CENTERS FOR EXCELLENCE IN ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS (ELSI) RESEARCH (CEER) RELEASE DATE: August 13, 2003 RFA Number: RFA-HG-03-005 Update: The following update relating to this announcement has been issued: January 8, 2009 - This RFA has been reissued as (RFA-HG-09-003). (Reissued as RFA-HG-06-025). (See Clarification NOT-HG-04-001). National Human Genome Research Institute (NHGRI) (http://www.genome.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.172 LETTER OF INTENT RECEIPT DATE: October 27, 2003 APPLICATION RECEIPT DATE: November 24, 2003 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 Citations PURPOSE OF THIS RFA The Ethical, Legal, and Social Implications (ELSI) Research Program of the National Human Genome Research Institute (NHGRI) invites center grant applications (P50 and P20) for the development of Centers of Excellence in ELSI Research (CEERs). These CEERs will bring investigators from multiple disciplines together to work in innovative ways to address important new, or particularly persistent, ethical, legal, and social issues related to advances in genetics and genomics. This solicitation is intended to augment NHGRI's ELSI regular research grants program by supporting research activities that cannot be effectively supported by R01 and other research grant mechanisms currently available. NHGRI remains committed to supporting single investigator-initiated projects that use the R01, R03, and other appropriate grant mechanisms, and the research consortium strategy for encouraging interaction among investigators working in an area. The current list of ELSI funding opportunities can be found online at: http://www.genome.gov/page.cfm?pageID=10000930. RESEARCH OBJECTIVES Background and Significance In April 2003, the last of the original goals of the Human Genome Project, the sequencing of the human genome, was finished, marking the culmination of this historic biomedical research enterprise. 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 approaches for applying genomics to improving human health and preventing disease. With this changing focus, new ELSI issues will inevitably arise, with regard to both accomplishing the necessary research and applying the new knowledge. Thus, a vigorous program of ELSI research, the results of which will inform policy development deliberations, will continue to be an essential component of genomics research. To date, the NHGRI ELSI Research Program has funded a large number of research grants from investigators in a wide range of disciplines. Many of these projects have used interdisciplinary approaches to investigate important ELSI questions. While considerable progress has been made on ELSI issues, much remains to be done. In addition, as the pace of genomic and genetic research increases, the development of research teams that have the expertise and flexibility to respond rapidly to the large number of emerging and evolving ELSI issues is critical. All of these factors contribute to a need for new and more innovative approaches, including new organizational structures and funding mechanisms, to carry out ELSI research. The creation of research centers with the resources and expertise to design and implement multi-faceted and multi-disciplinary investigations of particularly complex, persistent or rapidly emerging ELSI issues will be an important addition to ongoing genetic, genomic and ELSI research efforts. Scope of Research The CEER program is designed to support the development of a research group that will identify and investigate ELSI research questions that can best be approached through intensive and extended collaboration among investigators from multiple disciplines, using diverse methodologies. The investigators in a CEER will be encouraged to consider new ways to explore these questions, design innovative and efficient research projects, propose and disseminate health or social policy options based on Center research and, when feasible, facilitate policy development pertinent to a specific issue. Center applicants are particularly encouraged to identify cutting edge research topics and approaches that have the possibility of leading to high payoff solutions to important ELSI problems. A CEER must identify a theme around which it will be organized. The research agenda should be focused on a single issue or set of related issues. CEER themes could be related to one or more of the Grand Challenges identified in the NHGRI vision document, "A Vision for the Future of Genomics Research" (Nature (2003) 422: 835-847), also available at: http://www.genome.gov/11006873. In addition, applicants can suggest other significant ELSI challenges that extend beyond those identified in the document above. Following are examples of possible CEER research topics. They are only examples. o Genetic Privacy and Discrimination in Medical and Non-medical settings. (Grand Challenge III-1). Although a substantial amount of research and policy development has been done on the potential for insurance or employment discrimination based on genetic information, this topic remains one of the public's most persistent concerns. A Center focused on this issue could develop a multi-disciplinary team to: survey existing research data and relevant policies; examine in greater depth the ethical, social, cultural and psychological factors underlying the persistence of these concerns; analyze the legal, political and economic issues affecting the development and implementation of relevant state and Federal legislation; examine the impact of this legislation on the attitudes, behavior and decision making of individuals and insurance companies or employers; and, based on these investigations, develop recommendations for the modification of existing policies or the development of new, more effective policies. o 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). Examples of projects in this area would include analysis of the issues surrounding access to and use of genetic information and technologies to improve human health. A CEER focused on this theme could bring its multi-disciplinary research team together to identify the most likely scenarios for the diffusion of genetic technologies into health care, including estimation of a timeline; conduct research to examine factors that will influence utilization, such as costs, access, and barriers to access; and develop guidance for the fair use of new genetic technologies in the health care system. o Issues Surrounding the Conduct of Genetic Research (Grand Challenge III-1). Much effort has gone into developing guidance for the ethical conduct of genetic research, including the use of stored tissue specimens, community consultation when conducting genetic research with identifiable populations, and obtaining the consent of family members whose information may be obtained (or even unintentionally discovered) through the course of research. Studies are needed to examine the impact of these existing guidelines and practices. Do they adequately protect research participants? Do they create unnecessary barriers to the conduct of ethically and scientifically sound research? In addition, new challenging ethical issues in genomic and genetics research continue to arise, for which little guidance exists. The increasing availability and accessibility of large amounts of genetic information in public databases creates new concerns about protecting the privacy of individual research participants while at the same time ensuring access to the data for research purposes. The availability of this information also raises issues such as how best to ensure that this data is not used to draw inaccurate or unwarranted conclusions about individuals or populations. In addition, the continued development and use of multiplex genetic testing platforms raises questions about the appropriate handling of findings that are difficult to interpret or incidental findings that may have unanticipated implications for research participants. A CEER focused on these themes could utilize the multi-disciplinary resources of the Center to identify where the most pressing ethical issues will come from in the future; explore how best to address these issues; conduct primary data collection and analysis or secondary analysis of existing data, as needed; and develop recommendations and a multi-faceted plan for dissemination which may result in the development of new research ethics guidance. o The Impact of Genomics on Concepts of Race, Ethnicity, Kinship and Individual and Group Identity (Grand Challenge III-2). A Center focused on this topic could explore how different individuals and cultures conceive of race, ethnicity, kinship, group identity and self-identity; how those perceptions may influence the direction and framing of genetic and genomic research questions; how the findings are interpreted and presented to the public; and how the public understands these concepts. The CEER team could then develop guidance for researchers, media, educators, or policy makers on how to responsibly and appropriately interpret and use these concepts and the data generated from this type of research. Although aspects of each of these issues could be addressed through regular (R01) or small (R03) research grants, the CEER program will allow researchers to propose truly interdisciplinary, innovative and comprehensive approaches to exploring and addressing these issues. To further clarify the unique nature of the CEER program, the following list of attributes of a successful CEER application is provided. A successful CEER will: o promote intensive and sustainable interactions among basic genomic and genetic scientists, clinical and social scientists, and researchers from law, bioethics and the humanities; o be highly innovative and develop new concepts, methods, analyses, or ways to consider ELSI issues that will substantially advance the state of the art in ELSI; o propose a very substantial advance to addressing a critical issue in ELSI research. (Achieving a substantial advance can entail addressing potentially controversial issues or identifying and exploring issues surrounding emerging technologies that are not yet in common use. It also can involve the use of new or unproven approaches or methodologies. These high risk issues and methodologies should be balanced by the potential for very high payoff and will require a detailed plan and a very effective management strategy.); o encompass, as appropriate, the full spectrum of ELSI research from 'basic' analytical investigations that develop conceptual tools and shared vocabularies to data generating qualitative and quantitative studies to more 'applied', 'translational' approaches that use these conceptual tools and data to explore and define appropriate public- policy options or research or health care guidelines (These policy options and guidelines must incorporate diverse points of view, including, as appropriate, communities that may be particularly vulnerable or disproportionately affected by the issues being addressed.); o propose research that cannot be reasonably addressed by a standard R01 Research Grant (As multidisciplinary collaborations on the core research continue, additional funding may be sought through the ELSI regular research and small research grant programs to support other related research.); o add value beyond activities in genomics or in ELSI research that might already be ongoing at the applying institution; o include a strategy for disseminating the results of the Center's research; o increase the pool of ELSI researchers, by offering innovative, substantive training opportunities across appropriate disciplines. It will integrate the training of new investigators and broaden the training of established investigators; and o help ameliorate the ELSI community's shortage of investigators from underrepresented minority communities (African Americans, Alaskan Natives, Hispanic Americans, Native Americans, Pacific Islanders) by developing effective opportunities to recruit and encourage members of these communities to develop as independent ELSI investigators. A CEER will NOT: o simply continue research already being pursued by the team, or by others; o serve as the obvious next step in a project or field, which could be accomplished by assembling state-of-the-art components and innovating at the level of a typical R01; o be a program project; or o provide infrastructure for an existing program or department. MECHANISM OF SUPPORT This RFA will use the Specialized Center (P50) and Exploratory (P20) grant mechanisms. Responsibility for planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation with a receipt date of November 24, 2003. However, NHGRI plans to release this announcement as a Program Announcement in 2004. The anticipated award date for this RFA is July 2004. A high priority under this program is the establishment of new academic Centers in which state-of-the-art ELSI research can be conducted. At some institutions, the nucleus of a well-functioning collaborative research group that could conduct the research described in this RFA may already exist, and such groups will be able to submit suitable P50 applications for this program directly. However, some groups of investigators may require an opportunity to collect preliminary data, enhance their collaborative network by strengthening and establishing new multi-investigator or interdisciplinary relationships, demonstrate effective collaborations, explore organizational concepts, develop courses or curricula, or refine and fully develop the vision of the proposed P50 CEER project. The Exploratory Grant (P20) mechanism should be used when the applicant wishes to request a period of planning and preliminary investigation prior to preparing a P50 Center application. P50 Specialized Center Grants A P50 Center grant application may request up to five years of support. The length of award will be determined through the peer review and Council advisory processes. Genomics and genetics research is constantly evolving, and it is anticipated that most Center projects focusing on related ELSI issues are likely to have a limited lifetime during which support as a CEER will be appropriate, either because the project goals will have been accomplished or the Center will have developed to the point that support from another source will be more appropriate. Therefore, except in exceptional circumstances, the total length of support for any P50 Center under this program will not exceed ten years (the initial grant period of up to five years, plus one renewal for up to an additional five years). Each CEER will have annual administrative site (or reverse site) visits. After the site visit of the third year, a decision will be made about whether a fifth year of funding will be provided to the Center. Further, at that review, the Principal Investigator (P.I.) will receive advice about the NHGRI's interest in accepting a competing renewal application to extend the initial award. The requested budget for a CEER may be up to $750,000 in direct costs for the first year for continuing operations (e.g., personnel, standard office equipment, supplies, travel and other expenses). Future year budgets may exceed $750,000 for inflationary adjustments. Under this cap, it is anticipated that the size of the awards will vary because the nature and scope of research programs will vary. To accommodate collaborations that extend beyond single institutions, Facilities & Administrative (F&A) charges on the subcontracts, which are formally direct costs to the parent institution, will be excluded in considering the $750,000 operating costs limit. P20 Exploratory Grants The planning grant application must explicitly demonstrate how the planning activities will lead to the P50 application, and describe in substantial detail a vision of the research to be conducted under the subsequent P50 grant. The planning grant budget may request funds for partial salary of key investigators, travel, and some supplies and equipment. Planning grants will be awarded for up to three years and up to $150,000 direct cost per year. A planning grant is not required as a precursor to a P50 Center application. Funding of a planning grant does not obligate NHGRI to fund a subsequent P50 Center grant. FUNDS AVAILABLE NHGRI intends to commit approximately $3,000,000 (total costs) in FY 2004 to fund 2-3 Specialized Centers (P50s) and 2-3 Exploratory Centers (P20s) in response to this RFA. An applicant may request a project period of up to 5 years for a P50 and up to 3 years for a P20 and a budget for direct costs of up to $750,000 per year (excluding F&A costs on subcontracts) for a P50 and up to $150,000 per year for a P20. 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 NHGRI 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 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 o Faith-based or community-based organizations Foreign institutions are not eligible to apply. However, subcontracts to foreign institutions will be considered. Investigators from majority institutions are encouraged to consider partnering with minority-serving institutions. 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 Consortium participation: Annual meetings of investigators from funded Centers will be held. This will facilitate sharing of information about current and planned activities as well as communication of research findings and policy deliberations (and about experience in organizing and operating a CEER). Such meetings will encourage collaboration among Centers, reduce duplication of effort, and promote more rapid dissemination of knowledge and information. The initial meeting will take place shortly after the Center grants are funded. Funds for travel to these meetings for up to four investigators (the PI and three others) per year should be included in the requested budget. Multidisciplinary and diverse research teams: The CEER program is intended to facilitate the formation of multidisciplinary teams of investigators who will develop new ways to frame and investigate ELSI research questions. These research teams may include basic genomic and genetic scientists, clinical and social scientists, and researchers from law, bioethics and the humanities. However, it is essential that the theme be well anchored in genomic and genetic sciences. NHGRI particularly encourages the involvement of minority serving institutions and investigators from minority populations and those with disabilities. Management and organization: A CEER will include a well-integrated project plan. The application should describe the specific organizational structure that will be used to support the research, and the synergism that will result because of this arrangement. A well thought out and carefully described organization is required. The application should explain how different components of the CEER will interact and why they are essential to accomplishing the overall goals of the research. How the combined resources create capabilities that are more than the sum of the parts should be described. The PI will be responsible for ensuring that the scientific goals are met and for developing and managing a decision-making structure and process that will allow resources to be allocated to meet the Center's goals. Therefore, the PI will be required to commit at least 30% effort to the leadership and implementation of the Center. A timeline for the project should be included in the application that shows how the Center's goals can be met within the timeframe of the CEER grant. This timeline will be used to help assess progress toward the Center's goals. Training: In addition to a strong research component, a Center is required to have a highly effective training component that will leverage the strengths of the multidisciplinary nature of the Center and its investigators to train the next generation of ELSI scholars, genome/genetics researchers, clinical and social scientists, and researchers in law, bioethics and the humanities to be able to develop independent research programs that address important ELSI problems. The training component of the Center must include a specific plan for engaging the talents of individuals from underrepresented minority groups as outlined in the NHGRI Action Plan (http://www.genome.gov/10001707). Specific funds may be requested for training activities to include up to two post-doctoral trainees per year. The NHGRI has other program announcements that support student training. Doctoral dissertation research for students from under- representative minority populations is supported through this program announcement: https://grants.nih.gov/grants/guide/pa-files/PA-02-048.html. Further, it is expected after one year of support on this training grant, the post-doctoral fellow will have applied for a National Research Service Award (NRSA-F32). For more information regarding this program announcement, see: https://grants.nih.gov/grants/guide/pa-files/PA-99-122.html. For other ELSI funding opportunities, visit: http://www.genome.gov/10000930. While exploratory grants are not required to have a training program, the types of training activities, particularly for training of investigators from under-represented minority populations that are appropriate for the subsequent P50 Center should be explored during the course of the P20 funding. Site visits: Annual administrative site visits will be scheduled to assess progress being made in the Centers. Most will likely be held at the funded institution. Occasionally it may be necessary to hold reverse site visits, in which investigators travel to Bethesda to report on progress. WHERE TO SEND INQUIRIES Prior to submitting an application, potential applicants are strongly encouraged to discuss their project with NHGRI program staff. Inquiries may fall into three areas: programmatic/scientific/research issues; peer review issues; and financial or grants management issues: o Programmatic/scientific/research issues should be directed to: Elizabeth J. Thomson Program Director, Ethical, Legal, and Social Implications Research National Human Genome Research Institute Building 31, Room B2B07 Bethesda, MD 20892-2033 Telephone: (301) 402-4997 FAX: (301) 402-1950 Email: firstname.lastname@example.org o Peer review issues should be directed to: Rudy Pozzatti Scientific Review Branch National Human Genome Research Institute, NIH Building 31, Room B2B37 31 Center Drive Bethesda, MD 20892-2032 TEL: (301) 402-0838 FAX: (301) 435-1580 o Financial or grants management matters should be directed to: Jean Cahill Chief, 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 LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by October 27, 2003 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 should be sent to: Elizabeth J. Thomson Program Director, Ethical, Legal, and Social Implications Research National Human Genome Research Institute Building 31, Room B2B07 Bethesda, MD 20892-2033 Telephone: (301) 402-4997 FAX: (301) 402-1950 Email: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. 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: https://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, including all appendices, must be sent to: Scientific Review Branch National Human Genome Research Institute, NIH Building 31, Room B2B37 31 Center Drive Bethesda, MD 20892-2032 TEL: (301) 402-0838 FAX: (301) 435-1580 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. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHGRI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 NHGRI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the National Advisory Council for Human Genome Research. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. To ensure that applications for this CEERs program are evaluated appropriately, the standard NIH review criteria have been adapted to be more appropriate for applications of the scope described in this PA. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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. SIGNIFICANCE: Does this study address an important emerging or particularly persistent ELSI problem related to genomic and genetic science? If the aims of the application are achieved, will our understanding or ability to address these issues be advanced? Will these studies have an effect on the field of ELSI research? Will they be relevant and useful to the larger scientific and public policy communities? 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? 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 approaches? For proposed multi-component centers, is there a demonstrated scientific gain from the interrelatedness and synergy among the components? If any individual component were removed, would the ability of the CEER to accomplish its overall aims be impaired? MANAGEMENT: Is the management plan, including the management structure, appropriate and adequate to support the CEER? Is there an effective plan for use of fiscal resources, shared facilities and human resources to attain the research aims and overall CEER goals? Is there an adequate plan for the organization and coordination of the CEER personnel? Is there a high quality plan for making critical decisions or choices about the overall research direction for the CEER? Where appropriate, are the approaches used or under development to implement the research plan cost effective? PRINCIPAL INVESTIGATOR: Does the PI have the ability, expertise and experience to lead, coordinate, and manage all of the activities of the CEER? Does the PI have sufficient leadership qualities and experience to develop and implement the CEER plans for the entire project? INVESTIGATORS: Are the additional investigators identified in the application appropriately trained, from multiple disciplines, and well suited to carry out this work? To what degree will the individual and combined expertise of the key personnel contribute to the accomplishment of the overall goals of the proposed research? Is the level of effort for the key personnel adequate? MULTIDISCIPLINARITY OF RESEARCH TEAM: Is the training, background, and expertise of the multi-disciplinary research team appropriate to achieve the specific aims and overall goals of the proposed Center? Does the multi-disciplinary team bring novel capabilities to the research program? Is there evidence of effective collaboration among key personnel? Is there evidence that the team has sufficient expertise in both ELSI and genomic/genetic science? Are investigators from minority populations and/or those with disabilities included? TRAINING: What is the quality of the proposed training plan and its likely effectiveness in producing well-trained researchers who can develop new approaches to ELSI questions and research? Are there plans to develop new training opportunities and to integrate them with other on-going or planned training? Plans to achieve effective training of underrepresented minorities receive particular attention. ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed research plan take advantage of unique features of the scholarly environment? Is there evidence of adequate institutional support, including improvement of infrastructure and relief from other academic duties where necessary? Is the environment adequate for proposed training activities? 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 CONSIDERATIONS 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: October 27, 2003 Application Receipt Date: November 24, 2003 Peer Review Date: March, 2004 Council Review: May, 2004 Earliest Anticipated Start Date: July, 2004 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 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://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 https://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 Nos. 93.172 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 https://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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