RESEARCH PARTNERSHIP AWARDS FOR RAPID RESPONSE TO COLLEGE DRINKING PROBLEMS RELEASE DATE: December 18, 2002 RFA: AA-03-008 National Institute on Alcohol Abuse and Alcoholism (NIAAA) ( LETTER OF INTENT RECEIPT DATE: March 14, 2003 APPLICATION RECEIPT DATE: April 14, 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 purpose of this RFA is to provide a mechanism for developing and conducting research which requires rapid funding in order to address unexpected and time-sensitive research opportunities to address drinking on college campuses. An over-arching goal is to establish ongoing partnerships between college administrators and established alcohol research scientists for the purpose of exchanging information, and designing interventions to prevent or reduce alcohol-related problems among college students. Applications submitted in response to this RFA should propose research plans for innovative and effective interventions, and should demonstrate the qualifications of the research personnel and adequacy of facilities and resources to achieve the stated goals of the project. Study designs should address a hypothetical situation of alcohol abuse and/or associated problems among college students, and propose practical solutions and interventions that can be implemented immediately. Study designs may propose interventions focused at the individual, campus, or community levels. Grantees funded under this RFA U01 program will be coupled with one (or possibly more) grantees funded under the companion U18 RAPID response program announcement to form a performance unit for the purposes of implementing one or more of the final protocols. They may receive suggestions for the strengthening of approaches under study. Together they will develop final study designs. Award of the cooperative agreement does not imply that any particular proposed protocol will be implemented. Since the final studies will be designed by the Steering Committees, each of which is composed of a research awardee, a partnered service awardee, and the NIAAA Staff Collaborator, the final protocols may not reflect any single protocol submitted in response to this RFA. The protocols will be implemented as needed, at time(s) and site(s) to be determined by the Steering Committee. Not all awards will commence at the same time. RESEARCH OBJECTIVES Alcohol use on college campuses is not a new problem; it has been documented in the United States for at least 50 years. Available research indicates that approximately 80 percent of college students drink and that half of college student drinkers engage in heavy episodic drinking. Excessive drinking among college students is associated with a variety of negative consequences including fatal and nonfatal injuries; alcohol poisoning; blackouts; academic failure; violence, including rape and assault; unintended pregnancy; sexually transmitted diseases, including HIV/AIDS; property damage; and vocational and criminal consequences that could jeopardize future job prospects. The consequences of excessive and underage drinking affect virtually all college campuses, college communication, and college students, whether they choose to drink or not. It is estimated that 1,400 college students die each year from alcohol-related unintentional injuries, including motor vehicle crashes. The estimates include a half million students injured and more than 600,000 alcohol related assaults, Other problems include sexual abuse, unsafe sex, academic problems, suicide attempts, vandalism, property damage, drunk driving and police involvement. These potential fatal and devastating problems do not address the needs of non-alcohol consuming students who must suffer the consequences (interrupted sleep, assaults, riding in automobiles with intoxicated drivers, etc.) related to the behavior of their peers. Over the past 10 to 15 years, colleges and universities have addressed the problem of underage and "binge" drinking in a variety of ways. Preventive interventions have been implemented in response to: policy directives from the U.S. Department of Education, administrator and faculty concerns about alcohol problems on their campuses, and community reactions to nationally publicized alcohol-related deaths among college students. However, rigorous studies of the effectiveness of these naturally occurring policies and initiatives have been rare, as have studies of investigator-initiated interventions that focus on changing campus environments as a means of preventing alcohol problems. With rare exceptions, scientifically-grounded research on strategies to prevent college-based alcohol abuse has focused on so-called "individual" interventions, such as motivational counseling for high- risk students and groups, or approaches that challenge positive expectancies (beliefs) about the benefits of alcohol use. These types of interventions seek to change individuals' knowledge, attitudes, intentions, and skills regarding alcohol use, without attempting to change factors in the environment which facilitate and promote alcohol misuse. Survey data indicate that environmental factors play a major role in promoting and supporting excessive drinking among college students. Campuses differ significantly in the amount of "binge" drinking that takes place, suggesting that more than selective factors are at work. For example, lower levels of "binge" drinking are found among students who attend "commuter" colleges where most students live off-campus. Students who live at home drink less than those who live in apartments or dormitories; and students who live alone drink less than those with roommates. This type of information can help inform the choice of target groups for interventions and aspects of their design. Environmental interventions (particularly laws and policies that target youth) have demonstrated effectiveness in reducing drinking and related problems in the underage population at large. Therefore, it has been argued that these types of interventions (constraining the availability of alcohol, enhancing enforcement of existing policies) have the potential to reduce alcohol problems among college students. For example, it has been found that the restrictiveness of State drunk- driving laws that target youth and young adults appears to be inversely related to measures of college-student drinking, especially for males. It has also been found that the number of alcohol outlets within one mile of campus and the presence of a bar on campus correlated positively with levels of drinking and "binge" drinking on campus. The interventions being tested may involve changes in campus or community policies and practices to directly address factors contributing to abusive drinking, or they may involve changes in campus systems or structures to promote non-drinking norms. Multi-component interventions may be tested that combine environmental strategies or link them with interventions that focus on individuals. For example, the institution of new policies or changes in policy enforcement might be combined with interventions that target high-risk students. The selection of interventions for study should be justified in terms of their potential impact on specific alcohol problems, adverse drinking practices, high-risk populations, and/or permissive social norms. In addition, the feasibility of implementing the intervention should be discussed, as well as its generalizability, even where the choice of interventions is beyond the investigator's control (i.e., natural experiments). In recognition of the need to address the serious consequences of alcohol abuse among college students, the National Advisory Council to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) established the Task Force on College Drinking in 1998. The Task Force was composed of college Presidents and administrators as well as selected experts in alcohol research. In April, 2002 a report entitled, A Call to Action: Changing the Culture of Drinking at U.S. Colleges, was released and is available on the NIAAA webpage: The report supported the use of comprehensive integrated programs with multiple complementary components that target (1) individuals, including at-risk or problem drinkers; (2) the student population as a whole; and (3) the college and the surrounding community. This announcement is intended to provide an opportunity for investigators to identify an approach that might be appropriate given this unique environment and circumstances and to design and perform one or more studies of intervention or prevention with regard to college drinking. It is understood that each college environment and student community is different. Differences in ethnic mix, rural vs. urban, private vs. public, etc. can result in different approaches to appropriate interventions. Although this announcement is designed to support research on unanticipated opportunities, the following are some of the areas in which research plans might be developed. These are in no way meant to be exhaustive or limiting, but mere examples of topics that might be studied. Such topics might include: - The implementation and evaluation of a program of alcohol screening and brief interventions - Changes in campus or community policies and practices to directly address factors contributing to abusive drinking, or they may involve changes in campus systems or structures to promote non-drinking norms. - Policies and practices of campus health-care systems and providers with regard to alcohol abuse; - Policies directed toward high risk groups, such as athletes or students in the Greek system; - Emergency action plans by campus administrators in response to adverse alcohol-related injuries and deaths; - The academic environment, including class and examination schedules and academic standards; - Campus policies, such as rules and administrative proclamations regarding alcohol use on campus, in dormitories, and at campus events; - Disciplinary procedures, such as parental notification, mandatory counseling, and other sanctions for rule violations; - Planning and conducting marketing campaigns aimed at correcting student misperceptions about alcohol use; - The formation of a campus and community coalition consisting of community leaders and law enforcement to directly address the problem of student drinking. Outline of Study Design To address the research questions of this program, the application should include, at a minimum, the following major components: o The study design should address a hypothetical situation of alcohol abuse and/or associated problems among college students. o The study design should propose practical solutions and interventions that can be implemented immediately. o The study design may propose interventions focused on the individual, campus, or community levels. o Duration of the intervention should be at least 6 months and minimum follow-up should be at least 1 year. o Specific hypotheses for preliminary study, design, and assessment are left to the discretion and creativity of the applicants. Elaboration of the Model Study Design Although the outline of a model strategy is given above, applicants should develop and fully elaborate the key elements of the study design. Final Protocol Development After awards are made, the Steering Committees will collaboratively develop potential study protocols that may differ from the model outlined here, provided the research questions of this RFA are addressed and the Institute agrees that the resultant design is still within the general scope and will serve the purposes described in this RFA. Each Steering Committee will consist of a research U01 awardee, a partnered service U18 awardee, and the NIAAA Staff Collaborator. Applicants should request funds to attend two meetings in the Washington, D.C. area per year. Consultant Services Applications should include provisions for consultancy to college presidents and other administrators in the design of specific prevention activities to be studied. Consultants are individuals who will be available in emergency situations to provide assistance in planning and implementation. Consultants should be recognized experts in alcohol research. The consultants must agree to work with College Presidents when asked by NIAAA Project Officer. The budget allowable for a consultancy is a maximum of two modules ($50,000). Pilot and Feasibility Studies Each application should have provisions for Pilot Studies, Feasibility Studies, or a combination of the two. They are described more fully below. These projects may be implemented prior to, or after partnering with a University Administrator (service partner) under PA –XXX. Pilot Studies A pilot study is a short term study of 2 semesters or 1 year total length of time. The maximum budget allowed for a pilot study is two modules ($50,000). The pilot project can provide a flexible means to develop and explore a particular activity or direction prior to being partnered, or at the initial stage of partnering, with a service partner (college president). The goals of a pilot study are short-term and easily accomplished within the allowable timeframe. Feasibility Studies A feasibility study is a short term study of 1 semester or 6 months total length of time. The maximum budget allowed for a feasibility study is one module ($25,000). The feasibility project can provide a flexible means to develop and explore a particular activity or direction prior to being partnered, or at the initial stage of partnering, with a service partner (college president). The goals of a feasibility study are more modest than for a pilot study, and easily accomplished within the allowable timeframe. MECHANISM OF SUPPORT This RFA will use the NIH U01 award mechanism. As the research applicant you will be 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 29, 2003. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. The NIH (U01) is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE The NIAAA intends to commit approximately $4 million in FY 2003 to fund 1 to 5 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $500,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. As the level of research activity is expected to increase when awardees under this RFA partner with University Administrators (service partner) awarded under PA-XXX, applications may not be fully funded at the outset. The remaining award will become available as projects are implemented. Although the financial plans of NIAAA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The application should include a proposed protocol that meets the objectives and scope outlined in this RFA and responds to the required major components as stated in the "Research Questions" and "Study Design" sections. The application should indicate the key professional personnel who will serve as consultants and provide advice/assistance to college/university administrators, when requested by NIAAA. The applications should include plans for pilot and/or feasibility studies that can be undertaken at a designated college/university research site when requested. Such studies may be undertaken in conjunction with a RAPID award to college/university administrators, as described in the companion program announcement. The applications should include budgetary allowance for attendance at two mandatory meetings per year. These meetings of all awardees under this RFA and those under the RAPID PA XXX will be held at approximately 6-month intervals in the Washington, D.C. area. Award of the cooperative agreement does not imply that any particular proposed protocol will be implemented. Since the final study will be designed by a Steering Committee of the investigators of at least one research award (U01) and one service award (U18), the final protocol may not reflect the research plan submitted by the applicant in response to this RFA. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official at the time of award. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a clinical research cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIAAA project staff. The NIAAA is not to assume direction, prime responsibility, or a dominant role in the activities. Details of the roles of the parties are described later in this section. A. Principal Investigator Rights and Responsibilities Principal Investigators will have primary and lead responsibilities for the project as a whole including participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, as well as collaboration with other awardees and with assistance from NIAAA staff. The Principal Investigator defines the details for the project in accordance with these Terms and Conditions of Award; retains primary responsibility for the performance of the activity; and agrees to close coordination, cooperation, and assistance of NIAAA extramural staff in aspects of scientific and technical management of the project as described herein. Each Principal Investigator (or designee) is responsible for attending all Steering Committee meetings. The Steering Committee shall be responsible for determining the frequency and scheduling of meetings. Each Principal Investigator (or designee) will be expected to participate in all other Steering Committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. Each Principal Investigator is responsible for obtaining local institutional review board (IRB) approval of all study protocols implemented at U.S. or foreign sites and comply with both IRB and Steering Committee policies and procedures. Each Principal Investigator is responsible for collaborating with the designated service partner(s) and other member(s) of the Steering Committee. Each Principal Investigator is expected to publish and disseminate results of both independent and shared research. When joint protocols are competed, publish in collaboration with other involved site(s). Each awardee institution and its corresponding investigators will be responsible for developing and implementing research aims; adjusting research priorities in accordance with current developments and available budget funds; participating in analyses; and accepting the participatory and cooperative nature of the group process and policies relevant to this program. Each Principal Investigator is expected to be responsible for contracting with consultants to the Steering Committee on an as needed basis. B. NIAAA Staff Responsibilities The NIAAA staff role in this cooperative agreement will extend beyond the level normally required for stewardship of a grant because of the need for coordination of study protocols among performance sites, technical assistance in the analysis of data, and monitoring and possible reassessment of project objectives as the study proceeds. The NIAAA extramural staff perform different functions in research projects supported under the cooperative agreement mechanism. 1. Program Official The Program Official provides normal stewardship of the award and has overall responsibility for monitoring the conduct, progress, and fiscal management of the program. Progress of the project will be reviewed by the Program Official annually at the time of each continuation application to assure that satisfactory progress is being made in achieving the objectives of the project and that each performance site is following the program goals and procedures recommended for use by all participants in the cooperative program and approved by the Steering Committee. 2. NIAAA Staff Collaborator The NIAAA Staff Collaborator has substantial scientific input in collaboration with award recipients, in both planning and conduct of the research. The NIAAA Staff Collaborator will: 1) participate as a voting member on each Steering Committee which oversees each collaborative research effort, and relevant technical subcommittees or working groups as appropriate; 2) participate in the formulation of protocols and other planning related to the completion of the research; 3) participate in pairing of research and service award partners; 4) participate in monitoring the progress of the research and quality control; and 5) participate in the analysis and interpretation of data, and possibly in associated publications and presentations. C. Collaborative Responsibilities 1. Steering Committee A Steering Committee will be the main governing unit of each study and will have primary responsibility for all decisions. Each Steering Committee will be composed of a Principal Investigator (or designees) of the U01 research award, the partnered Service Awardee (U18) and the NIAAA Staff Collaborator. Each will have one vote, should a vote of the Steering Committee be necessary to make a decision. The functions of each Steering Committee include: defining protocol objectives and approaches; designing and implementing the protocol; developing procedures for data collection and management and quality control; establishing procedures for assessing performance; analyzing and interpreting study data; and publishing/presenting study findings. D. Monitoring Study Progress The Data and Safety Monitoring Board (DSMB) is an independent board of experts established by the NIAAA which oversees the integrity of data and safety of clients. The Institute convenes the DSMB once a year. Its major function is to review reports of subject safety and data integrity on a regular basis. The Board is also responsible for reviewing and approving the final protocol prior to the start of the recruitment phase, and for approving the progression from one phase of the trial to the next. E. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIAAA may be brought to arbitration. An arbitration panel will be composed of three members; one selected by the Steering Committee (with the NIAAA member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NIAAA, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Peggy Murray Director, International Research and Training Program Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 302 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2594 FAX: (301) 480-2358 Email: o Direct your questions about financial or grants management matters to: Judy Fox Chief, Grants Management Branch Office of Planning and Resource Management 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: 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: RFA-AA-03-008 Extramural Project Review Branch 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) Telephone: (301) 443-4375 FAX: (301) 443-6077 by the letter of intent receipt date listed. 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 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: Additional Materials to Include in the Application 1. All costs required for the proposed protocol must be included in the application and must be fully justified. Requested budgets should include travel to the Washington, D.C. area for two 2 day Steering Committee meetings each year during the duration of the trial, except for the first year when three meetings may be required. In addition, budgets should include travel to the Washington, D.C. area for two meetings per year that include all of the awardees. 2. The application should discuss the capability of the applicant organization to participate and interact effectively in multi-center research projects. 3. The application must include a written commitment to accept the participation and assistance of NIAAA staff in accordance with the guidelines outlined under "NIAAA Staff Responsibilities" as stated above. The application must also include a written commitment to the cooperative organization and willingness to serve on the Steering Committee and adhere to the decisions reached by that Committee, including following a consensus protocol. 4. The application must name a single Principal Investigator (PI) who will have scientific responsibility for the application as a whole including all research activities included under it. Applications from a consortium of institutions must name a single Senior Investigator for each participating institution (other than the applicant institution) who will be responsible for on-site scientific direction and implementation for the consensus protocol. Senior Investigators in consortia must also document relevant experience in alcoholism prevention research. 5. The application must provide a clear, concise plan showing the scientific discipline of the PI and of all key scientific, technical and administrative personnel, and a mechanism for replacing key professional or technical personnel should the need arise. 6. Allowable costs. The total direct costs allowed for any application will be up to $500,000 per year for up to 5 years. Up to $50,000 per year will be allowed to support the costs of the consultant services to advise and assist the college/university administrators. Pilot studies are expected to cost up to $50,000 per year for one year. Feasibility studies are typically expected to cost up to $25,000 per year for one year. 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 includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at 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: 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: RFA-AA-03-008 Extramural Project Review Branch 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) Telephone: (301) 443-4375 FAX: (301) 443-6077 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. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the (IC). 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 (IC) 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 NIAAA National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your 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 your application's overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA - Clearly discernible research design, involving generation and/or testing of hypotheses - Rationale for the proposed methodology - Feasibility and timeliness of the proposed research - Availability of adequate facilities and resources necessary for the research - Qualifications of the research personnel RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 14, 2003 Application Receipt Date: April 14, 2003 Peer Review Date: June-July 2003 Council Review: September 17, 2003 Earliest Anticipated Start Date: September 29, 2003 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 MONITORING PLAN AND DATA SAFETY AND 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 Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 (; a complete copy of the updated Guidelines are available at 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 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 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 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.891, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and administered under NIH grants policies described at and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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