and Human Services (HHS)
EXPIRED
ADVANCED RESEARCH COOPERATION IN ENVIRONMENTAL HEALTH SCIENCES Release Date: June 1, 2000 RFA: ES-00-006 National Institute of Environmental Health Sciences http://www.niehs.nih.gov Letter of Intent Receipt Date: August 1, 2000 Application Receipt Date: October 19, 2000 PURPOSE 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 multi-disciplinary 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 Research Program Project Grant that focuses on establishing research partnerships between investigators at Research Intensive Universities (RIUs) with significant environmental health sciences research and at Minority Serving Institutes (MSIs). 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 Institutes (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. 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 Request for Applications (RFA), "Advanced Research Cooperation in Environmental Health Sciences," (ARCH) 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/ ELIGIBILITY REQUIREMENTS 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 Program Administrator listed under INQUIRIES. Applicant Organization and Investigators For this RFA, the applicant organization must be an MSI. 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. 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 Athose 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 training that utilizes state of the art methodologies that can be used to conduct environmental health sciences research. MSI/RIU partners should be within a reasonable working distance (100 miles or less). If there is a significant distance between the collaborating institutions (greater than 100 miles,) the Principal Investigator should provide information on how the collaboration will work and a description of past successful collaborations with the partner RIU, if applicable. MECHANISM OF SUPPORT The NIEHS ARCH Program will use the NIH Minority Biomedical Research Support Thematic Project Award (S11). The NIEHS ARCH Program will be a two-tiered program and feature two levels of support. The maximum requested direct costs and project period will be $1 million per year for a maximum of five years for ARCH-I. The maximum requested direct costs and project period will be $500,000 per year for a maximum of five years for ARCH-II. The fundamental differences between ARCH- I and ARCH-II awards include maximum direct costs; the numbers of allowable research and pilot projects; and support for faculty recruitment. ARCH-I awards will have a minimum of two Research Projects and two Pilot Projects. ARCH-II awards will support a minimum of one Research Project and two Pilot Projects. ARCH-I awards will provide support for faculty recruitment, while ARCH-II awards will not support faculty recruitment. More detailed distinctions between ARCH-I and ARCH-II awards can be found under the "Research Program Development Core" section. FUNDS AVAILABLE It is anticipated that approximately one to two ARCH-I and one to two ARCH-II grants will be awarded depending upon the availability of funds and the quality of the applications received. Awards are not renewable, and supplements, except as described under the section, "Other ARCH Program Requirements, Budget Limits and Evaluation," are not allowed. The NIEHS will make a commitment for funding an institution for the full term of the award. However, the fourth and fifth years of ARCH funding will be restricted pending the results of an in-depth review of the grantee's progress toward meeting the goals of the grant. The criteria for this review are described in the Mid-Program Evaluation Criteria for ARCH Awardee section of this RFA. RESEARCH OBJECTIVES Background The National Institutes of Health (NIH) has initiated many programs over the past twenty years to assist minority-serving institutions to develop the scientific resources necessary to participate in the NIH research mission. Although there have been successes, investigators at minority institutions have not generally been competitive for the mainstream NIH research programs. 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 Institute. 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 a strong interest in such research. 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. While 12 percent of the population is Black, less than 0.25 percent of persons holding a Ph.D. in science are Black. The figures are even lower for Black Ph.D.s in the biomedical sciences. Furthermore, the number of doctorates, both M.D.s and Ph.D.s, in other ethnic minority groups (such as American Indians or Hispanics) is proportionally lower than for Blacks. Two ARCH awards were made as a result of the first ARCH RFA solicitation. These awards were made to Southern University of Baton Rouge, Louisiana and Xavier University of New Orleans University. Their RIU partners are The University of Texas Medical Branch at Galveston (UTMB) and Tulane University Medical Center, 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. Both of these projects feature unique scientific partnerships that allow for faculty development at the MSIs while supporting sound scientific research at both institutional partners. 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 NIH/NIEHS Research Project Grant (RPG) support, typically R01/R15 grants, or awards from other agencies that use the peer review mechanism to generate competitive programs for support of scientific research proposals by funding agencies, for example, U.S. Environmental Protection Agency or the National Science Foundation. 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 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, R01, P01, F31/32, T32 etc.) that will provide research support after the ARCH 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. In addition, it is anticipated that as a result of the research collaboration between an MSI and RIU, talented minority undergraduates will be attracted to the graduate training program(s) of the RIU. As the program project develops, the RIU and MSI may wish to develop a collaborative training program that takes advantage of the unique strengths of each institution. 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 Program Grant (R01 or R15 if R15 eligible) support. Key factors for an ARCH program project are as follows: o There must be a unifying, well-defined goal or problem area of research to which each project relates and contributes. 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 encouragement of 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. o For ARCH-I awards there must be a commitment of the MSI to the recruitment of new faculty that have successfully competed for NIH R01/R15 grants in areas of science relevant to the mission of the NIEHS or have successfully competed for peer reviewed awards from other funding sources. 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 program director) and RIU leader to develop a tightly integrated program of collaborative research will be a significant consideration in the evaluation of the application. The administrative/planning core must provide the support of the 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 the conduct of the research and development activities such as seminars, workshops, reference collection, computer support, etc. o An Internal Advisory 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 recognized leaders in biomedical sciences, that will provide overall guidance and advice to the Principal Investigator and program investigators on program direction. o A Senior Scientific Advisor (SSA)who has been successful in attracting RPGs (R01, P01, etc.) from the NIH. This individual will assist the Principal Investigator in the overall development of the MSI research infrastructure and advise the MSI investigators on the preparation of research grant applications. The SSA can have affiliation with either the MSI or the RIU. Research Program Development Core Two types of projects (Pilot and Research) will be supported as part of the ARCH programs 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 two 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. The number of Research projects supported by the ARCH grant cannot exceed the number of Pilot projects. Pilot projects are intended to provide an MSI investigator an opportunity to develop his/her research skills and/or to obtain the preliminary research data needed for the submission of a NIH Research Project Grant (R01/R15) application. Distinctions between ARCH-I awards and ARCH-II awards include: o the minimum number of Research and Pilot projects; o total direct cost; and o faculty recruitment. The minimum number of Research/Pilot projects funded in an ARCH-I award will be two Research projects and two Pilot projects. The minimum number of Research projects and Pilot projects funded in an ARCH-II award will be one and two respectively. ARCH-I awards can be funded maximally at $1 million in direct costs for up to five years. Maximum ARCH-II awards will be $500,000 in direct costs for up to five years. Applicants are strongly encouraged to contact Program staff (see below) in order to determine whether the proposed MSI-RIU collaboration is best suited for an ARCH-I or ARCH-II application. Pilot projects are established between an MSI investigator and an RIU mentor/collaborator. The maximum project period for a Pilot project is 30 months. However, the project leader for a Pilot project may delay the start of the Pilot project for up to six months after the award of an ARCH grant to begin the project. This will provide the MSI investigator a period of time to establish his/her research laboratory. 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 investigators. Copies of all proposals, with documentation of their reviews, relative ranking, and final action must be retained by the ARCH Program Project Principal Investigator. o the tracking of the results of each Pilot project (abstract, R01/R15 application, 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 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 a 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 $1 million (ARCH-I) and $500,000(ARCH-II). Indirect costs for the subcontract to the RIU that are included as a part of the MSI direct costs are not included in the $1 million/$500,000 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% effort o RIU Leader - 15% effort o MSI or RIU Senior Scientific Advisor - 10% effort o Administrative Assistant at MSI - 50% effort o Administrative Assistant at RIU - 25% 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 year. 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 (1). B. Research Program Development Core The ARCH grant will provide up to $400,000 (ARCH-I)/$200,000 (ARCH-II) in direct costs per year for research program development at the MSI to include: 1) Pilot projects between ARCH (MSI and RIU) investigators, 2) MSI faculty recruitment of NIH R01-level scientists, (only for ARCH-I applications), and 3) Facility Core at the MSI. In addition, the ARCH grant will provide the RIU up to $125,000 per year for each Research project. 1) Pilot Projects. Items that may be included are MSI and RIU investigator salaries, technical support, supplies, small equipment items, travel and other items which are necessary for the conduct of the pilot project. The maximum direct cost for each Pilot project is $75,000 per 12 month period, and the maximum length of a Pilot project is 30 months. At least two Pilot projects must be recommended by the Special Emphasis Panel (SEP) in order to be eligible for an ARCH-I award and at least two Pilot projects must be recommended by the SEP for an ARCH-II award. 2) MSI Faculty Recruitment for ARCH-I. Funds may be requested to help recruit up to two talented investigators to the MSI who have been successful in obtaining NIH RPG support, typically R01 grants. The ARCH-I award will provide up to $125,000 per year (direct cost) for three years for the establishment of a research laboratory at the MSI. These funds may be used to provide partial salary support (up to 50 percent) and laboratory set-up costs for investigators newly recruited to the MSI. The institution must provide a commitment of 50 percent salary support for the recruited investigator that is derived from non-Federal funds. Because it is unlikely that a specific individual to be recruited can be identified, a well-described plan for recruiting these individuals should be included in the application. MSI faculty recruitment will not be a feature of the ARCH-II awards. 3) 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 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 Principal Investigator may request up to $100,000 per year (direct cost) for the Facility Core. 4) Research Projects. Research projects are conducted by the RIU in conjunction with MSI investigators. The maximum direct cost for a Research project is $125,000 per year, and funding may be requested for up to five years. At least two Research projects must be recommended by the SEP in order to be eligible for the ARCH-I award and one Research project must be recommended by the SEP to be eligible for an ARCH-II award. OTHER ARCH PROGRAM REQUIREMENTS, BUDGET LIMITS AND EVALUATION A. Submission of Research Project Grants (RPG) applications to the NIH. Administrative and Research Program Development support is intended to provide the MSI investigators the time, information and skills required to prepare NIH RPG applications, typically R01s/R15s. Since the ARCH grant is not intended to provide long term research support, MSI investigators are required to apply for other NIH/NIEHS grants that will provide the long-term support required for environmental health sciences research projects. B. Graduate Student Support. 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. C. Supplemental Funds for Additional MSI Investigators or Postdoctoral Trainees. As the program develops, supplemental funds may be requested with the approval of the NIEHS staff, for the support of additional MSI faculty and postdoctoral trainees on RIU Research projects. D. Mid-Program Evaluation Criteria for ARCH Awardee. In addition to the usual review of the noncompeting 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 NIH RPG applications submitted by and awarded to MSI investigators(R01, R03, R15, P01, K01). o Success in attracting MSI faculty who have successfully competed for NIH RPGs. o Status of the MSI research infrastructure, and plans for sustaining and nurturing it after the ARCH funding ends. The in-depth mid-program evaluation will be used as a basis for awarding the fourth and fifth year of funds. E. 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; (3) ensure that the application conforms to established guidelines and criteria for an S11 application; and (4) determine the intention to apply for ARCH-I or ARCH-II. Applications submitted as ARCH-I will be reviewed only as ARCH-I applications. This means that if not enough projects are recommended for funding at the ARCH-I level, the application will not be considered by default for ARCH-II funding. The initial contact with NIEHS program staff is the responsibility of the potential applicants 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. Program staff are particularly cognizant of the scope of their programs and of 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 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. SPECIAL REQUIREMENTS Annual meetings, to be held in Research Triangle Park, NC, are planned for the exchange of information among investigators. Applicants must budget travel costs for all key personnel at both the MSI and RIU to attend these meetings in their applications. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided 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 research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, and is available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 to: Ethel Jackson, D.V.M. Chief, Scientific Review Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-24 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7846 Fax: (919) 541-2503 Email: jackson4@niehs.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: GrantsInfo@nih.gov The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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: Ethel Jackson, D.V.M. Chief, Scientific Review Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-24 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7846 Fax: (919) 541-2503 Email: jackson4@niehs.nih.gov Applications must be received by October 19, 2000. 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. REVIEW CONSIDERATIONS 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 receive a written critique and 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, assigned a priority score, and receive a second level review by the NIEHS National Advisory Council. Review Criteria 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. The review criteria are as follows: 1. Significance: Does the study address an important environmental health sciences problem? If the aims of the application are achieved, then how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive the field. 2. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigators: Address the adequacy of their time commitment. Assess measures that will strengthen and enhance collaboration between MSI and RIU investigators. 5. Environment: Does the environment in which the work will be performed contribute to the probability of success? Do the proposed experiments take advantage of the unique features of the scientific environment or employ useful collaborative arrangements? 6. When human subjects are involved, the adequacy of plans to include women and minorities in the study design and the potential of that design to address the scientific question(s) proposed must be addressed. 7. When vertebrate animals are used, ensure that appropriate animal welfare and IRB concerns have been addressed. E. Research Program Development Core: Faculty Recruitment for ARCH-I. 1. For ARCH-I proposals, plans to recruit new faculty that have successfully competed for NIH RPG grants. 2. The commitment of the MSI to recruit investigators with respect to money, laboratory and office space, and other support. In addition to the above criteria all applications will also be reviewed with respect to the following: o Evaluate the facilities, resources, and environment of the applicant institution (including existing relevant equipment, animal, and/or computer resources, and departmental or interdepartmental cooperation); o Appropriateness of proposed budget and duration in relation to the project's objectives. 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 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. AWARD CRITERIA The anticipated date of award is July 1, 2001. 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; o commitment of the university to establish a research infrastructure that is sustainable after ARCH support ends; o potential of the MSI investigators to obtain NIH research project grants (R01s/R15s) or support from other funding agencies that use the peer review process, relevant to the mission of the NIEHS; o potential of the ARCH program to make a significant contribution to the NIEHS mission; o quality of the Research and Pilot projects scientific merit as determined by peer review; and o availability of funds. Schedule Letter of Intent Receipt Date: August 1, 2000 Application Receipt Date: October 19, 2000 Peer Review Date: February 2001 Council Review: May 2001 Earliest Anticipated Start Date: July 1, 2001 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Frederick L. Tyson, Ph.D. Scientific Program Administrator Chemical Exposures and Molecular Biology Branch Office of Program Development Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, 111 T.W. Alexander Drive, MD EC-21 Research Triangle Park, NC 27709 Telephone: (919) 541-0176 Fax: (919) 316-4606 Email: tyson2@niehs.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jacqueline M. Russell Grants Management Specialist Grants Management Branch Office of Program Operations Division of Extramural Research and Training National Institute of Environmental Health Sciences Telephone: (919) 541-0751 Fax: (919) 541-2860 Email: russell@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113, 93.114, 93.115 and 93.866. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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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NIH Funding Opportunities and Notices
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