ELSI SMALL GRANT RESEARCH PROGRAM (R03) RELEASE DATE: January 15, 2004 PA NUMBER: PA-04-051 (Reissued as PA-08-013) (See NOT-HG-06-013 for details on expiration of this Notice. Also see NOT-HG-05-002) 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. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE: May 17, 2006 unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Human Genome Research Institute (NHGRI) (http://www.genome.gov/) National Mental Health Institute (NIMH) (http://www.nimh.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.172, 93.866, 93.865, 93.173, 93.847, 93.279, 93.113, 93.115, 93.242, 93.361. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA is designed to solicit research projects that anticipate, analyze and address the ethical, legal, and social implications (ELSI) of the discovery and use of new information and technologies resulting from human genetic and genomic research. Of particular interest are studies that examine issues and, where appropriate, develop policy options in the following areas: 1) intellectual property issues surrounding access to and use of genetic information; 2) the ethical, legal and social factors that influence the translation of genetic information to improved human health; 3) the issues surrounding the conduct of genetic and genomic research; 4) the use of genetic and genomic information and technologies in non health care settings; 5) the impact of genetics and genomics on concepts of race, ethnicity, kinship and individual and group identity; 6)the implications, for both individuals and society, of uncovering genetic and genomic contributions to not only disease, but also normal human traits and behaviors; and 7) how different individuals, cultures and religious traditions view the ethical boundaries for the uses of genetics and genomics. This Small Grant PA, which is limited to applications requesting up to $50,000 in direct costs per year for no more than two years, makes use of a streamlined application process and is designed to encourage the development of small, focused research projects by legal, historical, ethics and social sciences scholars whose analytical style of inquiry often has not been adequately encouraged or supported by the more traditional NIH R01 application process. It is also designed to support smaller exploratory studies that may provide preliminary findings or pilot data for larger research proposals in all research areas of interest. Applications requesting more than $50,000 in direct costs should be submitted under the ELSI Regular Research Grant (R01) PA, PA-04-050: ELSI Regular Research Program (http://grants.nih.gov/grants/guide/pa-files/PA-04-050.html). RESEARCH OBJECTIVES Background and Significance The publication of an accurate, comprehensive sequence of the human genome in April 2003 marked the completion of the international Human Genome Project (HGP). The attention of the biomedical research community is now turning to the interpretation of this fundamental source of knowledge about human biology and to the development of new approaches for applying genomic technologies and information to improving human health throughout the lifespan. Advances in genetics, comparative genomics, high-throughput biochemistry and bioinformatics are providing biologists with research tools that promise to allow human health and disease to be analyzed and understood at an unprecedented level of detail. Clinical opportunities for gene-based pre-symptomatic prediction of illness and adverse drug response are emerging at a rapid pace, and the therapeutic promise of genomics has ushered in an exciting phase of expansion and exploration in the commercial sector. Proactive and sustained efforts will be needed to ensure that the potential benefits of these new technologies are maximized and potential harms minimized. To achieve this goal, research that anticipates and addresses the ethical, legal and social implications (ELSI) of the rapidly increasing availability and use of genetic and genomic technologies and information will be critical. Research Scope With the highly efficient methods of DNA sequencing and genomic analysis that have been developed during the course of the HGP, new genetic tests and personal genetic sequence information will become more widely available and will be used in a variety of settings. In the next few years, people will have to continue to seriously consider numerous ethical, legal and social questions raised by the availability and use of this information, and then formulate and implement policies to address many of them. Without reliable data, provided by rigorous research, on which to base such decisions, or to develop sound theoretical models to guide the decision-making, there is a danger that such policies may be ill-informed and consequently ineffective, inappropriate, or even counter-productive. To facilitate the continued development of this body of research, the participating institutes will support research in the ELSI area, including basic investigations directed at developing conceptual tools and shared vocabularies, 'applied' projects that produce empirical data, and 'translational' projects that use such tools and data to identify effective public-policy options. As with all ELSI research, it is important for this research program to consider the perspectives of individuals from diverse racial, ethnic and socioeconomic backgrounds, as well as children, older adults and people with disabilities. High priority will be given to those projects that examine issues and, where appropriate, develop policy options in the areas identified as grand challenges during the NHGRI’s two-year long planning process focused on the future of genomic research. These grand challenges are described in detail in A Vision for the Future of Genomics Research, (Nature (2003) 422:835- 847) (http://www.genome.gov/Pages/About/vision.pdf). They are described below, along with some examples of research questions and areas of interest. The examples should be understood as illustrative only, and not as limiting. 1. Intellectual Property Issues Surrounding Access to and Use of Genetic Information (Grand Challenge I-3). There are a number of important issues in this area, including the impact that laws, regulations, and practices in the area of intellectual property have on both the development and commercialization of genomic technologies and derived products, and the access to and use of such technologies and information by both researchers and the public. To maximize the positive impact of genomics on human health, it will be necessary to achieve a balance between the commercial incentives for development of useful products that are provided by the patent system, versus the research benefits of free and open access. Research to explore the way in which these competing priorities can be balanced to achieve maximal public benefit is critical. Because genomic research is global, it is also important to examine the impact of international treaties, laws, regulations, practices, belief systems and other social and cultural factors on these and related questions. 2. Ethical, Legal and Social Factors that Influence the Translation of Genetic Information to Improved Human Health (Grand Challenges II-5, II-6 and III-1) These Grand Challenges address issues of access to and use of new genetic information and technologies to improve human health. Research in this area is critical given the increasingly rapid introduction of new genetic technologies into healthcare, the growing use of multiplex genetic testing and the likely availability of new genetic tests for common complex diseases. Questions to be addressed include, but are not limited to: How are genetic services accessed and used? Are there barriers to equitable access, and, if so, how can they be removed? What effect does the provision of genetic risk information have on actual health behaviors? What are the most effective strategies for genetic testing and counseling in large populations? What are the most effective methods for providing risk information on genetic testing for common complex diseases? How will the growing mainstream use of new genetic technologies affect the health care system as a whole? How will it affect the provider-patient relationship? What will be the impact on the health insurance industry and managed care organizations of the availability and increasing use of new genetic technologies? Research also is needed to critically evaluate new genetic tests and interventions in terms of utility, validity, efficacy, and cost and benefits to individuals and to society. 3. Issues Surrounding the Conduct of Genetic Research (Grand Challenge III- 1). As technological capacity for studying human biology expands, new questions arise concerning optimal ways to do research that involves human participants. In the past decade, for example, much effort has gone into developing guidelines for the use of stored tissue specimens, for community consultation when conducting genetic research with identifiable populations, and for obtaining the consent of family members whose information may be obtained (or unintentionally discovered) when conducting pedigree research. Research is now appropriate to examine the impact of such guidelines on the safe and effective conduct of genetic and genomic research. In addition, research is needed that will provide data that can serve as the basis for the development of guidelines for the safe and effective conduct of other types of genetic research in the future. For example, what will be the impact on individuals, families and society of the current proliferation of large cohort studies that collect DNA samples that are linked to identifiable private health and demographic information? How can researchers most effectively protect the privacy of participants, their families and their communities, without erecting unnecessary roadblocks to the conduct of important research that benefits society? What are the most effective procedures for ensuring that participants are fully informed of the potential risks and benefits of these studies? 4. Issues Surrounding the Use of Genetic Information and Technologies in non-Health Care Settings (Grand Challenge III-1 and III-3). Another important area of research is the exploration of the ethical, legal and social implications of using genetic information and technologies in non- health care settings, such as employment, insurance, education, adoption, criminal justice, or civil litigation. Examples of questions that might be addressed include, but are not limited to: What are the ethical and social implications of the possible use in educational settings of genetic information on predisposition to hyperactivity, to learning disabilities or to substance abuse? What would be the legal implications if genetic information about behavioral traits, including liability to drug abuse, were determined to be admissible in criminal or civil proceedings? How would this information be interpreted and used? What are the public attitudes and values that could influence how this information may be used? How would the use of this information interact with individual and societal concepts of privacy and responsibility? Are existing legal protections against discrimination adequate to ensure against the misuse of genetic information in non-health care settings, or is there a role for additional, genetic- specific legal protections? Genomics also provides greater opportunity to investigate hypotheses concerning the geographic ancestry of individuals and populations. Potential research topics stemming from this use of genomic data include issues relating to the use of such information to determine the likelihood that an individual is a member of a particular group (for example, in criminal forensics). 5. The Impact of Genomics on Concepts of Race, Ethnicity, Kinship and Individual and Group Identity (Grand Challenge III-2). The relevance of genomics-derived data to concepts of race, ethnicity, kinship and identity has to be considered within complex historical, social and psychological contexts. Potential research questions in this area might include, but are not limited to: How do different individuals and cultures conceive of race, ethnicity and kinship, and what role do they believe genetic factors play in shaping those identities? How does genetic information influence individual and group identity for individuals from different ethnic or cultural groups or for individuals with disabilities? How does the scientific community understand and use these concepts in designing and conducting genomics and genetics research, analyzing data, and presenting research findings? How do the media interpret and report on these findings? 6. The Implications, for Both Individuals and Society, of Uncovering Genomic Contributions to Normal Human Traits and Behaviors (Grand Challenge III-3). Biological research in the future will undoubtedly address the question of whether there are genetic contributions to non-disease-related biological attributes such as handedness, cognition, diurnal rhythms, aging and various behavioral and personality characteristics. The findings of such research may have profound and complex implications for how individuals, families and society understand health and illness. Examples of questions that might be addressed in this area include, but are not limited to: How will such discoveries interact with current concepts of health and normality? How are these concepts perceived by individuals with disabilities or individuals from different cultural or socio-economic backgrounds? How will information on these traits or characteristics be understood and used, both by the general public and by policy makers? What policies will need to be developed to protect against the potential misuse of such information to stigmatize or discriminate against individuals and groups? 7. How Different Individuals, Cultures and Religious Traditions View the Ethical Boundaries for the Uses of Genomics (Grand Challenge III-4). It is important for society to define the appropriate and inappropriate uses of genomics. Research could explore how different individuals, cultures and religious traditions view the ethical boundaries for the uses of genomics. For instance, which sets of values determine attitudes towards the appropriateness of applying genomics to such areas as reproductive genetic testing, 'genetic enhancement' and germline gene transfer. Among the many questions that could be explored are: How are these areas defined and understood? How does this conceptualization shape values and attitudes? Are there aspects of these concepts and values that are common to all cultures and religious traditions? How are these issues viewed by individuals with disabilities? How are potential ethical boundaries for the application of genomics viewed by the research community? What might be the impact on society and the future of genomic research of the development of public policies that define and apply boundaries to the research enterprise? The research areas and possible research questions described above should be seen as a guide to areas of particular interest, but should not be understood to be an exhaustive listing of all possible research topics. As genetic research evolves and the interpretation and use of genetic information continue to emerge, applicants are encouraged to identify additional research topics and issues. The research design of all applications should be appropriate to the nature of the project(s) proposed and the discipline(s) involved. Interdisciplinary, collaborative projects among bioethicists, genome scientists, social scientists, clinical researchers, public health researchers, behavioral researchers, health economists, legal scholars, historians, theologians and/or other scholars in the humanities are particularly encouraged. This Program Announcement is complemented by PA-04-050, the ELSI Regular Research Grant (R01) Program (http://grants.nih.gov/grants/guide/pa-files/PA-04-050.html). The R01 program will accept applications for grants with direct costs greater than $50,000 per year for more than two years. An R01 grant application may build upon the preliminary work done through a small research grant (R03). The NHGRI ELSI Research Program also will accept conference grant (R13) applications on these and related topics. For application guidelines and instructions, please refer to PAR-03-176: NIH Support for Conferences and Scientific Meetings. http://grants.nih.gov/grants/guide/pa-files/PAR-03-176.html. MECHANISM OF SUPPORT This PA will use the NIH R03 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA 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 or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct general questions about scientific/research issues to: Ms. Joy Boyer ELSI Research Program National Human Genome Research Institute Building 31, Room B2B07 Bethesda, MD 20892-2033 Telephone: (301) 402-4997 FAX: (301) 402-1950 Email: jb40m@nih.gov o Direct general questions about financial or grants management matters to: Ms. Jean Cahill Grants Management Branch National Human Genome Research Institute, NIH Building 31, Room B2B34 31 Center Drive Bethesda, MD 20892-2032 TEL: (301) 402-0733 FAX: (301) 402-1951 Email: jc166o@nih.gov Specific programmatic and financial contacts at each of the participating NIH Institutes can be found online at: http://www.genome.gov/10001789. 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. For the purposes of this ELSI small grant program announcement, all of the participating institutes have agreed on the following guidelines and will use the standard application receipt dates. Institute specific small grant program guidelines and receipt dates should not be used in responding to this announcement. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. The application should not exceed a total of ten pages for the following sections: specific aims, background and significance, progress report/preliminary studies, and experimental design and methods. Tables and figures are included in the ten page limitation. The ten page limit does not include Sections 5-9 (Human Subjects, Consortia, Literature cited) or the appendices. All small grant (R03) applications must use the modular grant application instructions. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm 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. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique 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 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 In the review of small grant (R03) applications, additional weight will be given to the qualifications and track record of the principal investigator and the significance and timeliness of the issue being addressed. The application does not need to be strong in all categories to be judged likely to have major 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 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 research environment in which the work will be done contribute to the probability of success? Do the proposed approaches take advantage of unique features of the research 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Technical merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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