and Human Services (HHS)
EXPIRED
DEVELOPMENTAL PROJECTS IN COMPLEMENTARY APPROACHES TO CANCER CARE RELEASE DATE: February 2, 2004 PA NUMBER: PA-04-053 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date. The non-AIDS portion of this funding opportunity expires on the date indicated below. Replacement R21 (PA-06-400) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.395 (NCI); 93.361 (NINR); 93.121 (NIDCR); 93.213 (NCCAM) THIS 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 The National Cancer Institute’s Office of Cancer Complementary and Alternative Medicine (OCCAM), the National Center for Complementary and Alternative Medicine (NCCAM), the National Institute of Nursing Research (NINR), and the National Institute of Dental and Craniofacial Research (NIDCR)invite research grant applications from interested investigators to conduct innovative developmental pilot research investigating complementary approaches in cancer. The intent of this initiative is to encourage and support the development of basic and clinical complementary cancer research and to provide the basis for more extended research projects by establishing the methodological feasibility, strengthening the scientific rationale for these projects, and collecting preliminary data. This announcement is also intended to stimulate and facilitate the entry of promising investigators into research in these topics through a program of exploratory investigator- initiated R21 grants. The exploratory/developmental (R21) grant mechanism is used for pilot projects or feasibility studies to support the exploration of feasibility, as well as the development, of projects investigating complementary approaches in cancer and for the generation of preliminary data. The R21 mechanism is specifically intended to support innovative ideas where preliminary data are sparse or do not exist. The R21 supported projects are intended to serve as a foundation for planning and developing future research projects (R01s). The objective of this Program Announcement (PA) is to encourage applications from individuals who are interested in testing novel or conceptually creative ideas that may produce innovative advances in the understanding and use of complementary approaches in cancer. RESEARCH OBJECTIVES The widespread use of a variety of nutritional, psychological and natural medical approaches has been well documented. Recent surveys demonstrate that between 9 and 91 percent of U.S. cancer patients use these kinds of therapies at some time after their diagnosis. Despite the broad use of complementary approaches in the treatment for cancer, there is a lack of data available to indicate whether these practices are efficacious and safe. Various NIH advisory groups have cited the need for increased research on these approaches for the treatment of cancer and have encouraged the NIH to support the evaluation of such therapies. There is a paucity of funded R01 research grants in these topics in cancer research. Therefore, to increase the number and quality of investigator- initiated R01 research grants on complementary approaches in cancer, the NCI's Office of Cancer Complementary and Alternative Medicine took the lead in developing this PA for Developmental Projects in Complementary Approaches to Cancer Care. The intent of this initiative is to encourage and support the development of basic, and clinical (prevention, therapeutic, and palliative) cancer research in complementary approaches. Another goal of this initiative is to facilitate communication and collaboration between practitioners in complementary approaches and the conventional cancer research communities. For the purpose of this PA, applicants may consider complementary approaches as they relate to the prevention, diagnosis, and treatment of cancer, cancer- related symptoms, and side effects of conventional treatment. In addition, applicants may consider research that focuses on the potential interactions of complementary approaches with conventional cancer therapies. Complementary approaches that are considered responsive to this announcement include (but are not limited to) those involving nutritional approaches, natural products, mind-body approaches, energy therapies, herbal medicines, and interventions based upon those within traditional medical systems such as Traditional Chinese Medicine or Ayurvedic medicine. Topics of program interest include but are not limited to: Approaches related to management of cancer-related symptoms and side effects of conventional treatment. Design and pilot testing of interventions for comparative studies of complementary modalities as interventions for end of life and palliative care (e.g., relaxation therapy, music therapy). Development of methodologies to improve assessment of the impact of complementary approaches to treatment; e.g., instrument development, biobehavioral markers, acceptance of longitudinal designs or prevention. Feasibility studies of behavioral interventions that incorporate principles of cultural competency, in particular within populations that utilize culture-specific traditional methods of treating cancer. Applications that are relevant to understudied populations (i.e., the use of complementary approaches in children or older adults. Descriptive studies of the prevalence of CAM use in understudied populations including the impact of such use on the primary modality of treatment are also appropriate. Nutritional approaches in the prevention and treatment of cancer, as well as to prevent disease recurrence. Preclinical studies of candidate complementary approaches with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management. Preclinical studies to advance understanding of mechanism of actions a well as drug-drug interactions. Isolation and pharmacological studies of active ingredients from herbal or other traditional medicine preparations, including a defined reconstitution of more than one pure ingredient, such as drug-drug interaction. Applications that seek to clarify markers of exposure to bioactive food components and their biological response in specific targets are also appropriate. Applicants are encouraged to review the most recent NCI Plan and Budget Proposal for additional information about topics that are of program relevance to the NCI. These documents are available through http://www.cancer.gov/publications, by email at cisocc@pop.nci.nih.gov, or by telephone at 1-800-4-cancer and are published each year. The document for fiscal year 2004: The Nation’s Investment in Cancer Research: A Plan and Budget Proposal for Fiscal Year 2004 is NIH Publication No. 03-4373. Applicants are also encouraged to review the topics that have been processed through the NCI’s Best Case Series program. For additional information, see http://www.cancer.gov/cam or contact Dr. Wendy Smith listed under INQUIRIES. The National Institute of Nursing Research (NINR) also encourages applications that are consistent with its strategic plan and research themes for the future. In keeping with its research themes, projects that may lead to improved strategies for managing the effects of illness to improve quality of life, reducing health disparities, and enhancing the end-of-life experience for patients and their families are particularly welcome. For further information on NINR’s strategic plan, the applicant may refer to http://www.ninr.nih.gov/research/diversity/mission.html. The National Institute of Dental and Craniofacial Research (NIDCR) highlights in its strategic plan (http://www.nidcr.nih.gov/about/strat-plan/) and in its Plan to Eliminate Health Disparities (http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf) oral and pharyngeal cancers as one of the diseases of interest. The NIDCR encourages applications that explore complimentary approaches for the prevention of primary and recurrent lesions from these cancers. Also of interest are studies on complimentary approaches that improve the quality of life for individuals receiving treatment for oral and pharyngeal cancers. The NIDCR will not support the conduct of pilot clinical trials under this PA. The interests of the National Center for Complementary and Alternative Medicine include the safety, efficacy, and mechanisms of action of the CAM modalities described above as applied to the prevention and treatment of cancer, as well as treatment for cancer symptoms and side effects of conventional therapies. NCCAM’s interest in studying complex natural products focuses on the polypharmacy of these products. Therefore, NCCAM will not accept applications to isolate the active constituents of complex natural products for the express purpose of developing these constituents as discrete drugs. NCCAM does however support research characterizing single constituents extracted from complex natural products for the purposes of identifying and/or standardizing whole products, comparing the activities of single constituents and complex products, or identifying mechanisms of action for the whole product. In addition, it is highly recommended that applicants contact program staff listed at the end of this announcement with questions about specific issues in cancer research or in complementary approaches. Applicants should also review the document Strategies for Success: How to Write a Grant in Cancer Complementary and Alternative Medicine available through the NCI’s Office of Cancer Complementary and Alternative Medicine (OCCAM) (see program contacts under INQUIRIES and http://www.cancer.gov/cam). It is the sole responsibility of the applicant to obtain all necessary clearances from the Food and Drug Administration (FDA) as required. It is expected that applicants will have contacted the FDA about necessity of an Investigation New Drug (IND) request well before submission of the current application. In addition, applicants are strongly encouraged to consult their local Institutional Review Boards (IRBs) concerning IND status and the IRB approval process. MECHANISM OF SUPPORT This PA will use the NIH Exploratory/Developmental (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The earliest anticipated award date is September 2004. The applicant may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. This PA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $275,000 or less, use the modular budget format. 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. 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 Domestic or foreign institutions/organizations o Faith-based or community-based organizations 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 two areas: scientific/research and financial or grants management issues: o Direct inquiries regarding specific questions related to this announcement, questions about scientific/research issues and/or methodological issues in investigating complementary approaches in cancer research to: Wendy B. Smith, M.A., Ph.D. Research Development and Support Program Office of Cancer Complementary and Alternative Medicine National Cancer Institute 6116 Executive Blvd, Room 609 Bethesda, MD 20892-7302 Rockville, MD 20852 (for express/courier service) Telephone: (301) 435-7980 FAX: (301) 480-0075 Email: smithwe@mail.nih.gov OCCAM website: http://www.cancer.gov/cam Direct inquiries regarding specific scientific research issues in cancer to: Preclinical studies of candidate CAM with appropriate models to demonstrate efficacy and toxicity, and improvement over current clinically approved cancer treatment and disease management. Preclinical studies of mechanism of actions, drug-drug interactions: Yali Hallock, PhD Developmental Therapeutics Program Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, EPN Room 8058 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8783 FAX: (301) 402-5200 Email: hollocky@mail.nih.gov Clinical studies of CAM to improve the therapeutic index of conventional systemic or surgical therapies for cancer by either improving efficacy or decreasing toxicity of conventional therapy: Dr. Roy Wu Clinical Grants and Contracts Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, EPN Room 7009, MSC 7432 Bethesda, Maryland 20892-7432 Rockville, MD 20852 (for express/courier service) Telephone: 301-496-8866 FAX: 301-480-4663 Email: wur@mail.nih.gov Symptom management during active treatment and/or at the end of life: Ann O'Mara, PhD, MPH, RN Program Director Community Clinical Oncology Program National Cancer Institute 6130 Executive Boulevard, EPN Room 2011 Bethesda, MD 20892-7340 Rockville, MD 20852 (for express/courier service) Telephone: 301-496-8541 FAX: 301-496-8667 Email: omaraa@mail.nih.gov Survivorship research: Diana Jeffery, Ph.D., Program Director Office of Cancer Survivorship National Cancer Institute Division of Cancer Control & Population Sciences 6130 Executive Boulevard. EPN Room 4088 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 435-4540 FAX: 301-594-5070 Email: jefferyd@mail.nih.gov Nutritional approaches in the prevention and treatment of cancer, as well as to prevent disease recurrence: William F. Anderson, MD Medical Officer GI and Other Research Group Division of Cancer Prevention National Cancer Institute 6130 Executive Boulevard, EPN Room 2144 Bethesda, MD 20892-7317 Rockville, MD 20852 (for express/courier service) Telephone: 301-594-7672 FAX: 301.435.6344 Email: wanderso@mail.nih.gov Biomarkers for assessing nutritional status and targets of action of bioactive food components: Cindy D. Davis, Ph.D. Program Director Nutritional Science Research Group Division of Cancer Prevention National Cancer Institute National Institutes of Health 6130 Executive Boulevard, EPN Room 3169 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: 301-594-9692 FAX: 301-480-3925 Email: davisci@mail.nih.gov For issues concerning relevance to NINR contact: Martha L. Hare, Ph.D., R.N NIH/National Institute of Nursing Research 6701 Democracy Boulevard One Democracy Plaza, Room 710 Bethesda, MD 20892-4870 Bethesda, MD 20817 (for express/courier service) Telephone: 301-451-3874 FAX: 301-480-8260 Email: harem@mail.nih.gov For issues concerning CAM and oral and pharyngeal cancers contact: Maria Teresa Canto, DDS, MPH Program Director, Population Sciences Clinical, Epidemiology and Behavioral Branch Division of Population and Health Promotion Sciences NIDCR 45 Center Drive MSC 6402 Natcher Bldg, Room 4AS43B Bethesda, MD 20892-6402 Telephone: 301-594-5497 FAX: 301-480-8322 Email: maria.canto@nih.gov For questions concerning relevance to NCCAM contact: Barbara Sorkin, Ph.D., Program Officer, Oncological Sciences NIH/National Center for Complementary and Alternative Medicine 6707 Democracy Boulevard, Room 401 Bethesda, MD 20892-5475 Telephone: 301-496-8004 FAX: 301-480-3621 Email: sorkinb@mail.nih.gov o Direct your questions about financial or grants management matters to: Ms. Eileen Natoli Grants Administration Branch National Cancer Institute 6116 Executive Boulevard, EPS Room 243 Bethesda, Maryland 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8791 FAX: (301) 496-8601 Email: natolie@gab.nci.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) 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. 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. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: All investigator initiated R21 applications 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. For the NIH Exploratory/Developmental Grant (R21), applicants may request direct costs in $25,000 modules, up to a total direct cost of $275,000 for the combined two year award period. 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 mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 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 Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups 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 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 written critique o Receive a second level review by the appropriate national advisory council or board 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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 to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Does the applicant describe how the results of this exploratory/developmental research will lead to the development of an R01 application? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel 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 work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 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. RESEARCH INVOLVING NATURAL PRODUCTS USUALLY PREPARED AS COMPLEX MIXTURES: If the study will involve natural products usually prepared as complex mixtures, applicants should follow guidance provided at http://www.csr.nih.gov/REVIEW/cnprd.htm. 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. ADDITIONAL REVIEW CONSIDERATIONS 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 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). 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. 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://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). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). 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.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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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