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CAM PRACTITIONER RESEARCH EDUCATION PROJECT GRANT PARTNERSHIP RELEASE DATE: April 21, 2004 PA NUMBER: PAR-04-097 EXPIRATION DATE: September 16, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.213 APPLICATION RECEIPT DATES: September 15, 2004; September 15 2005; September 15, 2006 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PAR o Research Objectives o Mechanisms 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 Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR The goal of this program announcement is to increase the quality and quantity of the research content in the curricula at complementary and alternative medicine (CAM) institutions in the United States where CAM practitioners are trained. This initiative is not designed to directly train researchers, but rather to enhance CAM practitioners’ exposure to, understanding of, and appreciation of the evidenced-based biomedical research literature and approaches to advancing scientific knowledge. CAM professional schools responding to this program announcement must partner in the development and implementation of their program with a research-intensive institution, such as a university, medical, dental or nursing school, or other type of health professional school. For the purpose of this specific program announcement a CAM institution is defined as a U.S. domestic nationally or regionally fully accredited academic, health care or research institution with a primary goal of training students to be CAM practitioners. Only schools that offer a doctoral degree in a designated CAM practice that is licensed or certified at the state level will be eligible to submit an application in response to this announcement. Some examples of eligible institutions include but are not limited to colleges/schools of naturopathy, chiropractic, and traditional Chinese medicine. NCCAM recognizes that a number of accredited CAM professional schools that train students in specific CAM therapies do not require a doctoral degree as the terminal degree to practice. While this program announcement is limited to schools offering doctoral degrees, it is anticipated that the experienced gained from this initiative will provide data that will inform the incorporation of research education at CAM institutions offering other types of terminal degrees and certificates. RESEARCH OBJECTIVES Background CAM practitioner training and curricula in naturopathic, chiropractic, Oriental medicine, and other CAM modalities are well established. However, inclusion of biomedical research information, in terms of courses and short-term research experiences, varies considerably among CAM practitioner training curricula, and is often less common and less extensive compared to curricula in other types of health professional schools. Increasing the research content in CAM practitioner training curricula would enhance the ability of CAM practitioners to critically evaluate biomedical literature, have a more in depth knowledge of the therapies prescribed to their patient’s by allopathic physicians in integrative medical settings, become better able to participate in clinical research, and may stimulate some trainees to seek advanced training and career development in biomedical research. Research Scope This initiative will support the development and enhancement of lecture and methods courses in biomedical research, support short-term faculty and student research projects (such as summer projects), strengthen the research skills of faculty, and promote the incorporation of research training components across the whole curricula in CAM practitioner training institutions. All of this must be done in close partnership with a research-intensive institution (referred to as the partnering institution in this announcement) such as a conventional health professional school (medical school, dental school, nursing school) or university with a tradition of rigorous research. Since existing CAM practitioner curricula range widely in research content, initiatives that will lay new groundwork to introduce research-based information into a curriculum for the first time, as well as initiatives that will expand existing research training programs in CAM professional schools, will be accepted. Where research programs are already underway, a significant expansion must be proposed. Specific activities supported by this initiative may include, but are not limited to the following: o Development of an overall research curriculum development plan; o Assessment of students’ interests and needs as part of curriculum development; o Introduction and/or strengthening of research content in coursework across the entire CAM practitioner curricula; o Support of faculty development in research methodology by supporting short-term faculty sabbaticals for research training, especially at the partnering research- intensive institution; Funds may be used for such items as partial salary support, supplies, small equipment, and travel to scientific meetings; o Development of mechanisms to facilitate and encourage longer term collaborations between faculty at the CAM practitioner institution and research faculty at the partnering institution; o Support for short-term research projects for CAM practitioner students, such as summer projects, at the partnering research-intensive institution. Funds may be used for supplies, small equipment, and travel to scientific meetings related to the R25 educational program short term research projects. Individuals already supported by NIH training and career development award mechanisms (K, T, and F grants) may not receive stipends or salary support from this program, however, limited support to defray participation costs may be provided. o Strengthening of existing research-oriented courses and development of new courses in research methodology, such as biostatistics and clinical trial methodology, as well as courses related to preclinical/basic scientific studies; o Support of adjunct faculty appointments for research scientists to teach or participate in research courses at CAM institutions; o Development of a plan for program evaluation; o Development of long range plans for sustainability of the successful curriculum changes after NCCAM support ends. Because of the complexities of modifying existing professional school curriculum in collaboration with another institution, an advisory committee is required to help chart the progress of the proposed plan and help resolve issues that may arise. This committee should be chaired by the principal investigator and should include senior staff at the CAM Institution who are in charge of curriculum development and senior staff at the research-intensive partnering institution who have agreed to participate in this Education Project Grant. The frequency of meetings should be decided by the principal investigator, but should not be less than twice a year. A roster of the advisory committee must be provided in the application along with letters from the nominated members indicating their willingness to serve. For successful applicants, an additional two advisory members from outside the two participating institutions will be selected at the time of award, but should not be named in the application. MECHANISM OF SUPPORT This PAR will use the NIH Education Project Grant mechanism (R25). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This PAR uses just-in-time concepts. It also uses the modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_I_1.htm. The maximum duration for support that can be requested is 4 years. It is expected that the majority of time during the first year of funding will be devoted to the development of plans for implementation in the following years of support. Planning during the first year could include but is not limited to any of the following: o Developing the content of new research training courses or planning how existing courses could be modified to include research training elements in collaboration with faculty from the partnering institution. This could include determining the number of hours and content of new courses; what the prerequisites would be, where they would fit in the curriculum; whether they would be required or elective, who would teach the courses or course modules, etc. o Reaching consensus among course directors and others in authority at the CAM Institution on plans to modify the curriculum; o Developing plans with faculty from the partnering institution on how short term research experiences for students and faculty will be structured, selected, and evaluated; o Determining how specific faculty from the partnering institution will contribute to teaching and mentoring of students at the CAM institution who are interested in research training; o Developing guidance to encourage and implement collaborations between faculties at the CAM institution who are interested in research with faculty at the partnering institution; o Developing strategies to advertise changes in curriculum to attract interested students and faculty who are interested in research to this new program; o Developing an evaluation plan for the whole education project; o Finalizing the advisory committee roster and setting up a schedule of meetings. Because it is expected that the first year will be devoted mostly to planning, the maximum total direct cost that may be requested for the first year is $100,000. The maximum annual direct cost that may be requested for the subsequent years of the grant, when implementation of the plans are expected to take place, is $200,000 per year. Facilities and administrative costs for this Education Project Grant will be limited to 8 percent modified total direct costs for both the applicant organization and for subcontracts. The total subcontract costs to the research intensive institution should not be more than one third of the total requested budget. As part of the direct cost for years after the first year, the principal investigator should budget travel expenses for the principal investigator and one senior member of the team from the partnering institution to attend an annual CAM R25 awardees meeting in Bethesda, Maryland. After the first 12 months of support, a programmatic review will be conducted to assess progress. The review criteria will be based on the suggested planning activities for the first year described above. The main goal of this review will be to discuss progress and future plans with the principal investigator and his/her team and to provide advice to help ensure the success of the project. Subsequent to this review, funds for the remaining years of the project will be approved and released. We anticipate approval of continuing support after the first year for all funded grants. However, if progress is judged to be inadequate then a grant may be phased out at or before the end of the second year of support. Grantees who successfully transition through the first year of their initial award period have the option of submitting one 4-year competitive renewal on the same receipt date as new applications (September 15 of the appropriate year). It is expected that competitive renewal applications will focus on further implementation and refinements of their programs and implementation of strategies that will provide sustainability of the programs once NCCAM support has ended. Maximum direct costs of each year of the competitive renewal will be $200,000 with a limit of 8 percent of modified total direct cost for facilities and administrative costs for both the applicant organization and for subcontracts. ELIGIBLE INSTITUTIONS You may submit an application if your institution is a CAM institution as defined below, and 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 Domestic institutions/organizations o Faith-based or community-based organizations o Foreign institutions and foreign collaborations are not eligible for this award. For the purposes of this Program Announcement, the CAM and research-intensive partnering institutions are defined in the following manner: o A CAM institution is defined as a U.S. domestic nationally or regionally fully accredited academic, health care or research institution with a primary goal of training students to be CAM practitioners. Only schools that offer a doctoral degree in a designated CAM practice that are licensed or certified at the state level will be eligible to submit an application in response to this announcement. o For the purposes of this initiative, U.S. domestic osteopathic medical institutions that teach manual manipulation as part of the core curriculum required for all students for a doctoral degree may be considered a CAM institution and may collaborate with another conventional institution as the research-intensive partner institution. If the osteopathic medical institution is part of a conventional research intensive health professional school or university, then the partnering institution may be within the same health professional school or university. o A research-intensive partnering institution is defined as a U.S. domestic academic, health care and/or research institution with a tradition of rigorous research and a record of substantive NIH research funding that does not have as a primary goal of training CAM practitioners. Examples are conventional healthcare professional schools such as medical schools, dental schools, or nursing schools or research-intensive universities. For this program announcement, the applicant institution must be a CAM institution. 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 his/her 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: The following supplemental information must be provided in the Resources Section (Section 7) of the application, not in the appendix. o A document or documents verifying current national and/or regional accreditation of the CAM institution; o A document outlining the present curriculum required for doctoral students at the CAM Institution; o A roster of the proposed advisory committee and a letter from each nominated member indicating his/her willingness to serve; o A letter of support from the appropriate official at the CAM Institution in charge of curriculum development, such as the President or appropriate Dean, describing how the institution will provide support for the proposed plan outlined in this application; o A letter of support from the appropriate official in the unit (department, branch, school, etc.) at the research-intensive institution, describing how the unit will support the proposed plan outlined in the application. NCCAM Policies In addition to applicable NIH policies, applicants should follow these NCCAM policies. o Applications that plan to include research on natural products should follow NCCAM’s policy on Quality of Natural Products: http://www.nccam.nih.gov/research/policies/naturalproducts.htm o Applications that plan to include clinical research should follow NCCAM’s policy on Terms of Awards for Clinical Trials: http://www.nccam.nih.gov/research/policies/terms-of-awards.htm 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: Nancy J. Pearson, Ph.D. Program Officer National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892- 5475 Bethesda, MD 20817 (for express mail/courier service) Telephone: (301) 594 0519 FAX: (301) 480 3621 Email: pearsonn@mail.nih.gov o Direct your questions about peer review issues to: Martin Goldrosen, Ph.D. Chief, Office of Scientific Review National Center for Complementary and Alternative Medicine National Institutes of Health 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892 (for express/courier service use 20817) Telephone: (301) 594 2014 Fax: (301) 480 2419 Email: goldrosm@nccam.nih.gov o Direct your questions about financial or grants management matters to: Brian Campbell Grants Management Specialist National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Bethesda, MD 20817 (for express mail/courier service) Telephone: (301) 594 8738 Fax: (301) 480 3631 Email: campbeb@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS 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) 435-0714, 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. APPLICATION RECEIPT DATES: Receipt dates: September 15, 2004, 2005, 2006 Peer Review: February/ March Council Date: May/June Earliest Possible Start Date: July SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and four 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) Also send one copy of the application to: Martin Goldrosen, Ph.D. Director, Office of Scientific Review National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Bethesda, MD 20817 (for express mail/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at described above. 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. PEER REVIEW PROCESS Applications submitted for this PAR 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 National Advisory Committee on Complementary and Alternative Medicine REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the 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 Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will they enhance CAM practitioners’ exposure to and understanding of evidence-based biomedical research literature and approaches to advancing knowledge through research in CAM? What will be the effect of the education project on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of this CAM Education Project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is an adequate program evaluation plan proposed? Have the investigators considered how the program will be sustained? INNOVATION: Does the CAM Education Project employ novel educational and scientific concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the CAM Education Project proposed appropriate to the experience level of the Principal Investigator and other researchers and educators? ENVIRONMENT: Does the educational and scientific research environment in which the work will be done at the CAM institution and partnering institution contribute to the probability of success? Does the proposed CAM Education Project take advantage of unique features of the educational and scientific research environment and employ useful collaborative arrangements with the partnering institution? Is there evidence of institutional support at both the CAM institution and the partnering institution based on the letters of support from appropriate officials at each institution and the description of interactions between the two institutions in the text of the proposal? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: 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.) 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. SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. 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 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 Availability of funds o Relevance to program priorities 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 is 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as appropriate, 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. 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 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 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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