This Program Announcement expires on March 13, 2004, unless reissued. MENTORED SCIENTIST DEVELOPMENT AWARD IN RESEARCH ETHICS Release Date: September 27, 2001 PA NUMBER: PAR-01-144 National Institutes of Health (http://www.nih.gov/) Application Receipt Dates: March 12, 2002, March 12, 2003, March 12, 2004 PURPOSE The National Institutes of Health invites biomedical, behavioral, and public health researchers to apply for the Mentored Scientist Development Award (MSDA). The MSDA will support training in research ethics for health professionals working at academic and other health-related institutions in biomedical, behavioral, or public health research, particularly research involving human participants. The goals of the MSDA are two fold. First, the award should enhance the career of the candidate such that he or she would become an independent investigator in applied research ethics. Second, the candidate would become a resource in the area of research ethics for the sponsoring institution and its scientific community. As such, applications for the MSDA should include a mentored research experience that will measurably enhance the candidate"s scientific career as a research ethicist. This MSDA program is intended to support two kinds of individuals: (1) those who have an established career in another field, and now want to move into research ethics, and (2) those who are already in the field of research ethics but, because of their junior status, require a period of mentored career development in order to become independent scientists in the field of research ethics. This initiative together with a parallel Program Announcement, Short-Term Courses in Research Ethics (T15), is part of NIH’s efforts to develop a comprehensive program in research ethics. As used in this program announcement, research ethics refers to ethical, legal, and social principles guiding the responsible conduct of research, particularly focusing on scientific integrity and protection of the interests of research participants. 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 Program Announcement (PA), Mentored Scientist Development Award in Research Ethics, 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/. ELIGIBILITY REQUIREMENTS The candidate must have a doctorate or its equivalent and should have demonstrated the capacity or have shown the potential for highly productive, independent postdoctoral research. The applicant must be willing to commit a minimum of 75 percent of his or her full-time professional effort to conducting research and pursuing research career development activities for the period of the award. The candidate must identify a mentor with extensive research and academic experience in ethical issues related to biomedical research. It is important that the mentor be an individual with established credentials in the field of research ethics or a closely related field. The sponsoring institution should submit the application on behalf of the candidate. Candidates may be members of domestic public or private organizations, such as medical, dental, public health, or nursing schools or other institutions of higher education. Minorities, women, and individuals with disabilities are encouraged to apply. Candidates must be U.S. citizens or non-citizen nationals or must have been lawfully admitted for permanent residence. Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT This PA will use the K01 mechanism, which provides an additional period of support to a doctoral-level candidate in a new research area or in an area that would enhance the candidate"s career in research ethics. The candidate and mentor are responsible for the planning, direction, and execution of the program on behalf of the sponsoring institution. Candidates must show the potential for highly productive, independent careers in the field of research ethics. The project period is for three, four, or five years depending upon prior experience and the need for additional research experience. Awards are not renewable. RESEARCH OBJECTIVES Advances in biomedical and behavioral research and their application to human research have highlighted the importance of ethical issues in these areas. The advent of gene transfer research, xenotransplantation, HIV vaccine trials, the testing of therapies in settings which preclude informed consent (e.g., coma and severe trauma), as well as ongoing attention to past abuses such as the Tuskegee Syphilis Study have catalyzed a realization that greater emphasis on research ethics is needed. As part of the plan to address this issue, the NIH has chosen to increase the cadre of researchers trained in the social, legal, and ethical issues arising from biomedical, behavioral, and public health research. The areas described below, although not exhaustive, represent scientific areas where research can substantially inform public policy in this field. Researchers proposing training in other areas must show the relevance of such training to social, legal, and ethical issues in biomedical, behavioral, nursing, social science, or public health research. o Ethical and legal guidance for protection of human participants in research. o Scientific integrity and responsibility. o Interplay of medical and research ethics in clinical research. o Privacy and confidentiality protections for research participants. o Implications of innovations in biotechnology and biomedical research, risks to participants from developing laboratory and information technology. o Ethics review processes in research organizations and institutions. o Cultural issues in ethical principles and standards. o Ethical issues related to health services research. Environment The sponsoring institution must have a well-established academic program in research ethics or a related field. It must have suitable library facilities and make a commitment to assist the trainee with access to institutional resources (such as a hospital or research environment) suitable for the proposed field of study. It must provide a qualified person to serve as a mentor. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate, mentor, and institution must be able to describe a career development program that will maximize the use of relevant research and educational resources. Program The award provides three to five years of funding. At least 75 percent of the candidate"s full-time professional effort must be devoted to the program, and the remainder devoted to other research-related and/or teaching pursuits consistent with the objectives of the award. For example, if the applicant has proposed a research plan involving ethical issues in clinical research, continuation of his or her current activities in that area could be considered "other research-related pursuits." The candidate may find it appropriate to include relevant didactic and laboratory or field research experiences. Mentor The candidate must receive appropriate mentoring throughout the three- to five-year program. The mentor should be a senior individual who is well known in the field of research ethics or a closely related field. Because suitable mentors may not be available at the sponsoring institution, applicants may choose a reasonable and workable mentorship from another institution. Allowable Costs 1. Salary: This award will provide salary and fringe benefits for the candidate up to $75,000 per year. In addition, the institution may supplement this contribution up to a level that is consistent with the institution"s salary scale, however, supplementation may not be from Federal funds unless specifically authorized by the program from which such funds are derived. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the MSDA. Continuation of clinical or research activities that relate to the proposed area of concentration in research ethics is acceptable. 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 of equivalent qualifications, rank, and responsibilities in the department concerned. 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. 2. Research Development Support: This award will provide up to $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, including at least one meeting convened by the NIH for awardees to discuss research progress, (d) statistical services, including personnel and computer time. 3. Ancillary Personnel Support: Salary for mentors, secretarial or administrative assistance is not allowed. 4. Facilities and Administrative Costs: These costs will be reimbursed at eight percent of the total direct costs excluding equipment. Evaluation In carrying out its stewardship of human resource-related programs, the HHS may request information essential to an assessment of the effectiveness of this program. Accordingly, candidates are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. Other Income Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: o The funds may be expended by the sponsoring institution in accordance with the HHS/NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the sponsoring institution. o The funds may be used for health-related research purposes. o The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks must be made payable to the Department of Health and Human Services, NIH, and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the sponsoring institution. Usually, funds budgeted in an HHS/NIH-supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be re-budgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of an MRSDA career award must receive prior written approval of the program administrator. Special Leave Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the awarding organization is required. To obtain prior approval, the award candidate must submit a letter to the institute describing the plan, countersigned by his or her department head and the appropriate local institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the awarding institute and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the sponsoring institution. Termination or Change of Institution When a grantee institution plans to terminate an award, the awarding institute must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support will be considered at the new institution, provided a new career award application is submitted by the new institution, the period of support requested is no more than the time remaining within the existing award period, and the new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. The awarding institute may require a review by an initial review group and/or the appropriate national advisory council or board. Alternatively, staff of the awarding institute may carry out the review, depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the sponsoring institution and career award candidate in writing of this determination, the reasons for the discontinuation, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html). A complete copy of the up-dated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 PA 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. APPLICATION PROCEDURES The career award section of PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. For purposes of identification and processing, the PA title and number must be typed in item 2 on the face page of the application and the "YES" box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five 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) Applications must be received by 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. Only domestic institutions are eligible to apply for support under this program announcement. Potential applicants are encouraged to discuss their plans and objectives of their proposed courses with the NIH staff listed under INQUIRIES before submitting an application. The application must address the following issues: Candidate o Establish the candidate"s commitment to a career in research ethics. o Establish the candidate"s potential to develop into a successful independent investigator or (for more senior candidates) establish that the candidate has achieved a successful independent career in biomedical, behavioral, or public health research. o Summarize the candidate"s immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Letters of recommendation. Three sealed letters of recommendation addressing the candidate"s potential for a career in research ethics must be included as part of the application. Career Development Plan o Describe the career development plan, incorporating consideration of the candidate"s goals and prior experience. It should describe a systematic plan to obtain the necessary background and research experience to launch a career in research ethics. Research Plan o The candidate and mentor together must describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design, and Methods. Mentor o The application must include information on the mentor(s), including research qualifications and previous experience as a research supervisor. The application must also include information that describes the nature and extent of supervision that will occur during the proposed award period. A letter from the proposed mentor indicating his or her commitment to the candidate"s training must be included in the application. Environment and Institutional Commitment o The sponsoring institution must document a strong, well-established research program related to social, ethical, and legal issues stemming from biomedical and behavioral research, including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate"s development into a productive, independent investigator. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review (CSR). Incomplete applications will be returned to the applicant without further consideration. Applications received in response to this program announcement will be reviewed for scientific and technical merit by an initial review group in the CSR, in accordance with standard NIH peer review procedures. 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 the applications under review, will be discussed and assigned a priority score and receive a second level of review by the National Heart, Lung, and Blood Advisory Council. Review Criteria The following review criteria will be applied: Candidate o Is the candidate appropriately trained and suited to the proposed career development activities, i.e., well trained and productive in his or her current field and prepared for the proposed career development activities? Career Development Plan o Is the career development plan proposed one which will give the candidate sufficient grounding in principles, content, and methods of ethics related to biomedical research such that the candidate can establish an independent research career in the field? Research Plan All candidates for this award will have had previous research experience and in some cases will have been principal investigators in other scientific fields. A sound research plan that is consistent with the career development plan and the candidate"s level of research development must be provided. Significance: Does this project address an important problem? How well does the proposed research experience complement the proposed career development activities? Approach: Are the methods adequately developed, well integrated, and appropriate to the research plan and career development goals of the candidate? Does the candidate acknowledge potential problem areas and consider other approaches? Mentor o Is the mentor sufficiently qualified, experienced, and available to assist the candidate sufficiently in the proposed career development and research activities? Institutional Environment and Commitment o Is the institution"s (or institutions" - if the candidate and mentor are located at different institutions) commitment sufficient to increase the probability of success? Is there appropriate collaboration among departments and units within the institution? Are there special features in the institutional environment that can increase the chances of success? Are the resources adequate? o Is the sponsoring institution willing to develop an appropriate mix of research, teaching, and administrative responsibilities for the candidate? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following criteria where they are applicable: o The adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of any research activities. o The reasonableness of the proposed budget and duration in relation to the proposed activities. o The adequacy of the proposed protection for humans, animals, or the environment to the extent they may be adversely affected by the activities proposed in the application. 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. INQUIRIES Written and telephone inquiries concerning this PA are encouraged, especially during the planning phase of the application. Inquiries regarding programmatic issues may be directed to: Lawrence Friedman, M.D. National Heart, Lung and Blood Institute Building 31, Room 5A03 Telephone: (301) 496-9899 FAX: (301) 402-1056 Email: lawrence_friedman@nih.gov Direct inquiries regarding fiscal matters to: Suzanne White National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: whitesa@nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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, and 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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