and Human Services (HHS)
EXPIRED
PULMONARY COMPLICATIONS OF SICKLE CELL DISEASE RELEASE DATE: January 16, 2004 RFA NUMBER: RFA-HL-04-015 (see addendum NOT-HL-04-106) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): (93.938, 93.939) LETTER OF INTENT RECEIPT DATE: April 26, 2004 APPLICATION RECEIPT DATE: May 24, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citation PURPOSE OF THIS RFA The purpose of this initiative is to stimulate translational research on the pulmonary complications of sickle cell disease. The RFA encourages collaborative research between investigators in hematology and pulmonary science that combines basic and clinical approaches. Acute chest syndrome affected 29% of all sickle cell disease patients followed in the Cooperative Study of Sickle Cell Disease (CSSCD) between 1979 and 1988. Chronic pulmonary disease, characterized by perfusion/diffusion defects and pulmonary hypertension, also has emerged as a significant problem. Both acute chest syndrome and chronic sickle cell pulmonary disease are responsible for significant morbidity and mortality, especially in adult patients. This RFA will support 3-5 programs where pulmonary and sickle cell disease researchers conduct both basic science and clinical investigation to elucidate mechanisms for these complications and develop new treatments. RESEARCH OBJECTIVES For many years, it has been recognized that sickle cell disease affects the lungs, yet the mechanisms are still not well-defined. The second most common acute complication of this disorder is the so-called "sickle cell acute chest syndrome," which is characterized by lung infiltrates, with or without fever. While some episodes are secondary to pneumonia, many are not. Other associated conditions include embolism of peripheral blood clots and/or fat (see below). The CSSCD (1978-1988) database recorded acute chest syndrome in 29% of patients. About half of these patients had only one episode of acute chest syndrome, but some patients had six or more. Risk factors included age and genotype. Episodes occurred more frequently in younger patients, in Hb SS genotype, and least frequently in Hb S?+ thalassemia. The ?-thalassemia gene did not alter the incidence of acute chest syndrome. In 1995, the Multicenter Study of Hydroxyurea showed that administration of hydroxyurea to sickle cell anemia patients decreased by half the incidence of both painful episodes and acute chest syndrome events. A collaborative study of the etiology of acute chest syndrome with bronchoscopy and a comprehensive search for microbial pathogens suggested a vascular etiology in some cases (fat emboli), and in other cases, viral or bacterial agents were identified. Thus, infection and embolization may increase hypoxia, red cell sickling, and vaso-occlusion. Little is known about the clinical course of sickle cell acute chest syndrome. It would be useful to know in which proportion of cases the initial infiltrate progresses to more extensive disease, and if progression is affected by antibiotics, intravenous fluids, or transfusions. Sickle cell acute chest syndrome can be associated with multi-organ failure but the frequency of this association and their pathogenetic relationships are unknown. The syndrome of chronic sickle cell lung disease is also recognized. This syndrome is characterized by abnormalities in pulmonary function tests (primarily perfusion and diffusion defects), chest x-rays, blood gases, and non-invasive cardiac studies. However, the detailed anatomical and physiological abnormalities that occur in chronic lung damage in sickle cell disease are not well-described. Development of pulmonary hypertension is typically associated with changes in the vessel walls, such as intramural and perivascular connective tissue deposition, hyperplasia/hypertrophy of smooth muscle cells, and sometimes intramural thrombosis with recanalization. Since patients with sickle cell disease have a higher than normal incidence of pulmonary hypertension, pathological red cells may initiate or amplify remodeling of hypertensive lung vessels. In pulmonary hypertension, death often occurs suddenly, and this association should be understood more thoroughly. A CSSCD study of 209 adult sickle cell deaths found that a relatively large number (37%) occurred suddenly in patients without apparent damage to vital organs. Clearly, the acute and chronic lung syndromes require more study before therapy can be improved. Since lung perfusion pressure is one of the lowest in the body, these syndromes are likely to be associated with vascular occlusion. Red blood cells arrive at the pulmonary capillaries already deoxygenated, so in sickling disorders, red cells are either sickled or the blood is markedly viscous when it reaches the pulmonary capillary bed. No good data exist on the ability of sickle cells to adhere to the endothelium of the pulmonary microvasculature. Evidence exists that the vasculature of the lung differs from the vasculature elsewhere in structure as well as responsiveness to chemical signals. Investigation of the interaction of these differences with sickle cells may provide insight into causes of pulmonary complications in sickle cell disease. This initiative aims to encourage research on the effects of sickle cell disease on the lung and pulmonary vasculature. Examples might include, but are not limited to: 1. Improved definition of the pathophysiology of "acute chest syndrome" with particular emphasis on the abnormalities of pulmonary circulation that may occur. The role of infection and embolism, if any, should be more clearly defined. The use of new diagnostic techniques is encouraged. 2. Better measures of the chronic effects of sickle cell disease on lung function with newer diagnostic methods that focus, e.g. on vascular effects. Emphasis could be placed on ways to determine the role of abnormal lung physiology on sudden death syndrome in sickle cell disease. 3. Correlation of various phenotypes of sickle cell disease (haplotype differences, double heterozygosities, etc.) on the manifestations of acute and chronic pulmonary problems. The role of cellular viscosity and whole blood viscosity in these differences could be investigated. 4. Study of sickle cell adhesion to pulmonary vascular endothelium with comparison of their adhesion to systemic vessel endothelium. These studies also could include variables such as macro- versus microvascular origin of endothelium, shear stress, hypoxemia, etc. Studies of cell-to-cell interactions that may play a role in cell binding, receptors, adherence proteins, and the state of the red cells (e.g. density, state of hemoglobin’s polymerization, etc.) could be performed. 5. Study of the effect of sickle erythrocyte adherence on endothelial function: permeability, secondary adherence of platelets and neutrophils, effects on release of endothelial-derived vaso-active substances, such as nitric oxide and endothelin. 6. Controlled trials of therapies for acute and chronic sickle cell lung disease. The role of exchange transfusion, anti-thrombotic agents, nitric oxide, prostacyclin, arginine, or other modalities could be investigated. For example, it might be useful to monitor pulmonary vascular flow and pressure before, during, and after exchange transfusions for severe acute chest syndrome. Such studies, which could show how transfusions affect these patients, may involve invasive procedures within an intensive care medical setting. 7. Determination of the utility of echocardiography (ECHO) for detection of early pulmonary hypertension. Correlation of exercise ECHO findings with variables such as RBC rheology and endothelial adherence, sickle haplotypes, frequency and severity of painful episodes, and humoral indices of activation of platelets and the coagulation system could provide new data. 8. Studies of the physiological basis of sleep hypoxemia in sickle cell patients, its relationship to acute and chronic pulmonary dysfunction, and its contribution to sickle cell pathology are appropriate. 9. The impact of asthma and related therapies, such as the use of vasoconstrictive decongestants, on the severity of acute and chronic sickle cell pulmonary complications is of interest. MECHANISM OF SUPPORT This RFA will use the NIH R01 (Investigator-initiated research project grant) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this program will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is April, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts, and the modular 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_2001/part_i_1.htm. FUNDS AVAILABLE The participating organizations intend to commit approximately $6 million in total costs in FY 2005 to fund 3 to 4 new and/or competitive continuation grants in response to this RFA. An applicant may request a budget for total costs of up to $2 million per year and a project period of up to 4 years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award also will vary. Although the financial plans of the participating organizations provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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 under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS 1. The intent of this initiative is to integrate clinical and basic scientific research on the pulmonary effects of sickle cell disease. To be considered responsive to this announcement, both clinical and basic research must be proposed, and at least one of the specific aims must be clinical. Translation of findings from basic to clinical studies is an important goal of this initiative, so there must be involvement of researchers with experience and/or training in pulmonary medicine and hematology. 2. In order for a specific aim to be considered clinical for this RFA, the investigator must directly interact with the patient, and studies must include subjects with the disease of interest. Biomedical and behavioral studies of etiology, pathogenesis, prevention, diagnosis, and treatment of pulmonary complications in sickle cell disease are responsive. Small population-based epidemiologic studies, where the research can be completed within 4 years, also may be proposed. However, clinical research projects focused on large epidemiologic studies or Phase III clinical trials will be considered unresponsive to this RFA. In studies involving the use of specimens, the investigators must have direct interaction with the patient and relate the research results to the patient status or outcome for this to be considered a clinical project. The requirement for investigator interaction with study participants is intended to eliminate research on archived tissue. 3. All basic research specific aims must be related to the overall clinical focus of the grant application. 4. Applicants are encouraged to establish links with existing resources, including General Clinical Research Centers, the NHLBI Program in Genomic Applications, and NHLBI clinical research networks, as appropriate. 5. Each grant application must have a well-delineated organizational structure and administrative mechanism that fosters interactions between pulmonary and sickle cell investigators, establishes regular communication, encourages the translation of basic research findings to clinical applications, and ensures a productive research effort. 6. Applicants should provide a detailed data and safety monitoring plan for the clinical research proposed. The monitoring plan will be considered as part of the peer review of the application. This plan should address informed consent, recruitment, reporting of adverse events, patient safety, oversight of clinical issues in the protocols, storage and analysis of confidential data, and dissemination of any research results. NHLBI may wish to convene a Data and Safety Monitoring Board to oversee the clinical projects in the grants funded by this initiative. This will be determined after review and selection of the grants. Costs associated with a Data and Safety Monitoring Board (DSMB) should be included in all budgets whether the DSMB is convened by the investigator group or by the NHLBI. 7. Applicants should budget for travel to Bethesda, Maryland for an annual meeting of the grantees in this program. Scientific progress in this program will be discussed at this annual meeting. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. Exclusions Applications proposing programs that do not include clinical research will be considered non-responsive to the RFA. Certain types of investigations, although potentially of scientific interest, will not be appropriate for support by this program. Investigators wishing to develop proposals related to excluded categories are strongly encouraged to contact the NHLBI (see Inquiries, below) for information about other opportunities. Examples of excluded research are: o Phase III clinical trials o applications that do not include studies in humans; o projects having a primary focus on research resource development. General Clinical Research Center (GCRC) Applicants from institutions that have a GCRC funded by the NIH 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. Additional Considerations All grant applications submitted in response to this RFA should include sample size and statistical power calculations appropriate to the proposed study design. In addition, applications that include development of research resources are encouraged to describe a plan to share such resources with other researchers. This could include appropriate information technology (such as DNA/protein microarray databases) or shipment of tissues. Please note that applications having a primary focus on research resource development will be considered non-responsive. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: o Direct your questions about scientific/research issues to: Henry Chang, M.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute Rockledge II, Room 10158 (MSC 7950) Bethesda, MD 20892 - 7950 (20817 for overnight couriers) Telephone: (301) 435-0067 FAX: (301) 480-0868 Email: changh@nih.gov Andrea L. Harabin, Ph.D. Senior Scientific Advisor, Lung Biology and Disease Program Division of Lung Diseases National Heart, Lung, and Blood Institute Rockledge II, Room 10108 (MSC 7952) Bethesda, MD 20892 - 7952 (20817 for overnight couriers) Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: HarabinA@nhlbi.nih.gov o Direct your questions about peer review issues to: Anne Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive Room 7214, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: ClarkA@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Marsha Mathis DEA-GOB/NHLBI/NIH Rockledge II, Room 7158 Bethesda, MD 20892 - 7950 (20817 for overnight couriers) Telephone: (301) 435-0170 FAX: (301) 480-3510 Email: MathisM@nhlbi.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NHLBI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRES. 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 document 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at: http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all five collated sets of the appendix material must be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRES. Please note that applications delivered by individuals are no longer accepted; all applications must either come via courier delivery or via the US Postal Service: (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. Principal investigators should not send supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you have not received such a letter four weeks after submitting the application, contact Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration prior to the Initial Review Group meeting. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the 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 Heart, Lung, and Blood 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 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 these criteria in assigning your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Each project will be evaluated with respect to the following criteria: (1) 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? (2) 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? Is it likely that the approach will identify new mechanisms or treatments? (3) 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? (4) 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)? (5) 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 and employ collaborations between hematologists and pulmonologists? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the application will also be reviewed with respect to the following: o 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). o 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o 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 o DATA SHARING: The adequacy of the proposed plan to share data or resources. Applicants who request more than $500,000 in direct costs in any year of the research must include a data sharing plan in their application. The reasonableness of the plan or the rationale for not sharing research data will be reviewed, but it will not factor into the scientific merit or priority score (see below). o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o MONITORING PLAN: The safety and data monitoring plan will be evaluated for adequacy (see Monitoring Plan and Data Safety and Monitoring Board, below). RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: April 26, 2004 Application Receipt Date: May 24, 2004 Peer Review Date: Oct/Nov, 2004 Council Review: Feb 27, 2005 Earliest Anticipated Start Date: April 1, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic 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: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "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 award 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 RFA 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 No. 93.837, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 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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