SCREENING AND INTERVENTION FOR YOUTH IN PRIMARY CARE SETTINGS RELEASE DATE: December 16, 2003 RFA Number: RFA-DA-04-006 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 (SAMHSA) (http://www.samhsa.gov) Agency for Healthcare Research and Quality (AHRQ) (http://www.ahcpr.gov/) Health Resources and Services Administration (HRSA) (http://www.hrsa.gov) COMPONENT OF PARTICIPATING ORGANIZATIONS: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 LETTER OF INTENT RECEIPT DATE: January 19, 2004 APPLICATION RECEIPT DATE: February 19, 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 National Institute on Drug Abuse (NIDA) invites grant applications for the conduct of health services research to expand the role of primary care in the prevention and treatment of problem drug use, abuse, and related health problems among youth in the pre-dependency phase of drug abuse, with specific emphasis on marijuana use (alone or in combination with nicotine, alcohol, and other drugs of abuse). This request for applications (RFA) seeks to build on recent efforts to address problematic alcohol and nicotine use in primary care settings in order to similarly expand the availability and delivery of efficacious drug abuse interventions. Thus, applications are encouraged that propose to: (a) develop, modify, or test efficacious drug use/abuse screens or assessments to be embedded into more comprehensive behavioral health screening/assessment instruments for use with youth in primary care settings; (b) develop, modify, or test brief behavioral prevention and treatment interventions for use with youth in primary care settings; and (c) test methods for integrating drug abuse screening, assessment, and brief prevention and treatment interventions into primary care. For the purposes of this RFA, the term youth is intended to include all individuals within the age range of 12 to 24 years. The term primary care setting is defined broadly to include all outpatient clinics (public and/or private) and private practices that offer office-based general medical care. These clinics and practices are staffed by allopathic or osteopathic physicians often with other health care providers such as physician assistants, nurse practitioners, nurses, social workers, or behavioral health practitioners typically within the following categories: pediatrics, adolescent medicine, internal medicine, general medicine, family practice, obstetrics and gynecology. Not included in this RFA are the following care settings: emergency rooms, acute care facilities, chronic care facilities, and addiction treatment facilities. RESEARCH OBJECTIVES Background Primary care and substance abuse prevention and treatment traditionally have been delivered through separate systems and in distinct settings. New ways of coordinating primary care and drug abuse prevention and treatment services hold promise for the implementation of more holistic, integrated, and cost-effective approaches in the provision of health care for individuals with problem drug use, abuse, and related health problems. Indeed, primary care settings are potentially one of the key points of access to screening, assessment, prevention, early intervention, referral, and treatment for youth with problem drug use and related health problems. Many young people who do not meet the diagnostic criteria for drug dependence use drugs in quantities and in ways that are unsafe for them putting them at risk for interruptions in normative maturational processes; health problems, including HIV and other sexually-transmitted diseases; interpersonal complications with family and friends; difficulties at school or at work; and physical injuries such as motor vehicle accidents. Marijuana is one of the three most commonly used drugs among youth. Nearly 50 percent of 12th graders report having tried marijuana at least once, and one-quarter of 12th graders may be current users. Marijuana use affects the brain and can impair short-term memory, perception, judgment and motor skills, and can lead to higher accident rates, mood fluctuation, and tolerance and cross-tolerance to other drugs. Marijuana use can contribute to social alienation and isolation, school problems, alliance with deviant peers, lack of bonding to prosocial institutions, behavioral problems and delinquency, and family conflict. Marijuana can also adversely affect the fetuses of pregnant users. Many youth who use marijuana and/or other illicit drugs also misuse alcohol and nicotine products. Often, these individuals do not seek help from drug abuse treatment specialists, but they do visit a primary care provider or come into regular contact with other medical caregivers. In fact, about 70 percent of adolescents in the U.S. see a physician at least once a year. Despite this seemingly obvious connection, drug abuse prevention, screening, referral, brief behavioral treatment intervention, and aftercare treatment (e.g., monitoring relapse potential, medication management of methadone or buprenorphine) are rarely provided in primary care settings. Primary care providers often fail to associate behavioral problems, psychosocial problems, dysfunctional eating, academic underachievement, sexually transmitted diseases, and other presenting problems with drug use and abuse in their adolescent and young adult clients. Similarly, physicians routinely faced with the many medical consequences of drug abuse such as, HIV/AIDS and other sexually transmitted diseases, hepatitis and other infectious diseases, heart attacks, and pulmonary problems often do not consider the contribution of drug use and abuse to the medical symptoms and chronic diseases they see in clinical practice. Primary care providers have begun to address the clinical symptoms and medical consequences of alcohol and tobacco abuse, but they seldom screen for, or even acknowledge, the problematic use and abuse of illicit drugs (e.g., marijuana, heroin, cocaine, methamphetamine, hallucinogens, club drugs, inhalants), let alone address problem drug use as an integral part of patient care. Furthermore, little research has examined effective ways to educate and encourage practicing primary care providers to address problem drug use, abuse, and related health conditions in their standard care routines. Research has not yet systematically assessed the effectiveness and impact on practice behaviors of the limited post-graduate training related to drug abuse and addiction that is available to primary care providers and health care teams currently in practice. Also lacking is research on practical incentives for primary care providers to focus on problem drug use as a treatment priority. It is unclear the extent to which the current lack of attention to problem drug use in primary care settings is related to factors such as the stigmatized nature of drug use and its associated problems; lack of efficacious tools for screening, assessing, preventing, or treating problem drug use in primary care settings; lack of health care provider training in substance use disorders and associated medical and mental health consequences; and/or organizational, management, or financing issues, including limited reimbursement for care. Models of integrated care have begun to emerge, and those that currently exist hold promise for informing applications responding to this solicitation and for serving as research sites where study hypotheses can be tested in real-world settings. For example, the Agency for Healthcare Research and Quality (AHRQ) supports a set of Primary Care Practice-Based Research Networks, a group of U.S. practices devoted to providing primary care for patients and investigating questions related to community-based practice. In addition, the Health Resources and Services Administration (HRSA), in partnership with other federal agencies, implements the Health Disparities Collaboratives in health centers across the U.S., which involves a four-pronged strategy to improve health care and eliminate health disparities by developing leadership; implementing a model of change; building infrastructure to support and sustain improvement; and developing community partnerships. Internationally, Australia, Canada, and Norway are among a number of countries that have been experimenting with comprehensive integrative and/or shared care models. In these models, much of the medication monitoring, early intervention, and care management provided to patients with problem drug use and abuse occur within primary care offices. To date, little is known about whether modification of these international models would work in the United States. NIDA is interested in building on the advances in shared care found in other countries to integrate drug abuse services into primary care in the U.S. Research Areas of Interest This RFA is designed to solicit grant applications for the conduct of behavioral health services, prevention, and treatment development research to expand the role of primary care in drug abuse intervention for youth (ages 12-24 years) in the pre-dependency phase of drug abuse, with specific emphasis on marijuana use (alone or in combination with nicotine, alcohol, and other drugs of abuse). NIDA encourages applicants to include developmentally appropriate, gender- sensitive, and culturally-relevant approaches in designing their research. Furthermore, NIDA encourages applicants to conduct research on activities supported under SAMHSA’s initiative on Screening, Brief Intervention, Referral and Treatment (RFA No. TI 03-009), SAMHSA’s initiative on Targeted Capacity Expansion Program for Substance Abuse Treatment and HIV/AIDS Services (RFA No. TI 01-007, TI 02-009, TI 03-008), AHRQ’s Primary Care Practice-Based Research Networks, and HRSA’s Health Disparities Collaboratives. Screening and assessment instruments: This announcement encourages research to develop screening and assessment instruments for problem drug use and related health problems in youth, ages 12-24 years, which can be self-administered or administered by a variety of health care providers. There are several screening and assessment instruments geared toward adolescent substance abuse, but they tend to be stand-alone instruments and lacking in evidence of strong psychometric properties. NIDA is interested only in screens and assessments that are or can be embedded into other more comprehensive behavioral health screening/assessment instruments, in order to maximize efficiency and likelihood of use in primary care settings. Moreover, studies are needed to clarify instrument psychometrics, with particular attention given to validity. Instruments designed to screen for potential drug and related health problems should perform differently than instruments designed to provide a thorough assessment of drug problems, such as diagnostic instruments. Two key dimensions of instrument performance are sensitivity and specificity. Studies of instruments should describe optimal levels of sensitivity and specificity for the proposed purpose of the instrument within primary care settings. Research on the utility of screening instruments in improving clinical outcomes for adult populations, such as screening for depressive disorders in primary care settings, has yielded disappointing results. Some studies suggest that screening instruments perform worse than chance at identifying patients who are in need of psychiatric services, and that even patients who are correctly identified do not have better outcomes than those who go unidentified. Studies of screening for adolescent drug problems in primary care might benefit from building on the lessons learned from these earlier adult studies. The following research areas are illustrative of those that might be proposed: o Develop and test new, or refine existing, screening/assessment instruments to be embedded into comprehensive behavioral health assessments for use in primary care settings to screen for and assess problem drug use, with emphasis on tools that are simple, brief, easy-to-use (e.g., flash cards, online tools, manualized protocols), have optimum levels of sensitivity and specificity, and can be administered by a variety of health care providers. o Develop and test new, or refine existing, screens/assessments for use in primary care settings to screen for or assess health problems associated with problem drug use in youth, with an emphasis on sexually transmitted (HIV/AIDS, chlamydia, hepatitis B) and other infectious diseases. o Evaluate the effects of drug abuse screening tools on primary care providers ability to recognize patient problems and intervene accordingly. o Develop and evaluate screening or assessment instruments that are culturally or gender sensitive and relevant for diverse racial and ethnic minority populations as well as for females and males. o Develop and test technological (e.g., hand-held technologies, touch-screen software, expert systems models ) innovations to facilitate the implementation and adoption of screening and assessment for problem drug use in youth. o Develop and test data management systems for gathering, maintaining, and sharing patient information to facilitate efficient implementation of problem drug use screening and assessment in primary care settings, with attention to patient confidentiality and HIPAA regulations. Brief prevention and treatment interventions: This announcement encourages research to develop brief behavioral interventions for preventing and treating problem drug use and related health problems in youth. Given the role of primary care in the overall health of youth, effective behavioral or combined behavioral and pharmacological interventions delivered in this setting have potential for initiating drug abuse treatment. Existing brief interventions such as motivational interviewing, motivational enhancement therapy, and psychoeducational interventions have potential for use in primary care settings, but their effectiveness for youth in primary care settings is unclear. Moreover, primary care settings present several challenges to delivering behavioral or combined interventions targeting problem drug use. These challenges including limited time with patients, competing demands during office visits, staff competence or confidence in delivering interventions require innovative thinking about treatment interventions within primary care settings. NIDA encourages studies that develop new interventions, or modify interventions originally designed for different populations or different settings, to be applied effectively in primary care settings. Investigators developing brief behavioral treatment interventions in response to this RFA are also encouraged to review NIDA’s Behavioral Therapy Development Program Announcement (http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html). The following research areas are illustrative of those that might be proposed: o Develop and test brief universal, selective, and indicated prevention interventions for use in primary care settings to prevent initiation or escalation of problem drug use in youth. o Develop and test new brief behavioral prevention and treatment interventions, or modify and test existing efficacious interventions for use with youth seen in primary care settings, especially for not-yet-chronic drug users including minimal interventions such as brief check-ups, urine drug screening, etc. Modification and testing of existing efficacious interventions for use with this population may include changes in duration, content, and mode of presentation (from primary care provider presentation to book or computer-based expert systems presentation) for application in or concurrent with primary care. o Develop and evaluate behavioral interventions to increase adherence to medication regimens for treating drug abuse, associated health consequences (e.g., HIV), or comorbid mental health problems. o Develop and evaluate strategies for optimizing prophylactic regimens in at- risk youth, such as hepatitis B vaccination. o Develop and evaluate brief drug abuse prevention or treatment interventions and sexual risk reduction interventions that are gender and culturally sensitive and relevant for diverse racial and ethnic minority populations as well as for males and females. o Develop and test caregiver-based interventions, including clinician strategies for educating parents and other adult caregivers on how to intervene with their adolescent and other children in order to prevent initiation or escalation of problem drug use. o Develop and test new behavioral interventions to prevent and reduce risk behaviors associated with contracting or transmitting HIV and other infectious diseases among youth who are using all types of drugs. Methods for integrating drug abuse services into primary care practices: This announcement encourages research to test methods for integrating drug abuse screening, assessment, and brief prevention and treatment interventions for youth into primary care systems. Primary care providers are increasingly called upon to address a wider range of health problems at the same time that the structure of managed health care and other business practices have shortened patient contact time and limited reimbursement rates. Consequently, the viable introduction of new drug abuse screening, assessment, and brief interventions for youth into primary care settings will require well-planned integration methods that acknowledge and accommodate the practice- and systems- level constraints of primary care, including financing, organization and management practices, staffing, and staff training and supervision. Such accommodation may involve embedding new clinical tools for addressing problem drug abuse within existing behavioral health assessments and interventions, modifying existing organizational and management procedures, and augmenting existing staff training and monitoring practices. The following research areas are illustrative of those that might be proposed: o Evaluate organizational and management processes for adopting and implementing brief behavioral prevention interventions or treatments (alone or in combination with pharmacotherapies) conducted within primary care networks or similar organizational structures. o Identify types of organizational contexts within primary care settings that facilitate or hinder the prevention and/or treatment of problem drug use, abuse, and related health problems. o Develop and test models for introducing/transporting efficacious screening and brief behavioral prevention and treatment interventions (alone or in combination with pharmacotherapies) including those developed under SAMHSA’s initiative on Screening, Brief Intervention, Referral and Treatment (RFA No. TI03-009) into existing primary care settings. o Develop and test tools and strategies for improving referral to more intensive treatments, when indicated, in order to facilitate patient adherence and increase cost efficiencies. o Develop and test case management strategies for managing referrals and monitoring client participation in more intensive treatments. o Determine effectiveness of currently existing shared care models, as well as internationally developed models that have experimented with comprehensive integrated care (i.e., medical monitoring, early intervention, and care management), modified as needed for the U.S. health care delivery system. o Develop and test staff training, monitoring, and supervision practices that facilitate effective implementation of drug abuse services within primary care settings. o Identify staffing patterns for effective implementation of integrated service models. MECHANISMS OF SUPPORT This RFA will use the NIH research project (R01), the small grant (R03) and the exploratory/development (R21) award mechanisms. 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 $3 million in FY 2004 to fund 6 to 8 new and/or competitive continuation grants in response to this RFA. NIDA will commit $2,500,000 and SAMHSA will provide $500,000. AHRQ is not providing any funds directly but has earmarked $100,000 to support at least one grant. HRSA is interested in supporting research under this RFA pending (a) availability of funds, and (b) receipt of high quality applications relevant to HRSA's mission. Furthermore, NIDA may give funding priority within this RFA to applications to conduct research on activities supported under (a) SAMHSA’s initiative on Screening, Brief Intervention, Referral and Treatment (RFA No. TI03-009); (b) Primary Care Practice-Based Research Networks supported by AHRQ; or (c) Health Disparities Collaborative supported by HRSA. 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 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. At this time, it is not known if this RFA will be reissued. The Agency for Healthcare Research and Quality (AHRQ) has a particular interest in funding under this announcement projects that will be conducted by primary care practice-based research networks (PBRNs). A PBRN is defined as a group of ambulatory practices devoted principally to the primary care of patients, affiliated with each other (and often with an academic or professional organization) in order to investigate questions related to community-based practice and to improve the quality of primary care (http://www.ahcpr.gov/research/primarix.htm). ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations A variety of community-based primary care organizations and networks are eligible to participate in research supported by this announcement. In addition, consolidated health services organizations such as those supported by the Health Resources and Services Administration (HRSA) may be particularly well suited to serving as research sites for investigators studying real-world primary care settings. In addition, health care organizations such as HMOs, community health centers, large clinics or networks of community-based practices, are encouraged to participate in this research initiative (http://bphc.hrsa.gov/). 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: Jerry Flanzer, 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: jflanzer@mail.nih.gov Dorynne Czechowicz, M.D. Division of Treatment Research and Development National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 4231, MSC 9563 Bethesda, Maryland 20892-9563 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: dczechow@nida.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 242, 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-04-006 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: DA-04-006 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 unfounded 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 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 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: Please assess the extent to which the study aims are consistent with the goals of the RFA. 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? 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? 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? Innovation is particularly encouraged in conducting research on activities supported under SAMHSA’s SBIRT initiative, AHRQ’s primary care practice-based research networks, and HRSA’s Health Disparities Collaboratives. (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? (6) APPLICABILITY: How does the proposed work improve or advance current clinical practices and/or inform health policy? How does the work address the identification and removal of barriers to improvements in clinical practice and/or health policy? 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: January 19, 2004 Application Receipt Date: February 19, 2004 Peer Review Date: May 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). 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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