ADVANCED RESEARCH COOPERATION FOR ENVIRONMENTAL HEALTH RELEASE DATE: June 19, 2003 RFA: ES-03-009 National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.113, 93.114, 93.115 LETTER OF INTENT RECEIPT DATE: October 21, 2003 APPLICATION RECEIPT DATE: November 21, 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 mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental exposures. The NIEHS achieves its mission through multidisciplinary biomedical research programs, prevention and intervention efforts, and communication strategies that encompass training, education, technology transfer, and community outreach. An important element of the NIEHS mission is to develop the research capacity of minority-serving institutions that have research scientists who are committed to understanding the impact of environmental exposures on human health. To address this need, the NIEHS has developed a Thematic Program Project Grant (S11) that focuses on establishing research partnerships between investigators at Research Intensive Universities (RIUs) with significant biomedical health sciences research and at Minority Serving Institutions (MSIs) with graduate and/or professional schools conferring doctoral degrees. MSIs for the purposes of this solicitation are academic institutions, either medical or non-medical, that have a minority enrollment greater than 50 percent. This includes Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions (HSIs), and Tribal Colleges and Universities. The purpose of this grant is to establish a research infrastructure and a hypothesis-driven research program at a Minority Serving Institute that develops a cadre of investigators that will successfully compete for Research Project Grant (RPG) support. RESEARCH OBJECTIVES Background Research programs in environmental health science at MSIs have not been extensively pursued or realized. NIEHS believes there is a critical need for a focused program to increase the participation of minority schools and investigators in the health research mission of the NIEHS. To address the need for increased minority participation the NIEHS has developed this program, which focuses on establishing research partnerships between investigators at RIUs with significant environmental health sciences research and investigators at MSIs with graduate/professional schools with a strong interest in such research. The low level of involvement of minority serving institutions in environmental health science and the lack of sufficient training opportunities for minority scientists represent two major obstacles to developing an effective cadre of investigators at MSIs engaged in research efforts aimed at addressing environmental health issues. One way of meeting these challenges is to increase the pool of well-trained investigators, especially in minority groups where the proportion of biomedical investigators is strikingly lower than the percentage of minority U.S. citizens. Currently, there are four collaborative ARCH programs that are supported by the NIEHS. Awards were made to Southern University Baton Rouge, Xavier University, Florida A&M University, and Florida International University. RIU partners are the University of Texas Medical Branch at Galveston (UTMB), Tulane University Medical Center, Wayne State University, and the University of Miami, respectively. The Southern-UTMB collaboration scientific thematic focus is on the molecular mechanisms of butadiene toxicity. The Xavier-Tulane collaboration focuses on xenobiotic regulation of transcription. The Florida A&M-Wayne State collaboration focuses on signal transduction and Florida International-Miami ARCH project addresses marine and freshwater toxics and arsenic speciation. All of these projects feature unique scientific partnerships that allow for faculty development at the MSIs while supporting sound scientific research at both institutional partners. (See ARCH website: http://www.niehs.nih.gov/translat/arch/arch.htm) The most recent ARCH RFA solicitation, ES-00-006, utilized a two-tiered award program for either ARCH I or ARCH II programs. Key differences between ARCH I and ARCH II programs were the number of research projects allowed and requirement of a Faculty recruitment component. The current initiative has some significant differences with regards to what an ARCH award will support. There will only be one type of ARCH award available, as in the initial ARCH RFA (ES-98-005), eliminating opportunities for ARCH I or ARCH II designations. Additionally, there will be a greater emphasis placed on the pilot project component allowing for collaborative pilot projects at both the MSI and RIU. Further, only one research project will be funded at the MSI, however there will be an increase in resources allocated for that project to allow more opportunities for collaboration. There will not be a faculty recruitment component for ARCH awards made in response to the current RFA. Objectives and Scope The ARCH grant is a mechanism for the support of a broadly based research program involving investigators at an MSI and established investigators at an RIU sharing knowledge and common resources. The goal of the ARCH grant is to establish a group of investigators at an MSI that can successfully compete for National Institutes of Health (NIH)/NIEHS Research Project Grant (RPG) support, typically R01/R15 grants, or awards from other agencies that use the peer review mechanism, for example, U.S. Environmental Protection Agency, the National Science Foundation, or the American Cancer Society. To achieve this goal an ARCH grant will provide support for a broadly based multidisciplinary research program that has a well-defined central research focus or objective. The NIEHS envisions the support received from the ARCH grant as the foundation necessary for achieving the above stated goal. It is anticipated that the MSI scientists will compete for other types of NIH/NIEHS and peer reviewed grants during the period of ARCH funding as part of the overall strategy for this effort. Thus, as the ARCH program develops at the MSI institution, it is expected that the MSI investigators will compete for other types of grants in areas relevant to the NIEHS mission (K01, R15, R03, R01, P01, F31/32, T32, etc.) that will provide research support after the ARCH award support ends. Information on the mission and program interests of NIEHS is available on the web site: http://www.niehs.nih.gov/dert/programs/special/special.htm. MECHANISM OF SUPPORT This RFA will use the NIH S11 award mechanism. 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 July 1, 2004. This RFA uses just-in-time concepts. This RFA uses the non-modular budgeting format. Applicants must use the forms for regular research grants, follow the specific instructions in the PHS 398 application kit, and provide a complete detailed budget (Forms Pages 4 & 5) with narrative justifications. 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 The NIEHS intends to commit approximately $3,000,000 in FY 2004 to fund three new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $750,000 per year. Because of the nature and scope 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 NIEHS 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. ELIGIBILE INSTITUTIONS As described below, there are specific eligibility criteria for the partner institutions that must be met in order to apply for this RFA. Potential applicants are strongly encouraged to contact the NIEHS program administrator listed under WHERE TO SEND INQUIRIES. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, women and individuals with disabilities are always encouraged to apply for NIH programs. The Principal Investigator must have his or her primary appointment at the applicant MSI institution. SPECIAL ELIGIBILITY REQUIREMENTS Applicant Organization and Investigators For this RFA, the applicant organization must be a Minority Serving Institution (MSI). The MSI must have a graduate or professional school that offers at least one doctoral degree (Ph.D., M.D., D.V.M., D.D.S., etc.) The Principal Investigator must have his/her primary appointment at the applicant MSI, and have a strong interest in environmental health sciences. The ARCH application must also include a Research Intensive University (RIU) with significant research support in environmental health sciences, and an RIU leader (co-investigator) who has demonstrated interests in environmental health sciences. Applications that include RIU investigators who are current NIEHS grantees are strongly encouraged, but not required. Only one application will be accepted per eligible minority serving institution and each RIU may participate in no more than one application in response to this RFA. MSI and RIU Collaboration The MSI/RIU collaboration must be between an MSI with a strong interest in environmental health sciences and RIU investigators with a significant research base in peer reviewed environmental health sciences-related research support such as R01, P20/30, P42, etc. Environmental health has been defined as "those aspects of human health, including quality of life, that are determined by physical, chemical, biological, social and psychosocial factors in the environment (World Health Organization, 1993)." Thus, collaborations may focus on any component of environmental health science-research as defined by the preceding definition of environmental health. ARCH awards will support research that utilizes state of the art methodologies in the conduct of environmental health sciences research. The need for continuous and active communication among sites dictates that only MSIs in the United States, its possessions or its territories are eligible to apply. Ideally, the collaborating institutions should be in close proximity to one another, less than 100 miles apart. However, if the distance between institutions exceeds 100 miles, applicants should describe procedures and/or processes that will be used to overcome any potential problems associated with the geographical separation. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. ARCH programs will: (1) help minority institutions develop state-of-the-art environmental health science research programs; (2) create more opportunities for researchers employed by minority serving institutions to establish research collaborations and professional networks with NIH grantees employed by research intensive institutions; (3) increase the role of ongoing research in maintaining a vigorous, stimulating academic and intellectual milieu that will inspire and prepare students and fellows to pursue research careers in environmental health sciences; and (4) provide support for pilot research. Support of pilot projects is intended to bolster the skills and abilities of investigators, to obtain preliminary data, and to publish in peer reviewed journals that can help ensure successful competition for traditional research grants and awards. The purpose of this initiative is to form a cooperative program that will augment and strengthen the research infrastructure and research capabilities of faculty, students, and fellows at minority institutions by supporting the development of new, and/or the enhancement of ongoing, basic science and translational research that focuses on topics deemed to be of high priority and significance because of their critical importance to environmental health. ESSENTIAL CHARACTERISTICS OF ARCH GRANTS Overall Characteristics The ARCH grant will support a broadly based multidisciplinary research and development program that is a collaborative effort between an MSI and an RIU. The program focus should be on establishing a group of investigators at the MSI that can compete for NIH Research Project Grant (R03, R21, R01 or R15 if R15 eligible) support. Key factors for an ARCH grant are as follows: o There be should be a unifying, well-defined goal or problem area of research to which each project relates and contributes. This may be a specific disease outcome, e.g., asthma, diabetes, cancer, low birth weight or children=s health, autoimmune disorders, etc. or a more general area, such as, gene- environment interactions, xenobiotic gene regulation, molecular mechanisms of toxicity. o There must be the participation of established investigators from the RIU and MSI, and all investigators must contribute to, and share the responsibilities for, fulfilling the program objectives. The program should include enough participation to make a collaborative effort successful, and yet not so diverse in scope as to make program collaboration and communication ineffective. o The RIU investigators included in this project must have significant peer- reviewed research project grant support that is relevant to the NIEHS mission (see NIEHS web site: http://www.niehs.nih.gov/external/intro.htm) o There must be a demonstrated commitment of the MSI and RIU institutions to the support and encourage the ARCH program. Such support usually involves release time of faculty, capital improvements that will facilitate the research, and assistance in the acquisition of scientific equipment and supplies. A letter of support from the Chancellor or President of the applicant institution will be required to demonstrate support for the ARCH program from the highest level of institutional administration. o All MSI ARCH investigators must spend a sabbatical period in the laboratory of their RIU collaborator. This sabbatical period must consist of a minimum of one semester and can include summer research experiences. It is anticipated that during the sabbatical period, the MSI ARCH investigator will further hone his/her research skills and write and submit a grant application under the tutelage of his/her RIU collaborator. Administrative and Planning Core There must be strong leaders at both the MSI and RIU who are substantially committed to the project, are capable of scientific leadership and are willing to accept responsibility for the administration and integration of the program. Assessment of the ability of the program Principal Investigator (ARCH Director) and RIU leader to develop a tightly integrated program of collaborative research will be a significant consideration in evaluation of the application. The administrative/planning core must provide the support of administrative and research development infrastructure for the entire program and should not be duplicated within any other components or within support normally provided by the MSI or RIU institutions. The responsibilities and activities for the administrative and planning core include: o Appropriate and adequate organization and facilities for conduct of the research and development activities such as seminars, workshops, reference collection, computer support, etc. Specifically the administration and planning core must develop and support a grants writing course (not a seminar) that is available to all MSI ARCH grant investigators and other MSI faculty. Additionally this core must also subscribe and provide access to electronic library services that allow MSI ARCH grant investigators to remain current with scientific literature relevant to their research pursuits. o An Internal Steering Committee formed of the individual project leaders (RIU and MSI investigators) that will assist the Principal Investigator in making scientific and administrative decisions in the operation of the program. o An External Advisory Committee, comprised of at least three members who are outside both the MIU and RIU and are recognized leaders in the biomedical sciences related to the scientific theme of the program, that will provide overall guidance and advice to the Principal Investigator and program investigators on program direction. o A Senior Scientific Advisor (SSA) who is on the faculty of the MSI and has been successful in attracting RPGs (R01, P01, etc.) from the NIH. This individual will assist the ARCH Director in the overall development of the MSI research infrastructure and advise the MSI investigators on the preparation of research grant applications. The SSA must have affiliation with the MSI and serve as a liaison between ARCH grant investigators and administration. Research Program Development Core The function of the core is to strengthen, stabilize and consolidate interaction and cooperation between the Minority Serving Institution and the collaborating RIU=s environmental health science program. All research projects will be part of the Research Development Core. Two types of projects (Pilot and Research) will be supported as part of the ARCH program and both types must be present. It is of paramount importance that each project (Pilot and Research) be of sufficient scientific merit to warrant independent support and that each project is an integral part of the ARCH program. To be funded, an ARCH program must have at least three Pilot projects and one Research project that are judged to have significant and substantial scientific merit on their own. Research projects are R01-type projects that have as the project leader either RIU or MSI faculty who have been Principal Investigators on R01 grants from the NIH in the past three years. A faculty member from the other collaborating institution is required to be included in the project. The maximum project period for a Research project is five years. One research project will be funded by an ARCH award. The roles of both the MSI and RIU collaborators must be clearly described in the ARCH grant application. Pilot projects are intended to provide an MSI investigator an opportunity to develop his/her research skills and/or for the MSI investigator to obtain the preliminary research data needed for the submission of a peer reviewed research grant application. Additionally pilot projects may provide RIU collaborators/mentors an opportunity to develop/pursue new research activities that generate preliminary data to be used in subsequent traditional grant submissions. Pilot projects can also be developed in the RIU investigators established area of research. Pilot projects are established between an MSI investigator and an RIU mentor/collaborator. The maximum project period for a Pilot project is 36 months. Pilot project leaders may be either MSI or RIU investigators. In order to assess the success of the Pilot projects and to provide for new Pilot projects, the application must include a provision for: o The scientific merit review of new Pilot projects that may be submitted by MSI or RIU investigators. Copies of all proposals, with documentation of their reviews, relative ranking, and final action must be retained by the ARCH Director. o The tracking of the results of each Pilot project (abstract, peer reviewed grant applications, publications, presentations, etc.). These records must be available to NIEHS program staff. A. Facilities Core may be proposed provided it meets the criteria listed below: o The Core must provide service, on a continuing basis to two or more Research or Pilot projects. This support may be directed to different projects as the scientific program advances. o The Facility Core should utilize state-of-the-art techniques and equipment in order to maximize the efficiency of the entire ARCH program. o Core support funded by this grant should provide service for only Research and Pilot projects. Service provided to other projects may be done on a fee- for-service basis or there must be some reciprocal service provided to the program that is substantially of the same value. o The Facilities Core(s) must be located on the MSI campus. ALLOWABLE COSTS The ARCH award will provide multiple components of support that in total will provide funds for the establishment of research and development collaboration between groups of investigators at an MSI and an RIU. The general budget categories and dollar levels that can be supported by this award are listed below. However, the specifics for each budget category are the responsibility of the Principal Investigator. The total direct cost that may be requested for an ARCH program is limited to $750,000 per year. Indirect costs for the subcontract to the RIU that are included as a part of the MSI direct costs are not included in the $750,000 per year budget limit. A. Administrative/Planning Core 1. The ARCH grant will provide up to $150,000 (direct cost) per year for administrative/planning support. These funds are intended to support the research infrastructure necessary to provide MSI investigators an adequate opportunity to develop competitive research applications. Funds for the conduct of Pilot and Research projects including salary are to be included in the Research Program Development Core budget. The MSI Principal Investigator and the RIU leader are responsible for development of the Administrative/Planning Core budget. A listing of some of the items that may be included in this core is provided below. Budget Item and Maximum Allowable Support: o Principal Investigator - 25 percent effort o RIU Leader - 15 percent effort o MSI or RIU Senior Scientific Advisor - 10 percent effort o Administrative Assistant at MSI - 50 percent effort o Administrative Assistant at RIU - 25 percent effort o Computer network support/Office supplies - as justified o Seminars/Program enhancement/courses - as justified o Travel for ARCH investigators - as justified o Travel for external advisory committee - as justified 2. An additional request of up to $100,000 for major equipment items for MSI investigators may be included in the Administrative/Planning Core budget in the first two years. This equipment may be in addition to equipment that is requested for the Research/Pilot projects or the Core facility. These equipment items must be well justified and be an integral part of the research program the MSI investigator(s) plan to develop. These funds are in addition to the $150,000 for the administrative/planning core budget items identified above. B. Research Program Development Core The ARCH grant will provide up to $550,000 in direct costs per year for the research program development core at the ARCH to include: 1) At least three collaborative pilot projects between ARCH (MSI and RIU) investigators; and 2) one collaborative Research project between MSI and RIU investigators [most likely will be at RIU] [Describe Facility Cores separately from the Research Program Development Core]. 1. Pilot Projects Items that may be included are MSI and RIU investigator salaries, technical support, supplies, small equipment items, travel and other items that are necessary for the conduct of the Pilot Project. The maximum direct cost for each Pilot Project is $100,000 per 12-month period, and the maximum length of a Pilot Project is 36 months. At least three Pilot Projects must be recommended by the Special Emphasis Panel (SEP) in order to be eligible for an ARCH award. Pilot Projects may be located on either the MSI or RIU campus and each Pilot Project will be a collaborative effort between MSI and RIU investigators. 2. Research Projects Research Projects are to be conducted by RIU and MSI investigators. The maximum direct cost for a Research Project is $150,000 per year, and funding may be requested for up to five years. One Research Project will be supported per ARCH award. C. Facility Core The Principal Investigator may request up to $100,000 per year (direct cost) for the Facility Core. The Facility Core unit is a resource for the Research/Pilot projects that provides centralized services or equipment to several projects. At a minimum, a Facility Core must provide service or equipment for at least one Pilot Project and one Research Project. The Facility Core must be located at the MSI and the support may be directed to different component research projects as the scientific program advances. The ARCH program is not intended to provide support for graduate students. Such support should be obtained through competitive training programs of the NIH/NIEHS such as the Individual (F31), Institutional (T32) National Research Service Awards or through supplements to ongoing RPGs. D. Supplemental Funds for Additional MSI Investigators or Postdoctoral Trainees As the program develops, supplemental funds may be requested for support of additional MSI/RIU faculty and postdoctoral trainees on RIU Research projects. This includes Research Supplements for Underrepresented Minorities (http://grants.nih.gov/grants/guide/pa-files/PA-01-079.html) and is restricted to the RIU Research Projects. Other types of administrative supplement requests will require approval of NIEHS staff prior to submission, and is contingent upon availability of funds. ADDITIONAL CRITERIA A. Mid-Program Evaluation Criteria for ARCH Awardees. In addition to the usual review of the non-competing application each year, there will be an in-depth review of the progress of each ARCH award toward meeting the program goal at the end of the third year of the grant period. The criteria to be used for the evaluation are the following: o Number of peer reviewed publications with an MSI author/co-author. o Number and type of peer reviewed grants submitted and awarded. o Quality and efficacy of mentoring activities provided by the RIU. o Status of the MSI research infrastructure, and plans for sustaining and nurturing it after the ARCH grant funding ends. The in-depth mid-program evaluation will be used as a basis for awarding the fourth and fifth year of funds. B. Pre-application Phase. Communications between a potential Principal Investigator and program staff of the NIEHS at the pre-application planning phase will serve to (1) advise the applicant concerning the areas of program interests of the NIEHS; (2) facilitate the receipt of a well-organized, tightly-focused application; and (3) ensure that the application conforms to established guidelines and criteria for an S11 application. The initial contact with NIEHS program staff is the responsibility of the potential applicant and should be made as early as possible. This interaction may take the form of correspondence, such as a letter of intent, telephone conversations, etc. The program staff are particularly cognizant of the scope of their programs and the S11 guidelines and are especially qualified to advise applicants concerning the preparation of a complete and well-developed application. This communication will enable the program staff to discuss issues such as the need for integration of all projects into the theme of the overall program, the established review guidelines, the proper format of the applications, and the necessary relevancy of the proposal to the programs supported by the NIEHS. 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: Frederick L. Tyson, Ph.D. Program Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences 111 T.W. Alexander Drive, MD EC-21 P.O. Box 12233 Research Triangle Park, NC 27709 Tel: (919) 541-0176 Fax: (919) 316-4606 Email: tyson2@niehs.nih.gov Direct your questions about peer review issues to: Leroy Worth, Jr., Ph.D. Scientific Review Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: worth@niehs.nih.gov Direct your questions about financial or grants management matters to: Ms. Lerlita Dingle Garcia Grants Management Specialist Grants Management Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-22 Telephone: (919) 316-4638 Fax: (919) 541-2860 Email: garcia1@niehs.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 NIEHS 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: Leroy Worth, Jr., Ph.D. Scientific Review Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: worth@niehs.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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, telephone (301) 435-0714, Email: GrantsInfo@nih.gov 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 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: Leroy Worth, Jr., Ph.D. Scientific Review Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive (79 T.W. Alexander Drive, 4401 Building, 3rd Floor)(Express/Courier Service) Research Triangle Park, NC 27709 Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: worth@niehs.nih.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. 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 NIEHS. 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 NIEHS 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 Advisory Environmental Health Sciences 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 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 method? 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? 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: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. The following is a listing of items considered by the review committee. A. Overall Program 1. A program cohesiveness that clearly indicates that the presence of the ARCH program will make a difference in the research infrastructure and capacity of the MSI. 2. The likelihood that the collaboration between the RIU and MSI will be successful. B. Administrative and Planning Core 1. Scientific and administrative leadership ability and experience of the MSI Principal Investigator and the RIU leader, and their commitment and ability to devote adequate time to the effective management of the ARCH program. 2. Appropriateness and adequacy of multidisciplinary teams constituting the program's members. 3. Academic environment and resources in which the research will be conducted, including availability of space, equipment, human subjects, animals, or other resources as required, and the potential for interaction with scientists from other departments. 4. Administrative organization to foster the scientific development of the investigators and institution. 5. Institutional commitments to the program including provision of space, technical resources, personnel, equipment, release time and salary for faculty. In addition, fiscal responsibility and management capability of the institutions to assist the MSI Principal Investigator and the RIU leader in following DHHS, PHS, and NIH policies. 6. Appropriateness of the budget in relation to the proposed program. 7. Human subjects protection, animal welfare, and biohazard issues. 8. Appropriateness of first year equipment requested, if any, for the program. 9. External advisory committee composition and arrangements to provide ongoing direction and guidance. 10. Demonstration of effective collaboration between MSI scientists and RIU scientists to achieve programmatic goals, such as to help minority institutions develop state-of-the-art biomedical research programs; create more opportunities to establish research collaborations and professional networks with NIH grantees employed by RIUs; to provide support for the pilot research needed to show the skills and abilities of investigators by obtaining the preliminary data and publications that can help ensure successful competition for traditional research project grants during the performance period of the grant. 11. The nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators. C. Research Program Development Core: Facility Core 1. Utility/benefit of the Facility Core to the program. 2. Qualifications, experience, commitment of the personnel involved in the core. 3. Appropriateness of the budget. D. Research Program Development Core: Scientific Projects The review of the individual Research Projects is similar to the review of individual project grant applications (R01/R15) for the Research and Pilot Projects. These projects must have substantial scientific merit and, in essence, be of sufficient quality to be supported if they were submitted as individual projects. Research Project proposals that are not at this level of quality will not be funded. The review criteria are intended to focus more on the global picture of each project and the program overall rather than concentrating on the details of each experiment in their critiques. 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 BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 21, 2003 Application Receipt Date: November 21, 2003 Peer Review Date: February 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 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. 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 involving human subjects 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 read the AMENDMENT "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research B 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. 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 RFA 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. 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 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 promote the non-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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