and Human Services (HHS)
EXPIRED
RESEARCH EDUCATION GRANTS IN DRUG ABUSE AND ADDICTION RELEASE DATE: February 2, 2004 PA NUMBER: PAR-04-054 EXPIRATION DATE: September 18, 2006 (See PAR-06-550 for modification) (Also see NOT-OD-06-104) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.279 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism 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 This PA replaces PAR-99-093, published in the NIH Guide for Grants and Contracts, April 29, 1999, at http://grants.nih.gov/grants/guide/pa-files/PAR-99-093.html. The National Institute on Drug Abuse (NIDA) Research Education grant is a flexible and specialized mechanism designed to foster the development of drug addiction researchers through creative and innovative educational programs. Programs that focus on preparing researchers in cross-disciplinary integration and/or translational research of neuroscience, basic behavioral, prevention, clinical, treatment, and services research are particularly encouraged. Of particular interest are educational experiences that will attract, train, and further the career development of physician scientists and other clinical professionals, underrepresented minority scientists, and adolescent, pediatric and geriatric researchers interested in pursuing research relevant to the mission of NIDA. NIDA invites grant applications to support innovative educational programs that focus on preparing researchers in clinical research careers relevant to drug abuse and addiction. This mechanism of support is not to be used to substitute the Ruth L. Kirschstein National Research Service Award training and fellowship mechanisms and policies supported by the NIH. RESEARCH OBJECTIVES This PA invites applications using the R25 mechanism that will focus on providing creative and innovative education research experiences at all levels of professional career development (i.e., independent scientists, postdoctoral fellows, clinical residents, medical students and/or graduate students). This educational training experience must hold the promise of fostering new research approaches that advance the current drug abuse and addiction field. It is expected that these institutional research sites will develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers as researchers, as clinicians, or, optimally, as a combination of the two. Educational partnerships between institutions such as, research institutions, drug abuse treatment organizations, primary care organizations--are highly encouraged in order to broaden research training and educational opportunities and, as a result, increase the number of well-trained clinical and health services researchers in the drug abuse and addiction field at large. EDUCATION PROGRAM OBJECTIVES There is a serious shortage of well-qualified individuals prepared to conduct needed clinical, prevention, health services, and treatment research with drug abusers and underserved populations of children and adolescents, women, elderly, and racial and ethnic minorities affected by drug abuse. At present, few academic institutions have a coordinated curriculum and other essential elements relevant to preparing individuals for a career in clinical research with drug abusers and related populations. A related need is for increased numbers of service providers who are sufficiently sophisticated consumers of research to evaluate and apply research-based findings. Drug Abuse and Addiction Research Education Grants support only educational activities focused on basic, clinical, prevention, and health services and treatment research, and may not be used for support of non-research clinical training. This mechanism may be used, however, to provide drug addiction research education to those in clinical training or in a clinical research track within a clinical training program. Formats for the research training programs may vary to include a series of short courses, seminars, workshops, or structured short-term or long-term research experiences; or curriculum development, design, implementation and evaluation. NIDA expects applicant institutions to propose their own creative and innovative research training programs. Examples of potential programs include, but are not limited to, the following: 1. Educational/research experiences that enhance the participation and commitment of clinical researchers to careers in addiction research. Examples include educational programs that: o Provide mentored clinical research opportunities designed specifically for students enrolled in medical or graduate school degree programs and clinical residents. o Encourage clinical doctoral-level or equivalent (e.g., MD, PhD, MD/PhD, DO, DSW, DSN, DDS) students and/or postdoctoral fellows/residents to embark on research projects directly applicable to clinical practice. o Develop or enhance the research curricula and mentoring provided during residency training and/or create research training tracks within residency programs. o Improve the quality of mentoring in drug abuse and addiction research areas, particularly improvements in the retention and advancement of physician scientists as well as adolescent, pediatric, and geriatric researchers. o Provide educational experiences relevant to the conduct of drug abuse related clinical, prevention, treatment and services research. o Provide clinical research career enhancement opportunities for new clinical doctoral-level or equivalent students at the intersection of basic, clinical, treatment and services research. 2. Cross-disciplinary educational and research experiences that prepare drug abuse and addiction researchers to conduct interdisciplinary research (e.g., behavioral, neuroscience, genetic, epidemiological, clinical, etc.) or to translate approaches from basic behavioral, social science, cognitive neuroscience, and biomedical fields to clinical, prevention, treatment and services research. Examples of cross-disciplinary and translational approaches include: o The use of cognitive, affective, and social neuroscience in the development and evaluation of behavioral and pharmacological treatment interventions for drug abuse and addiction. o Interdisciplinary approaches to the development, adaptation, and modification of treatment and preventive interventions to enhance and facilitate the rapid advancement of research from bench to clinical research settings and then to community treatment programs and services settings. This PA further encourages collaborative programs involving academic clinical research departments and basic science departments, as well as clinical or community treatment settings and multiple academic or research institutions such as schools of public health, departments of preventive and community medicine, primary care organizations or other entities with appropriate expertise for the development and establishment of educational training programs in drug abuse clinical, prevention, health services, and treatment research and practice. Applicants should describe planned processes for: (a) conducting and monitoring recruitment and selection of students, (b) planning research activities and selecting mentors for students, (c) evaluating student progress, and (d) assessing the quality and effectiveness of the overall training program. Schools, departments, and clinical sites participating in the joint applications should be involved in the planning, implementation, and assessment processes listed above. These cross-disciplinary educational programs are likely to involve active collaborations or special arrangements between institutions and/or departments such as those with drug abuse research center support grants, schools of public health, departments of community and preventive medicine, and other departments and institutions that have the necessary expertise and resources to fulfill the objectives of this PA. Any of these entities may act as the applicant organization, as long as the qualifications of the participants and the focus of the program are on the training of clinical researchers to work with drug abusing and related populations. MECHANISM OF SUPPORT This PA will use the NIH Education Research Program Grant (R25) award mechanism. Awards will be limited to a maximum of $350,000 in direct costs per year. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. ELIGIBILIBILITY REQUIREMENTS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions/organizations o Foreign institutions are not eligible to apply o Faith-based or community-based organizations It is anticipated that in most cases these programs will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty would have active research projects in which students can gain relevant experiences. If multiple sites are to be used, the applicant institution must be one of those sites and a strong justification must be included. Institutions with existing Institutional National Research Training Grants (T32) or other federally funded training programs may apply for an education research grant provided the proposed educational experiences are distinct from those training programs receiving NIH support. This program announcement will support the research education of United States citizens only. 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. SPECIAL REQUIREMENTS An active research base that includes funded drug abuse research projects should be available for the education of candidates enrolled in the program. The requisite faculty and the commitment of sufficient faculty time are critical factors for this educational program. Graduates of the program should have some fundamental knowledge of at least the following areas, with in-depth knowledge of some of them: o Neurobiology, cognitive, affective, and social neuroscience o Genetic and environmental vulnerability o Principles of pharmacology, including the pharmacokinetics and pharmacodynamics of major drugs of abuse. o Clinical aspects of drug abuse, including knowledge of screening, assessment, and diagnostic methods, direct and indirect effects of drug abuse, major prevention and treatment (e.g., behavioral, pharmacological) modalities, consequences of drug use (e.g., medical, psychiatric, social), treatment of drug abusers with comorbid medical and/or psychiatric disorders and development of modes of integrated care. o Research methodologies such as epidemiology, biostatistics, structural equation modeling, multilevel analysis, IRT, Rasch, qualitative and quantitative measurement models applied to research design and analysis, drug abuse surveillance, and data use. o Health service delivery, including prevention, referral, screening, assessment, and treatment; organizational dynamics, culture, and climate; quality management; provider career development; patient satisfaction, financing; cost-effectiveness; and dissemination of research to practice. o Prevention science and health education; developmentally appropriate intervention design and strategies. o Racial/minority, health disparity, cultural, and gender issues. o Protection of human subjects and related ethical issues in the conduct of research. ALLOWABLE COSTS Allowable costs must be consistent with NIH policy and be reasonable, allowable, and well-documented and justified for the research education program. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Personnel Costs - individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Normally, all personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 25% of the total direct cost. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students is considered a regular part of an individual's academic duties, then mentoring and other interactions with students are non-reimbursable from grant funds.) Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Consultation costs, equipment, supplies, necessary travel, and other program-related expenses must be justified as specifically required by the program proposed and not duplicate items generally available for educational programs at the host institution. Participant Support - participants in the education program may receive subsistence allowance, which includes partial costs of meals and lodging (unless furnished as part of the fee for registration). They may also receive partial tuition, other education-related and travel expenses, including foreign travel, if strongly justified. Note that effort and how the dollar amount is determined must be included when describing the participant support and also be listed in the budget justification area. Individuals supported by NIH training and career development mechanisms (K, T or F Grants) may not receive stipend or salary support from the Research Education Grant in Drug Abuse and Addiction. However, if funds are not available from other sources, limited support to defray participation costs (e.g., travel, meals, lodging) may be provided. Partial costs for off-site rental space will be considered if it is short- term and shown to be necessary for the implementation and execution of the educational program (seminar, workshop, etc.). Matching funds from applicant institutions or other organizations for such off-site costs are strongly encouraged. Facilities and Administrative (F&A) Costs, formerly known as "indirect costs," may be allowed for the applicant organization and any approved subcontract based on 8% of total direct costs exclusive of tuition and fees and expenditures for equipment. Normally, funds will not be provided for fringe benefits or health insurance for participants involved in this education program. Note that all costs associated with consortium/contractual arrangements, both direct and F&A costs are considered direct costs and are included in the $350,000 direct costs ceiling limitation for this program. Normally, funds for the research education evaluation plan are not expected to exceed 5% of the total direct costs. 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 inquiries regarding scientific/research issues to: Suman A. Rao, Ph.D. Deputy Research Training Coordinator Office of Science Policy and Communications National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5230, MSC 9591 Bethesda, Maryland 20892-9591 Telephone: (301) 443-6071 FAX: (301) 443-6277 Email: [email protected] M. Beth Grigson Babecki, M.A. Deputy to Training Coordinator Division of Neuroscience and Behavioral Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard. Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-0899 FAX: (301) 594-6043 Email: [email protected] William J. Bukoski, Ph.D. Office of the Director Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5153, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 402-1526 FAX: (301) 443-2636 Email: [email protected] Paul A. Coulis, Ph.D. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5199, MSC 9593 Bethesda, Maryland 20892-9593 Phone: (301) 443-1801 FAX: (301) 594-6566 Email: [email protected] Dorynne Czechowicz, M.D. Division of Treatment Research and Development National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4231, MSC 9551 Bethesda, Maryland 20892-9551 Phone: (301) 443-0107 FAX: (301) 443-6814 Email: [email protected] Pamela Goodlow, Ph.D. Special Populations Office National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4216 MSC 9567 Bethesda, MD 20892-9567 Phone: (301) 443-0441 FAX: (301) 480-8179 Email: [email protected] o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 234, MSC 8401 Bethesda, Maryland 20892-8401 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: [email protected] Direct inquiries regarding financial or grants management matters to: Gary Fleming, J.D., M.A. Chief, Grants Management Officer National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 242, MSC 8403 Bethesda, MD 20892-8403 Phone: (301) 443-6710 FAX: (301) 594-6847 Email: [email protected] COURIER/EXPRESS DELIVERY ADDRESS: Rockville, MD 20852 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]. SUPPLEMENTARY INSTRUCTIONS Applications that do not conform to the specific instructions detailed below will be returned without review. 1. Application face page: item number two on this page must include the program announcement number and the title, Research Education Grants in Drug Abuse and Addiction (R25). 2. Description, Performance Sites, and Key Personnel (Form Page 2): under Performance Sites include "Consortium/Contractual Arrangements," with a description of plans for collaborating with other institutions for purposes of exchange and sharing of resources, including faculty, equipment, and facilities. If multiple sites are to be used, the applicant institution must be one of those sites and for other sites a strong justification must be included. 3. Resources (Resources Format Page): describe the educational environment; include a description of the facilities, laboratories, participating departments, computer services, and any other resources to be used in the conduct of the proposed education program. Use continuation pages, as necessary. 4. Research Plan: part "d" of this section should be re-titled "Research Education Program Plan" and should contain material organized under the following subheadings, as appropriate to the specific program: a) Program Direction - describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to drug abuse and addiction, and can organize and administer the education program, as well as evidence of institutional and community commitment and support for the proposed program. b) Program Faculty/Staff - describe the characteristics and responsibilities of the faculty; provide evidence that participating faculty and preceptors are actively engaged in research or other scholarly activities related to drug abuse and addiction. NIDA recommends forming a multidisciplinary Clinical Addiction Research Education Committee, which is essential to the overall administration of a Clinical Research Education Program in Drug Abuse and Addiction. A primary responsibility of this committee is the recruitment and selection of students, procedures for the selection of research activities and mentors for students, and evaluation of student progress. The committee should consist of experts representing basic, behavioral and clinical disciplines concerned with drug abuse and its treatment and prevention. Schools, departments, and clinical sites participating in joint applications should be represented on the Committee. Evidence should be provided of the Committee's function, structure, composition and frequency of meetings. c) Proposed Research Education Program - provide programmatic detail on the special activities proposed (e.g., courses, curricula), including a description of plans to provide education to participants regarding the responsible conduct of research. d) Program Participants - provide detail about the proposed participants; include a description of plans for recruiting as participants individuals from underrepresented racial/ethnic groups, women and persons with disabilities. Competing continuation applications must include a detailed account of experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. e) Research Education Evaluation Plan - include evaluation plans for determining success of the program in achieving its goals and objectives. The inclusion of evaluation instruments is encouraged. Please note that applications that do not have an adequate evaluation plan will be considered non-responsive to this program announcement. 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. 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 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 by the National Institute on Drug Abuse in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate National Advisory Council on Drug Abuse 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 Grant applications to the Research Education Grants in Drug Abuse and Addiction should be characterized by innovation, scholarship, and responsiveness to the special and/or changing needs of drug abuse and addiction research. 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: SIGNIFICANCE: Does the proposed research education program address the objectives stated in this program announcement? APPROACH: Is the proposed specialized curriculum appropriate and adequate to achieve the research education goals outlined? Are the course requirements and sequence, and timetable for completing the planned activities also appropriate? Is there an adequate plan for evaluating the effectiveness of the program in achieving its objectives? Will a multidisciplinary Clinical Addiction Research Education Committee be involved in the overall administration of the grant? For competing continuation applications, has the program been adequately evaluated and has the level of success been satisfactory? Is the need for further R25 support clear? INNOVATION: Does the curriculum include original and unique approaches or methods for addressing the needs put forth in the goals and objectives? Are plans to challenge existing paradigms or develop new approaches or techniques described? INVESTIGATOR: Does the program leadership demonstrate a record of achievements and are their qualifications appropriate to meeting the proposed goals and implementing the stated plan? ENVIRONMENT: Is the scientific/education environment described, indicating the unique features and probability of success of the program? Is institutional commitment to the proposed program documented? Is the institute able to attract and recruit appropriate trainees? If multiple sites are to be used, is this adequately justified in terms of the educational experiences provided? Are plans provided for the coordination and communication between multiple sites? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). 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 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 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. 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. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov) under the Funding, or may be obtained by calling (301) 443-2755. 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). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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