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MDMA: RESEARCH AREAS NEEDING MORE EMPHASIS RELEASE DATE: August 26, 2004 PA Number: PA-04-152 EXPIRATION DATE: January 2, 2008, unless reissued. 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 FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA: The purpose of this PA is to provide an optimally comprehensive, strategic, and balanced MDMA (3,4-methylenedioxymethamphetamine) research program, given the upsurge in MDMA abuse worldwide, including its abuse outside the rave scene. Although researchers have made great strides in characterizing MDMA’s neural mechanisms and neurotoxicity, it is necessary now to focus on specific areas of MDMA research, across all research disciplines, urgently needing our attention. For the purpose of this PA, the term “MDMA” is defined as 3,4- methylenedioxymethamphetamine and its very close structural analogues, such as p-methoxyamphetamine (PMA), p-methoxymethamphetamine (PMMA), and 3,4- methylenedioxy-N-ethyl-amphetamine (MDEA), insofar as they share specific subjective, discriminative stimulus, or toxicological properties with 3,4- methylenedioxymethamphetamine; however, methamphetamine and other amphetamines that are characterized by neurotoxic effects on central dopaminergic systems in experimental animals are not included in this definition. “Ecstasy” is defined as a preparation (usually a tablet) supposed by its users to contain MDMA. RESEARCH OBJECTIVES This PA is designed to increase the scope of NIDA’s MDMA research portfolio. Clinical and preclinical research is needed. Research on racially and ethnically diverse populations in various social and cultural settings is encouraged. Studies with adolescent subjects are especially encouraged. When appropriate, research should include males and females, address gender issues, contain sex/gender-based hypotheses, and perform a sex/gender analysis of the data. Epidemiology and Prevention: Despite a decrease in MDMA use in 2002 and 2003, MDMA remains a prominent drug of abuse among youth. In addition, (a) MDMA users often combine it, or use it in sequence with, other drugs, (b) emergency department mentions continue to raise cause for concern, (c) MDMA-related deaths have been reported, and (d) MDMA use has expanded beyond the context of rave/dance clubs to a broad range of settings and populations. Furthermore, despite scientific evidence of short- and long-term deleterious consequences, such as effects on learning and memory, there appears to be a perception of MDMA as a benign or harmless drug. Epidemiologic and prevention research is needed to better characterize and understand the extent and patterns of MDMA use, and to develop effective population-appropriate interventions to prevent the initiation or continuation of MDMA use. Applications to test the effectiveness of interventions for the prevention of MDMA use are of great interest, including interventions that target youth and young adults. These prevention interventions can take place in a variety of contexts (e.g., school, community, peer networks, clubs, Internet, concerts, etc.). Examples of research that are encouraged by this PA are given below, and are not meant to be exclusive: o Identify risk and protective factors for MDMA use in different populations. Examine the relevance of existing theories regarding drug abuse initiation and progression for youth and the use of MDMA. o Identify the health, social and behavioral consequences experienced by MDMA users in different populations. Determine whether MDMA can produce psychopathological deficits. For example, is there a correlation between MDMA use and major depression or suicide? Determine MDMA users’ perceptions of their need for treatment for problems they attribute to MDMA use. To what extent do users perceive that use of MDMA has negative effects or impairs their lives (e.g., affects school or work attendance or performance)? What are users’ perceptions regarding the addictive potential of MDMA? o Examine how MDMA is used in combination or in sequence with other drugs, and for what reasons, in different populations. o Analyze what substances drug dealers are representing as “ecstasy,” and how these substances relate to adverse consequences. o Assess whether and how user expectations and factors in the social environment, i.e., the setting, the physical availability of the drug, and social norms regarding its use, influence the effects experienced by users. o Investigate MDMA-related knowledge, perceptions, attitudes and norms among MDMA users and non-users in different populations. Determine sources of information about MDMA, and the effects and consequences of this information, and explore reasons for use and non-use of MDMA. o Examine the roles of youth social networks and the Internet in the transmission and dissemination of information and misinformation about benefits, risks, effects, and consequences of MDMA use and MDMA use in combination with other drugs. Assess how information is evaluated and utilized with respect to decisions pertaining to MDMA use and associated behaviors. o Examine how and to what extent MDMA users undertake behaviors and activities in an effort to reduce consequences. For example, within specific study populations (e.g., circuit party attendees, inner-city youth), what is the perception of availability of kits or services for testing “ecstasy,” and what proportion of users utilize these kits/services? Are there drugs that are used specifically to counteract perceived negative consequences of MDMA use? For example, what proportion of MDMA users takes selective serotonin reuptake inhibitor (SSRI) antidepressants as an attempt to decrease MDMA neurotoxicity or alleviate post-MDMA depression? o Characterize the role and influence of the Internet on patterns and trends of MDMA abuse. o Test the effectiveness of universal MDMA prevention interventions focused on entire populations (e.g., school and college-based programs, PSA media messages for youth, primary care intervention modules). o Test selective interventions (e.g., peer-driven network approaches) focused on at-risk populations that may include individuals with other drug use experience, proximity to club drug use locations, or involvement with peers using MDMA. o Implement and evaluate indicated interventions focused on individuals who have initiated MDMA use and/or alterations in the environment of MDMA use (e.g., intervention modules for the club scene; media approaches, especially through the Internet; emergency room interventions; peer-driven network approaches). HIV/AIDS and Other Medical Consequences: o Conduct studies to understand HIV transmission and progression in MDMA users vs. non-MDMA users. Are there differences between MDMA users and non- users relative to behavioral risks for HIV and other infectious diseases? For example, do the pharmacological effects of MDMA (intoxication; feelings of empathy, self-confidence, and heightened perception) influence the likelihood of other risk behaviors, such as risky sex and use of other drugs and alcohol? o Compare MDMA users and non-users to determine if, how, and to what extent the persisting effects of MDMA on the brain and behavior may influence potential neurotoxic and mental complications of HIV/AIDS. o Characterize long-term differences in dental complications among MDMA users and non-users. o Design and conduct case-control studies to compare the health and behavioral outcomes of infants and children of MDMA users and non-users, to examine how the lifestyles of MDMA users may affect the health of their offspring, and to characterize the extent and severity of anomalies among infants exposed to MDMA vs. those not exposed to MDMA. Preclinical and Basic Clinical: o Determine the extent to which, and the conditions under which, MDMA is reinforcing and addicting. Studies employing choice procedures to examine relative reinforcement in comparison with other drugs of abuse or natural reinforcers are especially of interest. Also of interest are long-term studies on changes in reinforcing efficacy of MDMA over repeated administration, including the neurobiological substrate changes responsible for these effects. o Identify the behavioral, cognitive, psychological or biological risk factors contributing to MDMA abuse, addiction, acute toxicity, and persistent effects of MDMA. For example, does a baseline of low serotonergic activity in the brain increase the vulnerability to abuse MDMA? Does a history of mood disorder increase the likelihood or severity of persisting MDMA-induced depression? Do physical or psychosocial stressors enhance the neurotoxicity of MDMA? Are there gender differences in vulnerability to the effects of MDMA? Is adolescence a risk factor? o Characterize acute and chronic drug-drug interactions between MDMA and (a) drugs intentionally co-abused with MDMA, (b) substances other than MDMA in “ecstasy” tablets (or other “ecstasy” preparations), (c) selective serotonin reuptake inhibitors (SSRI’s) and other antidepressants. Users of MDMA often take SSRI antidepressants in an attempt to prevent neurotoxicity and post- MDMA depression; however, the interactions of SSRI’s and other antidepressants with MDMA have not been adequately characterized. Examples of drugs in categories (a) and/or (b) include LSD, dextromethorphan, methamphetamine, PMA, ephedrine, cannabis, and ketamine. o Characterize the acute and chronic cardiovascular and cerebrovascular effects of MDMA. o Characterize the recovery from MDMA-induced neural damage over long durations, under various conditions (e.g., normal aging, stress, other ongoing pathology). o Determine the consequences of chronic MDMA ingestion on pain perception. Preclinical: o Determine which dosage parameters (e.g., cumulative lifetime dose, duration of MDMA abuse, peak plasma levels achieved, time since last dose, or frequency of use) contribute to the neurotoxicity of MDMA. o Determine how different populations of glial cells react to the relatively specific neural injury induced by MDMA. o Measure the persistent consequences of prenatal and neonatal exposure to MDMA, especially the effects of MDMA exposure during very early stages of brain development. Determine the mechanism of action of MDMA in producing any such effects. Measure the spontaneous recovery from MDMA-induced developmental deficits, as well as the effects of behavioral and environmental treatment interventions. Characterize the pharmacokinetics of MDMA in the mother and fetus during early development. o Determine the pharmacology and toxicology of metabolites of MDMA. o Using animal models of long-term cognitive, emotional, sleep, sexual, neuroendocrine, and immunological consequences of MDMA abuse, determine the causes of these functional changes (e.g., are the functional deficits due to serotonin terminal loss?), examine possible treatments to restore function, and study the modifying effects of other drugs of abuse. o Examine MDMA effects in animal behavioral models that mimic social situations of human abuse, and that are sensitive to the functional consequences of acute and repeated drug administration. Basic Clinical: o Assess the influence of alternate routes (i.e., other than oral) of MDMA administration – rectal, snorting, smoking, or injection – on the effects of MDMA. o Develop more sensitive and specific methods for detecting serotonergic neurotoxicity in living humans, as well as methods that better define its functional consequences. o Perform well-controlled post-mortem studies in MDMA users in order to quantitatively assess serotonergic and other neurotoxicity. o Determine whether continued MDMA use causes progressive psychological or neurological impairments over time. While scientific evidence has been obtained that MDMA can injure many of the brain’s serotonergic neurons, and that there are at least subtle (sub-clinical), persisting functional consequences associated with this neurotoxicity, it is not known whether more severe, pathological cognitive, psychological, and other functional (e.g., behavioral, sleep, temperature regulation, neuroendocrine, sexual function) deficits occur in some individuals, or whether the likelihood of more severe deficits changes with normal aging or other factors (e.g., stress, pre- existing psychopathology). o Determine whether MDMA intoxication, combined with various environmental stimuli, affects performance related to driving, operating machinery, etc. o Determine the causes, characteristics, and consequences of post-MDMA negative moods (termed “midweek blues” and “terrible Tuesdays”). For example, besides mood, what additional deficits (e.g., in cognition or sleep) occur in this post-acute interval, and are there individual or gender differences in vulnerability to this effect? Do these effects worsen or abate with repeated MDMA use? Treatment-Related Studies: o Assess the degree to which there is a need for treatment of MDMA addiction or other persisting MDMA-induced deficits, such as learning and memory deficits. Studies of treatment readiness in MDMA users are lacking. o Develop and evaluate medical screening and assessment instruments for MDMA abuse and its consequences that clinicians can use in a variety of clinical settings, including primary care, where MDMA users (typically adolescents and young adults) may normally be seen (perhaps because of the MDMA abusers' concerns regarding their MDMA abuse consequences). o Assess spontaneous recovery from MDMA effects, during abstinence, in humans. o Measure the benefits and risks of pharmacological treatments for persisting MDMA effects in humans. o Using animal models, determine the effects of various experimental treatments on persisting effects of MDMA. o Assess the degree to which people in treatment for other drugs of abuse use MDMA. o Develop and evaluate new behavioral treatments, or adapt existing behavioral treatments that have shown efficacy in populations that abuse other drugs, for MDMA abuse (for detailed information, see the NIDA Behavioral Therapies Development Program Announcement, PA-03-066). o Evaluate and develop pharmacotherapies or other types of therapies for reversal of acute MDMA intoxication or for prevention of long-term neurotoxic effects of MDMA. o Investigate possible gender, individual, or cultural differences (i.e., mediators or moderators) in treatment responses of MDMA abusers. o Examine the unmet need for treatment services to address MDMA abuse, the barriers to the provision and receipt of treatment for MDMA abuse, and strategies for improving access to and utilization of treatment services by MDMA abusers. MECHANISMS OF SUPPORT This PA will use the NIH research grant (R01), small grant (R03)(PA-03-108: NIH SMALL RESEARCH GRANT PROGRAM (R03), and exploratory/developmental grant (R21)(PA-03-107: NIH EXPLORATORY/DEVELOPMENTAL RESEARCH GRANT AWARD (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting format (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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. 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 your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Jerry Frankenheim, Ph.D. Division of Basic Neuroscience and Behavioral Research (DBNBR) National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-1312 Fax: 301-594-6043 Email: JFranken@nida.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D. Chief, Grants Management Branch National Institute on Drug Abuse 6101 Executive Boulevard, Room 270, MSC 8403 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gfleming@nida.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 D&B; number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B; number should be entered on line 11 of the face page of the PHS 398 form. 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) 435-0714, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting $500,000 or more must carry out the following steps: 1) Contact IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member in the IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by an appropriate national advisory council or board. 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 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. 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? 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? 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? 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)? 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting $500,000 or more in direct costs in any year of the proposed research are expected to 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. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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 AND SAFETY 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 and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $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 "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. 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. 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 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. 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). 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. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. 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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