NOVEL APPROACHES TO PHENOTYPING DRUG ABUSE RELEASE DATE: September 15, 2003 (see addendum NOT-DA-04-001) RFA Number: RFA-DA-04-005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 LETTER OF INTENT RECEIPT DATE: December 22, 2003 APPLICATION RECEIPT DATE: January 22, 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) requests applications that propose and evaluate novel approaches to understanding the drug abuse phenotype(s). Specifically, the purpose of this initiative is to support innovative studies that better describe, discriminate, and predict the complex nature and course of drug abuse so as to offer more precise phenotypic indicators for testing the hypothesized underlying genetic and environmental risks for drug abuse. The term "drug abuse" as used in this RFA refers broadly to several different but related concepts including drug abuse and drug dependence as defined by diagnostic criteria, as well as drug involvement, hazardous drug use, drug seeking behavior, and the like. While it is recognized that these concepts may not be interchangeable, the term drug abuse is used for the purposes of fluency. The term "drug" refers primarily to cannabis, cocaine, opiates, nicotine, but also includes the entire range of substances of abuse. Like other common human diseases, drug abuse is considered a "complex" disorder that reflects the interplay between underlying genetic susceptibility and environmental risk. Despite the real promise of molecular genetics, there has been limited success in reliably identifying specific susceptibility genes for drug abuse. Although this difficulty is often attributed to genetic heterogeneity, attaining greater clarity of the phenotypic heterogeneity of drug abuse looms large as a major challenge for the field. Ultimately, the successful identification of specific genes and related mechanisms, underlying physiologic systems, and other etiological processes hinges on precise and specific phenotypic definitions and greater understanding of how such phenotypes influence and are shaped by environmental factors, developmental course, and individual characteristics. Although researchers and treatment providers acknowledge that drug abuse is diverse, complex, and dynamic, such knowledge has not been well integrated into research, treatment, and prevention strategies. For example, while extant research conceptualizes drug abuse as a heterogeneous and dynamic construct, most analytic approaches operationalize drug abuse as a dichotomous and static outcome, and consider as covariates (or even statistical error) factors that may represent critical clues about drug abuse etiology, treatment, prevention and, ultimately, genomic search strategies. RESEARCH OBJECTIVES Background Available evidence indicates that drug abuse is a genetically and phenotypically complex disorder that results from the interplay between underlying genetic susceptibility and environmental risk. Like many other relatively common human diseases, drug abuse is believed to arise from multiple genes exerting small effects, gene-by-gene interactions, gene-by- environment interactions, and a host of environmental factors and risk- conferring behaviors. As a consequence of the multifactorial nature of drug abuse, the phenotypic expression is highly heterogeneous. Drug abuse is heterogeneous in terms of risk factors, gender distribution and expression, comorbid conditions, types and number of drugs of abuse, symptom expression, and severity. The course of drug abuse is a dynamic one characterized by patterns of persistence and remittance, drug switching and drug combinations, and drug preferences. Drug abuse reflects developmental processes that unfold gradually over time, display continuity and discontinuity, and follow along multiple trajectories leading to similar or different "endpoints." Drug abuse is characterized by substantial individual differences with regard to numerous aspects including age of onset and rate of progression from initial drug use to persistent use, abuse, and dependence. Although contemporary theoretical models depict drug abuse as a heterogeneous and dynamic construct, this information has been comparatively less integrated into quantitative approaches to the study of drug abuse. Three examples illustrate this point. First, while it is well known that drug abusers often suffer from a range of psychiatric conditions, comorbidity is typically treated as a covariate to be "controlled" statistically when, alternatively, comorbidity may very well be an important feature of the outcome variable itself. Second, drug abuse is characterized by substantial polysubstance involvement. Although marijuana abusers are likely to also be involved with nicotine and alcohol, marijuana abuse is conventionally operationalized in a dichotomous fashion with little attention to the nature and extent of polysubstance involvement. Furthermore, the diagnosis of marijuana dependence is a topic of debate that could be informed by alternative measures that more precisely reflect the characteristics of sustained marijuana involvement, such as cognitive impairment and "withdrawal behaviors." Third, extant research indicates that drug abuse typically follows a course characterized by cyclical patterns of harmful drug use, remittance, and relapse. Yet, rarely has the course of drug abuse been used to operationalize the drug abuse phenotype. In sum, much prior quantitative research has defined drug abuse in a superficial manner whereby potentially critical features of drug abuse have been overlooked. Insofar as research over the past several decades indicates that drug abuse is a complex human condition that is multifaceted, future research should place greater emphasis on describing the defining features, influences shaping differential expression, and patterns of familial aggregation of the diverse manifestations of drug abuse. Such a call for research takes on increasing importance in the context of molecular genetic studies where an imprecise case definition will greatly hamper the detection of risk- conferring genes and gene-by-environment interactive effects. Because the identification of gene-by-environment interactions is likely to prove key to understanding the etiology, prevention, and treatment of drug abuse, success hinges on continued refinement and advancements by epidemiologists, clinicians, and social scientists in identifying relatively homogeneous subtypes and salient behavioral (and biobehavioral) manifestations of drug abuse from the heterogeneous mixture of drug abuse as operationalized in current research. Areas of Interest This initiative encourages innovative and diverse research efforts from multiple research disciplines including epidemiology, psychiatry, human development, genetic epidemiology, sociology, biostatistics, pharmacology, and psychology. Projects supported through this program will be expected to hold promise of producing more precise and specific phenotypic definitions and greater understanding of how such phenotypes influence and are shaped by environmental factors, developmental course, and individual characteristics. It is hoped that the resultant scientific knowledge will aid the identification of specific genes and related mechanisms associated with drug abuse. Examples of particular issues that would be appropriate under this announcement include, but are not limited to, studies that: o Identify common or universal behavioral manifestations of drug abuse or, conversely, detect reliable subtypes of drug abuse; o Focus on dynamic (versus static) phenotypes based on course of drug use such as persistence of drug abuse, rate of progression from initial drug use to drug abuse, change in drug abuse symptomatology, and patterns of remittance and relapse; o Evaluate such dynamic phenotypes according to key variables such as age of onset, gender, and psychiatric comorbidity; o Employ the methods of genetic epidemiology to elucidate more precise and/or familial patterns, subtypes, and phenotypes of drug abuse, and ascertain the heritability thereof; o Evaluate phenotypes defined in terms of consequences that are fine-tuned to specific drugs, such as cognitive impairment and "withdrawal behaviors" associated with marijuana involvement; o Consider polysubstance abuse, drug preferences, drug switching, and the role of drug availability; o Compare and contrast phenotypic definitions across multiple data sets, particular those with diverse sample characteristics and opportunities for drug exposure; o Develop innovative statistical approaches to capture and evaluate the heterogeneity of drug abuse, particularly over time, including the use of latent variable approaches; o Examine the relative salience of particular symptoms, combinations of symptoms, patterns and timing of psychiatric comorbidity, and extent of severity; o Investigate potential "vulnerability phenotypes" or "pre-clinical markers" that represent indicators of specific risk for developing drug abuse; o Inform the debate about drug abuse liability, such as the common versus specific liability notions of drug abuse; o Address the salience of initial drug exposure (e.g., timing, type, amount, context, subjective and objective responsivity) on subsequent drug abuse risk and course; o Assess potential underlying vulnerability factors or endophenotypes that may mediate genetic risk, including neurophysiological and temperament indices; o Examine whether and how drug abuse phenotypes persist or change over time, across different contexts, and over generations; o Investigate developmental influences (e.g., timing of drug exposure relative to developmental milestones) in the manifestation of drug abuse; o Identify sources of drug abuse heterogeneity by gender and racial/ethnic group with particular focus on key dimensions of critical differences at individual and group levels; Applicants are strongly encouraged to carefully consider issues related to statistical power. Although projects involving primary data collection are appropriate for some projects, such as laboratory-based studies, applicants are strongly encouraged to take advantage of existing sources of data including epidemiologic surveys that may offer adequate sample size, enhanced generalizability and comparability, and considerable cost-savings. Applicants choosing to rely on secondary data are advised to carefully evaluate the appropriateness of the dataset and to discuss within the application the inherent strengths and limitations of the dataset to address their specific aims. Applicants are also strongly encouraged to fully explicate and justify the statistical procedures used to address their specific aims. SPECIAL REQUIREMENTS Annual Meetings Principal Investigators of grants resulting from this RFA will be asked to participate in meetings to be convened during each funding year to report progress, discuss problems, and share information related to the conduct of their grants. Other scientists external to and knowledgeable about these studies may also be invited to participate. Requests for funds to support attendance at these meetings, to be held in the Washington D.C. area, should be included in the budget request. MECHANISMS OF SUPPORT This RFA will use the NIH research project (R01), the small grant (R03) http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html and the exploratory/development (R21) award mechanisms http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. 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 $2 million in FY 2004 to fund 5 to 10 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. 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: Kevin P. Conway, Ph.D. Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Suite 5153, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 402-1817 FAX: (301) 480-2543 Email: kconway@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 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 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 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@nih.gov As of October 18, 2003, both the Office of Extramural Affairs and the Grants Management Branch will move to 6101 Executive Boulevard, Bethesda, MD 20892. The Office of Extramural Affairs will be located in Suite 200, MSC 8401. For express/courier service the address remains Rockville, MD 20852. 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 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 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) 435-0714, 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 6001 Executive Boulevard, Room 3158, MSC 9547 * Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) *Please note change of address listed under Where to Send Inquiries Section. 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: December 22, 2003 Application Receipt Date: January 22, 2004 Peer Review Date: May 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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