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NOVEL TARGETS AND THERAPY DEVELOPMENT FOR ISCHEMIC STROKE RELEASE DATE: July 23, 2004 RFA Number: RFA-HL-05-004 EXPIRATION DATE: January 12, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.839, 93.853 LETTER OF INTENT RECEIPT DATE: December 10, 2004 APPLICATION RECEIPT DATE: January 11, 2005 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 Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA Ischemic stroke is the third leading cause of death in the United States. With the aging of the population, the number of stroke patients in the US is likely to grow. There is a critical need to develop safe and effective therapies to improve the clinical management of stroke patients. Thus, the NHLBI and the NINDS invite research applications that will improve the understanding of brain hemostasis, identify new molecular targets, explore promising agents, and develop novel therapeutics for cerebral ischemia. This program intends to support basic, translational, and early clinical studies. RESEARCH OBJECTIVES Ischemic stroke is a leading cause of death and long-term disability in the United States. There are approximately 750,000 ischemic strokes annually in the US, of which about 150,000 are fatal. The estimated costs to the healthcare system exceed $35 billion per year. The majority of ischemic strokes are due to arterial occlusions, which can rapidly produce a core of infarcted brain tissue surrounded by hypoxic but potentially salvageable tissue, i.e., the ischemic penumbra. The goal of therapy is rapid restoration of blood flow with preservation of the ischemic penumbra and minimal neuronal damage. The lack of knowledge about brain hemostasis has been a significant impediment to the development of new therapies for stroke. Recent data have demonstrated that hemostasis is organ-specific and its fine regulation in the cerebrovasculature is likely to have features that are characteristic of the brain. Plasminogen activators seem to have special functions within the brain in addition to fibrinolysis. They interact with cellular receptors and engage specific signal transduction pathways. Moreover, tPA has been shown to be neurotoxic, vasoactive, and to alter blood-brain-barrier function. This knowledge adds a level of complexity and presents challenges to thrombolytic therapy, since the concepts and treatments developed for myocardial infarction and acute coronary syndromes may not be applicable or safe for the therapy of stroke. Thus, the major focus of this initiative is basic research on hemostasis and thrombosis in the brain along with inflammatory and other sequelae of these processes. The only FDA approved drug for the treatment of acute thrombotic stroke is tissue plasminogen activator (tPA). Currently, 1-3% of stroke patients in the US receive this therapy; presentation beyond the three-hour therapeutic time window is the leading reason for treatment disqualification. Several phase III trials of intravenous fibrinolytics administered 3-6 hours from symptom onset have failed to show a treatment benefit. Fibrinolytic therapies for stroke have been hampered by a risk of hemorrhage. Treatment strategies are needed that can be administered over longer periods with low risk of hemorrhage. The rate of ischemic stroke in the pediatric population is about 3.3/100,000 children. The causes of stroke vary but prothrombotic state and heart disease appear to contribute significantly. Ischemic stroke is also a serious complication in up to 30% children with sickle cell disease (SCD). The treatment of stroke in children is not well studied and the sickle cell population may offer opportunities in this area. There is a critical need to identify new therapeutic targets and develop treatment strategies that a) have lower bleeding risk, b) can be used over longer time- windows, and c) minimize neuronal damage. Opportunities also exist to develop combination treatments with less collateral damage. New methods of controlling inflammation and complement activation to limit neuronal or endothelial injury, and ways of inhibiting platelet plug formation may facilitate the development of safer and more effective treatment strategies. Novel fibrinolytic agents also offer promise in acute cerebral ischemia and there are at least three potential directions: (I) designer plasminogen activators with improved potency and lower bleeding potential, (II) direct use of plasmin, and (III) targeted delivery at preferred sites of action. Complementary pharmacologic agents have been effective in increasing reperfusion in coronary vessels when combined with fibrinolytics; however, development of these agents for acute stroke poses special challenges due to the greater vulnerability of brain parenchyma to hemorrhagic transformation. Examples of promising complementary agents are activated protein C and PECAM-1 (platelet endothelial cell adhesion molecule 1) with anti-inflammatory and anti-apoptotic properties, platelet antagonists, direct thrombin inhibitors, low molecular weight heparins, tissue factor/FVIIa inhibitors, and soluble endothelial ADPase (CD39). Hemorrhage reduction strategies may include: (a) combined local use of inhibitors, such as neuroserpin, with fibrinolytic agents and (b) compounds that limit injury to the blood-brain barrier, such as matrix metalloproteinase inhibitors. Such approaches need to be rigorously tested in appropriate animal models or in early clinical studies. The ultimate goals of this initiative are to improve understanding of brain hemostasis and to develop safe and effective therapies for patients with ischemic stroke. Animal studies and Phase I/II clinical trials are encouraged but Phase III clinical trials will not be supported. Collaboration among investigators in diverse areas is also encouraged. Examples for research topics Areas of investigation that would be appropriate for this RFA include but are not limited to: o Characterize unique properties of hemostasis, thrombosis, and inflammation in the brain with an outlook toward new therapeutic development o Identify and characterize biomarkers for rapid diagnosis that would enable earlier treatment of ischemic stroke, e.g., P-selectin, CD40L, CRP, tissue factor, and cell microparticles o Studies of stroke in sickle cell disease o Develop selective and safer thrombolytic therapies o Investigate agents for prevention of cell death and neuroprotection o Explore antithrombotic agents, such as CD39, PARs antagonists, and inhibitors to FXa, thrombin, complements, or inflammation o Develop effective combination or sequential therapies, such as mechanical reperfusion linked to fibrinolytic agents MECHANISM OF SUPPORT This RFA will use the NIH R01 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 project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is DECEMBER 1, 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. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $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. FUNDS AVAILABLE The NHLBI intends to commit approximately $ 4.0 million and the NINDS intends to commit approximately $ 1.0 million in FY 2006 to fund 10 to 15 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $250,000 per year. Research projects involving extensive animal studies and/or human trials can request up to $500,000 per year for direct costs with appropriate justification. Facilities and administrative costs (F&A;) for consortia are not included in this direct cost ceiling. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html for more information on the exclusion of the facilities and administrative (F&A;) costs requested by consortium participants or contact the Grants Management Specialist listed under “where to send inquiries”, below. 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 will also vary. Although the financial plans of the NHLBI and the NINDS 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS The goal of this initiative is to develop new targets and therapies for ischemic stroke by focusing on basic, translational, and early clinical research. In order to be responsive to the RFA, studies must propose approaches to identify novel targets in basic and/or preclinical studies, or to develop new therapeutic strategies in clinical studies. Phase I/II clinical trials, but not phase III trials will be supported. Studies purely on pathogenesis of ischemic stroke will not be considered responsive to this RFA. The expectation is that the results from studies supported under this RFA will contribute to the development of novel therapeutic agents or approaches for cerebral ischemia. For clinical studies, a Data and Safety Monitoring Plan (e.g., creation of a Data Safety and Monitoring Board (DSMB), refer to Federal Citation at the end of the document); documented ability to enroll a specified number of patients; semi-annual reports; special expertise or facilities; review between Phase I and Phase II; and coordination among investigators (e.g., annual meetings), etc., must be included. Note that all applications that list direct costs equal or greater than $500,000 in any given year of the proposed research must have a data sharing plan (refer to Federal Citation at the end of the document). General Clinical Research Centers Applications from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources (NCRR) 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 the principal investigator should be included with the application. Grantee’s Meeting The NHLBI and the NINDS will sponsor annual meetings to encourage exchange of information among investigators who participate in this program. In their budgets, applicants should include funds for annual one-day grantees’ meetings. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. 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 issues: o Direct your questions about scientific/research issues to: Ahmed A.K. Hasan, M.D., Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive Rockledge II, Room 10180, MSC 7950 Bethesda, MD 20892 Telephone: (301)435-0064 FAX: (301)480-1046 Email: hasana@nhlbi.nih.gov Stephen Goldman, Ph.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive Rockledge II, Room 10192, MSC 7950 Bethesda, MD 20892 Telephone: (301)435-0565 FAX: (301)480-1046 Email: goldmans@nhlbi.nih.gov Thomas P. Jacobs, Ph.D. Stroke Program Director National Institute of Neurological Disorders and Stroke 6001 Executive Blvd, Room 2112 Bethesda, MD 20892-9525 Telephone: (301) 496-1431 FAX: (301) 480-2424 Email: TJ12G@nih.gov Scott Janis, Ph.D. Clinical Trials Program Manager National Institute of Neurological Disorders and Stroke 6001 Executive Blvd, Room 2210 Bethesda, MD 20892-9520 Telephone: (301) 496-9135 FAX: (301) 480-1080 Email: sj151t@nih.gov o Direct your questions about peer review issues to: Valerie Prenger, 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: PrengerV@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Robert Vinson Division of Extramural Affairs National Heart, Lung, and Blood Institute Building RKL II, Room 7156 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301)480-0166 Email: VinsonR@nhlbi.nih.gov Tina Carlisle Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd, Room 3264 Bethesda, MD 20892 Telephone: (301) 496-3938 FAX: (301) 496-3929 Email: carlit@ninds.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 IC 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. Valerie Prenger at the address listed under WHERE TO SEND INQUIRIES. 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 D&B; number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B; 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) 435-0714, 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/labels.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 copies of the appendix material must be sent to Dr. Valerie Prenger at the address listed under WHERE TO SEND INQUIRIES. APPLICATION PROCESSING: Applications must be received on or before 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. 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 not be reviewed. 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 NHLBI or NINDS National 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 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 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting $500,000 or more 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 rational 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. The policy is 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 10, 2004 Application Receipt Date: January 11, 2005 Peer Review Date: May-June, 2005 Council Review: October, 2005 Earliest Anticipated Start Date: December 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 ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the patients. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. Also, please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html for the current NIH policy on sharing of model organisms for biomedical research. 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. 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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This RFA 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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