and Human Services (HHS)
EXPIRED
GLOBAL INFECTIOUS DISEASE RESEARCH TRAINING PROGRAM AWARD RELEASE DATE: October 18, 2002 PA NUMBER: PA-03-012 Letter of Intent: December 20, 2002; December 20, 2003; December 20, 2004 Application Deadline: January 24, 2003; January 23, 2004; January 24, 2005 EXPIRATION DATE: June 23, 2005 (This PA has been reissued, see PAR-05-128) Fogarty International Center (FIC) (http://www.nih.gov/fic) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/default.htm) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Program Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of this announcement is to invite applications from eligible institutions to train or expand the capabilities of scientists and health professionals from developing countries to engage in infectious diseases research and training not related directly to HIV/AIDS. Proposals are requested for innovative, collaborative research-training programs that would contribute to the long-term goal of building sustainable research capacity in relevant infectious diseases at developing country institutions. The intent is to harness scientific knowledge and skills to enhance prevention, treatment and control of infectious diseases causing major morbidity and mortality in endemic countries. Previously, the Fogarty International Center (FIC) has supported several individual research-training programs for non-HIV/AIDS infectious diseases with major impact in developing countries through periodic Requests for Applications (RFAs). These RFA-based programs included International Training and Research in Emerging Infectious Diseases (ITREID); Actions for Building Capacity in Support of International Centers for Infectious Disease Research (ABC/ICIDR); Tuberculosis International Training and Research; and International Malaria Research Training. The FIC will now consolidate and standardize the requirements for all the non-HIV/AIDS infectious disease research-training programs under this program announcement (PA). Competitive renewal applications for awards made in each of the individual programs mentioned above, as well as new applications, may be submitted in response to this announcement. Developing country institutions may also apply for one- year planning grants to support the development of research training proposals. In addition, ongoing infectious disease research training awardees may apply for competing supplements to their award to expand their activities. PROGRAM OBJECTIVES Background: Despite eradication of many infectious diseases in the leading economic countries of the world, pathogens such as malaria and tuberculosis continue to impose a tremendous health burden in resource-poor countries throughout the world, claiming millions of lives annually and inflicting great morbidity that results in significant losses in economic productivity and social progress. Infectious diseases anywhere in the world can be a potential threat to people in other countries, including those living in leading economic countries. Attempts to control infectious diseases endemic to developing countries suffer due to an incomplete understanding of the pathogens, their disease manifestations and transmission mechanisms, inadequate preventive measures and interventions, and declines in health services and disease control efforts. A major barrier to improved research, treatment and control of infectious diseases is the scarcity of scientists and health professionals in endemic countries with relevant infectious disease research expertise. Research Training Objectives FIC will support research-training programs that focus on building sustainable infectious disease research capacity at an institution in an endemic developing country. Sustainable research capacity depends on building a critical mass of scientists and health professionals with critical expertise and complementary skills that enable the institution to conduct independent, internationally recognized infectious disease research relevant to the health priorities of their country. FIC will support research- training programs that focus on major endemic or life-threatening emerging infectious diseases and are structured to provide a variety of short-, medium- and long-term training opportunities for participants from a developing country institution within the context of ongoing U.S. research collaborations. Applications should present an assessment of the specific needs for infectious disease research training at the developing country institution and a proposed training plan to address those needs during the course of a five-year award. It is expected that each grant awarded will: 1. Substantially increase the expertise of trainees in relevant laboratory, clinical, epidemiological and/or social science research; 2. Fill gaps and strengthen the sustainability of endemic infectious disease research training at a specified developing country institution; 3. Expand and equalize collaborative scientific research interactions between U.S. and developing country scientists; 4. Provide data for evidence-based decision-making related to endemic infectious disease clinical treatment or prevention and control policies in the host developing country; 5. Take advantage of other sources of research and training support in the foreign country; and 6. Strengthen the capacity of developing country institutions by strategies that help insure trainees integrate into their home country institutions and pursue independently supported scientific careers. Needs Assessment Applicants should provide a detailed assessment of the specific needs at the developing country institution for the proposed training. The assessment should identify specific gaps in laboratory, clinical, epidemiological, vector-related and social science research expertise and skills needed to address the infectious disease focus of the proposal. The relevance of the infectious disease focus of the proposed training to the health of the host endemic country should be explained in detail. The involvement of the developing country institution and training faculty in formulating clinical treatment and prevention policies locally, nationally or internationally should be noted. The needs assessment should serve as a baseline against which progress can be evaluated in the future. Training Plan A) Focus of Training The proposed research-training program may focus on one or more emerging or endemic infectious diseases of major health importance to the population of the host developing country. Alternatively, research training may focus on multidisciplinary approaches to infectious pathogen transmission or disease risk factors such as nutrition, pathogen or vector resistance, or genetic, ecological, socio-cultural or economic determinants of one or more emerging or endemic infectious diseases of major health importance to the host developing country. Trainee research may focus on analyzing the basic mechanisms of host-pathogen interaction, understanding disease transmission and pathology or developing new interventions, prevention measures or diagnostic methods. Trainee research projects may be part of a training faculty member's peer- reviewed infectious disease research grant funded by NIH or other research support agencies. All trainee research projects should be scientifically reviewed by one of the following processes. Pre-doctoral or non-degree seeking trainee research projects that are not included as part of peer- reviewed training faculty member's research grants must be scientifically reviewed by the proposed training advisory group (see below). Post-doctoral trainee re-entry research projects at the developing country institution must be peer-reviewed at NIH as a competing supplement to an existing FIC infectious disease research training award (see below) or through applications to the Global Health Research Initiative Program for New Foreign Investigators (http://www.nih.gov/fic/programs/GRIP.html) or to the Fogarty International Research Collaboration Award program (http://www.nih.gov/fic/programs/firca.html). Applicants should also provide some training in skills needed at the host developing country institution to support sustainable independent research such as the use of scientific literature, scientific presentations, grant writing, bioinformatics, bioethics, good clinical practice, biosafety, data management, research administration, and the management of intellectual property. B) Types of Training Applicants should propose a variety of research training options (degree- related and non-degree training) to match the needs of the developing country institution. Long-term research training may include studies leading to an advanced degree or a mentored post-advanced degree experience. Long-term training may include academic courses related to infectious disease research (and English as a second language, if necessary). Short- to medium-term training in short courses, workshops or practical experience of up to several months in specific research methods or other laboratory, clinical, social science or field skills related to infectious disease research may be proposed in addition to long-term training. Training may occur in either the U.S. or developing country institution. However, applicants are strongly encouraged to provide support and mentoring by U.S. and developing country faculty for trainees to conduct the research related to their training in the host developing country to the greatest extent possible. Applicants should include plans for the transfer of appropriate training options to the developing country institution during the course of the five-year award. C) Training in Responsible Conduct of Research Applicants are required to provide all long-term trainees with training in the responsible conduct of research. For more information on this provision, see the NIH Guide for Grant and Contracts (volume 21, number 43 http://grants.nih.gov/grants/guide/notice-files/not92-236.html). NIH does not require a specific curriculum or format for instruction but the following areas should be included: conflict of interest, responsible authorship and institutional policies for handling scientific misconduct, human subjects, animal studies, data management and data sharing. The inclusion of international perspectives on these topics is strongly encouraged. The following information must be provided in the description of your plan: topics to be covered, format, faculty participating, instructional materials, frequency and duration of training and how trainee attendance will be monitored. D) Types of Trainees Applicants should describe the characteristics of the trainees they plan to recruit for each type of training. Training may be offered to a wide range of developing country scientists, including laboratory scientists, clinicians, and social scientists, and other health professionals, as well as technical and administrative staff. The intent should be to build a critical mass of researchers and support staff with the combined expertise and skills to conduct independent infectious disease research. Applicants are strongly encouraged to consider women and members of minority and socially disadvantaged populations in the developing country in the selection of trainees. E) Trainee Recruitment, Selection and Evaluation Training plans should also describe the following processes: o Trainee recruitment o Trainee candidate evaluation and criteria for selection o Pre-training orientation and preparation o Training mentorship o Training evaluation o Post-training integration into the collaborating developing country institution's infectious disease research activities o Tracking and evaluation of long-term impact of training on the careers of the trainees and research capacity in the developing country institution. F) Research Training Faculty and Environment Applicants should describe in detail the U.S. and developing country training faculty and advisors and their developing country training records, as well as relevant infectious disease research support and scientific collaborations at the developing country institution. Competitive renewal applications should contain detailed information about previous FIC-supported training efforts including: the impact of short- and long-term training experience and a comprehensive list of all trainees; their status before training-- including position, country of residence and employment record; type and length of training provided in the U.S.; and developing country and the trainee's current position. Applicants for competitive renewal awards should provide a list of publications in peer-reviewed scientific journals in which trainee research was supported by their previous FIC training award, i.e. publications in which trainees are authors and the FIC award is cited in the acknowledgements. The application should also include letters from participating U.S. and developing country faculty defining their specific roles (such as mentoring and teaching) and time commitments in the proposed training program. Pertinent research resources and the educational environment including the options available for distance learning for the proposed training at the U.S. and developing country institutions should be described. Applicants are encouraged to describe their plans for dissemination of training materials, as well as other coordination efforts, to other FIC research training programs in developing countries. G) Training Advisory Group A training advisory group composed of expert U.S. and developing country faculty who are not directly involved in mentoring trainees should be established to conduct trainee selection, scientific review of trainee projects and evaluation of trainees and training program progress. At least one member of the Training Advisory Group should be from an institution not involved in the training program. Inclusion of women scientists from developed and developing country institutions is particularly encouraged. Applicants should describe the composition and expertise of the proposed training advisory group, the specific responsibilities of the group and the processes for it to accomplish its responsibilities. H) Competing Supplements Principal Investigators may apply for one competing supplement annually to an active FIC Global Infectious Disease Research Training Program, Actions for Building Capacity in Support of ICIDR Program, Tuberculosis International Training and Research Program, or International Malaria Research Training Program awards for the following purposes: o Expanding their training programs geographically to other developing country institutions; o Adding new faculty in other infectious disease research training areas relevant to the developing country institution; o Taking advantage of new research or training opportunities; o Supporting U.S. minority or non-minority graduate or medical students and postdoctoral fellows for research training at the collaborating developing country institution; o Supporting research on other infectious diseases relevant to the collaborating country or HIV/AIDS-related interactions with the infectious disease focus of the program; o Supporting expanded training in relevant research enhancing expertise such as bioethics, good clinical practice, medical informatics, research management, management of intellectual property, scientific grant writing, scientific manuscript preparation and data management; o Providing advanced re-entry support for developing country participants who have completed substantial mid- to long-term research training to establish independent research projects at the developing country institution upon their return home. Competing supplement applications should include a detailed explanation of the scientific and administrative relationship between the supplemental research training proposed and the specific aims of the existing training award. Competing supplement applications should include a needs assessment for the proposed training expansion and relevant training plan information as described above. I) Planning Grants for Developing Country Institutions Developing country institutions may apply for a one-year planning grant to develop an infectious disease research-training program with U.S. collaborators. Planning grants should propose the following types of activities to organize and plan for a research-training program, and prepare and assemble an application to submit for support of that program the following year: o Consultation with U.S. and developing country faculty to assess the specific needs for infectious disease research training at the developing country institution; o Consultation with U.S. and developing country faculty to define the short- , medium- and long-term training components to address the specific needs for infectious disease research training at the developing country institution in a stepwise plan; o Consultation with U.S. and developing country collaborators to define their roles and institutional commitments in the research training program; o Targeted training of developing country faculty to fill gaps in infectious disease research expertise, responsible conduct of research and human subjects education and other research support areas; o Training ethical review committee members of developing country institutions to obtain certification related to the U.S. Federal-wide Assurance for the developing country institution; o Planning grant program director training in grant writing. MECHANISM OF SUPPORT This PA will use the NIH D43 international research training award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Under this PA, an applicant can submit: o A new or competitive renewal award application; o A competing supplement application to any of the following initiatives: Global Infectious Disease Research Training, Actions for Building Capacity in Support of ICIDR, Tuberculosis International Training and Research Program, or International Malaria Research Training award; or o A developing country applicant may apply for a one-year research training program planning grant. An applicant for a Global Infectious Disease Research Training Program award may request a project period of up to five years and a budget for total costs of up to $150,000 per year maximum (including eight percent facilities and administrative (F & A) costs). An applicant for a competing supplement to current FIC award may request up to $50,000 per year total costs (including eight percent F & A costs) for a maximum project period equivalent to the remaining project period of the parent award. A developing country applicant for a planning grant may request up to $25,000 total costs (including eight percent F & A costs) for one year. Only one application may be submitted from an institution proposing research training on a particular infectious disease or working at a particular developing country institution. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Domestic or foreign developing country organizations o Nonprofit o Private or public institutions, such as universities, colleges, hospitals, and laboratories Eligible institutions are institutions from the developing foreign countries listed below or from domestic U.S. institutions with scientific collaborations with the developing countries listed below. 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). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual from an eligible institution with the skills, knowledge, and resources necessary to carry out the proposed international infectious disease research training is invited to work with their institution to develop an application for support. U.S. applicants must apply with a developing country institution with which they have a demonstrable history of research collaboration. Developing country applicants should apply in collaboration with U.S. institutions capable of enhancing their proposed training opportunities. Applicants must have a strong infectious disease research program in the scientific area proposed for research training and the requisite faculty and facilities to carry out the proposed training activities. Applicants must be designated as the Principal Investigator of at least one active infectious disease research grant (with at least 18 months of support remaining at the time of application), from the NIH or other national or international research support organization, directly relevant to the research training proposed. Priority will be given to applicants with NIH research grants with foreign components at the collaborating developing country institution or to foreign developing country applicants directly supported by NIH research awards. Applicants should explain in detail how their relevant research grant support and activities are related to the proposed training plan. Individuals from underrepresented racial and ethnic groups, women, and 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 eligibility and scientific/research training issues to: Barbara Sina Ph.D. Division of International Training and Research Fogarty International Center National Institutes of Health Building 31 Room B2C39 Bethesda, MD 20892-2220 Telephone: (301) 402-9467 FAX: (301) 402-0779 Email: [email protected] o Direct your questions about peer review issues to: Donald Schneider Ph.D. Division of Molecular and Cellular Mechanisms Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 5160 Bethesda, MD 20892-7842 Telephone: (301) 435-1727 FAX: (301) 480-1988 Email: [email protected] o Direct your questions about financial or grants management matters to: Mr. Bruce Butrum Grants Management Officer Fogarty International Center National Institutes of Health Building 31, Room B2C29 Bethesda, MD 20892-2220 Telephone: (301) 496-1670 FAX: (301) 594-1211 Email: [email protected] 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, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this PA 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 IC 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 National Institutes of Health Building 31 Room B2C39 Bethesda, MD 20892 Telephone: (301) 402-9467 FAX: (301) 402-0779 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the Institutional NRSA section of 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: [email protected]. Budget Preparation Applicants should develop a budget that reflects the resources necessary to implement the components of the comprehensive developing country training plan included in their application. The budgets may include costs to support the various types of training proposed (tuition, stipends, salary, travel, per diem) for trainees and faculty, and costs to support the administration of the program and grant. Adequate resources to meet U.S. government requirements for training and training-related research should be included in the budget. SUPPLEMENTAL INSTRUCTIONS: All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the appropriate categories. All expenses related to faculty participation in the program should be itemized on the PHS Form 398 (budget form pages 4 & 5) in the appropriate categories. The total direct costs of the trainee participation budget should be identified on PHS Form 398 (budget form pages 4 & 5) in the "Other" category. The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs. Requested Salary Support The salary for the Principal Investigator, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the applicant institution. Trainee Stipends Trainees may be paid a stipend comparable to their professional experience in accordance with NRSA levels or grantee institutional policies while involved in long-term training at the grantee institution. Current NRSA stipend levels are described on the web site http://grants.nih.gov/training/nrsa.htm. Tuition, Fees and Insurance for Trainees Funds for tuition, academic fees and self-only or family medical insurance may be requested. Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for long- term trainees and tuition-free short courses. Network Meetings Funds to support the attendance of the Principal Investigator and one or two faculty or trainees at the annual network meeting for the program in the Washington, D.C. area. In-Country Activities Before any funds can be expended for in-country research activities under this award, the grantee institution must notify FIC staff, documenting a collaborative research arrangement between the U.S. and foreign country institutions. This can be documented through an endorsement from the Minister of Health or other appropriate foreign government official, as well as from the collaborating institutions. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this PA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an introduction addressing the previous reviewers' comments. PEER REVIEW PROCESS An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Receive a second level review by the Fogarty International Center Advisory Board and may receive review from the council of a co-sponsoring organization. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific training impact and thus deserve a meritorious priority score. For example, you may propose to carry out important research training that, by its nature, is not innovative but is essential to move a field forward. Significance 1. The need for the specific infectious disease research training proposed to fill specific gaps in infectious disease research expertise at the developing country institution. 2. The expected public health and scientific contributions related to the proposed infectious disease research training. 3. The demonstrated capacity (for competing renewal applications) or expected potential (for new applications) to achieve independent and sustainable laboratory, clinical or public health infectious disease research capacity through the proposed training efforts. Approach 1. The clarity and feasibility of the research training objectives. 2. Adequacy of the research-training plan to achieve the proposed training objectives including: a) A trainee recruitment and selection process that captures the most qualified individuals who could most benefit from the training proposed; b) A process to include an adequate representation of women, ethnic minorities and socially disadvantaged groups among the developing country trainees; c) A plan for pre-training orientation and preparation for maximizing the training experience; d) A process for matching trainees to appropriate mentors or instructors and research projects or needed research skills to fill recognized gaps in expertise at the developing country institution; e) A process for scientific peer review of trainee research; f) A plan to provide training in sustainable research enhancing areas such as laboratory safety, responsible conduct of research, scientific writing, grant writing, statistical methods, good clinical practice, medical informatics, data management, management of intellectual property, and English as a second language (if necessary); g) A process for periodic evaluation of trainee progress in acquiring academic and research skills; h) Approaches to support post-training integration into infectious disease research at the developing country institution to build sustainable research capacity; and i) A method to monitor the long-term impact of the infectious disease research training experience on the subsequent careers of the trainees, the infectious disease research capacity at the developing country institution and public health in the developing country. Innovation 1. The identification of innovative strategies for trainees to become actively involved in infectious disease laboratory studies, clinical or public health research studies or intervention trials relevant to national health priorities conducted at the developing country institution. 2. Innovation in training strategies to produce a critical mass of independent infectious disease researchers and sustainable research training by trainees at the developing country institution at the end of the program. 3. The creativity of plans to use modern information technology to facilitate trainee access to scientific information, distance learning and collaborative interaction. Investigators 1. Qualifications of the program director to lead and the U.S. and developing country faculty to participate as mentors in the proposed research training program. 2. Adequacy of the ongoing collaboration between the U.S. and developing country investigators and their institutions to provide a suitable framework in which the proposed training will occur. 3. The extent and effectiveness of previous research training efforts made by applicants in the proposed developing country. 4. Relevance of the sources of research support of the program directors and faculty to the research training plan proposed. Environment 1. The adequacy of the infectious disease teaching and research facilities and other resources, and ongoing research support related to the overall training environment at the U.S. and developing country institutions. 2. The U.S. and developing country institutional commitments to the proposed infectious disease research training. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protections for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) 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 NIH and other co-funders' program priorities o Geographic balance REQUIRED FEDERAL CITATIONS 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 AMENDMENT "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. 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 No. 93.989, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of the Public Health Service Act, as amended (42 USC 241 and 287b) and administered under Public Health Service (PHS) grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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