RFA-DA-04-009: BEHAVIORAL AND COGNITIVE PROCESSES RELATED TO ADOLESCENT DRUG ABUSE

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BEHAVIORAL AND COGNITIVE PROCESSES RELATED TO ADOLESCENT DRUG ABUSE RELEASE DATE: October 31, 2003 RFA Number: RFA-DA-04-009 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS 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: January 20, 2004 APPLICATION RECEIPT DATE: February 20, 2004 THIS REQUEST FOR APPLICATIONS (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 National Institute on Drug Abuse (NIDA) invites applications in the area of behavioral, cognitive and social cognitive research that have the potential to address issues related to drug abuse and addiction during adolescence. The objective of this RFA is to stimulate research that has the potential to advance our understanding of the causes, consequences, prevention and treatment of adolescent drug abuse and addiction. Research is encouraged that is model- driven, and either (1) explores and delineates basic processes, particularly judgment and decision-making processes, related to drug abuse vulnerability during adolescence, or (2) directly studies drug abuse and the effects of drugs on particular aspects of adolescent cognitive function, particularly judgment and decision-making. The research does not need to be conducted in drug-abusing populations or involve administration of drugs, but investigators must provide a clear statement indicating how the proposed research would advance the understanding of drug use and addiction in adolescence. Cognitive science research that involves adolescent clinical populations is appropriate under this RFA. The research relevant to this announcement involves human subjects; for information about neuroscience research involving adolescent animal studies, contact Dr. Robert Riddle, 301-402-3155. RESEARCH OBJECTIVES Background Accumulating evidence raises the concern that adolescence is a period of heightened vulnerability to the addictive properties of legal and illegal substances. Epidemiological data collected over the past two decades show that adolescents and young adults generally exhibit higher rates of experimental use and substance use disorders (SUDs) than older adults and that adult SUDs typically have onsets in adolescence or young adulthood. For example, approximately three-fourths of adult tobacco users in the U.S. begin smoking between the ages 11 and 17 and 60 percent before age 14. Fifty percent of illicit drug abuse in adults with SUDs begins between the ages of 15 and 18 and initiation is rare after the age of 20. Furthermore, earlier onset of substance use predicts greater addiction severity and morbidity. Moreover, epidemiological data indicate that there are both independent and interactive effects of gender and age in the prevalence and developmental onset of SUDs. Similarly, clinical evidence confirms that adolescence is a period of particular vulnerability. For example, adolescents demonstrate a more precipitous progress of illicit drug use than adults; and, despite smoking fewer cigarettes than adults, adolescents show higher rates of dependence at similar levels of use. More than a third of high school students who have ever tried smoking eventually become daily smokers and about 3,000 additional teenagers begin smoking each day. It has been reported that two-thirds of adolescent smokers report experiencing withdrawal symptoms during attempts to quit or reduce their smoking. Thus, nicotine effects during adolescence can be critical in determining the tenacity of addiction throughout the remainder of life. Although many studies have shown that family and sociocultural factors (e.g., parental drug use, school engagement, parental concern and monitoring, stress, religiosity, peer group deviancy), are associated with drug availability and experimentation, these factors alone do not account fully for adolescent drug use initiation and progression to addiction. Indeed, it is reasonable to suppose that individual, cognitive, and neurobiological characteristics interact with social conditions and experiences in producing trajectories that lead to some individuals progressing from experimentation to addiction while others do not. Learning, motivation, judgment and decision-making processes, and their underlying neurobiological substrates, for example, are likely to influence vulnerability to drug abuse and addiction. As the epidemiological data suggest, some decisions and choices made during the adolescent years can set the stage for subsequent SUDs. In order to be successful in preventing and treating SUDs, then, it is important to understand the mechanisms underlying adolescent judgment, decision-making and risk perception. Recent theorizing, for example, proposes that risk perception and decision-making are dependent on two information-processing systems: i) Analytical, normative decision-making is consciously controlled, effortful, accessible and deliberate. This system is rule-governed and flexible. ii) Heuristic decision making, by contrast, is preconscious, rapid, inaccessible and effortless: This latter system relies on an assortment of judgmental heuristics. It is slow to learn and it is sensitive to emotional state. The two systems are interdependent, but contextual variables and age determine which will be predominant in a given situation. Much of the interest in adolescents perception of risk and vulnerability is motivated by the desire to understand why youth engage in potentially self- injurious behaviors, such as drug use. To date, research in this area indicates that adolescents appear to be quite inaccurate in estimating risk. Studies further suggest that adolescents who engage in risky behaviors recognize that their behaviors entail risk, but that they may view the risks as less significant than do those who do not engage in the risky behavior. Thus, it is important to test hypotheses concerning differential adolescent risk perceptions and decision-making processes and to determine how such processes may be influenced systematically by cognitive, affective, contextual and/or social variables (e.g., peer influence). Basic findings regarding adolescent judgment and decision-making processes may prove useful for developing or tailoring existing preventive intervention curricula in order to more effectively teach adolescents to recognize and challenge common misconceptions about tobacco, alcohol and other drug use. Moreover, adolescent neurodevelopment involves changes in brain organization and function that may predispose to drug abuse and addiction. Adolescence has been characterized neurobiologically as reflecting relatively greater influence of excitatory motivational substrates against a background of immature inhibitory substrates. Greater drives for novel experiences and heightened sensation- seeking, coupled with an immature inhibitory control system, could predispose individuals to impulsive actions and risky behaviors, including experimentation with and abuse of addictive drugs. Further, drugs of abuse appear to have specific influences on areas mediating inhibitory control and, therefore, drug abuse in adolescence may affect normal development of these systems. Similarly, psychiatric illnesses commonly comorbid with SUDs often involve impulse control dysfunction putatively reflecting chronically deficient inhibitory and/or hyperactive excitatory neural mechanisms. Thus, adolescent substance use disorder may reflect, in part, a cognitive neurodevelopmental dysfunction. As such, research (including treatment research) targeting adolescents and young adults may benefit all age groups with SUDs. Research is needed to further characterize specific components of cognitive, motivational and social cognitive processing underlying adolescent neurodevelopment. In addition, research is needed to explore the influence of practices in child and adolescent psychopharmacology on the development of motivational neurocircuitry and risk for SUDs. More research is needed also to test the association between impulsivity, decision-making and risk for SUDs across clinical contexts and comorbid psychiatric disorders such as obsessive- compulsive disorder and attention deficit hyperactivity disorder. It remains to be determined whether adolescent vulnerability to SUDs reflects behavioral or cognitive precursors of adult psychiatric symptoms that confer greater risk for SUDs and/or represent a greater risk across all adolescent subgroups. Longitudinal studies, particularly those employing objective behavioral and cognitive measures of impulsivity and decision-making will be of significant value in understanding addiction vulnerability across age groups in normative and psychiatrically comorbid adolescents. Conceptual Basis and Rationale: This RFA underscores NIDA’s appreciation that basic behavioral, cognitive and social cognitive methods, models, and approaches should provide new directions and innovative ideas for understanding fundamental problems associated with drug abuse and addiction vulnerability during the adolescent period. Research on the development and function of processes such as inhibition, emotion, incentive motivation, judgment, decision-making, risk-taking, and automated cognition are examples of research topics that are relevant for delineating the conditions that contribute to the initiation, maintenance and escalation of drug abuse and addiction. It is likely that new and innovative basic research in these and other domains will inform and enhance our understanding of drug addiction and its underlying substrates. At the same time, cognitive science research that directly studies adolescent drug abuse and related clinical problems, or studies the effects of exposure to drugs of abuse on cognitive processes, can continue to make important contributions to understanding this complex problem. The goal of this RFA, therefore, is to invite research applications in basic behavioral, cognitive and social cognitive research relevant to adolescent drug abuse and addiction. Basic research that uses model-driven experimental approaches to problems relevant to issues of drug abuse and addiction (examples of such problems are listed below) is encouraged. Such research would capitalize on the rapid advances that have been made concerning the functional and neurobiological determinants of both simple and complex behavioral/cognitive operations. In the context of this RFA, model-driven research implies the use of an experimental approach intended to test the operation of specific processes through systematic use of control conditions to rule out alternative interpretations. Applications that employ either functional or neurobiological approaches to the study of cognitive processes are appropriate for this RFA. Study designs that can test for gender differences and/or make comparisons between adolescents and adults are encouraged. The research does not need to be conducted in drug-abusing populations or involve the administration of drugs, but it must have the potential to advance the understanding of the behavioral, psychosocial, cognitive or neurobiological processes related to adolescent drug abuse. In such cases, applicants should provide a clear statement as to the relevance of the research to drug abuse and addiction. The following are illustrative examples of the basic science topics that are relevant to drug use and addiction in adolescence. These examples are intended as a guide and are not meant to subsume or limit the behavioral, cognitive or social cognitive research themes that would be appropriate and welcome under this RFA. Nevertheless, it is expected that these topics would be studied in adolescent samples: o Study of modulation of judgment and decision-making by emotion, motivation and social context. (This broadly defined research theme is central to nearly all aspects of addiction, as well as to issues of comorbidity with other disorders.) o Study the developmental changes of normative decision-making and judgment heuristics. Determine how these cognitive processes are influenced by context (i.e., framing) and experience. (This research could have important implications for the design of interventions that optimize thinking and decisions about drug use, thereby reducing vulnerability to addiction.) o Relate individual differences in reward sensitivity in adolescents to judgment and decision-making. (This is particularly relevant to vulnerability to drug abuse and relapse.) o Study of affective/emotional development during adolescence and its interaction with decision-making and risk-taking. (This is especially relevant to the issue of vulnerability to addiction.) o Development of mathematical or computational models of cognitive processes, especially models of judgment. (Such models, particularly those that incorporate modulation by motivational/emotional states/social context are relevant and may provide new insights into many aspects of drug abuse and addiction.) o Basic studies of decision-making processes under conditions of risk, social context, uncertainty and high motivational states including arousal. (Risk- taking and decision-making are relevant to addiction vulnerability, risky sexual behavior and medical consequences of drug use such as exposure to HIV.) o Basic research on top-down and bottom-up control of attention and allocation of cognitive resources. (This research is likely to be relevant to cue-related drug craving and its relation to relapse.) o Study of inhibitory functions, especially with respect to suppression of prepotent or conflicting responses, as well as metacognition. (Such research has wide relevance to issues of drug abuse, addiction, and treatment since impaired inhibition is important for understanding relapse.) o Study of cognitive mechanisms that control the transition to and from automatic and controlled information processing, from analytical to heuristic processing. (For example, this type of research is directly relevant to understanding drug craving, drug abuse relapse, and treatment.) o Basic studies of cognitive mechanisms that play a role in the ability to monitor and evaluate ongoing cognitive performance. (This is particularly relevant to many issues concerning executive function and self-regulation.) o Study of age differences in cue-elicited emotional memory, with an emphasis on the adolescent period. (This is particularly relevant to vulnerability and the conditions eliciting drug craving and relapse.) o Impact of environmental/social stressors and stress responsivity on cognitive processes during the adolescent period. (This is relevant to a number of issues in addiction, particularly to vulnerability and the conditions eliciting drug craving and relapse.) o Studies of the neurobiological substrates of basic cognitive processes that might render adolescents vulnerable to drug abuse and addiction or be directly affected by drug abuse. (This has the potential to identify mechanisms of adolescent drug abuse.) MECHANISMS OF SUPPORT This RFA will use the NIH research project (R01), the small grant (R03) and the exploratory/development (R21) (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) 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 resubmitted 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 6 new and/or competitive continuation grants in response to this RFA. An applicant may request for the R01 a 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 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. At this time, it is not known if this RFA will be reissued. 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: Paul Schnur, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4258, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-1887 FAX: (301) 594-6043 Email: pschnur@mail.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 234, 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 234, 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 234, 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: 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: January 20, 2004 Application Receipt Date: February 20, 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 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 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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