MENTORED CLINICAL SCIENTISTS DEVELOPMENT PROGRAM AWARD (K12 AWARD) RELEASE DATE: March 11, 2002 PA NUMBER: PAR-02-076 January 6, 2010 - See Notice NOT-AG-10-004 Notice of Cancellation of NIA Participation.
(Reissued as PAR-07-346) (See Notice NOT-DA-06-013 NIDA Policy Update Mentored and Career Development (K) Awards) (see extension of expiration date NOT-DA-06-010) (see update, NOT-DA-05-005) (see update NOT-DA-05-001) EXPIRATION DATE: July 1, 2006. (Extended to January 3, 2007 per NOT-DA-06-031) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov/) THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA replaces, in its entirety, the Mentored Clinical Scientist Development Program Award (MCSDPA), PA-95-054, published in the NIH Guide for Grants and Contracts, Volume 24, Number 15, April 28, 1995. This MCSDPA is an award to an educational institution or professional organization to support career development experiences for clinicians leading to research independence. Under this award, newly trained clinicians are to be selected and appointed to this program by the grantee institution. In other respects, the research experience of the research candidates selected for support under this award should resemble those supported by the individual Mentored Clinical Scientist Development Award (K08) or the Mentored Patient-Oriented Career Development Award (K23). Applications for this award should propose a research plan that has: (1) intrinsic research importance, and (2) will serve as a suitable vehicle for learning the methodology, theories, and concepts needed for a well-trained independent clinician-researcher. The program should be designed to accommodate research candidates with varying levels of experiences. For example, a prospective research candidate with limited experience in a given field of research may find it appropriate to engage in a structured, phased developmental program, including a designated period of didactic training followed by a period of supervised research experience. The entire program should be comparable in scope and rigor to meeting the requirements for an advanced research degree. The National Institutes of Health's (NIH) institutes have modified this award to accommodate the career pathways of researchers in fields related to their unique missions. All applicants and potential research candidates are strongly advised to contact the prospective NIH awarding component for information about eligibility and the specific provisions of this award. RESEARCH OBJECTIVES Program Environment and Components - The applicant organization must have a well-established research and clinical career development program and qualified faculty to serve as mentors. The research candidate, mentor, and institution must develop innovative programs to maximize the available research and educational resources. The program award provides five years of renewable support. The award is intended to support research candidates who receive three to five years of support consisting of consecutive 12-month appointments. In general, the support is often divided into two distinct phases: Phase I, the didactic component; and Phase II, an intensive research experience under the guidance of a qualified mentor. During Phase I the candidate will acquire knowledge and research skills in scientific areas relevant to the career development goals of the research candidate. This phase must include relevant didactic and laboratory experiences that are consistent with the research candidate's prior experience and needs. During Phase II the candidates will carry out their research experiences. Program Director - The proposed Program Director should possess the scientific expertise, leadership and administrative capabilities required to coordinate and supervise an interdisciplinary research and development program. The Director should be experienced in the design and management of programs for developing investigators, and should be able to demonstrate a superior record of preparation of clinicians for independent research. In addition, applicants are encouraged to form a committee with representatives from appropriate basic and/or clinical science departments to advise the Program Director on management of the program. Mentors - Each research candidate appointed in the program award must have a primary sponsor who: (1) is recognized as an accomplished investigator, (2) is actively involved in basic or clinical research, and (3) has a successful record of providing the type of training required under this award. An assigned mentor will provide guidance for the development of each research candidate assigned to the program. The mentor must be committed to continue this involvement throughout the candidate's total period of development under the award. Candidates - At least 75 percent of the candidate's full-time professional effort must be devoted to the program and the remainder devoted to developing other clinical and teaching pursuits consonant with the objectives of the award. Summary - The Mentored Clinical Scientist Development Program Award (MCSDPA) is an award to an educational institution to support career development experiences for clinicians leading to research independence. Examples of research areas of interest of the supporting NIH institutes can be found in their strategic plans: National Institute on Aging (http://www.nia.nih.gov/AboutNIA/StrategicPlan/ or National Institute on Drug Abuse (http://www.nida.nih.gov/StrategicPlan/Index.html). Allowable Costs The National Institute on Aging limits K12 programs to no more than $500,000 per year in direct costs. Salary – For the National Institute on Drug Abuse, the information is available at http://grants.nih.gov/grants/guide/notice-files/not99-132.html. For the National Institute on Aging, the information is available at: http://www.nia.nih.gov/ResearchInformation/ FundingAndTraining/ResearchTrainingSupport/#Costs. These funds may be used for: (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; and (d) statistical services including personnel and computer time. The total salary requested for each research candidate 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. Facilities and Administrative (F&A) Costs - These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs or at the actual F&A cost rate, whichever is less. Under this PA, the K12 grant is not subject to the Streamlined Noncompeting Application Process (SNAP). In general this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. While the K12 is subject to Expanded Authorities, the one exception to this is that carryover of funds from one fiscal year to the next must be approved by the Grants Administration staff (see INQUIRIES). Other Income - The candidate may not retain any fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award. Such fees must be assigned to the grantee institution for disposition by any of the following methods: (1) expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution; (2) used for health-related research purposes; or (3) be paid to miscellaneous receipts of the U.S. Treasury. Checks should 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. Candidates may retain royalties and fees for activities such as scholarly writing or service on advisory groups. The candidate may retain honoraria from other institutions for lectures or seminars, provided these activities remain incidental and that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually funds budgeted in an institute-supported research or training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. An institute will consider the approval for use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of an NIH career award must receive prior written approval of the institute awarding component. Award Termination - 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 will notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right of the program director to appeal the decision. MECHANISM OF SUPPORT This PA will use the NIH Mentored Clinical Scientist Development Program Award (K12). As the applicant institution, you will be solely responsible for the planning, direction, and execution of the proposed program. The PA provides up to five years of support and is renewable based on a successful competing continuation application, programmatic needs and the availability of funds. The awards pursuant to this PA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. ELIGIBILE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, professional organizations, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign The applicant institution or organization must have adequate numbers of highly trained faculty in clinical and basic sciences with interest and capability to provide guidance to clinically trained individuals in the development of research independence. Institutions with a MCSPDA may recruit and select candidates on a local basis rather than submitting a separate application on behalf of each prospective research candidate. In all aspects, the PA is intended to provide support for the development of clinical scientists in the same manner and under the same conditions as the individual Mentored Clinical Scientist Development Award (K08) and the Mentored Patient-Oriented Research Career Development Award (K23). Therefore, research candidates for support under this PA must have the following: (1) a clinical degree or its equivalent, (2) initiated internship and residency training (or its equivalent), (3) a mentor(s) who has extensive research experience and a record of providing the type of training required under this award, and (4) willingness to spend a minimum of 75 percent of full-time professional effort conducting research, career development, and/or research related activities. Minorities and women are encouraged to apply. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaska Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups. Research candidates appointed under this program award must be U.S. citizens or non-citizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Non- citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Research candidates, who are or have been former principal investigators on NIH individual mentored career awards (K01, K08, K22, K23), research projects (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible for appointment under this program. Exceptions may be made for individuals who are reentering the research field after an extended absence or are making a significant shift in their research focus that requires that they have additional training. Research candidates may not concurrently hold any other PHS award that duplicates the provisions of this award. MCSDPA research candidates are encouraged to apply for independent research grant support during the period of support under this award. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Dorynne Czechowicz Division of Treatment and Research Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4231, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 443-2237 E-mail: firstname.lastname@example.org Dr. Robin A. Barr Office of Extramural Affairs National Institute on Aging 7201 Wisconsin Avenue, Room 2C218, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9322 Email: BarrR@mail.nih.gov o Direct your questions regarding peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 E-mail: email@example.com Dr. Mary Nekola Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2C212, MSC 9205 Telephone: (301) 496-9666 FAX: (301) 402-0066 Email: NekolaM@nia.nih.gov o Direct your questions regarding financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 E-mail: firstname.lastname@example.org Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: WhippL@nia.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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SENDING AN APPLICATION TO THE NIH: 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) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm This is a generic PA for the NIH MCSDPA. Therefore, it is strongly recommended that prospective applicants contact the staff person in the appropriate institute listed under "INQUIRIES" early in the planning phase of application preparation. Such contact will ensure that applications are responsive to the career development goals of individual institutes and centers. It should be noted that not all institutes support the MCSDPA. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. SPECIAL APPLICATION INSTRUCTIONS FOR K12 APPLICANTS Applications should follow the PHS 398 (05/2001) instructions for research grants with the following variations: Key Personnel - Key personnel include the principal investigator and all other individuals contributing substantively to the mentoring activities. They do not include the candidates. Table of Contents - Use the Substitute Form Page 3 Research Career Table of Contents. Section 1: Basic Administrative Data 1-3. Face Page, Description and Key Personnel (Form pages 1 and 2 and this Table of Contents) 4. Detailed budget for initial budget period (Form Page 4) 5. Budget for Entire Proposed Period of Support (Form Page 5) 6. Biographical sketches (Candidates and faculty -- biographical sketch format page; not to exceed four pages.) 7. Resources (Resources Format Page) Section II: Specialized Information 1. Introduction to Revised Application (not to exceed three pages) or Introduction to Supplemental Application (not to exceed one page). 2. Research Career Program Plan (Do not exceed 25 pages for items a through d. For revised or supplemental applications, use substitute title. a. Career Development Program The application should describe the overall theme of the program, the particular career development activities planned for candidates and the expected outcomes for candidates. It should document the experience of the program director and other faculty as mentors including information on the career outcomes of former candidates. It should include a clear commitment of staff time. Particular developmental activities mentioned such as seminars, scientific meetings, training in responsible conduct of research, and presentations should be linked to the overall theme and goals of the program. This section should identify explicitly the advantages to this site of a program-based career development award as opposed to, or in addition to, creating environments supportive of individual efforts by junior faculty to obtain career development and similar awards. The application should indicate what other teaching and/or clinical responsibilities, if any, are expected of the candidates and the extent to which these activities complement or enrich the research and research development experiences proposed in the award. Responsible Conduct of Research: The application must describe plans to give instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction, and amount and nature of senior staff participation. No award will be made if an application lacks this component. Candidates and the sponsor may wish to explore the availability of the following courses offered by the Intramural Research Program (IRP): Introduction to the Principles and Practice of Clinical Research, the Clinical Electives Program Course on Bioethics, and the Ethics Training provided by each individual institute. For more information visit the website of the Office of Research Integrity at http://ori.dhhs.gov. b. Research Activities Applicants should describe the funded research activities of the mentoring team. The description should include an account of how the ongoing research offers opportunities for candidates to develop research ideas and strategies and offers ways for them to combine methods or concepts from different funded projects that will further their own research careers. The research plan should show how the ongoing research exemplifies the organizing theme of the program and offers candidates ways to establish research consonant with that theme. The research plan should detail how individual candidates' research experiences will be/have been solicited and evaluated prior to initiation. If an outside advisory committee is used to select projects, applications should not name advisors in the application but describe how they will be chosen. Applications should describe research plans for at least two candidates. The individual descriptions should each be no more than three pages and should include: (1) a Statement of Hypothesis and Specific Aims, (2) Background, Significance and Rationale, and (3) Research Design and Methods. No preliminary data or results are expected in these descriptions. Literature citations may be included in a single section covering all citations in the application and are not a part of the three-page limit. Supporting material (not part of the three-page limit) should include a description of how the individual plans relate both to the K12 program and to the career objectives of the candidate, and should describe the particular mentors and mentoring resources that will be assigned to the candidate during this project. c. Progress Report/Ongoing Activities Existing resources and programs relevant to the program should be identified. These may include existing training grants, institutional clinical research curriculum awards or centers with resources for supporting junior faculty. The application should indicate how the K12 program will interact with these existing activities and add to existing capacity to advance clinical research at the institution. Support letters from other resource directors should be included at this point in the application. The letters are not included in the 25-page limit on items a through d. Competing continuation and supplemental applications should use this section to provide a progress report on the current funded activities. The aims of the current award should be briefly summarized. Significant accomplishments of current and past candidates should be described, including present appointment, past faculty positions, and grant funding. Published work relevant to their training should be summarized. Emphasis should be placed on how the program aspects of the K12 have facilitated or are facilitating the progress of the candidates. Progress reports are submitted using the Form PHS 2590, which can be obtained at: http://grants.nih.gov/grants/funding/2590/2590.htm. d. Environment and Institutional Commitment Beyond the research activities described in the research plan, the institution must describe what current and future resources are or will be used to encourage research by junior faculty and facilitate developing their research careers. It should document what equipment, facilities and resources will be made available to the candidates (see Resource Format Page in PHS 398). In addition, for each candidate identified in the application, and for future appointments to the K12 program, the institution must submit the Agreement to support the candidate as described in the PHS 398 form (05/2001) Section IV, pp. 60-61, with signatures as described in that section. For candidates named in the application, the form must be included with the application. It is not part of the 25-page limit for items a through d. For the following sections, follow instructions on PHS 398 (05/2001) beginning on p.17 as appropriate. e. Human Subjects Research - Special Populations - Human Subjects Research Section f. Vertebrate Animals g. Literature Cited h. Consortium/Contractual Arrangements i. Consultants Budget Instructions - All applications should follow budget instructions for non-modular applications. Personnel - Starting with the principal investigator, list the names of all applicant organization employees who are involved on the project during the initial budget period, regardless of whether a salary is requested. Include all named candidates. Indicate any remaining slots as "to-be-named". Percent of Effort on Project - Each candidate must spend at least 75 percent effort on this program. Budget for Entire Proposed Period of Support - All K12 applications should follow a non-modular format. Biographical sketches - Complete biographical sketches for all key personnel and all named candidates. Indicate on each candidate's biosketch whether the candidate is a U.S. citizen or a permanent resident. If the candidate is a permanent resident of the United States, a notarized statement to that effect must be provided by the time of award. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA Although the goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health, the reviewers are reminded that the primary purpose of this PA is training rather than conducting research. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Candidates o Program Directors/Mentors o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. SIGNIFICANCE: Does the proposed program offer training and career development experiences in an important area of research and/or public health significance? Are the needs for additional researchers and a K12 program well justified? 2. APPROACH: Are the planned activities adequately developed, consistent with the theme of the program, and sufficient to achieve the aims of the program? Are they appropriately tailored to the experience and interests of the candidates? Is the proposed training in the responsible conduct of research adequate? Competing continuations and supplements: Do current and past activities demonstrate prior success in advancing the careers of candidates? 3. CANDIDATES: Are the recruitment and selection processes adequate to achieve high-quality candidates? Are the accomplishments of named candidates and the quality of their planned research activities appropriate to their level of experience and expected progress during the award? Are the efforts to recruit candidates from racial or ethnic groups underrepresented in biomedical, behavioral or clinical research adequate? Competing continuations and supplements: Do current and past appointments show evidence of success at recruitment and training? 4. PROGRAM DIRECTOR AND CO-MENTORS: Is the proposed program director an acknowledged research leader/administrator with a track record of mentoring successful researchers? Do the proposed co-mentors complement the skills and experience of the principal investigator? Is their experience in research and prior success in training appropriate to their role? Is the need for particular mentors well justified by the aims of the program? Has the mentoring team committed sufficient time to ensure the success of the program? 5. ENVIRONMENT: Do existing facilities and resources enrich the potential of the proposed K12 award to provide strong research mentoring and development experiences for the candidates? Are support letters available from individuals who control access to these resources that show their willingness to collaborate? Does the institution indicate that the candidates will be provided a minimum of 75 percent time for the career development experiences and show how they will be protected from other administrative, teaching or clinical duties? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: 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 included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.ht m. 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 http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://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 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. 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 PA 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 No. 93.279 for NIDA and 93.866 for NIA, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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