PAR-04-148: NIDDK EDUCATION PROGRAM GRANTS (R25)

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NIDDK EDUCATION PROGRAM GRANTS (R25) RELEASE DATE: August 19, 2004 PA NUMBER: PAR-04-148 EXPIRATION DATE: September 18, 2006 (Reissued as PAR-06-554) (Expired September 18, 2006 per NOT-OD-06-104) (See Notice NOT-DK-06-016 Non-Competition for NIDDK Education Program Grants (R25)) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.847, 93.848, 93.849 THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR o Education Program Objectives and Description o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR The Education Grant Program at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is a flexible, curriculum-driven program aimed to create educational opportunities that will attract undergraduate and graduate students and postdoctoral fellows to careers in areas of biomedical or behavioral research of particular interest to the NIDDK and to foster their career development. The NIDDK is especially interested in attracting students and postdoctoral fellows from scientific disciplines underrepresented in disease-oriented biomedical research such as engineering, informatics, computer science, and computational sciences, and encouraging them to apply their expertise to research relevant to diabetes and other endocrine and metabolic diseases, digestive diseases and nutrition, obesity research and prevention, and kidney, urologic and hematologic diseases. This Program Announcement (PAR) replaces PAR-02-063 http://grants.nih.gov/grants/guide/pa-files/PAR-02-063.html which was published in the NIH Guide on February 14, 2002. The NIDDK Education Program grants (i.e. R25s) support the development and implementation of curriculum-dependent programs that may focus on educational activities before, during or after the completion of a doctoral level degree (e.g. Ph.D., M.D., D.P.H., D.D.S., O.D.) as long as they address a need that is not fulfilled adequately by any other grant mechanism available from the National Institutes of Health (NIH) and are dedicated to areas of high priority to the NIDDK. The R25 grant may not be used to conduct traditional biomedical research or as a research training grant. Applicants whose programs cannot meet the Special Requirements stated in these guidelines should refer to the traditional National Research Service Award (NRSA) Institutional (T32) http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html or Short-Term (T35) http://grants.nih.gov/grants/guide/notice-files/not98-027.html Training Grants as possible alternative sources of support. EDUCATION PROGRAM OBJECTIVES AND DESCRIPTION A. Background: The principal objective of this PAR is to develop the means to attract students (undergraduate and graduate) and/or postdoctoral fellows to NIDDK-relevant research. In particular, the participation of students from scientific disciplines that are underrepresented in many disease- oriented biomedical research programs should be encouraged. Programs should also focus on attracting underrepresented minority students and postdoctoral fellows to NIDDK-relevant research. Applicants are expected to propose unique, innovative, curriculum-based education programs that focus on scientific areas of interest to the NIDDK. This may be in the form of a course, seminar series, yearly symposium, or other appropriate educational tool. Evaluation of the proposed educational program must be integral to its design. It is anticipated that inclusion of faculty currently active in research related to the mission of NIDDK will be necessary in order to provide the highest quality of information and to introduce role models and future colleagues into the educational experiences. B. Program: The award provides support to institutions for up to 5 years for (1) the principal investigator;(2) an Advisory Committee to manage, coordinate and evaluate the program; (3) the faculty to design, develop, implement and continually refine the program curriculum; and (4) for other Program-related costs. No support will be provided for stipends or tuition costs of students and/or postdoctoral fellows. These Programs should provide curriculum-based, multi-disciplinary and interdisciplinary didactic and other educational experiences for undergraduate and graduate students and/or postdoctoral fellows. Examples of specific Programs may include, but are not limited to: o specific disease processes of interest to NIDDK (e.g. diabetes, cystic fibrosis, inflammatory bowel disease, obesity, hepatitis, renal diseases or hematological disorders); o the translation of basic science discoveries to patient care ("bench to bedside" research); o the relationships of specific organ systems (e.g. digestive, renal, endocrine, hematopoietic) to health and illness; o the appreciation and integration of whole animal physiology in current biomedical research; o information on how molecular techniques may be applied to NIDDK-relevant diseases and research; o the development of therapeutics related to diseases relevant to the NIDDK (e.g., how does one move from a genome sequence to health benefits?). C. Environment: The participating institution(s) must have well-established research programs and faculty qualified in curriculum development, implementation, and program evaluation to organize and develop the curriculum. Qualified faculty members must be available to participate in the program. The environment should be team-oriented and highly collaborative with a strong potential for a dynamic two-way exchange of information and ideas within and across diverse and disparate disciplines such as the physical, biomedical, behavioral, population and quantitative (mathematics, engineering, computer sciences, etc.) sciences. The institution must demonstrate a commitment to provide sustained leadership and dedicated faculty time to the development, implementation, and evaluation of the Program. D. Allowable costs 1. Salary: The principal investigator may request salary support for his/her role in leadership, management, coordination, and evaluation of the Program, in accordance with the percent effort commitment to the Program, which will usually be 10-50%. Faculty critical to the design, development, implementation, and refinement of the specialized curriculum essential to the didactic needs of the Program may request salary support in accordance with the percent effort commitment to the Program. Salary support may be requested for program faculty for their service on the Advisory Committee (see SPECIAL REQUIREMENTS). The principal investigator and Program faculty may derive additional compensation from other Federal sources or awards provided the additional compensation does not exceed the maximum annual salary level for Federal employees set at the Executive Level I of the Federal Pay scale and their total percent effort on all awards does not exceed 100 percent. 2. Advertising and Recruitment Costs: A small proportion of the budget may be requested for advertising and recruitment costs in order to attract the best possible candidates to the Program. 3. Ancillary Personnel Support and Other Costs: In general, salaries for secretaries, administrative assistants, and other ancillary personnel are not allowed. Requests for consultant costs, equipment, supplies, and other project-related expenses must be justified as specifically required by the proposed Program and must not duplicate items generally available at the institution for educational programs. 4. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. E. Change of Institution: The NIDDK Education Project Grant cannot be transferred from one institution to another. F. Change of Principal Investigator: If the principal investigator moves to another institution or resigns from the position, support of the award may be continued provided that the current principal investigator or the awardee institution has submitted a written request for change of principal investigator, countersigned by the appropriate institutional business official, to the NIDDK describing the reasons for the change. The biographical sketch of the proposed new principal investigator, including a complete listing of active grant support, must also be provided. The information provided must establish that the specific aims of the original peer reviewed education program to be conducted under the direction of the new principal investigator will remain unchanged, and that the new principal investigator has the appropriate educational and administrative expertise to lead the program as well as the support of the institution. NIDDK Program staff must approve of this change and should be contacted prior to submission of the letter (see INQUIRIES). G. Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular principal investigator. Changes in any of these parameters require prior approval by the NIDDK. A strong rationale must be provided for any proposed changes in the aims of the original peer reviewed Program. NIDDK program staff will evaluate the proposed changes to ensure that the Program remains within the scope of the original peer-reviewed education program. If the new Program does not satisfy this requirement, the award will be terminated. H. Progress Reports: An Annual Progress Report for the grant is required. This report should provide information on the development and implementation of the program/curriculum/symposium, modifications to the Program as originally proposed, the number of students/postdoctoral fellows participating in the curriculum or program, and updates on the evaluation of the Program by the Advisory Committee. These progress reports will be closely monitored by NIDDK staff to ensure that the Program is achieving its goals and meets the intent of the NIDDK for this specialized R25 grant mechanism. Progress reports are to be submitted using the Form PHS 2590, which can be accessed directly at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. Adapt the application for continuation so it contains the following information: o Appropriate Face Page o A detailed budget page that provides all salaries and fringe benefits and other budgetary information. o A brief description of the Objectives and Goals of the Program o A list of faculty and Advisory Committee members who have left the Program and of the new individuals who are taking their place or are being added. For each new person include their degree and department (or equivalent) and, if a multi-institutional consortium, their institution. o Biographical Sketches of: i. New faculty ii. New Advisory Committee members o A Report from the Advisory Committee that is separately attached and evaluates the development of and, in future years, the effectiveness of the Program and any recommended changes; the plans for recruitment/advertising including outreach to students from minority groups underrepresented in biomedical research; o Once the Program has been implemented, a list of the participants with their backgrounds, and their evaluation of the Program. I. Evaluation: In carrying out its stewardship of human resource related programs, the NIDDK may request information essential to an assessment of the effectiveness of this program. Accordingly, principal investigators are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of the participants' 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 on their career choices. MECHANISM OF SUPPORT This PAR will use the NIH Education Project Grant (R25) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. R25 education grants are not typical research instruments, but do involve experiments in education that require an evaluation plan in order to determine the degree of success or failure. Applicants may request up to five years of support to develop a specific education program. Applications should propose short-term education projects limited to five years or less, although the curriculum that is developed should be self-sustaining. Awards are not renewable. The total annual requested direct costs on the R25 grant are limited to $100,000. Facilities and Administrative (F&A) costs are payable at the rate of 8 percent of modified total direct costs. The 8 percent F&A cost rate will also apply to all subcontracts on R25 grants (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html). This PAR uses just-in-time concepts. ELIGIBLE INSTITUTIONS You may submit (an) application(s) 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, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Foreign institutions are not eligible to apply Applications may include more than one institution to create a Program through consortium agreements that includes all of the disciplines, research environments, students and faculty needed to accomplish the proposed educational objectives (refer to the following URL for guidelines on these agreements: http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium). However, only one of the participating institutions can be the recipient of an award. An institution may submit more than one application in order to support programs in different areas of scientific emphasis. 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. SPECIAL REQUIREMENTS o A specialized NIDDK-relevant education curriculum, not otherwise available at the institution, or a significant expansion of a pre-existing NIDDK- relevant education program, must be developed; examples of a newly developed Program include, but are not limited to, a single course, a portion of an established course, a yearly conference, a seminar series, or a group of short courses. o The principal investigator must assemble and chair a multidisciplinary Advisory Committee representing all of the disciplines, departments, schools, institutions, etc. involved in the NIDDK education program. The Advisory Committee will assist the principal investigator in the recruitment and selection of the Program faculty; the establishment and review of the specialized curriculum; and will monitor and evaluate the overall effectiveness of the program; o The program faculty should, if at all possible, be researchers or educators actively engaged in scientific areas of interest to NIDDK; involvement of clinicians is strongly encouraged; o A plan must be provided for the process and outcome evaluation of the NIDDK education program. Benchmarks should be specified, and specific plans and procedures to capture, analyze, and report outcome measures must be described; o A plan to integrate the proposed NIDDK education program with the current established curriculum of the applicant institution must be developed. Plans to coordinate the NIDDK education program through institutional curriculum committees must be documented in the application; o A plan for continuing the curriculum and for the periodic updating of the curriculum/program beyond the five-year project period should be described. The principal investigator should provide evidence of institutional commitment and plans to continue the Program after the period of grant support ends when the program involves curricula development aimed at strengthening the educational capability of the institution (e.g., a new curriculum for researcher or health care professionals in training). WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR and welcome the opportunity 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: James F. Hyde, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 609 Bethesda, MD 20892-5460 Telephone: (301) 594-7692 FAX: (301) 480-3503 E-mail: jh486z@nih.gov Judith Podskalny, Ph.D. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 667 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 FAX: (301) 480-8300 Email: jp53s@nih.gov Terry Rogers Bishop, Ph.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 619 Bethesda, MD 20892-5458 Telephone: (301) 594-7721 FAX: (301) 480-3510 Email: tb232j@nih.gov o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 FAX: (301) 480-8300 E-mail: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Denise Payne Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 733 Bethesda, MD 20892-5456 Telephone: (301) 594-8845 FAX: (301) 480-3504 E-mail: dp43b@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001, updated 09/09/2003). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. 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) 710-0267, Email: GrantsInfo@nih.gov The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS Applications for NIDDK Education Project Grants (R25) must be submitted on Form PHS 398 using the modified instructions below, which take into account all of the special features and requirements of this grant. 1. Description, Performance Site(s), Key Personnel: (Use Form Page 2 of the PHS 398): Complete as directed in the form PHS 398 instruction package; this should include the principal investigator, Advisory Committee Members, and other faculty participating in the program. Please make sure that you denote each individual's degree and departmental affiliation (or equivalent) AND, if a consortia of institutions, institutional affiliation. 2. Table of Contents to be organized as follows: a. Face Page b. Description, Performance Site(s), Key Personnel c. Table of Contents d. Detailed Budget Page for First Year e. Budget for Entire Proposed Period of Support f. Budgets Pertaining to Consortium/Contractual Arrangements g. Other Sources of Institutional Training and Education Support h. Biographical Sketches (not to exceed 4 pages per individual): o Principal Investigator o Advisory Committee Members o Other Participating Faculty i. Education Program (Not to exceed 25 pages, excluding tables) i. (If applicable) Introduction to Revised Application (Not to exceed 3 pages) ii. Purpose and Objectives iii. Specialized curriculum and other didactic experiences iv. Resources and Facilities/Faculty v. Program Leadership/Management o Principal Investigator o Advisory Committee o Recruitment Strategies o Evaluation Plan j. Checklist k. Appendices 3. Detailed Budget for the First Year: Use Form Page 4 of the PHS 398. Under PERSONNEL break out the individuals as follows with percent effort, salary and fringe benefits: A. The Principal Investigator (PI) B. The Faculty being paid from the Grant If costs are requested for Advertising and Recruitment, make sure that these costs are identified under each budget category. 4. Budget for the Entire Proposed Project Period of Support: Use Form Page 5 of the PHS 398 and provide projected future year budgets as instructed in the PHS 398. 5. Biographical Sketches and Other Support: Provide biographical sketches using the forms provided in the PHS 398 package for the Principal Investigator, Advisory Committee Members, and other participating faculty. 6. Education Program Plan: a. (If applicable) Introduction to Revised Application: If this is a revised application, in no more that three pages summarize how you have addressed the previous concerns of the reviewers and what new information is available that might be important for the reviewers to evaluate. Additionally, highlight (bold, italics, etc.) in the text of the plan changes made in response to the concerns of the previous review of the application. b. Purpose and Objectives: In this section provide background, purpose and objectives of the Program. c. Specialized Curriculum and Other Didactic Experiences: Describe the proposed course/seminar series/symposium/or other curriculum-based program. Explain how the development and implementation of this curriculum is critically linked to the purpose and objectives of the Program and to the potential research career development of enrolled individuals. Explain how this curriculum is distinguished from other curricula within the existing educational infrastructure and framework of the applicant/participating institution(s). Describe the utilization of any existing curriculum within the institution(s). d. Resources and Facilities/Faculty: Resources and Facilities: Briefly describe the infrastructure and facilities that are available and accessible to this Program. Faculty: Describe the track record in training scientists of each faculty member participating in the Program. e. Program Leadership/Management: o Principal Investigator: Describe the qualifications and role of the Principal Investigator to provide leadership and coordination of the Program. o Recruitment Strategies: Describe the characteristics of the pool of students/fellows who will be recruited for participation in the Program as well as any advertising strategies to be used. Comment on the size of the candidate pool expected, note any other institutional programs that might compete for this pool, and describe strategies for addressing this competition. Separately describe the strategies for recruiting minority students/fellows. o Advisory Committee: Describe how the Advisory Committee will function in providing oversight of the development, implementation and evaluation of recruitment strategies; will aid in recruitment and selection of students/fellows for the Program; will interact with faculty to establish, implement and evaluate the curriculum. In addition, indicate how the Advisory Committee will function to approve individual education plans, if appropriate (e.g., curriculum, research/methodology experiences), and monitor the overall effectiveness of the Program; o Evaluation Plan: Describe the information that will be collected, the periods for, and criteria to be used in evaluating this Program; 8. Consortium/Contractual Arrangements: Refer to the following website for guidelines on these agreements: http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium. 9. Appendices: follow instructions provided in the PHS Form 398 application package. 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 also are 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 three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all appendix material must be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. APPLICATION PROCESSING: The CSR will not accept any application in response to this PAR 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed by the CSR for completeness and by the NIDDK program staff for responsiveness in two areas: 1) Eligibility criteria; 2) Special Requirements. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the NIDDK National Advisory Council REVIEW CRITERIA The review criteria that will be applied to the application are briefly described below: o The degree to which the proposed Program addresses areas that are of importance to the NIDDK. The Program must demonstrate how its implementation will advance the objectives of this PAR as well as the overall mission of the NIDDK. o Novelty, innovation, and significance of the education program to scientific areas of importance to the NIDDK. The curriculum should include original and unique approaches or methods for addressing the needs put forth in the goals and objectives. Plans to develop web versions of courses supported through the R25 grants, as well as other means to support rapidly evolving areas of major interest to the NIDDK, will be evaluated. o Adequacy of the justification of the need for the proposed Program relative to other on-going education and/or training/career development activities being sponsored within the institution(s). o Qualifications of the Principal Investigator in terms of past track record of achievement and experience to provide direction, coordination and administration of the Education Program. o Qualifications of the key personnel and/or faculty that will participate in the Program. o Suitability and commitment of the Advisory Committee to provide oversight and input, and to monitor and evaluate the overall effectiveness of the program. o The overall quality and adequacy of the design of the Program to achieve its objectives; the degree to which the curriculum (sequence, topics, breadth, depth, etc.) will meet these objectives. o Adequacy of the required "Evaluation Plan" to assess the effectiveness of the Program in achieving its objectives, and the degree of portability of the proposed program. o Adequacy and appropriateness of the plan to recruit and enroll students and/or postdoctoral fellows, including under-represented minorities, to participate in the Program. o Evidence of institutional commitment and plans to continue the Program after the period of grant support ends when the program involves curricula development aimed at strengthening the educational capability of the institution (e.g., a new curriculum for researcher or health care professionals in training). o Appropriateness of the budget and duration of support needed to achieve the stated goals and objectives. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. AWARD CRITERIA Applications submitted in response to a PAR 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 Relevance to program priorities o Availability of funds REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (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.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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. 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 PAR in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PAR is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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NIH Funding Opportunities and Notices