CONTENTS
Definitions
Eligibility Requirements
Collaborations and Partnerships
Center Characteristics
Research/Pilot Projects
Training and Career Development
Budget/Support
Peer Review
Definitions
FAQ 1. What is the overall focus of this RFA?
ANSWER. The overall focus of the initiative is intended to stimulate the development of a competitive research environment in reproductive science at minority institutions. Reproductive scientists at minority institutions are invited to establish a collaborative partnership with NICHD-funded reproductive science research institutional programs. Our expectation is that such centers would bring together strong teams of investigators, around a reproductive science theme, to share essential facilities, services, knowledge, and other resources.
FAQ 2. How does NICHD define a minority institution?
ANSWER. For the purposes of this RFA, a minority institution is defined as one in which 50 percent or more of the students enrolled are from racial/ethnic minority groups and a significant proportion of the minority students are underrepresented in the biomedical sciences. The intent of this requirement is to link the research with institutions that educate individuals that are predominately from racial/ethnic minority groups. This initiative is viewed as a way of strengthening the research capacity of the minority institution, increasing the interest and involvement of these students in research, expanding opportunities for minority scientists, particularly those underrepresented within the scientific workforce, and in the long-term diversifying the scientific workforce.
FAQ 3. How are the racial and ethnic minority groups defined?
ANSWER. The federal government has a standard set of definitions for racial and ethnic minority groups including Blacks/Non-Hispanic, Asian/Pacific Islanders, Hispanics, and Alaskan/Native American. Racial/ethnic groups considered underrepresented in the biomedical sciences include African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders.
FAQ 4. A minority institution is defined as one in which 50 percent or more of the students enrolled are from racial/ethnic minority groups and a significant proportion of minority students are underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders). Is an institution required to complete a certification process to be so designated?
ANSWER. No certification process is necessary. Institutions will be requested to provide evidence that 50 percent or more of the students enrolled are from one or more of the federally recognized racial/ethnic minority groups and that a significant proportion of the minority students are underrepresented in the biomedical sciences as outlined in this initiative. Schools already designated as a minority institution (e.g., HBCU, Hispanic serving institution, and tribal university or college) can use that designation instead of actual student census figures.
FAQ 5. If the Principal Investigator and key investigators/co-investigators of the minority institution are not considered members of racial and/or ethnic minority groups, will the application be considered responsive to the RFA?
ANSWER. Yes. The RFA does not preclude this from happening. The minority status refers to the institution, not to the individual investigator. However, taking this approach does seem to defeat the intent of the RFA and may reduce the likelihood that the initiative can be viewed as a vehicle for increasing the research opportunities for individuals and involving individuals from minority groups, especially those underrepresented in biomedical research, as a way of increasing the diversity of the research workforce. To the extent possible, diversification among the proposed research group would meet the intent of the RFA, keeping in mind the focus on research excellence as a major objective.
FAQ 6. I did not submit a letter of intent. Is it necessary and can I still submit one?
ANSWER. A letter of intent indicates that a particular team intends to submit an application. It is not required nor is it binding. It is, however, very helpful for the Institute in arranging for peer reviewers. Thus, including as much information about the planned center, (e.g., key individuals involved, institutions involved) along with an e-mail address of the Principal Investigator and her/his telephone number, is very useful. Including as much information as possible about the planned research helps in identifying and planning for appropriate reviewers. Yes, you can still submit a letter of intent.
FAQ 7. What is meant by reproductive science research?
ANSWER. As stated in the RFA, reproductive science research encompasses the following broad topics: (1) reproductive biology, physiology, and genetics; (2) reproductive endocrinology; (3) reproductive medicine encompassing infertility, gynecology, and andrology; and (4) risk factors for reproductive disorders. The center may focus on areas of research important to the reproductive health of men and/or women. Children should be included, as appropriate, based on the research topic.
Eligibility Requirements
FAQ 8. Which institutions are eligible to apply?
ANSWER. The applicant institution must be a minority institution in the United States, its possessions or its territories that offers Ph.D., M.D., and/or equivalent health professional degrees. Each applicant institution must identify a formal collaborative affiliation with an NICHD-funded reproductive science research institutional program. The specific collaboration will depend on the research theme, the applicants, and the organization of each individual center.
FAQ 9. Some of the NICHD-designated reproductive science research institutional programs have a Program Director in addition to the Principal Investigator. Can the Program Director be the Co-director of the center?
ANSWER. No. Only the Principal Investigator of the NICHD-designated reproductive science research institutional program can be the Co-director and share in the leadership responsibilities with the Center Director at the minority institution.
FAQ 10. Our minority institution has a research program in reproductive science. Does that make us ineligible for this program?
ANSWER. The RFA does not preclude you from applying and it would depend on the nature of your program and its stage of development. However, in light of the fact that one purpose of this RFA is to encourage partnerships to help strengthen the research infrastructure and capability of the faculty and students at the minority institution in reproductive science, this might be viewed as defeating the intent of the RFA if the institution already has a formal advanced reproductive science research program.
Collaborations and Partnerships
FAQ 11. What is meant by collaborations and partnerships?
ANSWER. Each center will represent a partnership between a minority institution and one of the NICHD-supported reproductive science research institutional program with proven expertise in the design and conduct of basic science, translational, and/or clinical reproductive science research. Activities of a center will require extensive collaborative activities. The nature of the partnerships or collaborations are determined by the groups involved, their respective resources, expertise and roles in the research, and the topical subject matter of the proposed research. The applicant team must determine their strengths, weaknesses, and interests to propose a series of projects, cores and activities that will maximize their capabilities in addressing the goals of this initiative.
FAQ 12. What is the best approach to facilitate collaborations among the minority institution and the NICHD-designated reproductive science research institutional program?
ANSWER. There is no one best approach. We encourage each prospective applicant to review their strengths and weaknesses in order to identify gaps that need to be filled and that will help maximize their ability to address the goals of the initiative. Collaborators should be selected that can facilitate the objectives of each center in terms of the planned research projects as well as the availability of resources.
FAQ 13. What is the best way for the partners to communicate?
ANSWER. Institutions may differ in their research priorities, goals and objectives. We suggest that you start by building upon those differences. To attain effective working relationships, successful centers can expect to spend time fostering these relationships through continual attention and assessment. The centers should begin the process by consistently working together as partners in all aspects of planning and developing the research. An organizational structure that is clear and well thought out should help facilitate communications. We believe that the most important activity will be regular meetings among the partners, which will go a long way to secure a cohesive partnership.
FAQ 14. Does the cooperative agreement mechanism allow the NICHD to assume direct control of the center and the research projects?
ANSWER. No. Under the cooperative agreement mechanism, the NICHD staff will support and stimulate research by working jointly in a partner role, but will not assume direction, prime responsibility or a dominant role in the activity. The Center Director affiliated with the minority institution and the Co-director associated with the NICHD-supported reproductive science collaborating institution will be responsible for the scientific and administrative leadership of each center. Primary authority and responsibility for the research will remain with the Center Director and Co-director. The responsibilities include such items as defining the scientific objectives, pursuing research approaches, planing and conducting experiments, collecting and analyzing data, publishing results, interpretations, and conclusions of the studies.
Center Characteristics
FAQ 15. What are the roles of the administrative and research development cores?
ANSWER. Cores are intended to support the administrative and research activities associated with an individual center. There are two required cores. The administrative core is intended to support overall day-to-day administrative activities. The research development core is intended to support all of the research projects and activities supporting these projects.
FAQ 16. Can other cores be proposed in the application?
ANSWER. The RFA does not preclude the applicant from proposing other cores. The name is not as important as the function. The applicant may also use the terms: unit, service or facility to identify the nature of and rationale for a separate structure needed to support the activities of the center. However, it is important that the function be well defined and in keeping with the overall administrative and scientific structure of the center.
FAQ 17. What are the relative roles of the Steering Committee when compared to the Advisory Board in terms of management and guidance?
ANSWER. Each Center Director and Co-director will participate as members of the Steering Committee that will assist in the coordination of all centers. The Steering Committee will employ a consensus decision making process in guiding and evaluating the progress of member center programs, their proposed new research initiatives within the general scope of the approved programs, and the need for further collaboration either within or outside the center.
An independent Scientific Advisory Board will advise the Steering Committee in identifying and prioritizing research topics appropriate for study. The Scientific Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will consist of consultants with appropriate research expertise. The Board will (1) review the broad goals and accomplishments of the Center, (2) assess interim progress of all scientific projects and their relevance to the broad objectives of this initiative, and (3) assist in identifying, prioritizing, and reviewing proposed research projects that emerge during the course of the grant.
FAQ 18. What are the long-term future goals of the RFA?
ANSWER. It is our hope that a minority institution will be able to use the center grant to stimulate additional funded research activities. If successful, the center should be able to increase the competitive environment, add a substantial number of research projects, training and career development opportunities, and other activities to the ones supported by the initial funding of the center. We envision that each center will ultimately become a training and mentoring resource for developing and strengthening the research capacity of the nation by expanding opportunities for minority scientists, particularly those underrepresented within the scientific workforce.
Research/Pilot Projects
FAQ 19. The RFA refers to a reproductive science theme. Does this mean that all of the projects have to focus on one research subject?
ANSWER. No. The RFA is written broadly to stimulate ideas and to give potential applicants maximum flexibility in designing a center that will increase the knowledge base of reproductive science research and increase the research infrastructure of minority institutions. The research projects may focus on the same topic or may concentrate on several of the research topics listed under scope of research. However, this RFA solicits research that is very mission oriented. We are using the word "theme" in the broad sense to include all of the designated reproductive science research areas supported by NICHD and delineated in the announcement under research scope. The center may have one or more than one theme, focus or emphasis, but all of the projects involved must be responsive to topics described in the RFA.
FAQ 20. Can a center include under its research umbrella any or all topic areas that address male and female reproductive issues?
ANSWER. The selection and design of the research is within the purview and responsibility of the applicant team. Nevertheless, the research projects selected must be compatible with subjects that address reproductive science research areas within the mission of the NICHD, as outlined under scope of research. Thus, research targeting cancerous or precancerous reproductive conditions, reproductive processes related to the menopause or areas of andrology focusing on male sexual function/dysfunction and prostate growth/enlargement are examples of topics not solicited in this RFA.
FAQ 21. Does each application have to include three, five-year projects?
ANSWER. There must be three research projects active at any point in time. The length of individual projects, however, may vary depending on the nature of the study. Scientific considerations should determine the length of the project. All research projects should include a timeline so that the reviewers can include this estimate in the overall scientific merit of the project. In cases where a study will end before five years, another project must take its place.
The center should have a planning and evaluation component in place for reviewing new research projects. A detailed description should be in the application describing the selection process used to replace or add-on new research projects, and to deal with changing plans, approaches and timelines.
FAQ 22. How many traditional R01-type projects are required and how do we determine the lead or key investigator?
ANSWER. As stated in the RFA, at least two of the projects must be traditional R01-type research projects. Each R01-type research project may not exceed $250,000 in direct costs per year. Each Center may include, in addition to the two traditional research projects, one or more short-term research pilot projects. The total project period for the pilot projects may not exceed two years and each pilot project may not exceed $100,000 in direct costs per year.
Each project must involve participation by accomplished co-investigators from the collaborating institutions as either the lead/key investigator, or the co-investigator. The individual selected to be the lead or key investigator should be determined by the research focus and scientific expertise of the investigator.
FAQ 23. Can the short-term or pilot projects be used as training opportunities for developing investigators?
ANSWER. The purpose of the short-term project(s) is to support pilot or feasibility studies that can lead to a traditional research project(s) funded as part of the center grant. Pilot projects are used to answer very focused and specific questions that can be used to proceed with a major research project. We do not intend the pilot projects to represent training for developing scientists. They may be involved in the pilot research because there is much background work needed to develop a major research project. However, it is outside the scope of this RFA to use the pilot projects purely for training purposes.
Training and Career Development
FAQ 24. Can a formal training component be included in the application?
ANSWER. No. This is not a training grant mechanism. However, we believe that a strong research base and participation in research supported by this initiative can have significant impact on career development experiences of students enrolled at the institution. Applicants are encouraged to use existing NICHD research training and/or career development programs to encourage qualified and interested students, particularly those underrepresented in the scientific workforce to participate in research funded under this RFA.
Budget/Support
FAQ 25. Does the $1 million cost per center include direct and indirect costs?
ANSWER. An applicant may request a project period of up to five years and a budget for direct costs of up to $1 million per year. The $1 million direct costs per year do not include the Facilities and Administrative [(F & A) previously called 'indirect'] costs of the applicant minority institution. However, it does include the direct and indirect costs of all consortium arrangements. We encourage the applicant to use the center as an opportunity to obtain other funding and/or in-kind support from their associated collaborators and partners.
FAQ 26. Does the budget include costs for equipment?
ANSWER. Costs for small pieces of equipment are anticipated and allowed. We encourage the applicant to consider in-kind equipment support from their collaborators and partners.
FAQ 27. Can the RFA be used for purchasing major pieces of equipment or renovating existing facilities or building new facilities?
ANSWER. The term "infrastructure," as used in this RFA, does not refer to major pieces of equipment or renovation of existing facilities or building of new facilities. Therefore, these items are not covered in the RFA. Given the fact that the $1 million direct costs per year must be used to cover the costs of the center, research projects, and consortium arrangements (including their indirect costs), all expenses should be reviewed carefully. Our suggestion is that you consider using in-kind support, sharing equipment or existing core services from collaborators and partners.
Peer Review
FAQ 28. Who will determine if the application is responsive to the RFA?
ANSWER. As indicated in the RFA, upon receipt of each application NICHD staff will determine whether it is responsive to the RFA (e.g., direct costs of up to $1 million per year including F & A costs on consortium arrangements, required partnership and collaboration with an NICHD-designated reproductive science institutional program, and a minimum of three research projects with at least two of the projects being R01-types, etc.).
FAQ 29. Will the reviewers have the appropriate expertise and be aware of the intent of the RFA?
ANSWER. The NICHD Division of Scientific Review (DSR) plans to review the applications using a Special Emphasis Panel (SEP) formed to review the applications submitted in response to this RFA. DSR will select individuals with expertise reflected in the proposed projects or segments of the application. We will share with the reviewers the FAQs and discuss with them the RFA to ensure that they understand this initiative and what we are trying to accomplish.
FAQ 30. How will the reviewers rate the scientific merit of the applications?
ANSWER. As stated in the RFA, we will use the standard NIH review procedures, practices and criteria. The same standards that apply to any application will apply. Like other multi-project applications, we plan to rate each project separately as well as assess the overall merit of the center as a whole and the research and administrative cores. There are independent sets of criteria for these assessments that are included in the RFA. Using this approach provides Institute staff with useful information to facilitate making decisions that, in general, are made based on the rated quality of the center as a whole.
FAQ 31. Does the Principal Investigator have to have a record of successful NIH funding?
ANSWER. No. It is important for the PI to have a record of successful funding, although it need not be from the NIH, and be able to manage large research projects of the type proposed in the application. The Center Director should be able to provide overall leadership, in collaboration with the proposed Co-director, for a center such as the one described in the RFA.
FAQ 32. Would it be advisable to propose more than three research projects? How many research projects should be proposed?
ANSWER. There is no set number of projects that should be proposed. The primary requirement is that at least three of them must be recommended by the reviewers for funding. If less than three are recommended, the collection of projects does not constitute a center and will be ineligible for an award.