RFA-DA-04-008: GROUP THERAPY FOR INDIVIDUALS IN DRUG ABUSE OR ALCOHOLISM TREATMENT

Department of Health
and Human Services (HHS)

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GROUP THERAPY FOR INDIVIDUALS IN DRUG ABUSE OR ALCOHOLISM TREATMENT RELEASE DATE: December 10, 2003 RFA Number: RFA-DA-04-008 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279, 93.273 LETTER OF INTENT RECEIPT DATE: January 20, 2004 APPLICATION RECEIPT DATE: February 20, 2004 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this Request for Applications (RFA) is to invite research applications addressing group-format behavioral treatments for drug abuse and/or alcohol use disorders (AUD). Applications that focus on interventions to reduce the spread of infectious disease in substance abuse treatment populations are also of interest. This RFA builds on a meeting convened by the National Institute on Drug Abuse (NIDA) in 2003 on the challenges in conducting research on group therapy, and is part of an ongoing commitment of NIDA and National Institute on Alcohol Abuse and Alcoholism (NIAAA) to support the development and testing of behavioral treatments for drug abuse and AUD that can be delivered in community substance abuse treatment settings. Most behavioral treatments for drug abuse/dependence in community settings are delivered via group format, yet relatively few systematic studies of group therapy for drug abuse or AUD have been conducted. Further, the many methodological and logistical challenges in conducting group therapy research present significant obstacles to the development of this area of research. For these reasons, NIDA and NIAAA wish to support additional scientifically-sound and clinically-relevant research in this area. Applications are encouraged that: (1) develop new group therapies, based on strong clinical theory, or on translation of findings from basic behavioral, cognitive, affective, and social science studies and/or on current knowledge in neuroscience; (2) adapt existing group therapies originally developed for clinical problems other than drug abuse/AUD to incorporate drug abuse, AUD, and/or infectious disease risk reduction as targets of treatment; (3) adapt existing behavioral treatments originally developed as non-group format treatments to be delivered via group format; (4) develop treatment manuals for existing group therapies that have not yet been systematized, and test these therapies (i.e., reverse-engineering of existing group treatments); and (5) address the methodological and statistical tools necessary for examining the effects of group-format treatments. In addition, all applications should strive to incorporate tests of the mechanisms of action of group therapies, identifying important mediators and moderators of treatment effects. RESEARCH OBJECTIVES Background Rather than being a unified treatment approach, group therapy encompasses a wide range of behavioral treatment approaches with the common element of a group format. The theoretical foundations of group therapy vary widely, with typical 12-step groups grounded in a disease model of addiction, skills-based groups grounded in behavioral or cognitive theory, some psychoeducational groups grounded in a health-belief treatment model, other groups grounded in psychodynamic theory, and still others taking an eclectic approach. Group therapies also vary in the degree to which they focus on group process as a mechanism of change, with group treatments such as therapeutic communities relying heavily on feedback from other participants for therapeutic change, other approaches using group members experiences as an additional therapeutic tool, and still others largely delivering individual treatment in a group format. Such wide variability within this treatment modality makes it difficult to draw general conclusions about therapeutic effectiveness, especially given the small number of studies conducted on group treatment of drug abuse and AUD. Not surprisingly, the small number of controlled studies on group treatments for drug abuse/AUD shows mixed results, and the variability in the approaches, target populations, timing, and other dimensions of the therapies is likely to account for differential effectiveness found in these studies. Given the state of the science of group therapy research, more controlled studies of group therapies for drug abuse, AUD, and infectious disease risk reduction are needed. NIDA and NIAAA are guided by a three-stage model of behavioral treatment development. This RFA should be considered in the context of this model, which is described in detail in the Behavioral Therapies Development Program Announcement (http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html). In this model, Stage I, or early therapy development, involves research on the development, refinement, and pilot testing of behavioral interventions. Stage-I group therapy development may be based on compelling theory, clinical observation, and/or the translation of findings from existing research, including basic behavioral, cognitive, affective, and social science and/or neuroscience. Stage II involves the efficacy testing of clearly defined treatments that have shown promise. Stage III is research aimed at determining if and how efficacious behavioral treatments may be transported to community settings, through the development of therapist training methods and the community-based testing of efficacious treatments (e.g., technology transfer studies). Another type of treatment development research that is especially applicable to group therapies involves cases in which existing group therapies are being delivered, but have not yet been manualized or rigorously tested. In these cases, research might involve developing a therapy manual that captures the key elements of the therapy, and then testing this therapy in a pilot or controlled study. This type of study, sometimes called reverse-engineering of treatment, may encompass aspects of several stages of therapy development, depending on the research questions and design. Although research is needed at all stages of therapy development for group therapies, this RFA focuses on Stages I and II. It is important to note that this includes, but is not limited to Stage I and II research on the development and testing of group therapies in community settings. Of particular interest are the development of new group therapies, or the adaptation or manualization of existing group therapies, and the testing of these therapies in targeting drug abuse, AUD, and/or decreasing the spread of infectious disease. Attention to potential mechanisms of action of group therapies is relevant to every stage of therapy development, and applications should consider measurement and methods that allow for tests of how the group therapy of interest produces change. While applications that address either how a group therapy produces change, or whether a group therapy produces change (i.e., mechanisms of action or efficacy), are responsive to this RFA, strong applications will incorporate tests of both therapeutic mechanisms and efficacy. Special Issues Related to Group Therapy Research Group therapy research poses particular methodological, logistical, and human subjects challenges that applicants are encouraged to consider. Among the methodological challenges in conducting group therapy research are handling the heterogeneity within groups, handling changes in group membership, accounting for the potential non-independence of group members, deciding on randomization procedures (e.g., randomizing patients to groups vs. constituting groups and then randomizing to treatment conditions), and analyzing group data (e.g., choosing appropriate levels of analysis, scaling group data). Among the logistical challenges in conducting group therapy research are recruiting sufficient numbers of participants to constitute therapy groups, preventing and managing patient drop-out, and minimizing the delay between the study intake and the beginning of treatment. Perhaps primary among the challenges in group therapy research is choosing between closed groups, in which group membership is relatively fixed, and open or rolling groups, in which new members may join the group and existing members may graduate from the group as progress indicates. The choice between closed and open group therapy may have implications both for the study methodology and study logistics. For instance, closed groups may require long delays before the start of treatment while group members are being recruited. This may increase patient dropout, and pose questions about the necessity of offering an interim treatment. Closed groups also may increase the interdependence of group members, and may limit the degree to which group member data can be analyzed at an individual level. However, the variability in open groups may make following a treatment plan difficult, in which new group members are at different points in their treatment than existing members. Variability in group membership also complicates data analysis, adding potential confounds in explaining therapeutic change. Applicants are encouraged to be sensitive to any special human subjects issues that group treatment might produce, such as additional issues of confidentiality, and/or issues concerning mixed gender groups, etc., and to address all relevant human subjects issues in their proposals. Specific Areas The following are a few examples of group therapy research projects that would be responsive to this RFA. These are meant to highlight projects of particular interest to NIAAA and NIDA, but this list is not intended to cover the full range of projects of interest. Applications are encouraged to incorporate tests of therapeutic mechanisms of action, clarifying how therapies produce change, in addition to whether therapies produce change. o Develop and test a group therapy for a special population of alcohol and/or drug abusers (e.g., single-gender, adolescents with Conduct Disorder, etc.) based on findings that suggest a need for targeted treatments o Identify and test possible counter-indications for behavioral treatment delivered in a group format (e.g., mismatches between group treatment approaches and certain populations of alcohol and /or drug abusers, goals of treatment, timing of treatment, etc.) o Adapt and test a group therapy for drug and/or alcohol abuse and/or infectious disease risk-reduction from an efficacious group therapy for other clinical disorders (e.g., other addictive behaviors, anxiety disorders, mood disorders, chronic illness, etc.) o Adapt and test an individual-format treatment for delivery in a group format, or replicate and refine those methods, which are in the early stages of development. For example, Motivational Enhancement Therapy was formalized in an individual format, and has been implemented in a group format with mixed results. Additional studies are needed in this area. o Develop a treatment manual and therapist adherence and competence measures, and pilot test an existing group therapy with a promising clinical history, but which has not yet been studied systematically o Test hypothesized mechanisms of action of group treatment, and their relationship to therapy outcome (e.g., social support, social influence and persuasion, modeling, exposure, skills acquisition, acceptance of difficult life experiences, learning emotional regulation, embracing powerlessness in the face of addiction, creating opportunities to re-visit unresolved developmental issues, spirituality and religiosity etc.) o Test potential mediators and moderators of treatment effects, such as group cohesion, the role of powerful group members, the degree of group heterogeneity, group size, dropout, etc. o Investigate the relationship to therapy process and/or outcome of therapist characteristics, stances, or interventions (e.g., therapist directiveness vs. neutrality, degree of therapist self-disclosure, having co-therapists, peer vs. professional group leaders, ethnicity, and cultural competency of therapist, etc.) o Investigate possible common change processes across different group therapy approaches o Analyze previously-collected therapy data to clarify the mechanisms of action and efficacy of a group therapy o Develop and test measures necessary for research of group therapy, including measures of possible mechanisms of action, mediators and/or moderators of treatment effects, and therapy outcome MECHANISMS OF SUPPORT This RFA will use the NIH research project (R01), the small grant (R03) http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html and the exploratory/development (R21) award mechanisms http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NIDA intends to commit approximately $1.5 million and NIAAA will commit to $350,000 in FY 2004 to fund 5 to 6 new and/or competitive continuation grants in response to this RFA. An applicant may request for the R01 a project period of up to 5 years. For the R03, the project period is 2 years and direct costs up to $50,000 for each of those years. For the R21, the project period is 2 years and up to $275,000 in direct costs for the two-year period. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIDA and NIAAA 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: For NIDA: Melissa W. Racioppo, Ph.D. Behavioral Treatment Development Branch National Institute on Drug Abuse 6001 Executive Blvd. NSC Room 4230 Bethesda, MD 20892 (USPS) Rockville, MD 20852 (FedEx and other couriers) Tel: (301) 443-2261 Fax: (301) 443-6814 Email: mr313x@nih.gov For NIAAA: Charlene E. LeFauve, Ph.D. Division of Treatment and Recovery Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 For express mail use: Rockville, MD 20852) Telephone: (301) 402-9401 Fax: (301) 443-8774 Email: clefauve@NIAAA.nih.gov o Direct your questions about peer review issues to: For NIDA: 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: For NIDA: 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 For NIAAA: Judy Fox Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 (For express mail use: Rockville, MD 20852) Telephone: (301) 443-2434 Email: jsimons@niaaa.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 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 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 and NIAAA. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA and NIAAA 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 and the National Institute on Alcohol Abuse and Alcoholism National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (See http://grants2.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 20, 2004 Application Receipt Date: February 20, 2004 Peer Review Date: June/July 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA SAFETY AND MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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