NATIONAL ALCOHOL SCREENING DAY ACADEMIC EMERGENCY MEDICINE DEPARTMENT COLLABORATION RELEASE DATE: August 1, 2003 RFA Number: RFA-AA-04-001 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov) Substance Abuse and Mental Health Services Administration (SAMHSA) (http://www.samhsa.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.273 APPLICATION RECEIPT DATE: October 14, 2003 LETTER OF INTENT RECEIPT DATE: September 15, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) 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 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 Alcohol Abuse and Alcoholism (NIAAA), in collaboration with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Centers for Disease Control and Prevention (CDC) invites applications for the "NATIONAL ALCOHOL SCREENING DAY ACADEMIC EMERGENCY MEDICINE DEPARTMENT COLLABORATION". The purpose of the RFA is to provide a funding mechanism for timely translational research regarding screening, brief intervention and follow-up in emergency medicine departments as part of National Alcohol Screening Day. RESEARCH OBJECTIVES Alcohol problems are common, preventable and treatable. Research has shown that fourteen million American adults suffer from alcohol abuse or alcoholism, and more than 100,000 people die from alcohol-related diseases and injuries each year. About a third of all adults in the US engage in some kind of risky drinking behavior, ranging from occasional to daily heavy drinking. For as long as emergency departments have existed, physicians and nurses have encountered and helped individuals with alcohol problems. However, in most emergency departments, screening is not routine, emergency room patients are often not identified, offered brief interventions or referred for alcohol use disorders. Nationwide, alcohol use accounts for a large portion of Emergency Department (ED) visits each year. There are approximately 108 million visits to the nearly 4000 Emergency Departments in the United States each year. As many as 30% of these ED patients present with alcohol related problems. Controlled clinical trials of screening, brief intervention and referral (SBIR) have shown positive outcomes in decreasing or eliminating alcohol use, reducing injury rates and other alcohol associated risks, and reducing costs to society. Hospital EDs offer a concentrated opportunity not available elsewhere for alcohol abuse and addiction screening, brief counseling and referral. The ED is an ideal setting in which to meet people who drink in harmful or hazardous patterns with a targeted intervention at the time of an adverse event, what is known as "a teachable moment." Yet nationwide, ED physicians miss many opportunities for alcohol screening and brief intervention. Factors that contribute to low levels of screening by ED physicians include lack of: 1) a knowledge- base in alcohol abuse and addiction which is the rationale for treatment; 2) exposure to standardized clinical screening instruments; 3) training in brief intervention methods; 4) familiarity with referral resources; and 5) feedback about reductions in problem drinking that result from well-placed, targeted interactions with patients. A report released by the Institute of Medicine in 1990 recommended greater use of screening and brief interventions for a broad spectrum of alcohol-related problems. The report focused on opportunities for intervening in alcohol-related problems and emergency medicine settings were identified as an excellent opportunity to intervene and place special emphasis on alcohol problems. In addition, the "Tenth Special Report to the U.S. Congress on Alcohol and Health" states that the efficacy of brief interventions in emergency care settings, such as hospital emergency departments and trauma centers is a relatively new area of research. A summary of research findings can be found in the report to Congress. The research literature also shows that screening for alcohol problems using a validated self-assessment tool, combined with intervention in the form of brief advice and/or referral for further evaluation constitutes a simple, affordable and effective method for preventing the development and progression of alcohol problems. National Alcohol Screening Day (NASD) is a program funded through a partnership between two agencies of the Department of Health and Human Services: the National Institute on Alcohol Abuse and Alcoholism and the Substance Abuse and Mental Health Services. NASD is a one-day event that offers the first broad-scale, science-based education, screening and intervention program for alcohol problems. The program uses screening and brief intervention to empower Americans to reassess and change their drinking patterns to safeguard their health, and/or to get evaluation and treatment to prevent the progression of an alcohol problem. The NASD in-person screening and intervention is designed to be conducted in a wide variety of settings, including EDs, using a validated screening tool. This initiative presents extraordinary opportunities to demonstrate that it is possible to conduct emergency department screenings for alcohol problems among individuals visiting emergency settings and increase the likelihood of intervening via brief interventions and referrals to appropriate alcohol treatment. Translational research conducted in conjunction with National Alcohol Screening Day is needed to further develop and test effective methods for screening, identifying, and referring emergency room patients to alcohol treatment services. Specific areas of focus include the following: - Develop methods to effectively implement a model of screening and brief intervention into the practice of emergency medicine. - Identify ED patients with alcohol use disorders via screening over a period of time. - Develop and test methods to facilitate referral of appropriate patients from emergency departments to alcohol treatment specialists - Compare drinking patterns and problems in injured and non-injured emergency room patients. - Adapt the National Alcohol Screening Day approach into routine practice in high-volume emergency department settings, and evaluate its effectiveness with patients and providers. - Determine if NASD conducted in Emergency Department settings improves an individual's probability of accepting referral to treatment and/or decreasing alcohol intake. - Test the feasibility of ED practitioner's participation in NASD. The topics listed above are meant only as illustrations of the types of research that an applicant can propose for individual research studies. The project organization will include a coordinating center for data collection and analysis, a group of screening and brief intervention trainers, and 10-12 co-investigators located in academic emergency departments who will collaborate on the proposed study. The coordinating center will oversee collection and analysis of data from the academic emergency centers. Individual academic emergency centers will be responsible for the recruitment of staff screening participants, meeting Institutional Review Board approval, data collection and analysis, tracking of patients for follow-up, and distribution of incentives to respondents. All applications are welcomed that are appropriate to the research objectives of this RFA. MECHANISM OF SUPPORT This RFA will use the NIH Exploratory/Developmental Grant (R21) award mechanism (https://grants.nih.gov/grants/guide/pa-files/PA-03-107.html), and the NIH Small Grant Program (R03) mechanism (https://grants.nih.gov/grants/guide/pa-files/PA-03-108.html). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is February 27, 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 format. (See https://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 format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The participating IC(s) intends to commit approximately $475,000 in FY 2004: $300,000 to fund 10 to 12 academic emergency department sites and $175,000 to fund one data coordinating site. Applicants for the ED sites will use the R03 mechanism and may request a project period of up to 1 year and a budget for direct costs of up to $25,000. Applicants for the data coordination site will use the R21 developmental grant mechanism and may request a budget of up to $275,000 direct costs for a period of two years. 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 the IC(s) provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS The purpose of the RFA is to provide a funding mechanism for timely translational research regarding screening, brief intervention and follow-up in emergency medicine departments as part of National Alcohol Screening Day. An Academic Emergency Center is defined as an Emergency Department affiliated with an accredited medical school that both trains residents in emergency medicine and conducts research on emergency medicine topics. You may submit (an) application(s) if your institution is an Academic Emergency Center and 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 institution o Faith-based or community-based organizations Foreign institutions are not eligible to apply. 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. Individuals must work in an academic emergency medicine department. SPECIAL REQUIREMENTS The individual investigators will be required to attend a post award meeting with other awardees to decide on the final common research design. The individual investigators and their screening staff will also attend training on screening and brief interventions at their local site by a group of expert trainers in this area. Individual investigators will also be required to share data with the entire collaborative group of investigators. 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 inquiries about scientific/research issues to: Peggy Murray, M.S.W. Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 302 6000 Executive Boulevard Bethesda, MD 20892-7003 Telephone: 301-443-2594 FAX: 301-480-2358 Email: pmurray@mail.nih.gov Anton C. Bizzell, MD, Medical Officer Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 302 6000 Executive Boulevard Bethesda, MD 20892-7003 Telephone: (301) 402-0514 FAX: (301) 480-2358 Email: abizzell@mail.nih.gov o Direct your inquiries about peer review issues to: Eugene G. Hayunga, Ph.D. Chief, Extramural Project Review Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 o Direct your questions about financial or grants management matters to: Judy Fox (formerly Simons) Chief, Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 (301) 443-4704 (telephone) (301) 443-3891 (fax) Email: jsimons@willco.niaaa.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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 https://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 https://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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 IC 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: Chief, Extramural Project Review Branch ATTN: AA-04-001 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Fax: 301-443-6077 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 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 must be sent to: Chief, Extramural Project Review Branch ATTN: AA-04-001 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 409, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by 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. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAAA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 the NIAAA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the National Institute on Alcohol Abuse and Alcoholism National Advisory Council. 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 discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Application Receipt Date: October 14, 2003 Letter of Intent Receipt Date: September 15, 2003 Peer Review Date: Nov-Dec 2003 Council Review: February 4, 2004 Earliest Anticipated Start Date: March 1, 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 MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://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 "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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://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. 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 https://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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