RFA-DA-04-016: CONSEQUENCES OF MARIJUANA USE ON THE DEVELOPING BRAIN

Department of Health
and Human Services (HHS)

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CONSEQUENCES OF MARIJUANA USE ON THE DEVELOPING BRAIN RELEASE DATE: January 9, 2004 RFA Number: RFA-DA-04-016 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: March 16, 2004 APPLICATION RECEIPT DATE: April 16, 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 purpose of this RFA is to support investigations of the effects of exposure to marijuana, the most commonly used illicit drug among teenagers in the United States, on the developing brain. There is now overwhelming evidence that the development of the nervous system continues well into adolescence and that different developmental epochs are defined by different (although overlapping) processes, such as neurogenesis, migration and pattern formation, differentiation, and establishment of connections and their refinement. A substantial literature exists on the consequences of acute and chronic marijuana exposure in adults, including measures of cognitive and behavioral effects, as well as some measures of alterations in brain function, primarily in the domains of learning and memory. There have been relatively few studies, however, of the effects of exposure to marijuana during development, when those areas that are known to be affected in adults are being sculpted by intrinsic and environmental influences (e.g., exposure to other drugs, stress, interactions with peers, parenting, neighborhood factors, and other social variables). Investigations in animal systems have provided considerable evidence concerning the mechanisms and sites of action of the psychoactive ingredients in marijuana, and methodologies are now available to describe in detail the development of these neural systems and, thus, the effects of exposure to marijuana on development. It is the intent of this RFA to encourage research on effects of marijuana exposure on the developing brain, at points along a continuum of development from the prenatal period through the transition to adulthood. The focus is on influences on brain biochemical, physiological, morphological, and functional parameters, and/or on cognitive, behavioral, and social outcomes resulting from such influences. Human and nonhuman studies are sought. Analyses of gender, as appropriate, are encouraged. RESEARCH OBJECTIVES Background A substantial literature exists on consequences of acute and chronic marijuana use in adults (e.g., various cognitive and behavioral outcomes, and some measurement of brain function). However, this is not the case for preadolescents and adolescents, in either human or nonhuman animal samples. Available data from retrospective human studies show some associations between reported age of onset of marijuana use and cognitive outcomes as well as brain morphology. Studies on consequences of prenatal exposure to marijuana indicate effects in multiple developmental outcome areas as offspring progress through childhood and adolescence. It is widely accepted that the nervous system continues to develop well into adolescence, and that different developmental epochs are defined by different (although overlapping) processes, such as neurogenesis, migration and pattern formation, differentiation, and establishment of connections and their refinement. Evidence also indicates that considerable plasticity endures into adulthood. But very little is known about the consequences of marijuana exposure on the developing nervous system. Studies are needed to achieve increased understanding of the effects of marijuana on the developing brain, and the resulting behavioral manifestations of such effects. A critical aspect of this need for new knowledge relates to the specific timing of exposure; that is, the issue of how marijuana exposure affects brain development and resulting behavior as a function of when on the developmental continuum (from prenatal through adolescence) the exposure occurs. Timing of exposure is not simply a matter of age, but importantly also relates to a point in a process of development. Critical factors defining a point in a developmental process vary with the focus of the research; for example, in some cases developmental status may focus on neurological factors, in other cases neurological and neuroendocrine, and in still other cases neurocognitive, neuroendocrine, and social functioning. Preclinical, clinical, and epidemiologic approaches are appropriate for acquiring needed new knowledge. For example, animal models of adolescence appropriate for the study of persistent effects of cannabis may contribute to improved understanding of influences on neurobehavioral and neuroendocrine development, and of compensatory control systems during adolescence. These models may also permit investigation of questions related to long-term consequences of adolescent cannabis exposure on systems subserving plasticity, executive functions, and cognition. Many topics pertaining to marijuana effects on the developing brain can be addressed by both animal and human studies, and in some cases by utilizing complementary animal-human samples. Proposals based on analyses of existent data are acceptable for review if they address research questions relevant to the RFA. Studies nested within epidemiologic samples have the potential to isolate pre-existing conditions prior to marijuana use from post-use consequences, and may facilitate examination of important research questions such as whether marijuana use differentially affects neurological function for youth at high- versus low-risk for drug abuse. Investigations of issues pertinent to this RFA face multiple methodological challenges. Researchers have identified numerous study design and measurement considerations as important. These include: pre-existing differences between marijuana users and non-users prior to exposure, the nature of normative brain development, polydrug exposure and patterns of drug use, family history factors, social context and co-occurring environmental conditions, and duration of abstinence. Studies examining marijuana effects in the context of co-occurring use of other licit and illicit substance are needed, and are appropriate for this RFA. An additional consideration relates to gender analyses. In light of extensive data demonstrating gender differences in specific aspects of neurological, cognitive, and social development, and emerging evidence that the effects of drug exposure are affected by gender, it is also important for studies to incorporate gender analyses when appropriate and feasible. Areas of Interest This initiative encourages innovative and diverse research efforts to examine if, and how, marijuana exposure has demonstrable effects on the developing brain (whether shown in morphological alterations, differences in functional activation of specific brain areas, neurocognitive functioning, or behavioral manifestations). Relevant broad topics of investigation include associations between marijuana exposure and changes in plasticity in key brain regions; influences of repeated marijuana use on development of cognitive, emotional, and motivational processes; impact of marijuana exposure on thresholds for drug and non-drug rewards; and differences in reinforcing effects of marijuana relative to when in adolescence the exposure occurs. Examples of more specific research areas and issues that would be appropriate for this RFA include, but are not limited to, the following: o Data from studies of normal development of the human brain strongly suggest that connections among a number of brain areas important in executive function, and particularly behavioral inhibition, are undergoing rapid development during adolescence. Does exposure to marijuana during this developmental period alter the developmental trajectory of these brain areas and resulting behavioral manifestations? Are any alterations induced by exposure influenced by timing of initiation and extent of exposure? o A number of studies have demonstrated marijuana effects on learning and memory in adults. Are there similar effects in younger individuals? Does earlier exposure lead to more or less severe, or longer- or shorter-lasting effects, and if so, can these effects be related to an individual's age at the time of exposure? Can effects be related to neurocircuitry? o Does marijuana influence motivational and emotional states differentially as a function of when in development it is used? How do such influences vary with amount, frequency, and duration of use? What are the dynamic bi-directional processes between marijuana use and motivational and emotional states? o Are there identifiable neurobiological and/or behavioral/cognitive markers for those youth who progress from marijuana use to abuse, and to dependence? Do these mechanisms differ as a function of when in the developmental process marijuana use is initiated? o What characteristics identify youth who do not progress to marijuana abuse or dependence? What neurobiological or cognitive mechanisms are involved in successful cessation of marijuana use? o How do neuroendocrine, cognitive, and social changes related to pubertal status interact with marijuana use to produce effects on the developing brain? o How does tobacco and alcohol use by youth (prior, concomitant, or subsequent to marijuana initiation) influence effects of marijuana on brain development and associated consequences? What are the effects of co-occurring use of marijuana and other illicit drugs? o How does marijuana use interact with mental health conditions that may emerge during adolescence (e.g., eating disorders, mood disorders, schizophrenia), and how do such interactions affect brain development and related behaviors? What are the interactions of marijuana use with other co-occurring illnesses (e.g., HIV infection)? o Some adolescents use marijuana in combination with medications prescribed for mental or physical health conditions. What can be learned about the effects of marijuana on the developing brain and behavior by investigating the combined influences of marijuana and prescription drugs (e.g., medications for attention deficits, antiretroviral treatments for HIV infection)? o Long-term cohort studies show associations between prenatal marijuana exposure and performance in multiple domains (e.g., memory, attentional processes, aspects of executive function). What, if any, additional neurodevelopmental manifestations are present? What brain development processes are involved in consequences of prenatal exposure? Are those who were prenatally exposed differentially affected by use of marijuana, or other drugs, during childhood, pre-adolescence, or adolescence (e.g., behavioral, cognitive, and neurobiological outcomes, vulnerability to substance use disorders, and other mental health conditions)? o How can marijuana effects (subjective, performance, reinforcing) be characterized among adolescents, and how do these compare to those in adults? For example, are adolescents more sensitive to subjective effects of marijuana along an appetitive aversive continuum? Given metabolically equivalent doses, do adolescents show enhanced reinforcing effects that may contribute to a greater vulnerability? Are they differentially impaired on neurocognitive or performance measures relative to their adult counterparts? Do adolescents respond as do adult subjects to drug-associated environmental cues that elicit reports of craving? o Are long-term neuroadaptive changes seen in adolescents after repeated marijuana exposure? How do neurobiological adaptations seen in adolescent subjects contribute to subsequent vulnerability? Does marijuana exposure change the threshold of some central motivational barometer to shift responding for other rewards (including naturally-occurring, non-drug rewards, and rewards from other drug classes)? o What are the consequences of repeated marijuana exposure for multiple domains of development? For example, how does repeated marijuana abuse alter development of cognitive, emotional, or social processes? Neurobiological substrates that may serve as markers, indicators, or mediators for changes in these trajectories could also be examined. o Does marijuana use affect developmental shifting of circadian rhythms and related sleep behaviors in adolescence, and if so, how? What are the neurological implications? o Adolescence coincides with increased myelination in many regions of the brain, an important process that influences many domains of learning and behavior. Does marijuana exposure have an impact on glial proliferation, function, or survival? o Animal data have suggested that marijuana can negatively regulate stem cell proliferation in the adult hippocampus. What are the potential changes in rates of neurogenesis in the adolescent brain relative to marijuana exposure? How do these changes compare to those in adults? o What are the pharmacokinetics and toxicokinetics of marijuana and THC in the developing fetus? o What are the characteristics of molecular and biochemical marijuana- induced alterations of critical substrates of drug abuse (e.g., enzymes, receptors, neurotransmitters, etc.) related to development, time course, and associated pharmacodynamics and toxicodynamics? Investigators interested in the topics of this RFA may also be interested in one or more of the following NIDA RFAs: DA-04-011, Animal Models of Adolescent Drug Abuse: Integrative Studies of Brain and Behavioral Development (http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-04-011.html); 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); DA-04-014, Medications Development for Cannabis-Related Disorder (http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-04-014.html); DA-04-013, Prevention Research for the Transition to Adulthood (http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-04-013.html). MECHANISMS OF SUPPORT This RFA will use the NIH research project (R01) and the exploratory/developmental (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 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 $2 million in FY 2004 to fund 4-6 new and/or competitive continuation grants in response to this RFA. For the R01, an applicant may request a project period of up to 5 years and a budget for direct costs of up to $500,000 per year. APPLICATIONS REQUESTING A BUDGET THAT EXCEEDS $500,000 IN DIRECT COSTS IN ANY YEAR WILL BE RETURNED TO APPLICANTS WITHOUT REVIEW. For the R21, the project period is 2 years and up to $275,000 in direct costs for the two-year period (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). 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: Vincent L. Smeriglio, Ph.D. Human Development Unit Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 443-1801 Fax: (301) 480-4544 Email: vsmerigl@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. 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 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: March 16, 2004 Application Receipt Date: April 16, 2004 Peer Review Date: July/August 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). 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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