PAR-04-082: SMALL CLINICAL GRANTS IN DIGESTIVE DISEASES, NUTRITION AND OBESITY

Department of Health
and Human Services (HHS)

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SMALL CLINICAL GRANTS IN DIGESTIVE DISEASES, NUTRITION AND OBESITY RELEASE DATE: April 1, 2004 PA NUMBER: PAR-04-082 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 funding opportunities (PA-06-301 and PA-06-256) have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for 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) COMPONENT OF PARTICPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S): 93.848 This Program Announcement (PAR) replaces PAR-01-056, which was published in the NIH Guide on February 22, 2001. THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR This PAR supersedes PAR-01-056 published in 2001. The goal of this initiative is to encourage innovative clinical and epidemiological research into new therapies or means of prevention of digestive and liver diseases, nutritional disorders and obesity. The Small Clinical Research Grants Program is designed to support short-term clinical studies and help stimulate the translation of promising and potentially relevant new developments from the laboratory into the clinical setting. This PAR specifically encourages the submission of applications for pilot studies relating to gastrointestinal, pancreatic and liver diseases and nutritional disorders including obesity. They should focus on research that is particularly innovative and/or potentially of high impact. High impact research involves feasibility studies in which the technological, methodological, or theoretical approach to a problem lacks an historical precedent or sufficient preliminary data, but whose successful outcome would have a major effect on a scientific area. The small grants may be used as planning grants for full-scale multi-center clinical trials or for pilot studies that could lead to full-scale multi- center clinical trials designed to provide evidence for or against changes in the current standard of care. Such trials may use pharmacological, dietary, surgical, endoscopic, physical activity, or behavioral interventions aimed at disease therapy or prevention. Pilot epidemiological studies are encouraged that could lead to more extended research that would provide evidence for or against changes in health policy, especially as related to disease prevention. It is expected that these small clinical grants will serve as a basis for planning future multi-center research project grant applications (R01) or cooperative agreement (U01) awards. The major changes in this PAR are a refocus on different priority areas and an added stress placed upon innovative approaches to translate new findings from basic research into practical means of diagnosis, treatment and prevention of digestive and nutritional diseases (bench-to-bedside research). RESEARCH OBJECTIVES Background The goal of this small grants program is to provide flexibility for initiating preliminary, short-term studies, thus allowing new ideas to be investigated in a more expeditious manner without stringent requirements for preliminary data. Such support is needed to encourage experienced investigators as well as new investigators to pursue new approaches, underdeveloped topics, or more creative avenues of research. If successful, these awards should lead to significant scientific advances in digestive disease and nutrition research and should facilitate translation into clinical practice. One focus of this PAR is on diseases that ordinarily have little research support because they are uncommon or rare, or difficult to manage, or are not the focus of pharmacological therapy. There are several rare digestive diseases that may, nevertheless, have lasting and major consequences for the patients who have these conditions. These conditions are particularly challenging when they occur in children and have life-long consequences. These diseases are often too rare to be adequately investigated by a single individual or at a single medical research institution. For these reasons, applications for study of these conditions might be best performed by a consortium of investigators that come together with a common protocol to focus on natural history and clinical investigation rather than a specific therapeutic intervention. Examples of these rare or uncommon digestive and liver diseases that are of particular focus in this PAR include gastrointestinal motility disorders of children; eosinophilic gastroenteritis, intestinal pseudoobstruction, Wilson’s disease; sclerosing cholangitis in children; hepatic congenital fibrosis; autoimmune hepatitis; primary biliary cirrhosis; and familial pancreatitis. Many digestive diseases and nutritional disorders are diagnosed, monitored or treated using endoscopic or surgical techniques. These techniques are often the consequence of years of study and development by a talented and innovative investigator or group of investigators. Once the final technique is developed and reported in the medical literature, however, there is often little independent analysis of its efficacy and risk-benefit ratio. Thus, endoscopic management of gastrointestinal bleeding, gastroesophageal reflux disease, Barrett’s esophagus, retained biliary stones, pancreatitis and colonic ectasia may be widely practiced but have not been subjected to careful, large-scale, prospective randomized controlled trials. Among surgical procedures in digestive and nutritional disorders, there is also often little controlled evidence for efficacy and safety. Thus, small bowel transplantation, the use of living donor liver transplantation, the surgical therapy of obesity are a few areas in which surgical techniques have been introduced and widely used without controlled observations on the efficacy and relative safety of these approaches. This PAR is meant to provide a means for investigators to develop prospective randomized controlled trials of endoscopic and surgical therapies. Additional areas of special focus of this PAR are hepatitis B and C. These two diseases are major causes of morbidity and mortality from liver disease in the United States. Current estimates suggest that chronic hepatitis B affects 1 million and hepatitis C approximately 3 million Americans. Hepatitis C accounts for at least 30% of liver transplants done in the United States, while hepatitis B and its complications account for 5-10% of transplants. While there are many industry sponsored studies of new and innovative therapies of these diseases, many important approaches to the management, prevention and treatment of acute and chronic hepatitis B and C are outside of the usual interest of industry-sponsors of clinical trials. Thus, use of cytokines, innovative combination therapies, iron depletion, and complementary and alternative medical (CAM) treatments of hepatitis B and C might be the focus of a small grant application. In addition, approaches to management and therapy of hepatitis B and C in special populations might be the focus of a small grant application; such populations might include children, patients with hemophilia, patients with renal failure, solid-organ transplant patients, patients with human immunodeficiency virus co-infection, injection drug users, patients with continuing problems with alcohol or substance abuse, and patients with significant psychiatric disease, such as schizophrenia and bipolar disorders. Acute hepatitis C currently accounts for 20% of cases of acute viral hepatitis. Importantly, between 50 and 80% of persons with acute hepatitis C develop chronic infection and thus are at risk of the long-term consequences of this disease, such as cirrhosis, hepatic failure and liver cancer. Several small, uncontrolled studies have suggested that treatment of hepatitis C during the acute phase is highly effective, leading to sustained clearance of virus in 80 to 98% of patients. What is unclear is the optimal timing, dosage and treatment regimen for acute hepatitis. An application for support of a collaborative network of investigators interested in studying the natural history, immunopathogenesis, virology and treatment of acute hepatitis C is strongly encouraged. Studies on the prevention or treatment of overweight or obesity in children and adults, including dietary, physical activity, pharmacologic, and surgical approaches are of interest. The creative use of various devices, technologies, or communication strategies to help individuals monitor energy intake or energy expenditure in weight control programs would be appropriate. Innovative studies that test the synergy of creative partnerships among various groups such as industry, business, faith-based, academic, or community organizations to enhance obesity prevention or treatment outcomes are of interest. Studies of various approaches in combination to achieve weight maintenance or to maintain weight loss, such as physical activity or diet in combination with pharmacologic or surgical regimens would also be appropriate. Specific examples of research areas of interest include but are not limited to: o Disorders of GI function, including irritable bowel syndrome, gastroparesis, nonulcer dyspepsia, colonic inertia, pseudoobstruction, ileus, cyclic vomiting syndrome. o Disorders characterized by GI inflammation, including inflammatory bowel disease, celiac disease, collagenous colitis, microscopic colitis, eosinophilic gastroenteritis. o Disorders characterized by nutritional deficiency, including intestinal failure and short gut syndrome. o Preneoplastic conditions, such as Barrett’s esophagus. o Gastrointestinal endoscopy research. o Acute and chronic pancreatitis. o Hepatobiliary diseases, including acute and chronic hepatitis B and C, prevention and treatment of complications of liver transplantation, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson’s disease, hepatic congenital fibrosis, biliary atresia and neonatal cholestatic liver disease. o Prevention and treatment of obesity, including: modification of dietary practices or eating environments; strength training, aerobic conditioning, or other modifications of physical activity and sedentary behavior; modification of relevant associated behaviors that influence eating and physical activity patterns or environmental conditions that may have an impact upon energy balance. o Altered nutrient requirements associated with physical activities or disease states including how alterations in physical activities may change nutritional requirements; effects of disease states on nutrient requirements. o Interactions between nutrients, such as antioxidants and micronutrients on mediators of the inflammatory responses. o Role of alterations of dietary fatty acids on clinical mediators of disease, for examples, prostaglandins. o Genetic studies of digestive diseases or obesity seeking to assess the sensitivity or specificity of a genetically based test, or to identify genes influencing responses to a preventive or therapeutic intervention. Summary This program announcement is intended to encourage innovative clinical and epidemiological research and to facilitate the translation of promising and relevant new developments into the clinical setting. The emphasis is thus, on the development of small, randomized clinical trials and epidemiological studies. Basic laboratory research or studies of laboratory animals are not appropriate for this R03 mechanism. Studies that do not involve human subjects or are human studies that are not clinical trials or epidemiological studies will not be supported through this program announcement and will be returned to the proposed Principal Investigator without undergoing peer review. Consideration should be given to using the R21 (http://grants.nih.gov/grants/guide/pa-files/PA-04-108.html) or R01 mechanism for this type of study. The NIDDK is currently sponsoring several large, multi-center studies of specific digestive diseases and nutritional disorders. These studies include prospective studies in chronic hepatitis B and C; liver transplantation; acute liver failure; hepatotoxicity; non-alcoholic steatohepatitis; sclerosing cholangitis; biliary atresia; bleeding esophageal varices; inflammatory bowel disease; and both behavioral and pharmacological therapy of obesity; and outcomes research in bariatric surgery. Small grant applications for clinical studies that specifically overlap with ongoing studies sponsored by NIDDK may be denied funding. MECHANISM OF SUPPORT This PAR will use the NIH small grant (R03) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PAR may not exceed two years. The budget may be submitted for direct costs up to four modules of $25,000 each ($100,000 direct costs per year). These grants may not be renewed. Facilities and Administrative (F & A) costs will be awarded based on the negotiated rate at the time of each award. Replacement of the Principal Investigator on this award is not permitted. This PAR uses just-in-time concepts. It also uses the modular budgeting format. (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. 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 institutions/organizations o Faith-based or community-based organizations o Foreign institutions are not eligible to apply INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS New and experienced investigators in relevant fields and disciplines may apply for these small grants. New investigators are eligible, but they must be independent of a mentor and have strong institutional support. NIDDK K08 and K23 recipients, who are eligible for R03 grants, may consider applying for this R03 grant or for the R03 program for NIDDK K08/K23 recipients (PAR-04-044). Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. Applicants are encouraged to collaborate with the investigators in the Silvio O. Conte Digestive Diseases Centers, Clinical Nutrition Research Centers, and Obesity/Nutrition Research Centers for consultation in experimental design, intervention, and methodology, as well as usage of core facilities appropriate for carrying out their projects. Information describing the centers and their cores can be requested from the person listed in INQUIRIES. Applications from Veterans Administration (VA) Medical Centers and collaborations with VA Medical Centers are encouraged. Several digestive and nutritional conditions and diseases are particularly common among Veteran patient populations and account for considerable morbidity and mortality in Veterans. Conditions particularly common include chronic hepatitis C, hepatocellular carcinoma, portal hypertension and cirrhosis. VA Medical Centers often provide the ideal milieu for clinical investigation of therapies that might benefit Veteran populations. The advanced medical information systems developed by the Department of Veterans Affairs and the ability to follow and maintain patient contact over many years make the VA Medical Centers particularly well adapted to clinical and epidemiological research in digestive diseases and nutritional disorders. Interaction is encouraged between NIH-funded investigators and investigators at CDC Prevention Research Centers, a national network of 28 academic research centers that engage communities as participants in research on preventing chronic diseases such as cancer, heart disease, and arthritis. Information about CDC Prevention Research Centers may be found at: http://www.cdc.gov/nccdphp/bb_prc/index.htm. SPECIAL REQUIREMENTS This NIDDK small grant support is for new projects only; competing continuation applications will not be accepted. Small grant support may not be requested for thesis or dissertation research. In addition, these R03 awards may not be used to supplement research projects currently supported by Federal or non-Federal funds or to provide interim support of projects under review by the Public Health Service. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR 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 regarding scientific/research issues related to digestive or hepatobiliary diseases or nutritional disorders to: Patricia Robuck, Ph.D., M.P.H. Director, Clinical Trial Program Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 659 Bethesda, MD 20817 Telephone: (301)594-8879 FAX: (301)480-8300 Email: pr132q@nih.gov o Direct your questions regarding scientific/research issues related to obesity to: Robert Kuczmarski, Dr.P.H. Director, Obesity Prevention and Treatment Program Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 673 Bethesda, MD 20892-5450 Telephone: (301)451-8354 FAX: (301)480-8300 E-mail: rk191r@nih.gov o Direct inquiries regarding specific epidemiological programmatic issues to: James Everhart, M.D., M.P.H. Chief, Epidemiology and Clinical Trials Branch Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 655 Bethesda, MD 20817 Telephone: (301)594-8878 FAX: (301)480-8300 Email: je17g@nih.gov o Direct your questions about peer review issues to: Francisco Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd, Room 752 Bethesda, MD 20892-5452 Telephone: (301)594-8897 Fax: (301)480-3505 Email: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Sharon T. Bourque Grants Management Specialist National Institute of Diabetes, Digestive and Kidney Diseases 6707 Democracy Blvd., Room 719 Bethesda, MD 20892 MSC 5456 Telephone: (301)594-8846 FAX: (301)480-3504 Email: sb114m@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 the PAR must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS Items a - d of the Research Plan [Specific Aims, Background and Significance, Preliminary Studies (not required), and Research Design and Methods] may not exceed a total of fifteen pages. Detailed descriptions of protocols for the proposed involvement of human subjects and/or vertebrate animals, literature cited, consortium/contractual arrangements and consultant letters are not included in the fifteen-page limit. Describe the particularly innovative/high impact aspects of the proposed study in an introductory paragraph at the beginning of the research plan. Include a description of how the outcome of this project would provide a foundation for important new research in digestive diseases and nutritional disorders. Label this paragraph, "Justification as Innovative/High Impact Research." For revised applications, an introduction (not to exceed one page) in addition to the Research Plan is required. This introduction should respond to the comments and concerns of the initial review group delineated in the summary statement. 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 applications submitted in response to this PAR 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. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) 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 PAR that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete applications will not be reviewed. Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o 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 National Diabetes and Digestive and Kidney Diseases Advisory Council. 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 each 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? 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: o The potential applicability of the research findings to the clinical setting. 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.) ADDITIONAL REVIEW CONSIDERATIONS o Because the research plan is limited to fifteen pages, these R03 small grant applications may not have the same level of detail or extensive discussion normally found in a regular R01 research project grant application. Review emphasis will be placed on the conceptual framework and general approach to the problem, with less emphasis on methodological details. o Since pilot/feasibility studies may not include preliminary data, the review will focus on whether the rationale for the study is well developed and whether the proposed research is likely to generate data that will lead to additional studies that could potentially be funded as a regular research project grant (R01). 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 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PAR in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). 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 PAR is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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