EFFICACY OF INTERVENTIONS TO PROMOTE RESEARCH CAREERS RELEASE DATE: August 24, 2004 RFA Number: RFA-GM-05-009 (Reissued as RFA-GM-07-005) EXPIRATION DATE: November 16, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.859, 93.864 LETTER OF INTENT RECEIPT DATE: October 18, 2004 APPLICATION RECEIPT DATE: November 15, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 goal of this RFA is to support research that will test assumptions regarding the effectiveness of interventions that are intended to increase interest, motivation and preparedness for careers in biomedical research, with a particular interest in those interventions specifically designed to increase the number of underrepresented minority students entering careers in biomedical and behavioral research. Since it is likely that comparable interventions are applicable to students universally, the proposed research need not be restricted to underrepresented minority students. Indeed, comparative research may well be particularly illuminating and is, therefore, encouraged. RESEARCH OBJECTIVES The National Institutes of Health (NIH) recognizes that there is a significant under-representation of minority scientists engaged in biomedical and behavioral research in the U.S. Consequently, over the past 30 years the NIGMS, other institutes of the NIH, other agencies of the federal government and private foundations have instituted a variety of programs designed to redress this disparity. To accomplish the goal, the programs supported three main types of objectives: a) increasing the participant pool generally by stimulating students' interest at multiple stages, starting as early as middle school; b) retaining the participant pool via remediation, support services such as tutoring and financial aid, bridging programs, and activities designed to motivate; and c) strengthening the participant pool via acquisition of knowledge, academic enrichment and development of skills deemed important for success as a scientist. The types of interventions supported by the various programs have almost always included financial support and encouragement to underrepresented minority undergraduate and graduate students to participate in biomedical research in a variety of academic institutions. Emphasis has also been placed on providing financial support and encouragement directly to institutions themselves, with the expectation they would use their enhanced capacity and resources to encourage and sustain biomedical research among both faculty and students. Some consistent beliefs underlying these interventions have been: 1) when students are provided the opportunity to engage in state-of-the-art biomedical research, with appropriate facilities, support and mentorship, their appetite will be whetted to enter a career in biomedical research; and 2) once focused, they will show improvement in academic and other skills needed to pursue successfully a biomedical research career. Based upon these beliefs, one type of program component that has been supported is early exposure to laboratory research and a research-experienced mentor. Because these beliefs are consistent with the experience of many successful scientists and make intuitive sense to many, diverse programmatic interventions have evolved over the years. These include creation of intra- institutional student-researcher environments, on- or off-campus summer research experiences, attendance at professional scientific conferences and research seminars, tutoring in "gate-keeper" courses (e.g., organic chemistry, calculus), subsidy of GRE preparatory courses, post-baccalaureate transitional research experiences (pre-graduate school), and individual research fellowship support or training-grant-type support. To date, however, the use of these interventions has been based more on educated assumptions by the stakeholders than on systematic analysis. A notable exception is the Merit Workshop at the University of California, Berkeley, which grew out of Uri Treisman's observations of study behaviors of at-risk students that challenged prevailing assumptions (1992, College Mathematics Journal 23(5), 362-372). Nevertheless, there is a need for research designed to develop an empirical base of evidence upon which new interventions can be developed, and existing interventions can be improved. The purpose of the present initiative is to invite innovative grant applications that utilize research designed to identify and optimize strategies for engaging students and characteristics of interventions (e.g., content and structure of program and curricula, methods, intensity, duration, etc.) that encourage increased numbers of well-educated underrepresented minority students to enter careers in mainstream biomedical research and be competitive at the highest levels. It also invites applications for research that would test underlying assumptions of how interventions interest, challenge, motivate or otherwise affect students, especially regarding their choice of a career in biomedical and/or behavioral research. Since the focus of this RFA is on underrepresented minority students, proposed research involving non-minority students should be comparative, rather than addressing non-minority students exclusively. Examples of some basic types of questions that might inform this purpose are: Which characteristics of a student and program (e.g., skills, preparation) are likely to lead to the pattern of persistent engagement that enables the student to develop into a biomedical researcher? Which variables in a student's background and/or personality are likely to affect career choice, ability to excel and compete at the highest levels, and commitment to succeed? In which ways do variables in student personality, attitude, behavior, etc., influence the successful progression of career development? Is there an optimum age or level of maturity of a student that maximizes outcome? Are behavior patterns that are critical for a successful biomedical/behavioral research career teachable? To what extent do the teaching skills, preparedness, or motivation of one’s science teachers, beginning in elementary school, impact one’s career development. To what extent do peers, the immediate family, local community, and/or personal economics influence minority individuals' choosing to enter or remain with research careers? To what extent does the relative influence of these factors vary across minority/ethnic groups, other subpopulation groups, or the majority population? In which ways do (or could) various programs build on these factors and/or serve as interventions to mediate their effect? Which variables in interventions are likely to have the greatest effect on student career choice? To what extent do mentors or other persons serving as role models affect students' career choice? What are the most salient characteristics of mentors and role models? How are these key factors different and similar for each, and what different functions do mentors versus role models versus social support from peers and/or family play in affecting the success of minority researchers? At which developmental vs. career stages do role models or mentors make a difference in students' career choice? How does the relative effectiveness of different interventions change with age/developmental stage? What is the relative efficacy of support to institutions, individual investigators, and individual students? In which ways does collaboration, particularly with majority institutions or individuals, affect career choice among students who participate in training or related programs addressed to minority institutions or individuals? To what extent does the quality of the research infrastructure (environment, facilities) impact career choice, in positive and/or negative ways? It would be desirable if the proposed research would compare the effectiveness (and potential cost-effectiveness) of the experimental intervention(s) with that of existing practice. The efficacy of the interventions should be considered in the context of the student characteristics and the academic environment. Another desirable outcome would be the revelation of new principles that would inform practice. Applicants should discuss how recommendations based on the new evidence could be used to modify and/or reinforce existing practices, and/or inform novel interventions. Applicants should note that the proposed study should be a research, rather than an evaluation, project. If development of a database (e.g., problem-based, which is designed to address specific research questions) is proposed, the rationale for selection of the specific elements should be explained and justified. This RFA will result in grants supporting individual and possibly multi-site multidisciplinary research projects. It is expected that the research findings will be published in peer-reviewed journals. MECHANISM OF SUPPORT This funding opportunity will use the NIH R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE The participating ICs intend to commit approximately $2.4 million in FY 05 to fund six to eight new grants in response to this RFA. An applicant may request a project period of up to four years and a budget for direct costs of up to $300,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIGMS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution is a domestic one and has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Foreign institutions are not eligible to apply o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your 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: Clifton A. Poodry, Ph.D. Director, Division of Minority Opportunities in Research National Institute of General Medical Sciences, NIH 45 Center Drive, Suite 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 E-mail: poodryc@nigms.nih.gov Matthew A. Kinnard, Ph.D. Director, Extramural Associates Program National Institute of Child Health and Human Development National Institutes of Health 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-2736 Fax: (301) 480-0393 Email: kinnardm@mail.nih.gov o Direct your questions about peer review issues to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences, NIH 45 Center Drive, Room 3AN.12, MSC 6200 Bethesda, Maryland 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 E-mail: sunshinh@nigms.nih.gov o Direct your questions about financial or grants management matters to: Ms. Antoinette Holland Grants Management Officer National Institute of General Medical Sciences, NIH 45 Center Drive, Room 2AN.50, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5132 FAX: (301) 480-2554 E-mail: hollanda@nigms.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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Clifton A. Poodry, Ph.D. Director, Division of Minority Opportunities in Research National Institute of General Medical Sciences, NIH 45 Center Drive, Suite 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 E-mail: poodryc@nigms.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at: http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at 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 Appendix, and three signed photocopies (without appendices) 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 plus five sets of any appendix material must be sent to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences, NIH 45 Center Drive, Room 3AN.12, MSC 6200 Bethesda, Maryland 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 E-mail: sunshinh@nigms.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. The NIH 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 from the previous unfunded version of the application. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIGMS. 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 NIGMS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goal of the research supported by the present NIH grant mechanism is to inform evidence-based interventions that will increase the numbers of underrepresented minority students who enter careers in mainstream biomedical and behavioral research at a competitive level. 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 an impact on the pursuit of these goals. 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. o Significance o Approach o Innovation o Investigator o Environment 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 the proposed research address an important problem? If the aims of the application are achieved, what is the likelihood that novel interventions can result that will increase the numbers of underrepresented minority students who enter mainstream biomedical and/or behavioral research careers at highly competitive levels? What will be the effect of the research on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, rationale, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the PI justify adequately the rationale for the selected experimental interventions and the data to be collected, e.g., for database construction? Does this proposal incorporate a rigorous research-based experimental design? Is the pool of target students clearly identified and adequate to provide meaningful information? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator? If the proposal utilizes a research team, is the team composition, the unique expertise of the different team members, and their expected contributions to the project, adequately described and justified? ENVIRONMENT: Does the educational/scientific environment in which the work will be done contribute to the probability of success? Does the proposed research take advantage of unique features of the educational/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: 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 will be assessed. Plans for the recruitment and retention of subjects will also be assessed. (See Inclusion Criteria in the sections on Federal Citations, below.) ADDITIONAL CONSIDERATIONS DATA SHARING: A data sharing plan is not required. 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 18, 2004 Application Receipt Date: November 15, 2004 Peer Review Date: February-March, 2005 Council Review: May, 2005 Earliest Anticipated Start Date: July 1, 2005 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 unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 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. 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). 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 the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.