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RFA-GM-03-010: NIGMS' SUMMER RESEARCH EXPERIENCES FOR UNDERGRADUATES NIGMS' SUMMER RESEARCH EXPERIENCES FOR UNDERGRADUATES RELEASE DATE: June 16, 2003 RFA: GM-03-010 CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.859 National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/) LETTER OF INTENT RECEIPT DATE: January 19, 2004 APPLICATION RECEIPT DATE: February 17, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of General Medical Sciences (NIGMS) recognizes the increasing trend toward the use of interdisciplinary approaches to advance the nation's biomedical research endeavor and thus the need to encourage cross-disciplinary training for the next generation of researchers. Therefore, this RFA seeks to encourage cross-training of undergraduate students in the quantitative and physical sciences by providing opportunities to take part in mentored research experiences with NIH-supported biomedical investigators. Such programs should provide innovative, mentored, realistic summer laboratory research experiences for an appropriately targeted (as defined by the applicant) group of undergraduate students in biomedical research projects at the applicant institution. The proposed plan of undergraduate interdisciplinary research training should include strong faculty involvement, interactive group activities, presentations, and seminars. Applications are sought for programs that recruit students from the quantitative and physical disciplines such as, but not limited to, engineering, mathematics, computer science, and physics, to participate in biomedical and/or translational research. RESEARCH OBJECTIVES Background This program seeks to promote the initiation and development of distinct, innovative summer research experiences for a cohort of no fewer than five and no more than ten undergraduate students who would not normally be involved in the biomedical research endeavor. Programs that recruit students from disciplines not traditionally involved in biomedical research such as, but not limited to, engineering, mathematics, computer science, and physics, to participate in interdisciplinary biomedical and/or translational research are especially encouraged. Specific Objectives The proposed summer program is expected to be specifically designed for the undergraduate students majoring in 'non-biological' fields and should promote their understanding of the need to apply quantitative and related skills to solve biological questions. Development of interest among prospective research scientists in interdisciplinary approaches to biomedically related problems is the primary objective of this summer apprenticeship program. The Program Director should be an individual with the ability and authority to run an institutional, cross-departmental program. Participating mentors should have active, NIH extramurally funded research and preferably should have a demonstrated record of student training. In addition, participating mentors must be able to allocate sufficient time to mentor undergraduate participants in the summer research experience program. Additional information on NIGMS programs is available at the web site: http://www.nih.gov/nigms/. MECHANISM OF SUPPORT This RFA will use the NIH education research project (R25) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited applications will not be accepted. The anticipated award date is February 2005. This RFA uses just-in-time concepts. It also uses the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NIGMS intends to commit approximately $1.5 million in FY 2005 to fund 15 to 20 new or competing renewal applications. An applicant may request a project period of up to four (4) years and a budget for direct costs of up to $85,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary, but an applicant institution can only hold one award. Although the financial plans of 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Public or private non-profit domestic institutions, such as universities, colleges, hospitals, and laboratories that have a cohort of mentors with NIH or other extramural research support. Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, authority, and resources necessary to carry out the proposed mentoring program for undergraduates in research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Applicants should fully describe the proposed 'Summer Research Experiences for Undergraduates' Program plan and explain how its design will meet the goals of this initiative and the needs of the targeted student group. Applicants should describe the criteria to be used in the selection of students and their placement under the guidance of specific mentors. A detailed description of potential laboratory experiences as well as other enrichment activities planned for the students must be included. The enrichment activities must provide the students an understanding of basic biological concepts and of how mathematics, physics, and computer science can assist in solving biomedical research questions. Applicants should provide evidence of previous experience, if any, in mentoring the targeted population. The first week of the summer experience should also include instruction in laboratory safety, discussions of ethical considerations in research, and information on career options. The applicants need also show evidence of the distinct nature of the proposed summer program and a commitment to training the targeted pool. Applicants with existing grants to provide summer research experiences for undergraduates should describe the existing programs and explain how they do not duplicate the proposed research experiences and goals of the program designed under this initiative. Applicants can only submit one grant proposal per institution. NIGMS expects that students who enter a Summer Research Experiences for Undergraduates Program will receive support from the institution (grantee), i.e., access to equipment and library resources. Applicants should describe the type(s) of institutional resources that would be available for this program as well as a plan for monitoring student activities to ensure that the program goals are being met. Undergraduate students selected to participate in the summer programs should be U.S. citizens or permanent residents. Evaluation Requirements Each application must include an evaluation plan that clearly identifies measurable objectives, ascertains outcomes, and describes the steps to assess effectiveness of the proposed activities. An applicant should describe the current methods and facilities available for tracking student participants and must provide details of the methodology to be used to assess whether the program is meeting the program's objectives. Ideas on approaching evaluations of this type of program may be found on http://www.the-aps.org/education/promote/promote.html. This site is a project of the American Physiological Society that has received support from NIGMS. Although it is targeted to the evaluation of programs to increase the number of underrepresented minorities in biomedical science, the material on this site may also be used as a resource for developing evaluation plans for Summer Research Experiences for Undergraduates Programs. For each noncompeting renewal, the Program Director will report on evaluation of the impact of the Summer Research Experiences for Undergraduates on the student career choices in the participating departments. Reporting Requirements The Application for Continuation of a Grant (PHS 2590, rev. 5/01, https://grants.nih.gov/grants/forms.htm) or equivalent documentation must be submitted to, and be approved by, NIH to noncompetitively fund each additional budget period within a previously approved project period. The PHS 2590 (SNAP) application should include in the progress report a list of students supported, description of the enrichment activities provided, and a list of the mentors participating in the summer research experience. The annual progress report must also include information on how the proposed program objectives were fulfilled (reference: NIH Grants Policy Statement, NIH Publication No. 99-8, October 1998). At the end of the approved project period, a final report summarizing the accomplishments of the program (total number of students that participated during the entire grant period and the effect of their undergraduate research experiences on their current career plans) must be submitted. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: programmatic, peer review, and financial or grants management issues: o Direct inquiries regarding programmatic issues to: Hinda Zlotnik, Ph.D. Program Director, Summer Research Experiences for Undergraduates National Institute of General Medical Sciences, NIH 45 Center Drive, Room 2AS.37K, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301)594-3900 FAX: (301)480-2753 E-mail: Zlotnikh@nigms.nih.gov o Direct inquiries regarding 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.12F, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301)594-2881 FAX: (301)480-8506 E-mail: sunshinh@nigms.nih.gov o Direct inquiries regarding fiscal matters to: Antoinette Holland Grants Management Officer Division of Extramural Activities 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 summer program plan o Name, address, and telephone number of the Program Director o Names of other key personnel o Participating institution(s) 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 NIGMS 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: Hinda Zlotnik, Ph.D. Program Director, Summer Research Experiences for Undergraduates National Institute of General Medical Sciences, NIH 45 Center Drive, Room 2AS.37K, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301)594-3900 FAX: (301)480-2753 E-mail: Zlotnikh@nigms.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. SUPPLEMENTAL INSTRUCTIONS Allowable Costs: If appropriate, the budget may include: o Salary and Wages: (1) Student remuneration through salary, wages and fringe benefits for participation in summer research experiences. In order to provide student salary support, (a) students must perform actual and meaningful research work; (b) an employer-employee relationship must exist between the student and the institution; (c) total compensation must be reasonable for the research work performed; and (d) it must be the institution's practice to provide compensation for all students in similar circumstances. Caution should be used not to permit students to receive duplicate federal support (excluding Pell Grants and VA Benefits). (2) Staff salaries and wages should be limited to partial remuneration for the Program Director (no more than 10% effort) and an administrative assistant (no more than 25% effort). A strong justification of their role in the project should be provided. o Supplies and Other Expenses: The budget may include funds for research supplies up to $750 per student. Facilities and administration costs will be provided at a rate of 8% minus exclusions. Unallowable Costs: o Include, but are not limited to: stipends, equipment, housing, food, incentives, travel costs (e.g., to meetings or training sites), textbooks, tuition, and entertainment costs. Consortium agreements (related costs) are also unallowable. 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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Helen R. Sunshine, Ph.D. Chief, Office of Scientific Review National Institute of General Medical Sciences, NIH 45 Center Drive, Room 3AN.12F, MSC 6200 Bethesda, MD 20892-6200 APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. 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, describing the changes and improvements made, and marked text to indicate the changes. 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 Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the NIGMS National Advisory Council. REVIEW CRITERIA In their written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed summer research experience will have a substantial impact on the pursuit of the stated program goals: o Description of a distinct summer program that includes enrichment activities in addition to mentored research experiences and provides quantitatively trained students with the background needed to understand and pursue biomedical research; o Quality of the proposed summer program activities and likelihood that they will provide a meaningful research experience for the targeted population; o Rationale for the selection procedures of the targeted student population and evidence of adequate student pool; o Qualifications and experience of the research faculty as investigators and mentors, including evidence of adequate NIH-funded support; o Qualifications and experience of the program director to carry out the proposed program; o Merit of the measurable objectives and the plan for the evaluation of the impact of the program; o Evidence of institutional commitment; adequacy and availability of research resources and the research environment; o Cost-effectiveness of the project, appropriateness of the scope of the program and its potential benefit to the students. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: January 19, 2004 Application Receipt Date: February 17, 2004 Peer Review Date: June/July 2004 Council Review: September/October 2004 Earliest Anticipated Start Date: February 1, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Programmatic priorities o Geographical distribution of awardee institutions o Availability of funds REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving humans subjects be evaluated with reference to the risks to the subjects, the adequacy of the 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001 .htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://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 https://grants.nih.gov/grants/guide/notice -files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://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 https://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.

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