current programs provide training for participants from the Asian, African and Latin American regions (for descriptions of current programs, see http://www.fic.nih.gov/programs/bioethics/bioethicsaward.html), new applications focusing on countries of the Middle East, North, East and West Africa, Eastern Europe and the former Soviet Union are encouraged. Applicant institutions can request up to four years of support to create comprehensive curriculum development and training programs. Developing country institutions can request up to two years of support for program planning and curriculum development in preparation to apply for comprehensive training program support in the future. In addition, current International Bioethics Education and Career Development awardees may apply for competing supplements to their award to collaborate with other Fogarty International Center programs (for descriptions of other programs see the FIC web site http://www.fic.nih.gov/programs.html). Proposed curricula should provide a core set of advanced study courses that primarily focus on the internationally relevant aspects of the ethical, legal and social principles guiding the responsible conduct of research in developing countries. Support will be provided for training developing country health professionals working at institutions conducting biomedical, behavioral or public health research involving human subjects, and for ethicists or philosophers from developing countries with an interest in biomedical/clinical research. Appropriate training may include advanced degree and non-degree associated course work and practicum experiences such as participation in ethical review committees, development of intensive short courses designed for human subjects research ethical review committee members, analysis of ethical review guidelines or processes and research on ethical practices in biomedical or behavioral research in the trainees' countries. This RFA contributes to the Fogarty International Center's initiative to strengthen research bioethics expertise in developing countries. This RFA is intended to stimulate the development of new instructional programs in international bioethics at institutions that do not currently offer such programs or to expand existing instructional programs in international bioethics to include a major focus on issues relevant to developing countries. The goal of this initiative is to increase the cadre of developing country biomedical and behavioral scientists, clinical investigators, nurses and other health professionals and relevant academics with state-of-the-art knowledge of ethical considerations, concepts and methods in research involving human subjects. It is expected that such advanced training will enhance the career development of individuals from developing countries as well as strengthen bioethical expertise at the trainees' host institutions. TRAINING OBJECTIVES Background: Few developing country institutions provide formal training in bioethics, and few developed country programs for advanced bioethics training focus in depth on the internationally relevant aspects of bioethics, particularly those related to clinical investigations and traditional medical interventions in developing countries. Therefore, few developing country health professionals conducting laboratory or clinical investigations have received extensive training in the principles of bioethics, codes and legal aspects of ethical research, ethical experimentation on vertebrate animals, informed consent, decision-making related to collaborative agreements between host and sponsors of clinical research, elements of study design that affect the ethical conduct of clinical trials, or interventions that should be provided to study participants. Objectives of Training Program: This initiative is to train academics, health professionals and researchers from developing countries in culturally relevant bioethics related to research. Proposed training programs should equip them with the critical skills that are needed to provide bioethics expertise and leadership to their institutions, national governments and international bodies and potentially, to pursue studies on ethical practice in biomedical and behavioral research in developing countries. The specific objectives are: 1) Curriculum Development: To improve the quality of international ethics training by supporting the development of courses in fundamental areas needed to provide skills for teaching and research related to bioethics and the ethical review of research on acute and chronic diseases in developing countries. Curriculum should include topics most relevant to the bioethics issues widely experienced in conducting research involving human subjects in resource poor settings in developing countries including voluntary informed consent, standards of medical care, sensitivity to cultural differences, research on vulnerable populations, benefits sharing, use of human biological materials, human rights, conflict of interest, equivalent protections and harmonization of international guidelines. Applicants are encouraged to develop training modules including topics related to the specific research interests of the participating NIH Institutes and Centers listed above, for example, research on vulnerable populations related to drug use and abuse. 2) Training: To support appropriate advanced training for a cadre of developing country professionals who could assume the expert roles and leadership responsibilities when involved in ethics review, clinical trials and epidemiological studies in their countries. Applications that provide training for participants from the Middle East, North, East and West Africa, Eastern Europe and the former Soviet Union are encouraged. Training Program: Applications should propose programs for up to two years and no less than 12 months of advanced bioethics training for developing country trainees through an appropriate combination of instructional and practical experiences at the grantee, consortium or home country institutions. Applicants should provide a detailed description of the proposed courses and practicum opportunities currently available or to be developed along with explicit educational goals of each program component. Curriculum developed in comprehensive programs must be offered to trainees after a maximum of one year of the award. Training should be initiated in comprehensive programs during the first year of support, if feasible. Faculty: The Principal Investigator will direct the training program and, with associated faculty, design, implement, evaluate and refine, as needed, an international bioethics curriculum. The Program Director should possess the international bioethics expertise, leadership experience and the administrative capabilities required to create an interdisciplinary instructional program. He or she should be currently engaged in international ethics research as well as in mentoring international students. Proposed faculty should be actively engaged in the design and conduct of bioethical research, and have a record in obtaining funding for these activities. Faculty trained in ethics, philosophy, law, clinical research and public health are recommended. Faculty should also be accomplished research investigators and graduate training mentors. The capability of the participating faculty to develop bioethics curricula, instruct and mentor individuals to pursue careers in international bioethics must be documented. Applicants are encouraged to include faculty from developing countries. The role(s) of each proposed faculty member in course development, instruction and mentoring trainees should be described. Trainees: Applicants should describe how potential participants from diverse professional backgrounds (postdoctoral behavioral and biomedical scientists, physicians, nurses, midwives, traditional medicine practitioners, ethics review committee members, hospital directors and health policy-makers, as well as ethicists or philosophers, with an interest in biomedical/clinical research) will be recruited and selected as trainees including descriptions of selection criteria and selection committee members. Applicants should include strategies for recruiting and retaining adequate representation of women and ethnic minorities in the home countries of the developing country trainees. Individuals selected for training should demonstrate a high level of interest in bioethics, the immediate potential to provide bioethics expertise to their host institutions, national governments and international bodies and pursue studies on ethical practice in biomedical and behavioral research in their countries. A faculty mentor with appropriate research and training experience in ethical issues related to biomedical or behavioral research should be provided for each trainee during their training period. Applicants are encouraged to include plans for enabling trainees to develop and sustain bioethics programs on return to their home country. It is expected that, upon completion of their training, developing country participants supported by this RFA pursue independent and productive careers, including expert training and consultation and/or research in bioethics within their home institutions. MECHANISM OF SUPPORT This RFA will use the NIH R25 award mechanism that limits facilities and administrative (F & A) costs to eight percent of direct costs (less equipment). Applicants that request funding for subcontracts to foreign organizations may also include F & A costs up to eight percent of direct costs (less equipment). More information on the F & A costs allowed for foreign institutions and international organizations can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is June 2004. Under this RFA: o U.S. applicants can submit a new or competitive renewal award application for a comprehensive curriculum development and training program; o A developing country applicant may apply for a two-year program planning and curriculum development grant or a comprehensive curriculum development and training award; or o Current grantees of comprehensive curriculum development and training program awards can submit a competing supplement application. FUNDS AVAILABLE The participating ICs intend to commit approximately $1.8 million in fiscal year 2004 (FY04) to fund seven or eight new and/or competitive continuation awards and planning and curriculum development grants in response to this RFA. Comprehensive curriculum development and training program award: An applicant may request a project period of up to four years and a budget for total costs of up to $250,000 per year maximum (including eight percent F & A costs). Planning and curriculum development grant: Developing country applicants can request up to two years support for a program for up to $25,000 total costs (including eight percent F & A costs) per year. Competing supplement: Principal Investigators of active International Bioethics Education and Career Development awards may request a supplement of up to $25,000 per year total costs (including eight percent F & A costs) for the number of years remaining in the project period of the parent award. For application instructions, see the "Special Requirements" section below. The National Institute of Dental and Craniofacial Research will provide supplements to grantee institutions to cover the training related costs for oral health professionals or researchers per year up to a total of $200,000 per year. Because the nature and scope of the proposed training will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has all of the following characteristics: o Non-profit o Public or private o International or domestic o Non-Federal agencies, such as health professional schools or comparable higher education or research institutions. Eligible developing foreign countries include those low- and middle- income countries in the following regions: Africa, Asia (except Japan, Singapore, South Korea and Taiwan), Central and Eastern Europe (Hungary, Poland, the Czech and Slovak Republics, Romania, Bulgaria, Albania, Turkey and the countries of the former Yugoslavia), Russia and the Newly Independent States of the former Soviet Union, Latin America and the Caribbean, the Middle East (except Israel), and the Pacific Ocean region (except Australia and New Zealand). Applicant institutions should also have a substantial biomedical and clinical research portfolio including faculty conducting significant biomedical or behavioral research involving human subjects in developing countries. An institution may submit only one application and only one new or existing program will be supported at an institution. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed training is invited to work with their institution to develop an application for support (see the "Special Requirements" section for additional instructions). Consultants from other U.S. or international institutions may be supported to serve as faculty in the proposed program. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Competing Supplements: Principal Investigators of current comprehensive International Bioethics Education and Career Development awards may apply for one competing supplement annually to an active International Bioethics Education and Career Development Award to expand their programs to collaborate with other FIC research and research training programs (http://www.fic.nih.gov/programs.html) for the following purposes: o To provide international bioethics training to developing country participants in the other FIC-supported research and research training programs; o To provide international bioethics training to the ethics review committee members at the collaborating developing country institutions of other FIC research or research training programs; and o To support bioethics practicum experiences for trainees associated with the human subjects research conducted by the other FIC research or research training program participants in developing countries. Competing supplement applications should include a needs assessment for the proposed training expansion and detailed plans for the proposed collaborative activities. Competing supplement applications should also include plans to administer the joint activities and a letter of collaboration from the Principal Investigator of the other collaborating FIC program. Principal Investigator: A minimum of 25percent of professional effort is required in the first year of the award. Advisory Committee: The Program Director should establish an Advisory Committee for the proposed program. It is recommended that the committee include representatives of potential trainee countries or regions. The committee's responsibilities may include recruitment and selection of faculty, selecting trainees, evaluating trainee progress, and monitoring and evaluation of the overall effectiveness of the instructional program. Applicants should provide a detailed description of the committee's composition, function, and organizational structure. Evaluation: A plan must be provided for the evaluation of the curriculum developed and training provided. Dissemination: FIC strongly encourages grantees to make the educational tools and curricula developed publicly accessible on a web site or by other means. Annual Meeting: Program Directors will be invited to attend an annual networking meeting in the Washington D.C. area, organized by the Fogarty International Center, of all directors and selected trainees supported by this RFA. Applicants should include travel expenses for this meeting in their proposed budgets. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. FIC will hold a workshop for prospective applicants October 31, 2003 associated with the annual network meeting of the Principal Investigators of the current International Bioethics Educational and Career Development awards October 28-30, 2003. All potential applicants who wish to attend the workshop should contact the training program staff listed below by September 30, 2003. Support will be available for a limited number of potential developing country applicants to attend the workshop. All documents distributed at this workshop and a summary of questions and answers regarding this RFA raised at the workshop will be posted on the FIC website (http://www.fic.nih.gov/programs/bioethics.html) subsequent to the workshop. Additional inquiries may fall into three areas: training and research, peer review, and financial or grants management issues. o Direct your questions about training program issues to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 402-9467 Fax: (301) 402-0779 Email: sinab@mail.nih.gov o Direct your questions about peer review issues to: Sherry L. Dupere, Ph.D. Chief, Biology of Development and Aging IRG Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 5136, MSC 7840 Bethesda, MD 20892-7840 Telephone: (301) 435-1021 Fax: (301) 480-3567 Email: duperes@csr.nih.gov o Direct your questions about financial or grants management matters to: Mr. Bruce Butrum Grants Management Officer Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1670 Fax: (301) 594-1211 Email: butrumb@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, email address and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 402-9467 Fax: (301) 402-0779 Email: sinab@mail.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. SUPPLEMENTAL INSTRUCTIONS: Budget: The program director may receive salary and fringe benefits compensation for up to 25 percent professional effort (salary must not exceed the annual salary cap level from federal sources) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-013.html). Developing country trainees may be paid a stipend comparable to their professional experience similar to other equivalent trainees at the grantee institution in accordance with the grantee institutional policies. Applicants may wish to refer to the NRSA stipend levels as a guide (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-036.html). Funds for tuition, academic fees and self-only or family medical insurance for developing country trainees at the applicant and consortia institutions may be requested. Funds may be requested for one round trip economy class airfare per year on U.S. carriers (to the maximum extent possible) and local ground transportation for each long- term developing country trainee to travel to the applicant institution and return to their home country. Funds should be requested for airfare, per diem and lodging for three days comparable to U.S. government rates for the Program Director to attend an annual bioethics network meeting in the Washington, D.C. area. Support of up to $10,000 per developing country trainee may be requested in the "Other Expenses Category" for bioethics practicum projects of up to one year upon return to their countries after didactic training. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. The Center for Scientific Review will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as in investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the FIC. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below. As part of the review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the Fogarty International Center Advisory Board. REVIEW CRITERIA The goals of NIH-supported research and training 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 meritorious priority score. For example, an investigator may propose to carry out important training that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: 1. The need for the international bioethics curriculum and training proposed to fill specific gaps in expertise for prospective developing country trainees. 2. The expected contributions of the proposed international bioethics training to developing country institutions, national governments or international institutions. APPROACH: 1. The clarity and feasibility of the curriculum development and training objectives. 2. Adequacy of the program plan to achieve the proposed curriculum development and training objectives including: o Strong and appropriate courses and curriculum that provides balance and breadth in all critical areas in addition to providing practicum opportunities to fill recognized gaps in trainee expertise; o A trainee recruiting, application and selection process that captures the most qualified individuals with a variety of professional backgrounds from developing country institutions who could most benefit from the training proposed. o Appropriate assessment and enhancement of additional background skills needed by each trainee in areas such as research design methodology, technical writing, statistical methods, informatics and English as a second language; o Process for periodic evaluation of curriculum, trainee progress and faculty mentoring; o Plans to recruit an adequate representation of women and ethnic minorities in the home countries of the developing country trainees. INNOVATION: 1. Innovation in the international bioethics curriculum designed for developing country trainees; 2. Innovation in providing practicum opportunities for trainee involvement in the ethical design and review of laboratory, clinical or public health research, developing short courses or other education resources or analyzing ethical guidelines or practices. INVESTIGATOR: Qualifications of the program director to lead, and other faculty to participate in, the proposed curriculum development and training program. ENVIRONMENT: The adequacy of the teaching facilities and other training resources including possible research bioethics related opportunities and the overall training environment at the applicant institution. ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 17, 2003 Application Receipt Date: December 16, 2003 Peer Review Date: March 2004 Council Review: May 2004 Earliest Anticipated Start Date: June 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities including geographic balance o Interests of co-funding organizations 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 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 RFA 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 287b) 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 (also cite other relevant policies) 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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