RFA-DA-04-013: PREVENTION RESEARCH FOR THE TRANSITION TO ADULTHOOD

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PREVENTION RESEARCH FOR THE TRANSITION TO ADULTHOOD RELEASE DATE: December 4, 2003 RFA Number: RFA-DA-04-013 (see addendum NOT-DA-04-005) 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: 93.279 LETTER OF INTENT RECEIPT DATE: February 20, 2004 APPLICATION RECEIPT DATE: March 23, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 period spanning late adolescence and young adulthood (roughly from 18 through 25 years of age), is characterized by various developmental tasks and life changes and choices; it also is the period when use and abuse of drugs peak. The National Institute on Drug Abuse (NIDA) seeks research grant applications focused on this transitional period that test the efficacy of interventions to prevent and/or reduce drug use, abuse, and related problems including HIV-risk behaviors. Interventions should be based on existing knowledge of the etiology and patterns of drug use and abuse. Studies focusing solely on alcohol use will not be considered as responsive to this RFA. A related NIDA RFA (DA-04-009), Behavioral and Cognitive Processes Related to Adolescent Drug Abuse (http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-04-009.html), is designed to focus on the entire period of adolescence and on basic cognitive and biobehavioral processes related to drug abuse. RESEARCH OBJECTIVES Background and Significance The initiation of drug use and escalation from use to abuse are most likely to occur during critical developmental and social transitions. While much attention has been given to initiation of drug use during the transitions that occur during early adolescence (e.g., from elementary to middle school and changes related to the onset of puberty), far less research has focused on illicit drug use and abuse (except the use of alcohol) during the transition from adolescence to adulthood. That developmental period, recently identified as a separate life stage labeled emerging adulthood, is characterized by a variety of unique life changes and choices that occur roughly between the ages of 18 and 25. While previously the late teens and early twenties was a period of intensive preparation for imminent entry into adult roles, the new norm is for these emerging adulthood years to be set aside for experimentation and exploration of life possibilities and decisions. Transitions, including leaving home, embarking on careers, establishing intimate relationships including marriage, and parenthood characterize this stage of development and may affect substance abuse. Additional developmental transitions (i.e., actual change processes rather than the outcomes) also occur. These include further cognitive development (e.g., continued brain development, the emergence of personal beliefs and values), changes in one’s identity or self-definition (e.g., exploration of career roles), and affiliative transitions (e.g., shifts in relationships with parents and peers). These changes provide new opportunities for growth as well as new demands that can result in frustration and stresses that may lead to initiation or exacerbation of substance abuse, as well as antisocial behaviors and comorbid psychiatric disorders. While most young adults mature out of drug use as they move into adult roles, some do not. Thus, it is important to understand how drug involvement affects or is affected by developmental task completion and the mechanisms through which individuals age out of problem behaviors in order to facilitate the successful mastery of such tasks. Applying a developmental perspective to this life stage suggests looking at the interactions of individual characteristics and processes and environmental factors in the development of age-specific preventive interventions. During the period of emerging adulthood substance use increases, peaks, and then declines for most young people. According to the 2002 National Survey on Drug Use and Health (NSDUH) (SAMHSA, 2003), rates of past month illicit drug use climbed steadily for youth from 12 to 17, peaked among 18 to 20 year olds, remained high for those between 21 and 25 before dropping for persons 26 through 29. About a quarter of smokers and one third of new marijuana users start using after age 17 as do about 70% of cocaine users (almost all of whom progress from using other drugs). Emerging adults vary widely in their rates of use, and these rates depend, in part, on diverging intrapersonal, sociodemographic and life choice factors related to education, employment, living arrangements, marital status, and life style. For example, in 2002, 22% of full-time college students and 27% of their high-school-graduate age peers had used at least one illicit drug in the past 30 days. In addition, 15% of college students and 33% of other high school graduates were daily cigarette smokers and 41% of students and 37% of other respondents had consumed 5+ drinks in a row (i.e., binge drank) in the past 2 weeks (Johnston, Bachman & O Malley 2003). These high rates of drug use suggest the need to focus on preventing initiation and escalation of drug use among this age group. Subpopulations at greatest risk include males, those with a high school education or less, the unemployed, persons with past year co-occurring serious mental illness, and criminal justice populations. Increasing substance use after high school also is associated with leaving the parental home and acquiring freedom from adult supervision; declining substance use is associated with entry into marriage and parenthood. Drug use is somewhat contingent on earlier patterns of use. However, drug use patterns continue to change with fluctuations often related to life changes. For example, while parenthood and marriage may initially be protective, divorce may provoke substance use initiation or escalation. Areas of Interest The complexity of the issues related to drug use/abuse and associated consequences across the transition to adulthood indicate the need for a multidisciplinary, developmental approach to prevention research. Studies of interest under this RFA may focus preventive interventions at the intrapersonal, family, school/work, peer and broader social context levels and examine them alone or in combination. Studies might develop and test a variety of innovative preventive interventions targeting emerging adults at the universal, selective, or indicated levels for implementation in diverse settings. All such interventions need to be sensitive to cultural and gender differences. Investigators representing a broad array of academic disciplines and engaged in cross-cutting fields of science are encouraged to consider designing hypothesis-driven studies that use rigorous methodologies from epidemiological, basic, clinical, behavioral and social research. Competing continuations of ongoing longitudinal studies will not be considered. Intrapersonal Level Studies Personal characteristics associated with elevated risk for use or abuse of drugs include those that cannot be modified (e.g., gender) and others that are more malleable including expectancies related to use of specific drugs, interpersonal skills, emotional control, and physical health. Better understanding of how such factors interact and are affected by the social context (e.g., drug availability, job stress) would provide a basis for tailoring messages and interventions. For example altering alcohol expectancies has proven effective in reducing heavy drinking among college students. Similarly, determining expectancies then crafting prevention messages to specific groups of drug users might prove effective. Studies might include but are not limited to the following: o Implementation and assessment of culturally-tailored adaptations of interventions to emerging patterns of use among racial/ethnic groups with respect to drug use and drug-related problems. o Tests of preventive interventions designed to foster reduction or termination of drug use by altering drug expectancies and/or increasing the sense of adult responsibility associated with the subjective meaning of adulthood. Family and Intimates During emerging adulthood most youth move both physically and emotionally away from their family of origin. Yet researchers have ignored the changing nature of family ties throughout the young adult transition and their associations with drug use. Features of the leaving home transition vary with respect to timing or age at which it occurs, reasons for leaving home, and the young person’s affective reactions to leaving. The circumstances under which the young adult leaves home may be both a trigger for substance use initiation or progression or may have been triggered by substance use/abuse. Adolescent research shows that parents remain an important source of advice on the most important life decisions, such as those around college and work. Moreover, a salient feature of emerging adulthood for many young people is the continued economic dependence on parents, which generally has some social, psychological and perhaps later economic cost attached. Thus, research on the family of origin might explore impact of continuing parental influence and design interventions involving parents. Many young adults live in quasi-family settings during this transitional period (e.g., with a roommate, a group, or a romantic partner). Some create new families, by marrying and/or becoming parents during this age of transition. Studies of familial, peer and romantic ties and early parenthood may include, but are not limited to, the following: o Design and test interventions that involve parents in communicating about drugs as they prepare their child for college or full-time entry into the work force. o Develop a prenatal intervention to end or reduce use of drugs among high-risk pregnant women in the emerging adulthood age range. The intervention may be at the selective or indicated levels and might be implemented in primary care or non-traditional settings (e.g., worksite wellness programs; community recreation centers). o Design interventions to address the negative influence of one intimate partner on the drug use of the other, based on assessment of the factors that account for the patterns of influence on the other and on their relationship. o Test HIV prevention components for inclusion in drug abuse prevention interventions for the young adult population. Education, Work and Drugs Recent research has focused on binge drinking among college students. A number of those students that abuse alcohol also use illicit drugs. However, there has been limited preventive intervention research on college students use of illicit drugs and even less research designed to intervene with non-college young adults who have higher rates of illicit drug use or with specific subpopulations in this group. Explanations for these differential patterns include sociocultural theories that emphasize the influence of the work group and the work environment, and psychological theories that emphasize individual variables. However, few interventions aside from drug testing, Employee Assistance Programs (EAPs), and health-oriented preventive interventions have been used to address these problems and these interventions have generally not been rigorously tested. Thus, researchers might test the effectiveness of tailored wellness programs as part of apprenticeship programs operated by labor unions or formalized mentoring by other employers. In addition, intervention studies for young adults in college or job tracks might: need to add include but not limited to . o Examine the establishment, publication, and enforcement of college and university drug use policies and implementation of those policies on rates of alcohol and other drug use on campus and the local community to identify effective procedures and approaches to reducing substance abuse among students. o Develop preventive interventions for workplaces and college campuses that address drug use norms, work-related stress, and occupational group pressures to use drugs. Peers and Broader Social Contexts Some subpopulations of youth and contexts specific to young adult culture are extremely high-risk and probably contribute to drug use patterns, to the uptake of practices associated with particular drugs, and to consequences of these behaviors. The problems encountered and potential modalities for intervention among high-risk subpopulations of young adults are not well understood. The informal social contexts in which young adults hang out and may use drugs also have not been fully explored. These include including bars and social clubs, street gangs, and gyms and organized athletic activities. The broader social environment (e.g., community factors, mass media) can also contribute to both substance abuse problems and to amelioration of problems. Environment includes features of contexts in which individuals live and can be either positive features (e.g., anti-drug norms with college or workplace contexts; high density of anti-drug media messages) or negative features (e.g., high availability of drugs; lack of enforcement of rules or policies) and most of these features are malleable. For example, it is possible to focus on changing group social norms, public and organizational policies and practices, and sanctions for violating them through environmental interventions. Studies focusing on various contexts and circumstances of drug use may include the following, but not limited to: o Test the efficacy of existing preventive interventions and strategies (e.g., mentoring, job training and challenge activities) for very high- risk late adolescents (e.g., youth with comorbid psychiatric disorders, high school dropouts, persons under the supervision of the criminal justice system). o Examine ways to effectively communicate preventive messages to late adolescent and early adult populations using both traditional media (TV and radio messages) and non-traditional approaches (including DVDs and computer-based websites). o Examine processes that could facilitate the implementation of drug abuse prevention programs through novel delivery systems such as computer dating services, dance clubs, faith-based activities, and private fitness facilities. o Assess the impact of environmental and/or systems level interventions such as organizational policies and practices on illegal drug use. Such studies might examine the effectiveness of student health services and counseling services, or test the effectiveness of peer mentoring as ways to reduce new worker stress and facilitate integration. o Assess applications of brief interventions (e.g., feedback interviews) aimed at preventing drug use among young people in varied contexts (e.g., gynecological services, STD treatment clinics or student health center settings). MECHANISMS OF SUPPORT This RFA will use the NIH research project (R01), the small grant (R03) and the exploratory/developmental (R21) award mechanisms. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2004. Applications that are not funded in the competition described in this RFA may be submitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm . FUNDS AVAILABLE NIDA intends to commit approximately $1.5 million in FY 2004 to fund 3 to 5 grants in response to this RFA. An applicant may request for the R01 project period of up to 5 years. For the R03, the project period is 2 years and direct costs up to $50,000 for each of those years. For the R21, the project period is 2 years and up to $275,000 in direct costs for the two-year period. Because the nature and scope of the proposed research 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 NIDA 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(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 or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Susan E. Martin, Ph.D. Prevention Research Branch Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5163, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 402-1533 FAX: (301) 480-2542 Email: smartin@nida.nih.gov 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 220, MSC 8401 Bethesda, Maryland 20892-8401 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tlevitin@mail.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 242, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@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, 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 NIDA 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: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tlevitin@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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 three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health/DHHS 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (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 assignments within 8 weeks. The Center for Scientific Review (CSR) 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 unfounded application, originally submitted as an 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 from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Please assess the extent to which the study aims are consistent with the goals of the RFA. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Does the study address an important problem consistent with the goals of this RFA? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Is the investigator appropriately trained and well- suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) 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: February 20, 2004 Application Receipt Date: March 23, 2004 Peer Review Date: June/July 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 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. 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 SAFETY AND 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 Safety and 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 more than $500,000 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 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. 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. 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. 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 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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