and Human Services (HHS)
EXPIRED
NEUROIMAGING THE EFFECTS OF DRUGS OF ABUSE ON THE DEVELOPMENT OF THE HUMAN NERVOUS SYSTEM RELEASE DATE: February 6, 2003 RFA NUMBER: DA-04-002 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 LETTER OF INTENT RECEIPT DATE: May 19, 2003 APPLICATION RECEIPT DATE: June 18, 2003 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements 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 studies that take advantage of the rapidly evolving methodology of neuroimaging to further our understanding of the consequences of drug exposure, abuse and addiction on the developing human brain. Neuroimaging is progressing rapidly and new techniques are continually being developed and refined providing a window into the structural (e.g., anatomical magnetic resonance imaging, diffusion tensor imaging), neurochemical (e.g., positron emission tomography, magnetic resonance spectroscopy), and functional neurobiology (e.g., functional magnetic resonance imaging, optical imaging, electroencephalography, magnetoencephalography) of the nervous system. Recent research using these techniques has shown that exposure to drugs of abuse can have demonstrable effects on the human brain, effects that are very likely to be strongly influenced by the developmental state of the nervous system at the time that exposure occurs. Research that addresses the effects of drug exposure during development, spanning the continuum of development from in utero exposure through the transition to adulthood, is greatly needed. With this RFA we seek to encourage investigators experienced in the field of drug abuse, as well as researchers from the spectrum of disciplines that investigate neurobiological and neurobehavioral aspects of typical and atypical development, to apply their knowledge and expertise to the complexities of the effects of drugs of abuse on the developing human brain. Research proposed in response to this RFA need not involve subjects or participants that have been exposed to drugs of abuse, but may investigate brain areas and maturational processes that have been demonstrated to be affected by drug exposure. Investigators proposing such studies, however, must provide a clear statement indicating how the research will advance our understanding of the ways in which exposure to drugs of abuse alter the normal development of the nervous system. RESEARCH OBJECTIVES Background Investigations of the effects of drugs of abuse in animal models have yielded considerable insight into the structural and functional effects of drug exposure on the developing nervous system. Human cohort studies have added significantly to our understanding of the behavioral consequences of early exposure to drugs of abuse and, recently, functional neuroimaging studies have informed us greatly about drug exposure effects in adults. But very little is known about the consequences of drug exposure on the development of the human nervous system. For the most part, then, we currently have a very limited appreciation of the linkages between the effects of drugs of abuse on human behavior and the neurobiological basis of these effects and, most especially, the ways in which the effects of drugs of abuse may differ as a function of the developmental context in which exposure occurs. The rapid development of brain imaging technology and the continual emergence of new imaging techniques hold great promise for revealing the possible brain alterations that drugs of abuse may cause during development in infants, children and adolescents. At the most fundamental level, it remains to be securely defined whether or not, in fact, exposure to at least some drugs of abuse has demonstrable effects on the developing nervous system (whether these effects are shown to exist in morphological alterations, differences in functional activation of specific brain areas, neurocognitive deficits, etc.). In those cases where effects can be shown, there remain many questions of fundamental importance in understanding the interplay between drug exposure, neurobiological development and behavior. Although studies of the development of the human brain indicate that it nearly achieves its ultimate size in relatively early childhood, it is now well accepted that the maturation of the brain continues well into adolescence, and that considerable plasticity endures even in adulthood. Moreover, different developmental epochs are defined by different, albeit overlapping, processes such as neurogenesis, migration and pattern formation, differentiation, and the establishment and refinement of connections. Of importance, therefore, for understanding the effects of drugs of abuse is to define the differences in the effects of drug exposure when it occurs early in development, (i.e., in utero or infancy) vs. later in development (e.g., in early childhood, late childhood, or adolescence). Can differences in drug effects be related to the processes that predominate in the developmental continuum at the time of exposure, thus suggesting the mechanism of action of the drug under study? Comparisons among the effects of drugs of abuse can also be instructive. Different drugs of abuse can produce similar behavioral effects. Can comparisons of the functional activation patterns under the influence of different drugs identify common neurobiological mechanisms? Drugs of abuse are known to affect certain neurotransmitter systems (e.g., the catecholamine pathways), but many other disorders also affect these systems and some of these disorders present with behavioral manifestations similar to those seen with exposure to drugs. What can be learned about the actions of drugs of abuse from studies of other neurobiological/neurobehavioral conditions, and vice-versa? Epidemiologic data have shown that a substantial number of infants have been born prenatally exposed to drugs, and a growing number of children are beginning to experiment with drugs at an early age. The purpose of this RFA is to encourage developmental (including cognitive developmental) researchers, drug addiction researchers, neuroimaging researchers, and researchers from other fields that intersect with the study of drug abuse to apply brain imaging techniques to define and characterize the neurobiological consequences of drug exposure in the developing brain. Neuroimaging techniques now allow structural, functional and metabolic/biochemical measures to be made on human brain from birth onward. The intent of this RFA is to take advantage of these new methodologies to fund outstanding research aimed at assessing the neurobiological consequences of early exposure that can be related to the behavioral alterations that drug abuse and addiction produce. Areas of interest Research applications in these broad categories might include, but are not limited to: o Fundamental to the goals of this RFA are: 1) documentation of the effects of exposure to abused drugs on the development of the human nervous system, and 2) the determination of the effects of the time of exposure on neurobiological and neurobehavioral development. It is well documented that the effects of in utero exposure to some teratogens is greatly affected by the specific prenatal time at which exposure occurs. One can surmise that this is also true for exposure to drugs of abuse, but little data are available that directly address this issue. o Of critical importance to our understanding of the neurobiological bases of the effects of exposure to drugs of abuse during development are investigations that seek to correlate imaging data with careful neurocognitive and neurobehavioral assessments (particularly those suited to pediatric populations). Studies that propose to define the relationships between the behavioral consequences of drug exposure and the neurobiological aspects of development are strongly encouraged. o As mentioned previously, the study of animal models has greatly increased our knowledge of the effects of drugs of abuse on the development of the nervous system. Worthy of investigation, also, is the possibility that studies of drug effects in the human nervous system can inform investigations of animal models. For example, can the results of functional or chemical imaging studies in humans demonstrate activation in brain areas that had previously not been thought to be affected by drugs of abuse, thus providing a starting point for the initiation of more mechanistic investigations in animal systems? The rapid advancement of neuroimaging techniques, both in terms of sensitivity and resolution, raise this possibility. Applications proposing to conduct parallel studies of drug effects during development in both humans and animals, and especially non-human primates, are of particular interest. o New imaging modalities (e.g., Diffusion Tensor Magnetic Resonance Imaging) are now making it possible to analyze connectional patterns in the human brain and the potential effects of extrinsic influences on pathway development. Animal studies have provided strong evidence that alterations in the structure and function of a specific area of the brain, whether as a result of normal development or perturbation, almost invariably have both retrograde and anterograde effects. Studies of the effects of drug exposure on the development, refinement, and maintenance of connections within the brain are encouraged. o Both behavioral and pharmacological treatments have been shown to be effective in the treatment of drug abuse and its consequences. Advances in neuroimaging technologies, especially those that can provide information on the functional state of the brain, may now provide us with the opportunity to describe relationships between the therapeutic effect of different treatments and the underlying neurobiology. Is the effectiveness of specific therapeutic regimens affected by the age of the individual undergoing treatment? Does the maturational state of specific areas of the brain, those involved in decision-making for instance, compromise the potential efficacy of certain therapies? Does use of medications for treatment of a disorder, for example treatment of ADHD with stimulants, differentially affect neural development from when drug exposure occurs for nonmedical purposes or as a function of the time at which stimulant treatment is instituted? Does illicit drug use, in combination with use of medications, affect neural development? o More knowledge of nervous system development is needed for adolescents and young adults who are infected with the human immunodeficiency virus (HIV), and who are also using drugs of abuse. These individuals face risks to neurological development, cognitive functioning, and mental health that may be associated with the infection and with the use of illicit drugs. In addition, many are likely to be taking highly active antiretroviral medications. Greater understanding of the effects of exposure to drugs of abuse in combination with HIV infection, as well as consequences of the complex exposure to virus, drugs of abuse, and powerful medications may be facilitated by carefully designed neuroimaging studies. o Numerous studies have demonstrated gender differences in neurological development and in the development of specific cognitive capacities and abilities. Does exposure to drugs of abuse, at specific times in development, have differential effects that can be related to the sex/gender of the exposed individual? To hormonal state? Of particular interest in this regard is the increasing use of anabolic/androgenic steroids among adolescents. Psychological and psychiatric effects of steroid abuse have been well documented. Relatively little is known, however, about the relative frequency and severity of these effects as a function of age and gender and the possible neurobiological mechanisms that underlie these effects. o Inhalants (e.g., volatile gases, solvents, and aerosols) are among the most commonly abused drugs in school-aged children. Severe neurological effects of the chronic use of inhalants have been documented in adults, but very little is known about the neurobiological effects of exposure to this class of drugs on the human brain during development. Studies that seek to define the effects of inhalants on the developing human brain are encouraged. o Many drugs of abuse have similar cognitive and behavioral effects (e.g., cocaine and methamphetamine both affect reasoning and concentration) while concurrently producing differing effects (e.g., cocaine seems to have a lesser effect on tasks that call for organizing information than methamphetamine). Can these similarities and differences be explained by the involvement of common neurobiological pathways? Are the differences and similarities in the effects of drugs, and the underlying neurobiological mechanisms, dependent upon the age at exposure? Studies comparing the developmental consequences of exposure to different drugs are needed. o Drug abuse can result in behavioral manifestations, such as stereotypies, mood dysregulation, learning and memory deficits, and many others, that are shared with conditions and disorders with very different etiologies. Moreover, it has been well documented that drugs of abuse differentially affect specific neurotransmitter systems, as do specific developmental disorders and psychiatric conditions. Do these common behavioral manifestations and/or the involvement of certain neurotransmitters reflect common underlying neurobiological processes? Treatment regimes for specific disorders that employ psychoactive drugs, also, have documented effects on neurotransmitter systems affected by some drugs of abuse. Do such treatments interact with the effects of exposure to abused drugs, or alter the likelihood of progression to addiction? Further, some forms of mental illness and some developmental disabilities are characterized by their emergence during a specific period in the lifetime of the affected individual. Can drug exposure at a similar time result in similar effects? Research that seeks to demonstrate commonalities between the consequences of drug abuse and other disorders with similar neurobiological and neurobehavioral manifestations is particularly encouraged. o The neural circuits that mediate motivation and reward are intimately involved with many aspects of both the effects of drugs of abuse and the course of development of addiction. Relatively little is known of the maturation of these areas of the human brain (e.g., the amygdala, nucleus accumbens, orbitofrontal cortex, etc.) or of the effects of drug exposure on either their function or development. Of great interest, then, are studies of the effects of exposure on these areas and differences in these effects as a function of developmental stage at the time of exposure. Further, these same circuits have been implicated in some psychiatric disorders and may play a role in the behavioral manifestations of certain developmental disabilities. Studies that compare the function of these circuits in such disorders, with comparisons to the effects of drug abuse, are also encouraged. o Evidence that the psychological and physical consequences of drug exposure can vary greatly dependent on a number of factors, even in a single individual, attests to the complex nature of drug effects. Concurrent use of multiple drugs further complicates efforts to understand the neurobiological bases of the consequences of drug abuse. Thus, studies that can take advantage of populations of individuals exposed only to single drugs to explore underlying neural mechanisms, development and behavior are greatly needed. MECHANISM OF SUPPORT This RFA will use the NIH R01 award mechanism. 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 April 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 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 format. Otherwise follow the instructions for non- modular 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 $3 million in FY 2004 to fund 8 to 10 new and/or competitive continuation grants in response to this RFA. 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. 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 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. SPECIAL REQUIREMENTS Principal Investigators will be required to attend an annual meeting in the Washington, DC metropolitan area. The travel budget should therefore reflect appropriate allocation for this activity. The purpose of these annual meetings will be to share scientific information, assess progress, identify and solve common methodological problems, and identify new research opportunities. 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: Laurence R. Stanford, Ph.D. Division of Treatment Research and Development National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4232, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 402-3869 FAX: (301) 443-6814 Email: [email protected] o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: [email protected] o Direct your questions regarding 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) 594-6847 Email: [email protected] 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: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. 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 must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) 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 assignment 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 unfunded 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. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 the NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 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 discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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: o PROTECTIONS 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). o 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 included in the section on Federal Citations, below). ADDITIONAL CONSIDERATIONS o 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: May 19, 2003 Application Receipt Date: June 18, 2003 Peer Review Date: November/December 2003 Council Review: February 2004 Earliest Anticipated Start Date: April 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phases I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (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. 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. 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. 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 authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm 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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