DEVELOPMENTAL CENTERS FOR TRANSLATIONAL RESEARCH ON THE CLINICAL NEUROBIOLOGY OF DRUG ADDICTION RELEASE DATE: April 30, 2004 RFA Number: RFA-DA-05-003 (This RFA has been reissued, see RFA-DA-06-006) EXPIRATION DATE: November 18, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.279 LETTER OF INTENT RECEIPT DATE: October 18, 2004 APPLICATION RECEIPT DATE: November 17, 2004 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 Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Drug Abuse (NIDA) invites applications to support the development of translational research centers on the neurobiology of drug abuse that have a strong clinical/human neurobiology focus and the capability to integrate preclinical/animal studies that will serve to directly inform the direction of the clinical research. Advances in the technological armamentarium that can now be brought to bear on questions concerning the acute and chronic effects of drugs of abuse, the factors that influence addiction liability, the neurobiological alterations that may lead to abuse and addiction, and the effects of intrinsic and extrinsic influences on the course of treatment and relapse now make it possible to pose very specific questions on the nature of drug effects in the human nervous system. Despite technical advances, however, the spectrum of approaches that can be used in preclinical investigations renders animal research much more suitable for mechanistic studies of the neurobiology of drug abuse. This funding opportunity announcement is designed to encourage teams of investigators to propose the development of research programs with a primary focus on clearly defined issues in drug abuse and addiction in clinical populations that can simultaneously be investigated in animal models with the aim of, ultimately, using the preclinical findings to refine and direct the clinical research. It is expected that the centers funded through this RFA will be well positioned to compete for funding through a subsequent funding opportunity announcement for larger centers for Translational Research on Drug Addiction. RESEARCH OBJECTIVES Background: Animal models have yielded very important data on the neurobiological mechanisms of addiction and have been extremely useful in elucidating some of the mechanisms of addiction and abuse at the basic molecular, cellular, and systems levels. Recent clinical studies, with the advent of advances in areas such as structural, functional and chemical imaging and human genetics have provided new insights into the neurobiological changes caused by drug exposure and the factors that influence those changes. Most frequently, animal investigations and human investigations proceed on parallel tracks and, while clinical and preclinical findings may inform one another, the integration of the two is only rarely accomplished in a setting that has their integration as an explicit goal and an infrastructure to support that effort. A need exists in the drug abuse field for integrative/translational research centers capable of both clinical and preclinical investigations that are driven by the clinical questions and issues. This RFA represents a first step in addressing this need. Understanding drug abuse and drug addiction is an incredibly complex problem; to achieve a true understanding of any single facet of the problem will require an interdisciplinary and integrative research approach that employs a range of disciplines, levels of analysis and methodologies. The centers supported by this RFA would have as their primary focus human/clinical drug abuse issues and take advantage of the methodologies and investigative approaches available for use in preclinical studies, but not available for use in human studies for technical/design/feasibility/ethical reasons, to inform the directions of the clinical investigations and refine the clinical questions. For example, neuroimaging studies now provide an important opportunity to advance significantly our understanding of the areas of the brain, and to a limited extent, the processes involved in drug addiction. Neuroimaging studies in humans, however, can only provide very indirect information concerning the alterations induced by abused drugs at the cellular, molecular, genetic, or even the connectional level. It is expected that centers competing successfully for funding through this RFA will propose a program of research that has, as its focus, a well defined clinical question that will be investigated at multiple levels, taking advantage of model systems that offer methodological advantages that have the potential to yield results that can be directly translated into the clinical investigations. Finally, it is expected that the centers established following award to successful applicants will serve as a venue for training junior investigators in the clinical and preclinical neurobiology of drug abuse and in multidisciplinary approaches to scientific investigation. Objectives and Scope: The primary aim of this RFA is to support early stage development of interdisciplinary teams of investigators dedicated to the study of the impact of drug exposure, abuse, and addiction on the human brain and to position these teams to compete successfully for Centers for Translational Research on the Clinical Neurobiology of Drug Addiction that will be established in a future initiative. Successful applications will demonstrate a strategy for the development of a Developmental Center that will provide both a structure for the support of the team’s goals and a strong scientific rationale for both the composition of the team and the role of the team members. Proposed centers must be comprised of an Administrative Core and at least three, but no more than five, scientific projects. At least one of the scientific projects must propose to conduct clinical research and at least one must conduct preclinical (non-human) research. Since clinical drug issue(s) must define the central theme of each center, it needs to be demonstrated that the proposed preclinical project(s) directly relate(s) to the clinical component. High risk/high impact research that might be especially well investigated using the collaborative approach that the center organization is designed to foster is encouraged. However, the way in which such projects will directly contribute to achieving the overall scientific aims of center must be clearly detailed. The interdependence and integration of all of the projects in pursuit of the central clinical question must be clearly described. The investigators directing each of the projects are expected to be among the leaders in their respective fields. The Developmental Center mechanism may not be used as a substitute for individual grant support. Scientists named as Project Directors of the scientific projects, therefore, are expected to have independent, peer-reviewed, research support. It may be that one or more of the scientists best suited to address the scientific questions central to the proposed center is not sited at the center’s administrative home. Given the current facility of communication and information exchange, such collaborations among different institutions are encouraged if deemed the optimal way for achieving the goals of the proposed center. In those instances in which project investigators are geographically separated, it is imperative that a detailed plan for feasibility, regular communication, and coordination among the projects be delineated. The Director of the Developmental Center should have a demonstrated capability to organize, administer and direct the center. It is expected that the Director will serve as the scientific, as well as administrative, leader of the center. To that end, the Center Director must function as the Director of the Administrative Core and must serve as the Project Director of one of the scientific projects and devote a minimum of 20% effort overall to the center. If appropriate to the scientific aims of the proposed center, support for core facilities should be requested. As with the scientific projects, it is expected that the investigators that lead the cores will also be prominent in their respective fields. The contribution that each of the cores will make to the overall goals of the proposed center, and their integration into the overall structure of the center, should be clearly described. The proposed center should provide opportunities for young investigators who have the potential for independent research careers to gain skills and experience in state-of-the-art approaches to research in drug abuse and addiction. To achieve this aim, it is expected that relationships be developed between the center and the relevant pre- and postdoctoral training programs at the participating institutions. Areas of Scientific Interest: The following areas are illustrative of the topics that address the mission of the National Institute on Drug Abuse and should not be considered as being either comprehensive or exclusive of other areas. The neurobiological processes leading to abuse and addiction what brain processes, structures and circuits are affected by abused drugs; how are these altered over the time course of exposure; is there an exposure threshold beyond which addiction is inevitable and what factors determine that threshold? The cognitive neuroscience of addiction what facets of executive function are affected by drug exposure and how are they altered along the pathway to addiction, how is the neurobiological circuitry implicated in cognitive functions such as reward, inhibitory control, impulsivity, etc. affected by exposure; can cognitive measures be used to predict vulnerability to abuse and addiction or to predict treatment outcome? The developmental neuroscience of drug abuse how are the effects of drug exposure influenced by the developmental epoch in which exposure occurs; are there specific developmental time points in which exposure is more or less likely to lead to addiction; what are the developmental neurobiological factors that affect addiction liability; how are processes such as the development of tolerance; the emergence of withdrawal symptoms, or the efficacy of treatment affected by duration of exposure and developmental timeframe? The treatment of drug abuse and addiction what are the neurobiological bases of treatment effects; how do behavioral and pharmacological treatments interact with brain processes; what are the neurobiological effects of different behavioral and/or pharmacological treatment approaches; what are their neurobiological mechanisms; can neurobiological changes induced by treatment be used to predict treatment success or the optimal course of treatment? The interaction of drug abuse and HIV/AIDS does drug exposure influence the time course and severity of the neurobiological effects of HIV infection; does HIV infection, and its psychological effects; alter the neurobiological effects of drug exposure; does antiretroviral treatment affect abuse or addiction liability? Extrinsic and intrinsic influences on addiction and abuse what are the interactions between drug exposure and comorbid psychological, psychiatric, or developmental conditions; are there demonstrable genetic influences on the effects of abused drugs; how do personal and social factors (e.g., stress) affect drug abuse and addiction liability; can intrinsic (e.g., genetic factors, gender) and/or extrinsic (e.g., stress) factors explain individual differences in the effects of abused drugs? MECHANISM OF SUPPORT This RFA will use the NIH P20 award mechanism, which provides support for developing collaborative teams of high caliber investigators using diverse scientific approaches to the investigation of a highly focused research problem. Applicants may request support for only one period of up to three years; direct costs requested may not exceed $500,000 in any one year. In an effort to allow for multi-institutional involvement, for the purposes of this RFA , facility and administrative (F&A) costs for consortium activity at collaborating institutions will not be counted against the $500,000 limit to direct costs (but these costs should be delineated as instructed in form PHS 398. The applicant 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 for this RFA is June 2005. This RFA uses just-in-time concepts. The instructions for non-modular budget research grant applications should be followed. 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. FUNDS AVAILABLE NIDA intends to commit approximately $2,000,000 in FY 2005 to fund 2 to 3 new grants in response to this RFA. An applicant may request a project period of up to 3 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 provides 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 his/her 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: L. R. Stanford, Ph.D. Division of Treatment, Research, and Development National Institute of Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4232, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 402-3869 FAX: (301) 443-6814 Email: lstanfor@mail.nih.gov o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, Maryland 20892-8401 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tlevitin@mail.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 270, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director DA-05-003 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 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. SUPPLEMENTARY INSTRUCTIONS: Application Format Guidelines The primary purpose of this initiative is to support early stage development of interdisciplinary teams of investigators dedicated to the study of the impact of drug exposure, abuse, and addiction on the human brain. The application must clearly describe the hypotheses to be tested, the goals of the proposed research plan, and the approaches used in the Center. The application should utilize PHS Form 398 and include the following components in the specified order: Information for the Entire Center: o Face Page (noting this RFA in Item 2) - Information provided here should pertain to the entire Center. o Description, Performance Sites, and Key Personnel (Form Page 2) - Information provided here should pertain to the entire Center. o Table of Contents (Form Page 3) o Budget Information (Form Pages 4 and 5) - Categorical figures should be provided to reflect the budget of the overall Center. Since detailed budget justifications will be provided separately for each project and core, only items for which a narrative justification is not provided elsewhere should be described here. o Biographical Sketches of Key Personnel - Biographical sketches should be provided for key personnel of the entire Center, with the Principal Investigator being first. Other key personnel should be arranged alphabetically based by surname. o Resources - Resources described here should be restricted to those not described separately for the individual projects and cores (as described below). o General Description of the Overall Center (not to exceed 7 pages) - Provide an overview of the entire proposed Center describing the central research theme and the goals to be achieved. Describe how the overall Center will achieve its major scientific objectives and how the Center organization will foster the development of collaborative research efforts. Explain the proposed contribution of each of the projects and cores in addressing the central research question, how the components relate to each other scientifically, and how they will benefit from the establishment of the center. The proposed interactions and collaboration across projects and cores should be described in detail. o Preliminary Findings (not to exceed 3 pages) Briefly present preliminary results directly relevant to the proposed research and evidence of experience and expertise in the areas of investigation proposed. If applicable, describe briefly the history of interactions of the investigators whose collaborative efforts will be developed in the proposed center. o Administrative Core(s) and other Operational Plans (not to exceed 8 pages) In this section the operation of the Administrative Core, including the working administrative and logistical arrangements, as well as the resource support necessary to implement the research, should be fully elaborated. Plans for the overall and day-to-day management of the proposed center should be included, including the roles and responsibilities of the Center Director, Principal Investigators of the projects and cores, and other personnel with administrative and management responsibilities, should be described. Methods and means for the establishment and maintenance of effective communication and integration of the center components, at both the scientific and managerial level, should also be detailed. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included (documentation of these arrangements should be included in the "Letters of Support" section). Also included in this section is the manner in which an external advisory board will advise the Center. Prospective board members should not be chosen or contacted prior to a funding decision and therefore should not be named. o Research Career Development (not to exceed 2 pages)- A description of the manner in which Center activities will provide opportunities for young investigators and how the proposed center relates to existing training programs of participating institutions should be given Information for Each Project or Core: For each project or core, the information should be arranged in the following order: o Cover Page - Information provided here should pertain specifically to the project or core and should include the title of the core and the name and title of the PI. o Description, Performance Sites, and Key Personnel (Form Page 2) - Information provided here should pertain specifically to the project or core. o Budget Information (Form Pages 4 and 5) - Detailed budget information should be provided for each project or core, with a narrative justification given for all budget items. o Resources - Resources should be described for each project or core. o Research Plan for Individual Projects (not to exceed 15 pages): The research plan for each project should describe the specific aims, background and significance and preliminary results. In this section, why the particular research question is best addressed by a multidisciplinary, integrative, collaborative research approach and how the proposed project is to be linked and integrated with other proposed Center projects and laboratories should be described in detail. The description of the research design and methods should not include extensive detail on individual experiments. Instead, the general strategies to be used in addressing the aims of the project should be described, with appropriate citations for those experimental procedures and techniques that have been previously published and validated. New methodologies should be more completely described, especially those adopted to take advantage of the collaborative aspects of the center. For all investigative approaches, feasibility, potential pitfalls, alternative approaches, if necessary, and relevance to the scientific goals of the center should be discussed. o Descriptions of Individual Cores (Not to exceed 8 pages): The ways in which the core will contribute to the overall goals of the Center should be described. The description of each core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide to the proposed Center as well as the projects that will be served by the core. o Human Subjects - For each individual project and core involving human subjects describe the plans for protection of subjects from research risks, as well as plans for the inclusion of women, minorities and children, as described in the PHS 398 application instructions (Rev. 5/2001). This information does not count against the page limitations o Vertebrate Animals - For each individual project and core involving vertebrate animals, provide a detailed description and justification for the use of animals as described in the PHS 398 application instructions (rev. 5/2001). This information does not count against the page limitations. Other Information: o Literature Cited - This section should include and compile literature cited throughout the application. o Letters of Support from Institutions and Collaborators - Also included in this section should be assurances from Institutional Animal Care and Use Committees and/or Institutional Review Boards (though the latter are not required at peer review). o Checklist applies to entire application 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/labels.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 DA-05-003 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 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 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 the NIDA. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Council on Drug Abuse. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Criteria for scientific/technical review of the proposed Center applications will include the following: o Intrinsic merit of the intellectual focus and research: the focus on clearly defined issues in drug abuse/addiction in clinical populations; the overall quality, scientific merit, and innovation of the research to be done; the likelihood that the work will lead to fundamental advances within the field, to new discoveries, and/or to new technological developments; evidence of a range of disciplinary levels of analyses and methodologies. o Integration across projects and collaboration across laboratories: the adequacy of the proposed Center to integrate across research projects including preclinical and clinical approaches so that activities in each project inform and advance the others; the adequacy of the proposed collaborative activities to provide synergy to the proposed Center. o Appropriateness of the Center approach: the need for and suitability of the collaborative research approach; how the collaborative approach will add significantly to what could be done through other modes of research support. o Research competence: the capability and scientific credentials of the Center Director, project directors and other participating scientists; evidence of multidisciplinary and interdisciplinary expertise. o Center Director credentials: ability of the Center Director to organize, administer, and direct the Center and, in addition, head at least one of the proposed projects; a Center Director will devote a minimum of 20 percent of his/her time to the Center. The Director must be the scientific leader of the Center and a recognized leader in the field. o Institutional commitment: the nature and level of resource commitments from the home institution and from other participant institutions. o Appropriateness of management plans and arrangements in the Administrative Core: the feasibility and adequacy of the organizational and administrative plans; the appropriateness of the budget and the mechanisms to evaluate the Center's progress; the use of an external advisory board. o Quality and appropriateness of research career development components of the Center's activities: the likely effectiveness of approaches to attract and involve young investigators and students who show potential for significant future contributions and independent research careers in the work of the Center. Criteria for scientific/technical review of the proposed projects and cores will include the following: 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? Is the study well integrated into the project as a whole? 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? For preclinical projects: How well does the project relate to the clinical issues and theme of the proposed center? For cores: How well is the need for this core justified? How well does the core contribute to the purpose of the Center? 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 investigator recognized as a leader in the field? 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? Is there evidence of interdisciplinary and multidisplinary collaboration? 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). 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 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: October 18, 2004 Application Receipt Date: November 17, 2004 Peer Review Date: February/March 2005 Council Review: May 2005 Earliest Anticipated Start Date: June 2005 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 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 RFA 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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