PAR-98-087: SMALL GRANT PROGRAM FOR K08 RECIPIENTS

Department of Health
and Human Services (HHS)

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SMALL GRANT PROGRAM FOR K08 RECIPIENTS Release Date: July 9, 1998 PA NUMBER: PAR-98-087 P.T. National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces a program that will permit awardees of its Mentored Clinical Scientist Development (K08) awards to apply for Small Grant (R03) support that would run concurrently with the latter years of their K08s. Through this mechanism, which will allow up to $50,000 per year for two years in additional research development costs, the NIDDK is seeking to enhance the capability of its K08 award recipients to conduct research as they complete their transition to fully independent investigator status. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement, Small Grant Program for NIDDK Mentored Clinical Scientist Development Award (K08) Recipients, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402- 9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS This mechanism is available only to those currently holding the K08 award from NIDDK. Details of the K08 Award are given in NIH Program Announcement PA-95-053 (NIH Guide, Vol. 24, No. 15, April 28, 1995). Additional information about the K08 as it is implemented in NIDDK is given in the NIH Guide, Vol. 24, No. 38, October 27, 1995). Holders of NIDDK K08 awards will receive a letter from the NIDDK at the appropriate time in their award period, near the beginning of their third year, inviting them to submit an R03 application. Awardees must have at least two years remaining on their K08 at the intended start date of the R03 award. Under certain circumstances, and on a case-by-case basis, permission may be given for an applicant with less than two years remaining on their K08 award to apply for the R03. Applications may be submitted, on behalf of candidates, by domestic non-Federal nonprofit organizations, public or private, such as medical, dental, or nursing schools or other institutions of higher education. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply. MECHANISM OF SUPPORT Awards in response to this program announcement will use the small grant (R03) award mechanism. Planning, direction, and execution of the program will be the responsibility of the candidate on behalf of the applicant institution. Applications may be submitted for up to two years of support. Candidates may apply for up to $50,000 in direct costs per year to cover costs of research development for the -04 and -05 years of the career award. RESEARCH OBJECTIVES The NIDDK invites current recipients of its K08 awards to apply for grant support during the latter years of their awards through the NIDDK"s Small Grant Program (R03). Through this mechanism, the NIDDK is seeking to enhance the capability of its K08 award recipients to conduct research as they complete their transition to fully independent investigator status. It is expected that this opportunity to enhance their research capability during the terminal phase will have the following advantages: o increased fiscal independence for the K08 award recipient as a precursor to complete independence, o an opportunity to generate publications and data to form the basis for an R01 application, o an opportunity for a Scientific Review Group (SRG) to evaluate accomplishments made during the first two years of the K08 award and an opportunity for the applicant to provide more detailed research plans for the terminal phase of the award, and o an opportunity for the recipient to demonstrate success in the peer review process during the course of their K08 award. In implementing this program, the NIDDK will pay special attention to several factors, including the institutional commitment to the career goals of the applicant, the career development program itself, and how it will be enhanced by the availability of funds under the R03 program. In no case will the NIDDK discourage K08 recipients from applying for and receiving R01 awards during the course of their career awards, however, any K08 recipient who receives an R01 will not be awarded an R03 as well. Simultaneous with the publication of this announcement, the NIDDK will contact current K08 recipients in writing and advise them of the program. Those beginning their -03 or -04 years will be invited to apply for either a one- or two-year award as soon as feasible. 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 is 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 have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE 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://www.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits 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) 435-0714, email GrantsInfo@nih.gov. The program announcement title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. It is essential that the full grant number of the applicant"s K08 award be provided so that the R03 application can be linked to the appropriate parent K08 award, put this information in the Abstract and at the beginning of the Research Plan. In general, applications will be submitted for two years of support. Under exceptional circumstances, an application for one year may be submitted, applicants are encouraged to contact Program Staff for approval to submit an application for one year of support. Applicants may apply for up to $50,000 in direct costs per year to cover additional costs of research development for the - 04 and -05 years of the K08 award. None of the R03 award may be used for the Principal Investigator"s salary, which is covered by the K08. Funds may be used for technical support, equipment, supplies and other research development costs. Indirect costs (F&A costs) will be provided to the grantee institution at the full rate, this is in contrast to the "parent" K08 award, which will continue to provide F&A costs at the rate of 8 percent. Specific allowable costs: o Salary: none for the Principal Investigator this is covered under the K08, salary for technical support is permitted, but not mentor salary support, secretarial or administrative assistance. o Research development costs: tuition, fees, and books related to career development, supplies and equipment, travel to research meetings or training, statistical services, including personnel and computer time. Applications must address the following issues: o Research accomplishments to date under the auspices of the K08 award: This should include publications, presentations, manuscripts submitted or in preparation. Describe the progress that has been made toward the goals of the K08 award. o Research plan: Describe the research goals for the final two years of the K08 award. Describe how the availability of the resources provided under the R03 would enhance progress. If the original goals of the K08 award have changed, detail the changes. While the original K08 application had provided information about the research plan, this R03 application allows the candidate the opportunity to provide specific and detailed information about the research plan for the final two years, particularly with additional financial resources available. o Environment and career development plan: The institution"s continued commitment to the career development goals of the applicant should be documented. What facilities are to be placed at the disposal of the applicant? What educational opportunities, if necessary, will be available to the applicant? o A letter from the applicant"s mentor should be included. It should address the applicant"s progress, the applicant"s potential for a future research career, and the mentor"s continuing relationship with the applicant. It is expected that, during the final two years of the K08 award and with the added resources provided by the R03, the applicant will become increasingly independent of the mentor. Mail the signed, original, single-sided application, along with five exact, single-sided copies and five collated sets of appendix materials 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) REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review. Applications that are complete will be evaluated by the same scientific review group (SRG) that reviewed the competing K08 applications. 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 applications under review, will be discussed, assigned a priority score, and receive a second-level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score. o Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o 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? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? o Appropriateness of the proposed budget and duration in relation to the proposed research. o 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 SRG will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. The following special review criteria will be applied to these R03 applications: o Research accomplishments: what has the candidate accomplished to date toward the goals of the awarded K08? Have the research goals of the current application diverged from the original K08 aims? o Scientific merit of research plan: how feasible is the research plan for two years of work? o Potential: what is the potential of this mechanism to successfully prepare the candidate to be competitive for funding opportunities at the end of the award? Has the institution"s commitment to the scientific development of the candidate changed? o Relationship to mentor: does the mentor"s letter adequately discuss the candidate"s progress? What is the continuing relationship between candidate and mentor? INQUIRIES Inquiries are encouraged. We welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Paul M. Coates, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN-32, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8805 FAX: (301) 480-3768 Email: coatesp@extra.niddk.nih.gov Judith Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-12E, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: podskalnyj@extra.niddk.nih.gov Charles Rodgers, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-19J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: rodgersc@extra.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Donna Huggins Supervisory Grants Management Specialist Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive MSC 6600, Room 6AS-49J, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8848 Email: hugginsd@extra.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847, 93.848, and 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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 and contract 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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