STUDIES OF ENERGY BALANCE AND CANCER IN HUMANS RELEASE DATE: July 8, 2004 PA NUMBER: PA-04-124 January 3, 2007 - Effective with the February 5, 2007 submission date, all R01 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, the R01 portion of this funding opportunity expires on January 3, 2007. Unsolicited or investigator-initiated R01 electronic SF424 (R&R) applications may be submitted through the Research Project Grant (Parent R01) announcement. 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 for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Replacement R21 (PA-06-405) 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 EXPIRATION DATE for All R01 Applications: January 3, 2007 EXPIRATION DATE for All Other Applications: May 2, 2009 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393, 93.399 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Supplementary Instructions 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 PA The National Cancer Institute (NCI) invites investigator-initiated research applications on energy balance in humans. These studies will focus on research to define factors affecting energy balance and to define mechanisms influencing cancer risk, prognosis, and quality of life. These studies may range from new analyses of existing datasets to additional collection of data and biological specimens in ongoing investigations. In order to be eligible for this Program Announcement (PA), an applicant must have previously collected measures from human subjects on two or more of the following exposures: diet, physical activity, body composition, and/or related biomarkers (such as blood, urine, exfoliated cells, and/or tissue samples). It is anticipated that the knowledge gained will provide additional information to better understand the relationships among energy balance, cancer risk and prognosis. Competitive supplements to existing NCI-funded grants as well as new R01s and R21s are invited. RESEARCH OBJECTIVES Energy balance, defined as the integrated effects of diet, physical activity, and genetics on growth and body weight over the life course, has been a recent focus for understanding the chronology of many chronic diseases. Research from many sources supports the adverse effects of obesity, physical inactivity, and poor dietary practices on cancer risk and prognosis. The recent trends in obesity rates in the U.S. population call attention to a potential for significant increases in cancer incidence. With the rise in the prevalence of obesity in the United States, there is concern for how behaviors involving body weight, physical activity, and diet may affect the development of cancer, as well as cancer prognosis for cancer survivors. Research in the areas of diet, cancer risk, and prognosis typically focuses on a single cancer prevention-related risk factor, such as a specific nutrient or diet pattern. However, less attention has been devoted to the combined effects of body composition, weight, physical activity, and diet on the key physiologic processes involved with cancer initiation and progression. Many research studies have collected data on several or all of these parameters, but because the initial hypotheses may not have been related to energy balance, data analyses to determine links were not conducted. Some studies have explored the clinical metabolic effect of diet, weight loss, and physical activity on certain parameters that could potentially be related to cancer, with the most extensive work on insulin resistance. However, research has been more limited and is needed in the areas of sex steroid hormones, growth factors, lipid metabolism, and immune function and inflammatory factors, such as cytokines and prostaglandins. Adverse changes in energy balance and contributory factors are considered to be a major factor underlying many of the pathways involved in cancer initiation and progression. Epidemiologic and intervention research within human populations can provide essential self-report and objective measures about diet, anthropometry, and physical activity important in unraveling the role of energy balance in cancer risk and prognosis. These measures can be linked with analyses of biologic specimens such as blood, urine, exfoliated cells, and other tissues to study underlying metabolic and genetic etiologic mechanisms in relation to energy balance. Some of the interrelationships may include shifts in steroid hormones, insulin-like growth factors and insulin resistance, lipid metabolism, immunologic parameters, inflammatory factors, and adipose tissue products. In addition to understanding how these factors affect development of cancer, effects of differences in energy balance in cancer patients and survivors are included. Under this PA, at least three types of additional research could be supported within existing studies to test new hypotheses with existing data; to perform additional assays on existing biologic specimens to examine new hypotheses; and to collect and analyze additional self-reports or objective measures of diet, anthropometry, physical activity, and/or biological specimens. This PA complements NCI’s Transdisciplinary Research on Energetics and Cancer (TREC) Centers RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-05-010.html), which also focuses on enhancing the understanding of the mechanisms underlying the association between energy balance and carcinogenesis across the cancer continuum. TREC utilizes the U54 mechanism to involve scientists from multiple disciplines to encompass projects spanning the biology and genetics of behavioral, socio-cultural, and environmental influences upon nutrition, physical activity, weight, energy balance, and energetics. Studies funded under this PA are smaller in scope, encouraging the exploration of new hypotheses using existing data sets in a new way, resulting in the potential to inform and influence the development of research activities in TREC. Investigators funded under this PA will be invited to attend TREC meetings to share expertise and identify new research opportunities as research results evolve. This PA invites new R01 and R21 research applications as well as competitive supplements to existing NCI-funded grants that explore relationships between energy balance and cancer risk and prognosis by proposing new hypotheses within existing studies. The approach is also to encourage collaborations among scientists working in the areas of nutrition, physical activity, genetics, and other disciplines (such as chemistry or biochemistry) to utilize data from existing studies to study the impacts of diet, physical activity, and weight on the genetic, epigenetic, genomic, proteomic, and metabolic influences of cancer biology and prevention. Because primary measures related to cancer and energy balance are diet, physical activity, body composition (especially obesity), and related biomarkers, in order to be eligible to apply for this PA, the applicant must already have access to measures on two or more of these exposures. Examples of the types of research topics and approaches that would be responsive to this PA include but are not limited to: 1) Hypothesis-based analyses of stored blood samples from members of existing cohorts for assessment of biologic markers of cancer risk and prognosis, such as sex hormone-binding globulin (SHBG), insulin-like growth factors (IGF), lipids, and cytokines linked with repeated measures of diet, physical activity, and anthropometrics; 2) Collection and hypothesis-based analyses of biological specimens, such as blood, urine, or exfoliated cells, from cohort or case-control subjects for study as metabolic markers of diet and for genetic and hormonal analysis that can be related to energy balance measures and cancer risk and prognosis; 3) Analyses of fat aspirates from subjects enrolled in studies to evaluate the environmental and genetic determinants of cancer that may be etiologically associated with body fat distribution patterns and diet and physical activity measures; 4) Collection and hypothesis-based analyses of biological specimens, such as blood, urine, or exfoliated cells, from cancer survivors for linkage with questionnaire data on environmental factors that could be related to energy balance; 5) Analyses of data to examine the relationships among blood hormones and markers of energy balance in prevention studies to explore the association with cancer risk and prognosis; 6) Hypothesis-based analyses of stored blood samples from subjects in prevention studies to explore whether there is a differential effect on carcinogenesis according to hormonal status and weight gain; 7) Collection and hypothesis-based analyses of additional information related to energy balance, such as diet and physical activity, in ongoing cancer therapy trials of adults, children, and/or adolescents to determine if there is a relationship between obesity and long-term survival; 8) Collection and hypothesis-based analyses of biological samples from subjects in prevention studies to examine differences in racial and ethnic groups related to energy balance and cancer risk and prognosis; 9) Collection and hypothesis-based analyses of biological specimens, such as blood, urine, or exfoliated cells, from cohort or case-control subjects for linkage with questionnaire data on psychosocial, cognitive, or basic- biobehavioral factors that could be related to energy balance and cancer risk and prognosis; and 10) Collection and hypothesis-based analyses of biological specimens, such as blood, urine, or exfoliated cells, from cohort or case-control subjects, for linkage with questionnaire data on medication use, especially those known to be associated with weight gain that could be related to energy balance and cancer risk and prognosis. MECHANISMS OF SUPPORT This PA will use the NIH Investigator-Initiated Research Project Grants (R01), NIH Exploratory/Developmental Grants (R21), and Competitive Supplements to existing NCI-funded grants. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. An R21 applicant may request a project period of up to 2 years with a combined budget for direct costs of up to $275,000 for the 2-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. (Please note that facilities and administrative (F&A) costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040; http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html ) Applications for a competitive supplement may be submitted based on existing NCI-funded research RO1, P01, P30, and U01 grants. Applicants may apply for a supplement to a related R01, P01, P30, or U01 research award, as long as the following conditions are met: 1) The title of the awarded grant is same as that of the proposed supplement, 2) There must be an active parent grant during the entire funding period of this supplement. 3) The Principal Investigator for the supplement must be the Principal Investigator of the parent grant. Applications are accepted on regular receipt dates and are reviewed in the same way as any other competing application. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of supplements will vary. This PA uses just-in-time concepts. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.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. SPECIAL REQUIREMENTS Multi-Disciplinary Collaboration The approach is also to encourage collaboration among scientists working in the areas of nutrition, physical activity, genetics, and other disciplines (such as chemistry or biochemistry) to utilize data from existing studies to study the impact of diet, physical activity, and weight on the genetic, epigenetic, genomic, proteomic, and metabolic influences of cancer biology and prevention. Statistical Issues Applicants funded under this PA should thoroughly address sample size and power issues to ensure the statistical validity of results. Travel Investigators are strongly encouraged to participate in meetings of NCI- funded investigators supported by this PA and other energy balance initiatives. Investigators are specifically encouraged to attend the semi- annual meetings of grantees funded under the Transdisciplinary Research on Energetics and Cancer (TREC) Centers RFA. The semi-annual meetings of the TREC Centers’ investigators and other invited participants (e.g., recipients of awards for this initiative) will enable investigators working in relevant fields of research to better exchange scientific knowledge, share expertise, develop standards for studying the mechanisms involved in energy balance and cancer risk and prognosis, and identify new research opportunities. Applicants should provide budgets that include costs for two 2-day trips per year to attend meetings that are likely to occur on the East Coast [i.e., closer to the NCI]. 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 your questions about scientific/research issues to: Virginia W. Hartmuller, Ph.D., R.D. Epidemiology and Genetics Research Program Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd., EPN Room 5102, MSC 7324 Bethesda, MD 20892-7324 Rockville, MD 20852 (for express/courier service) Telephone: (301) 594-3402 FAX: (301) 402-4279 E-mail: email@example.com Noreen M. Aziz, M.D., Ph.D., M.P.H. Office of Cancer Survivorship Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd., EPN Room 4090, MSC 7397 Bethesda, MD 20892-7397 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-0598 Fax: (301) 594-5070 e-mail: firstname.lastname@example.org Jackie Whitted, Ph.D., M.P.H. Nutritional Science Research Group Division of Cancer Prevention National Cancer Institute 6130 Executive Blvd., EPN Room 3154, MSC 7328 Bethesda, MD 20892-7328 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-0129 Fax: (301) 480-3925 e-mail: email@example.com Direct your questions about financial or grants management matters to: Crystal Wolfrey Division of Extramural Activities National Cancer Institute 6120 Executive Blvd., EPS Room 234, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: firstname.lastname@example.org 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. SUPPLEMENTARY INSTRUCTIONS All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions for R21 applications: o Research Plan Items a-d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data are required but may be included if available. Please note that a Progress Report is not needed; competing continuation applications for an Exploratory/Developmental Grant (R21) will not be accepted. o Appendix. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included. 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: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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/Development Grant (R21), applicants may request direct costs in $25,000 modules, up to a total direct cost of $275,000 for the combined 2-year award period. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH Institutes or Centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1. Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2. Obtain agreement from the IC staff that the IC will accept your application for consideration for award; 3. Identify, in a cover letter sent with the application, the National Cancer Institute and the staff member who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 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 an appropriate national advisory council or board. REVIEW CRITERIA Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025) 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 applications 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? 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: 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 below on Federal Citations.) 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 below on Federal Citations.) 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 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. Details are available at http://grants.nih.gov/grants/policy/data_sharing. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. STATISTICAL ISSUES: Applicants funded under this PA should thoroughly address sample size and power issues to ensure the statistical validity of results. The reasonableness of statistical issues will be assessed by the reviewers. 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. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. 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 (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible. 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 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. A continuing education program in the protection of human participants in research is available online at http://cme.nci.nih.gov/. 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 plan 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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