ENHANCING STATE CAPACITY TO FOSTER ADOPTION OF SCIENCE-BASED PRACTICES RELEASE DATE: April 27, 2004 RFA NUMBER: RFA-DA-05-002 EXPIRATION DATE: August 18, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) Substance Abuse and Mental Health Services Administration (http://www.samhsa.gov) COMPONENT OF PARTICIPATING ORGANIZATONS: National Institutes on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: July 17, 2004 APPLICATION RECEIPT DATE: August 17, 2004 CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.279 THIS 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 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 As managers of publicly supported substance abuse service delivery, State Alcohol and Drug Abuse Agencies (referred to herein as State Agencies ) are in a unique position to bridge the persistent and nationwide gap between science and services. This initiative is designed to strengthen State Agencies capacity to support and engage in research that will foster statewide adoption of meritorious science-based policies and practices. Specifically, the National Institute on Drug Abuse (NIDA), with support from the Substance Abuse and Mental Health Services Administration (SAMHSA), will provide grants to State Agencies to conduct preliminary or pilot research that helps to create, implement, expand, and/or sustain a process of continuous science-based practice improvement in publicly supported drug abuse prevention and treatment programs. This initial research should serve as a foundation for more in-depth services research to be conducted subsequently by the State Agency and its collaborators to enhance continuous practice improvement in the prevention and treatment of drug abuse and to foster implementation of proven, innovative therapeutic and management policies and practices. State Agencies (defined as agencies responsible for administering the Substance Abuse Prevention and Treatment Block Grant) are required to be the applicant organization under this Request for Applications (RFA), and a state officer is required to be the Principal Investigator. State Agencies without adequate research capacity are encouraged to partner with researchers from organizations that do, such as universities and research institutes. In either case, applications must propose research questions of relevance and value to the State Agency regarding its efforts to improve the delivery of publicly supported drug abuse prevention and/or treatment services. Furthermore, NIDA encourages applicants to consider conducting research on SAMHSA supported activities designed to foster adoption of science-based practices, including State Incentive Grants (SIGs), other service and infrastructure development grants, and Block Grants and/or to consider how the proposed research will contribute knowledge that can be directly applied through such SAMHSA funding opportunities. RESEARCH OBJECTIVES Background Since publication in 1998 of the Institute of Medicine report, entitled Bridging the Gap between Practice and Research, NIDA has focused attention and resources on improving the process of transporting science-based practice into community-based services. Initial research-to-practice efforts focused on identification, manualization, and dissemination of science-based interventions; adoption by community-based programs; and service provider fidelity to manual guidelines. Yet in spite of these efforts to expand the delivery of efficacious practices, many communities find it difficult to select, implement, and sustain services innovations that can increase access to services and the quality and economy of services for those suffering from or at risk for developing problem drug use. Increasingly, researchers have turned their attention to the change processes that occur in organizations seeking to improve their drug abuse prevention and treatment practices. Focus has shifted from viewing the science-to- services process as a one-time linear transfer of innovation from researchers to providers, to viewing it as a complex multidirectional process of continuous practice improvement that involves the interaction of multiple individual- and systems-level factors. The process often involves providers becoming aware of a problem and being exposed to information about science- based innovations that may address the problem. Providers may then search for a solution by assessing available innovations, often in comparison with usual practice; adopt one or more innovations that appear promising for some clients; and then implement, reconsider, adapt, and, sometimes, sustain use of the innovation over time. This newly emerging science-to-services model, although complex, acknowledges the often chaotic, multidirectional, and iterative nature of innovation and practice improvement. Too often, however, practice improvement occurs in the absence of systematic examination, so that identifying the optimal process for ongoing innovation remains an elusive goal. Recently, NIDA’s Blue Ribbon Task Force on Health Services Research issued its final report of recommendations for increasing the relevance and use of drug abuse research in practice and policy (http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf). In its report, the Task Force exhorts NIDA to stimulate and support innovative research to determine the components (e.g., administrative and service delivery structures, organizational and management functions, personnel qualifications) necessary for adopting, adapting, delivering, and maintaining effective research-supported policies, programs, and practices. Such research would include the development and analysis of the research infrastructures states require in order to adequately and continuously examine and improve performance in their systems for delivering drug abuse prevention and treatment services. Given adequate infrastructure and capacity, State Agencies are uniquely positioned to bring synergy, coherence, accountability, and long-term success to practice improvement in drug abuse prevention and treatment services. Situated between federal research efforts to develop scientifically sound, effective services and the local communities where such services are delivered, State Agencies can examine the systems-level structures, policies, strategies, methods, and tools that facilitate practice improvement. Moreover, because they set policy and allocate public health resources, State Agencies can influence the nature and pace of innovation adoption so that science-based services delivered by a range of providers can and do reach large numbers of individuals in diverse community settings and produce replicable and sustainable effects at reasonable cost. However, State Agencies often lack the resources to conduct research needed to support their efforts to initiate, develop, implement, and sustain a continuous science-based practice improvement process. For example, state databases often lack the capacity to capture and/or integrate information about the nature and extent of community needs and resources and those factors that contribute to local adoption, adaptation, implementation, and sustained use of evidence-based innovations and practices. States may lack resources to obtain accurate information for estimating the cost to implement service innovations. Furthermore, states vary in their levels of readiness to institutionalize a practice improvement process that can refine data, clarify areas for improvement, and monitor the success of innovation efforts. Accordingly, this grant program is appropriate for states at any level of capacity development, and NIDA encourages State Agencies to conduct research geared to their specific level and needs on the path of developing, implementing, modifying, expanding, or sustaining a process of continuous practice improvement in their publicly supported programs. States will not be at a disadvantage either for being at an early stage of development or at a more advanced stage. Research Areas of Interest This RFA encourages State Agencies to conduct research which increases their capacity to ensure that science-based drug abuse prevention and treatment services can and do reach the large numbers of individuals who need them, are widely adopted in diverse community settings, are effectively implemented by a range of educators and health care and social services providers with varying levels of training and expertise, and produce replicable and sustainable effects at reasonable cost. In designing research, State Agencies should fully consider the chronic relapsing nature of drug abuse and the additional service delivery issues of developmental appropriateness for clients of different ages; gender sensitivity; cultural relevance; health disparities; comorbid mental, social, and medical conditions; and links between drug abuse and sexually transmitted and other infectious diseases. Appropriate and fundable research under this initiative includes preliminary or pilot studies on (1) state readiness and capacity for practice improvement; (2) systems-level factors that facilitate or impede the development, implementation, modification, expansion, or maintenance of continuous statewide process of practice improvement; and (3) cost or cost- effectiveness analysis of continuous statewide process of practice improvement. State Readiness and Capacity for Practice Improvement. There is substantial variation in states current readiness and capacity for practice improvement. Some states currently promote and disseminate science-based services with little information about the factors that contribute to local adoption, implementation, and sustained use. Scant knowledge about the most effective role of state leadership in fostering adoption of science-based practices precludes states from taking a systematic science-based approach to continuous practice improvement. NIDA encourages State Agencies to assess state readiness and capacity to develop, implement, modify, expand, or sustain a process of continuous practice improvement in publicly supported drug abuse prevention and/or treatment programs. The following research areas are illustrative of those that might be proposed: o Evaluate the capacity of service providers statewide to deliver coordinated/integrated services, to target services to specified subpopulations commensurate with treatment needs given their particular drug use and treatment careers, and/or to deliver services that support continuous recovery management. o Clarify differing provider organization needs for improvement in the quality and/or quantity of services as a function of community, setting, subpopulation, treatment approach, and other characteristics. o Quantify the training, expertise, and performance of substance abuse service providers statewide to identify ways to enhance career development policies and practices that ensure continuity of care, professionalism, and retention in the various substance abuse treatment provider professions. o Develop and assess the effectiveness of methods to enhance state capacity to synthesize (or support the synthesis of) available information on drug abuse prevention and treatment service needs to support priority setting and decision-making. o Identify monitoring tools and systems for assessing local provider performance and adherence to treatment guidelines; determine the degree of public support for administering incentives and sanctions based on performance. o Examine the effectiveness of research dissemination strategies currently in use to help service providers, community service programs, and state administrators keep abreast of current research, particularly regarding how well they support making timely, informed decisions about adopting, adapting, implementing, and sustaining use of science-based practices. Systems-level Factors that Facilitate/Impede Continuous Practice Improvement. Structural, organizational, management, staffing, and financial arrangements affect the accessibility, quality, cost, outcomes, and delivery of drug abuse services. For example, inconsistent management and high rates of staff turnover can have a negative impact on the continuity of practice improvement efforts. Similarly, innovations in financing policy and practice are a key component of the drive to improve services, given that practice is largely determined by complex reimbursement schemes involving state, local, and third party payers. Moreover, all of these systems include interrelated multi- level factors, suggesting that innovative changes may have direct as well as indirect effects on services. The following research and development areas are illustrative of those that might be proposed: o Develop and evaluate integrated systems for managing state and local data on substance abuse service delivery that can help validly determine how policies and practices affect the quality, outcomes, and costs of services. o Institute and assess the effectiveness of training, financing, and/or policy initiatives designed to establish and support data-based continuous practice improvement as a state-wide business practice. o Develop and assess systems to monitor organizational and management factors within provider agencies that can (a) identify programs, policies, and/or practices that optimize service efficiency and economy, quality, and long-term effectiveness; (b) guide the identification of innovative approaches to overcoming barriers to optimal service delivery; and (c) enable ongoing assessment of innovations, adoption of innovation, and implementation, evaluation, and sustained use of innovation. o Establish and assess systems and methods designed to link indicators of quality care to changes in the structure, organization, management, staffing, and financing of service systems. o Monitor and assess the effects of inter-organizational collaboration (e.g., high-involvement teams, high-performance teams, corrective action teams, service and quality improvement teams, project teams, task forces, steering councils, process management and improvement teams, problem- solving teams, cross-functional teams, departmental teams, regional/branch teams, self-directed or semi-autonomous teams, matrix teams) on the quality and outcomes of services in publicly supported drug treatment programs. o Establish systems and methods for monitoring effects of the state’s financing system(s) to (a) quantify financing effects on access to treatment for various subpopulations; and (b) assess how financing may facilitate or impede the delivery of integrated care services for managing the chronic relapsing condition of drug abuse. Costs and Cost-Effectiveness of Practice Improvement. A priority in understanding the public health relevance of drug abuse is cost-both service costs and societal costs. Economic and accounting costs must be applied throughout management cost systems. Accordingly, State Agencies will need to consider the costs and cost-effectiveness of developing, implementing, modifying, expanding, or sustaining a process of continuous practice improvement in publicly supported substance abuse programs. The following research areas are illustrative of those that might be proposed: o Identify the relative costs and distribution of drug abuse prevention and treatment services across the state; establish a system for tracking changes over time. o Identify cost efficient strategies to continuously upgrade the quality and professional standards of practicing providers and to train and attract new providers to the field. o Examine strategies for establishing and implementing a results-based reimbursement system statewide (e.g., pay-for-performance contracts with incentives to meet desired outcomes) for promoting optimal access to care, retention in care, and outcomes of care. o Examine the effects of pay-for-performance contracts on other treatment elements such as training, credentialing, and use of science-based practices, and efficient information systems. MECHANISM OF SUPPORT This RFA will use the R21 exploratory/developmental research award mechanism (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) As an applicant State Agencies will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is April 2005. 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. 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, with support from SAMHSA, intends to commit approximately $1.35 million in FY 2005 to fund 10 to 12 grants in response to this RFA. NIDA may give funding priority within this RFA to applications to examine SAMHSA supported activities aimed at fostering adoption of science-based practices or to applications designed to contribute knowledge that can be directly applied through such SAMHSA funding opportunities. An applicant may request for the R21 project period up to 2 years and up to $100,000 in direct costs per year (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIDA 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 State Agencies (defined as agencies responsible for administering the Substance Abuse Prevention and Treatment Block Grant) are required to be the applicant organization under this Request for Applications (RFA). Each state may submit no more than one application. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any state officer with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her state agency to develop an application for support. 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: Beverly Pringle, Ph.D. Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4222, MSC 9565 Bethesda, Maryland 20892-9565 Telephone: (301) 443-4060 FAX: (301) 443-6815 Email: bpringle@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: DA 05-002 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 five (5) copies of the appendix material must be sent to: DA 05-002 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. 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. (1) SIGNIFICANCE: Does this study address an important problem of relevance and value to the State Agency regarding its efforts to improve the delivery of publicly supported drug abuse prevention and/or treatment services? If the aims of the application are achieved, will the State’s capacity to continuously improve its publicly supported drug abuse service system be advanced? Will these studies advance the field? Does the study address an important problem consistent with the goals of this RFA? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Is the approach appropriate to the issues facing the particular state? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there adequate attention to systems-level and individual-level variables? (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 to understand opportunities for, and barriers to, adoption of science-based policies and practices? Does the project involve research on SAMHSA supported activities designed to foster adoption of science-based practices, including State Incentive Grants (SIGs), other service and infrastructure development grants, and Block Grants? (4) INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work, or does the investigator propose a reasonable partnership with others who are 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 environment in which the work will be done contribute to the probability of success? Do the proposed studies take advantage of unique features of the State environment or employ useful collaborative arrangements? Is there evidence of institutional support? (6) APPLICABILITY: Will the proposed work improve or advance current clinical practices and/or inform State health policy? How well will the work address the identification and removal of barriers to improvements in clinical practice and/or health policy? How well are the issues of relapse, comorbidity, developmental stage, gender, culture/ethnicity, and other factors taken into account? How well are organizational, management, and cost factors taken into account? Does the proposed research contribute knowledge that can be directly applied through SAMHSA funding opportunities, including State Incentive Grants (SIGs), other service and infrastructure development grants, and Block Grants? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: July 17, 2004 Application Receipt Date: August 17, 2004 Peer Review Date: November/December 2004 Council Review: February 2005 Earliest Anticipated Start Date: April 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: 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 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. 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). 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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