NCRR SERCA Guidelines

Special Emphasis Research Career Award (SERCA, K01) in Pathology and Comparative Medicine

Supplementary Program Guidelines for Mentored Research Scientist Development Awards (K01) - October 1998

I. Introduction

These guidelines summarize current policies governing the Special Emphasis Research Career Award (SERCA) in Pathology and Comparative Medicine which is offered by the Division of Comparative Medicine (DCM), National Center for Research Resources (NCRR), National Institutes of Health (NIH). This special award is made to develop multidisciplinary veterinary researchers who will direct their research careers to investigations in the broad field of comparative medicine. These guidelines are supplementary to the trans-NIH announcement titled "Mentored Research Scientist Development Award" (NIH Guide Vol. 24, No. 15, April 28, 1995).

The SERCA award emphasizes in-depth research experience in a variety of basic and clinical science disciplines. The overall program should be focused around a central concept; for example, the pathologic evaluation of induced and spontaneous mutant animals such as mice, rats or zebrafish and other aquatic species. Upon completion of the award, candidates should have acquired the knowledge and the skills necessary to compete for independent research support.

II. Background

Laboratory animals are used in nearly half of all research projects supported by the NIH. The SERCA is intended to stimulate the development of comparative medical researchers with interests in comparative medicine and related research problems. Examples of research needs and opportunities in this area include:

• Animal Models: discovery and development of natural and induced animal models of human biology and disease.
• Pathology: training in clinical, gross and histologic pathology, coupled with molecular and immunological techniques, to identify and characterize alterations in embryonic and postnatal development which result from genetic alterations in laboratory animals.
• Biotechnology: improvement of transgenic animal technology; cryopreservation methods; creation of genetically identical animals.
• Normative Biology: animal genetics; animal behavior; identification and characterization of non-traditional species for research; animal nutrition and reproductive physiology.
• Animal Disease: detection and characterization of diseases that may interfere with research and compromise animal welfare; vaccine development; and development of animals genetically resistant to disease.
• Animal Welfare: improved methods for evaluating and alleviating pain, distress and discomfort; development of environmental enrichment; and improved housing and maintenance technology.

III. Objectives of the Award

The objectives of the SERCA guidelines are as follows:

• To increase the monetary support of the SERCA awards to levels comparable to those of other biomedical career development awards.
• To encourage research-oriented veterinarians to develop independent research skills and gain experience in advanced methods and experimental approaches that will allow them to conduct animal-based research.
• To increase the pool of veterinary researchers who can conduct animal-based studies using advanced technologies to address disease problems.
• To provide individuals with experience and expertise in approaches to assess the results of molecular genetic alterations on the development and health of laboratory animals.
• To provide support for qualified individuals to pursue programs of research in basic and clinical research disciplines related to comparative medicine. These areas include the investigation of health problems in laboratory animals and the development of appropriate animal models for use in studies of human disease.

IV. Provisions of the Award

The SERCA provides five years of support for individuals who wish to become trained in the conceptual and technical skills needed for basic/clinical research investigation. Awards are made on an annual basis, and are subject to the availability of funds.

During the first three years of SERCA support, the awardee is expected to develop capabilities in basic, applied, or clinical biomedical research. These activities should be focused on a specific research area. Exposure to several research disciplines, such as physiology, biochemistry, genetics, immunology, pathology, microbiology, experimental surgery, pharmacology, nutrition and epidemiology may be proposed if it is appropriate for the development of a focused research effort. The awardee may pursue this training in different laboratories to obtain the necessary expertise.

In some cases, these activities will be part of a career development program designed by the awardee following formal training in laboratory animal medicine/comparative pathology or post-doctoral research experience in another area of comparative medicine. The SERCA is not a mechanism to obtain the Ph.D. degree. However, the research performed under the SERCA may be used to satisfy the thesis requirements for a Ph.D. degree.

In addition to the funds for salary and fringe benefits, a maximum of $20,000 (direct costs) per year may be requested for research support. Annual progress reports using the Simplified Instructions on page 2 of PHS Form 2590 (Revised 5/95 or latest revision) Continuation of a Public Health Service Grant are required for administrative review by DCM staff. Three months prior to the completion of the third year of SERCA support, the awardee must submit an expanded application using PHS Form 2590 for the final two years (years 04 and 05) of the award. The completed application should be submitted directly to DCM, NCRR, NIH. This application should include detailed plans for an expanded research program to be conducted during the last two years of the award. These plans should be presented as part of the "Progress Report Summary" (Form page 5) of the PHS Form 2590 and using continuation pages as needed in the format specified under "C. Specific Instructions - Research Plan" of the PHS Form 398 application instructions (PHS Form 398 page limitations for the research plan apply). The research plan, of the awardee's own design, should be an outgrowth of the training obtained during the first three years of the award. The application should also summarize progress made during the first three years of SERCA support, including a list of publications derived from that period. The research plan will be evaluated for scientific merit by outside peer reviewers. This scientific evaluation, along with overall progress made during the initial three years of support, will be considered by DCM staff in determining the candidate's eligibility for funding the last two years. If the proposal is not recommended favorably, withholding of future support will be considered.

As detailed above, the SERCA grant is made annually to the awardee's academic institution for each of the five budget periods. Allowable costs may include:

1. Awardee's Salary: A maximum of $75,000 for salary support may be requested. Institutional supplementation is permitted, but the funds cannot be derived from other federal sources.Fringe benefits will be provided.

2. Research Support: This support is limited to $20,000/year. This research support may include:

   • Equipment: Specialized research equipment essential to the proposed program. However, available institutional facilities should provide most of the necessary equipment.

   • Supplies: Consumable supplies essential to the proposed program.

   • Tuition for Training Courses: If essential to the awardee's individual project.

   • Other Costs: Funds for technical personnel, consultant costs, domestic travel, publication costs and other appropriate expenses which are essential to the proposed project.

3. Indirect Costs: Funds may be requested for reimbursement of institutional indirect costs at a rate up to, but not to exceed, 8 percent of the total allowable direct costs of the award.

V. Criteria for Eligibility

Candidates for a SERCA in Comparative Medicine must:

1. Hold a Doctor of Veterinary Medicine degree (or equivalent) from an institution that is recognized by the American Veterinary Medical Association (AVMA).

2. Have completed their clinical training, including specialty training in a relevant discipline, prior to receiving an award.

3. Not have been previously designated as Principal Investigator on any research project supported by sources from outside his/her institution. However, the awardee is encouraged to apply as a Principal Investigator during the last year of the SERCA award for outside support that would begin after the SERCA is completed.

4. Be nominated by an institution on the basis of his/her personal qualifications, interests, accomplishments, motivation and potential for a research career. Evidence of the institution's commitment to the candidate's research development must be provided. It is not essential that the applicant institution commit itself to the eventual placement of the candidate on its permanent faculty, but it is expected that the institution will select candidates with excellent potential for such an appointment.

5. Receive appropriate mentoring throughout the duration of the program. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors and serve as role models. Candidates must name a primary mentor, who together with the applicant, is responsible for the planning, direction, and execution of the program. The mentor(s) must be a recognized senior investigator(s) in the field of the proposed study, hold peer-reviewed research support, hold an academic appointment at the parent institution, and be experienced in postdoctoral research training. The mentor and laboratory for all post-Ph.D. activities should be different from those involved in any earlier doctoral training. The mentor should assist in the initial preparation of the SERCA application.

Minorities, women, and individuals with disabilities are encouraged to apply. At the time of award, candidates must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Non-citizen nationals are usually those born in possessions of the United States ( i.e., American Samoa and Swains Island). Individuals in the Unites States on temporary or student visas are not eligible.

A candidate for the SERCA may not concurrently apply for any other NIH award that duplicates the provisions of this award nor have another submitted application pending. SERCA award recipients are strongly encouraged to apply for independent research grant support, either Federal or private, during the last year of this award.

Prospective applicants are encouraged to discuss their potential eligibility for the SERCA program with DCM, NCRR staff before preparing an application.

VI. Application Procedures

SERCA applications may be submitted at any one of the three regular receipt dates (June 1, October 1, or February 1). Prior contact with the Director, Laboratory Animal Sciences Program, DCM, NCRR, is encouraged. Applications must be submitted on PHS Form 398 (Revised 5/95 or latest revision). This form is available from grants and contracts offices at most academic institutions, or may be obtained from:

Office of Extramural Outreach and Information Resources
Office of Extramural Research
National Institutes of Health
Rockledge II, Room 6207
6701 Rockledge Drive, MSC 7910
Bethesda, MD 20892-7910
Tel: (301) 435-0714
Fax: (301) 435-0525

In completing the application, follow the detailed instructions in PHS Form 398 (Revised 5/95 or latest revision). Items in the application form that require additional explanation for the SERCA are listed below. If additional space is needed to complete any of these items, use continuation pages and identify each item with its number and title.

I. Specific Instructions - Forms

A. Form Page 1 (Face Page)
Numbers below refer to items on the Face Page:

1. Item 1 - Title of the project.

2. Item 2 - Check "yes" and after "Title", write the name of the award: "SERCA-NCRR/K01."

3. Item 6 - The total project period must be for five consecutive years.

B. Form Page 2

1. Description. This should be an abstract of the entire application, not just the research plan. The three principal components of this application (i.e., the candidate, the research, and the environment) should be summarized.

2. Performance Site(s)

3. Key personnel engaged on project

The candidate's primary and secondary (if applicable) mentor(s) should be listed.

C. Form Page 3:

The page limits do not include letters from mentor(s), consultant(s), and collaborator(s).

D. Form Pages 4 and 5

Allowable Costs :

1. Salary: The NCRR will provide a salary for the award recipient of up to $75,000 per year plus commensurate fringe benefits for a minimum of 75 percent effort. Although a greater effort may be proposed, the maximum allowable salary is $75,000. The institution may supplement the NCRR contribution with other non-Federal funds up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require duties or responsibilities that would interfere with the purpose of the award. Direct salary is exclusive of fringe benefits and facilities and administrative costs.

   The total salary requested must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members with equivalent qualifications, rank and responsibilities in the same department. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure.

   SERCA recipients are encouraged to submit other grant applications during the last year of this award, as long as doing so does not have an impact on the 75 percent of full-time effort devoted to the SERCA award.

2. Research Development Support : The NCRR will provide $20,000 per year for the following expenses: (a) tuition, fees, and books related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meetings or training.

E. Form Page 6 - Biographical Sketches

Information concerning previous military service, internships, residencies, research assistantships and fellowships, plus present and past support for the candidate should be included. For all positions, indicate whether they were full- or part-time by inserting the words "full" or "part" in the space provided. If applicable, submit a notarized statement of alien registration. In addition, list all of the candidate's personal publications as part of the biographical sketch. Include original and four copies of not more than five publications and indicate those that have been submitted with the application by the notation "Copies Sent." A biographical sketch for the mentor(s) must be included.

F. Form Page 7 - Other Support

The "Other Support Page" (format page 7 of the PHS Form 398 [Revised 5/95 or latest revision]) will no longer be needed for the candidate and other key personnel in applications for Career Awards. It is still necessary, however, to provide information about the research activity of the mentor and co-mentor on mentored career awards. Information about the level and nature of the mentor's(s') research support will continue to be used by review committees to judge the strength of the research environment available to the candidate during the award period.

Applicants must provide information on the mentor's and co-mentor's current and pending research support relevant to the candidate's research plan in a table within the section titled "Statement by the Mentor(s) Consultant(s), and Collaborator(s)" in the Research Plan section of the application. Within this table, the following information on all related research projects must be provided: funding source, title of the project, name of the Principal Investigator, dates of the approved or proposed project, annual direct costs, and a brief description of the major goals.

G. Form Page 8 - Resources

This page should describe the resources (facilities and major equipment) of the applicant institution. Any arrangements for supervised research/training at another institution should be adequately described in Section III, item e.

II. Research Plan

The narrative for the Research Plan should use the outline provided in PHS Form 398. These comments are added for the following sections:

4. Research Design and Methods: Plans for the first three years must be described in detail. Information for the fourth and fifth years may be more general in the initial proposal, but should be adequate to allow evaluation of how the training received during the initial period of the award will be used to further investigate the hypothesis proposed as the overall focus for the application. While the initial concept of the research hypothesis and the associated training program should be formulated by the applicant, it is appropriate for the mentor to participate in the final development of the proposal presented in the initial application. A detailed research plan for the last two years is required as part of the noncompeting renewal application submitted during the third year of the SERCA. This renewal application should be developed solely by the awardee.

8. Consortium/Contractual Agreements: The candidate should list all centers, institutions or laboratories that will participate in his/her research career program. A detailed narrative description should be provided to identify:

1. The mentor(s) and other investigators who have agreed to participate in the program.

2. The institutional resources and space available to the candidate.

Each mentor and an authorized representative of the applicant institution must provide a letter that indicates support for the proposed program, including a commitment of space and resources to be provided. These letters must be submitted as part of the application.

The following sections must be added by the applicant: Candidate's Plans and References

1. Career Development Plan: A description of the career development plan, incorporating consideration of the candidate's goals and prior experience. It must describe a systematic plan to obtain the necessary theoretical and conceptual background, in addition to the research experience, necessary to launch an independent research career. Candidates must describe the availability of courses such as research design, biostatistics, epidemiology, ethics, and regulatory issues at their institution and the integration of these studies into their career development plan.

   Less experienced candidates may require an initial period of one or two years during which subjects are studied in a didactic environment. This would be followed by a period of intense, supervised research experience. Candidates with more research experience at the time of application may need a shorter developmental period. In both cases, the career development plan must be tailored to the needs of the individual candidate and ultimate goal of achieving independence as an animal-based researcher.

2. Other Activities: Provide detailed descriptions of professional activities, in addition to the research described above, to be engaged in during the first three years of the award, and an explanation of how these activities are related to research career development. Describe—in general terms—the plans for an expanded program of independent research that are to be implemented during the fourth and fifth years of the award. An estimate of the percentage of total work effort that will be devoted to research (including clinical research), teaching, practice and consultation, administration, research training received, academic studies, etc. should be listed. The total of these percentages should equal 100. It is required that the candidate devote at least 75 percent time/effort to research that is directly related to the SERCA's objectives.

3. References: List the names and addresses of three or more individuals who are well acquainted with the applicant's professional training, research, and competence. These references should include individuals who are capable of assessing the several stages of the applicant's career development. If possible, references should include some individuals who are not in the applicant's current department or institution, but are fully knowledgeable of his/her qualifications. These references must submit letters in support of the applicant which consider, among other things, the applicant's interest in and aptitude for research and the probability of he/she becoming an independent investigator. The applicant is responsible for assuring that all letters of reference are submitted by the application receipt date. All reference letters should be submitted directly to:

Scientific Research Administrator
Comparative Medicine Review Committee
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, Room 1074
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874

Mentor's Plans: The primary mentor should personally prepare and sign a description of the specific plans for supervision, guidance, counseling and any other formal and informal training of the candidate. Arrangements for secondary mentorship(s), if applicable, must be described fully and justified in the application. The mentor(s) should indicate how the supervision provided to the candidate will promote his/her transition toward the status of an independent investigator by the end of the five-year award. The mentor(s) must also provide a list of individuals and their current positions that he/she has trained previously. If the candidate is to be given an academic appointment, the rank, specific duties and responsibilities should be described. Continuation pages may be used if necessary. This plan must bear the signature, typed name and title of the mentor, and the date signed.

Training Faculty in Clinical and Basic Departments: List the names of all faculty members (other than mentor(s) already named) who will have a significant role in the overall growth and development of the candidate during the tenure of the SERCA. Include their degrees, titles, and departments.

Responsible Conduct of Research-Describe the plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction, as well as the amount and nature of faculty participation. No award will be made if an application lacks this component.

Mailing Instructions: Carefully check the application for completeness and signatures. Be certain that it is responsive to this Program Announcement by using these instructions as a guide. Postage is to be paid by the applicant. Both the application and the folder in which it is enclosed should be clearly labeled: "NCRR/SERCA/ K01."

The completed original application (signed original with appendices, if any) and three copies should be mailed or delivered to:

Grant Application Receipt Office
Center for Scientific Review
National Institutes of Health
Rockledge II, Room 1040
6701 Rockledge Dr., MSC 7710
Bethesda, MD 20892-7710**

Simultaneously, two additional copies with appendices and reprints (not more than five reprints, if any) must be sent under separate cover to:

Scientific Review Administrator
Comparative Medicine Review Committee
Office of Review
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, Room 1074
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874

** Use ZIP code 20817 for overnight mail

VII. Review Procedures and Criteria

Application Receipt and Review Schedule: Applications may be submitted for any one of the three regular receipt dates (February 1, June 1, or October 1). The initial review for scientific merit will be made by the Comparative Medicine Review Committee (CMRC) and the second review for programmatic and policy considerations will be made by the National Advisory Research Resources Council (NARRC). Applications approved by the NARRC will be considered for funding on the basis of their overall merit as determined by the initial review committee, relevance of the proposal to the research objectives of DCM, NCRR, and the availability of funds.

Criteria for Review: In the initial review of the application for scientific merit, particular attention will be given to the candidate's prior training and experience, career potential, research career development plans, proposed research environment, reference reports, institutional commitment, and other relevant information. The applicant must clearly demonstrate that the award will enhance the candidate's development as an independent investigator.

1. Applicant: The applicant's prior training, research experience, potential for a research career, experience and commitment to comparative medicine areas of research will be considered. Emphasis will be placed on potential, productivity and commitment; obtaining a Ph.D. degree, either before or during the award, will be of less importance. Evidence of prior participation in a research project, e.g. publications, abstracts, or presentations, will be important. To be most competitive, candidates should have clinical training and experience in laboratory animal science/comparative medicine areas.

2. The Research Plan: The major criterion used in evaluating the research plan and the associated training will be its likelihood to develop an independent, creative investigator. Proposals based primarily on methodology or on the acquisition of descriptive information will not be received well. The proposal need not be applicable directly to laboratory animal problems, but should be focused around a central biomedical concept or hypothesis that will provide opportunities for research training in the initial years and the framework for a meritorious research application for the final year of the award.

   While it is expected that exposure to methodologies in different laboratories may be useful, such training should be limited to that which is necessary for successful development of the research proposal.

3. The Mentor(s): The mentor should be a productive, senior investigator with appropriate expertise in the proposed area of research, have prior experience in providing postdoctoral research training, and have a strong commitment to the training and guidance of the applicant. In order to provide the applicant with a maximum breadth of exposure, the mentor should be a different individual than the person who previously provided doctoral or laboratory animal science training. This requirement may be waived if the research focus is so narrow that another suitable mentor cannot be identified. If research leading to a Ph.D. degree is part of the initial years of the award, the mentor should be changed after the degree has been obtained.

4. Research Environment: The research environment should be one that will not only provide the applicant with the necessary training, but will also provide exposure to a broad spectrum of research interests through seminars, symposia, journal clubs, etc.

VIII. Program Administration

The DCM, NCRR administrates the SERCA program in accordance with Public Health Service Grants Policy Statement for research grants and other relevant policies.

As part of the annual application for continuation support, the grantee institution must submit a statement that summarizes the awardee's activities relevant to the award; a detailed description of the awardee's progress in the program; and the extent and nature of his/her other activities such as administration, service in an advisory capacity to public or private nonprofit organizations, outside lectures, and professional practice and/or consultation.

In carrying out its stewardship of human resource related programs, the NCRR may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of the award period for updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities and other information which may be helpful in evaluating the impact of the program.

Questions concerning other aspects of SERCA program administration, as well as inquiries related to an applicant's eligibility and appropriate areas of research emphasis, should be directed to:

Director
Laboratory Animal Sciences Program
Division of Comparative Medicine
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, Room 948
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
Tel: (301) 435-0744
Fax: (301) 480-3819

Questions concerning fiscal matters should be directed to:

Grants Management Officer
Office of Grants Management
National Center for Research Resources
One Democracy Plaza, Room 1058
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
Tel: (301) 435-0844
Fax: (301) 480-3777

IX. Authority and Regulations

This program is described in the Catalog of Federal Domestic Assistance No. 13.306, Laboratory Animal Sciences and Primate Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

Issued by:

Division of Comparative Medicine
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, Room 948
6701 Democracy Boulevard, MSC 4874
Bethesda, MD 20892-4874
Telephone: (301) 435-0744
Facsimile: (301) 480-3819