RFA-HG-99-002: STUDIES OF THE ETHICAL, LEGAL AND SOCIAL IMPLICATIONS OF RESEARCH INTO HUMAN GENETIC VARIATION

Department of Health
and Human Services (HHS)

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STUDIES OF THE ETHICAL, LEGAL AND SOCIAL IMPLICATIONS OF RESEARCH INTO HUMAN GENETIC VARIATION Release Date: April 29, 1999 RFA: HG-99-002 P.T. National Human Genome Research Institute National Institute on Deafness and Other Communication Disorders National Institute of Environmental Health Sciences National Institute of General Medical Sciences Letter of Intent Receipt Date: June 15, 1999 Application Receipt Date: August 31, 1999 PURPOSE This Request for Applications (RFA) solicits projects that examine the ethical, legal and social implications of the study of human DNA sequence variation. Of particular interest are studies that explore: 1) how research on human genetic variation can be conducted in an ethically and culturally sensitive way, 2) how the information that results from this research will interact with current concepts of race and ethnicity, 3) how cultural and socioeconomic factors influence the interpretation and use of this information, and 4) how this information may influence access to and use of genetic health services by various groups. The study of sequence variation and the exploration of related ethical, legal and social issues have been identified as two of the new five year goals of the US Human Genome Project and will be of continuing interest to the NHGRI Ethical, Legal and Social Implications Research Program over the next several years. (For a more complete discussion of these goals, visit the NHGRI Five-year Plan web site at http://www.nhgri.nih.gov:80/98plan/.) HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RfA, Studies of The Ethical, Legal And Social Implications of Research Into Human Genetic Variation, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01), small research grant (R03) and education grant (R25) award mechanisms. NHGRI and NIEHS will accept applications using the R01, R03, or R25 mechanism. NIDCD will accept applications using R01 and R03 mechanisms only. NIGMS will accept only those applications using the R01 mechanism. Responsibility for the planning and direction of the proposed project will be that of the applicant. However, research teams supported under this RFA will be asked to collaborate and share information in order to reduce duplication of research efforts and assure that a variety of the research questions are addressed. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. This RFA is a one-time solicitation, although it may be re-released in FY 2000. The purpose of the RFA is to stimulate research on these issues and build a foundation for future explorations in this area. Future unsolicited competing applications proposing research in this area are encouraged and will be reviewed along side and compete with all other unsolicited investigator-initiated applications. Annual TOTAL costs for R01s and R25s should not exceed $400,000 and $250,000 respectively, for a maximum of three years. Annual DIRECT costs for R03s should not exceed $50,000 per year, for a maximum of two years. The anticipated award date is March 2000. FUNDS AVAILABLE It is expected that approximately $2 million per year for up to three years will be available from the above named Institutes beginning in fiscal year 2000, to fund approximately eight to ten projects. This level of support is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the identified Institutes, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. The level of support for these projects may be increased if a large number of highly meritorious applications are received and if funds are available. RESEARCH OBJECTIVES Background and Significance The NIH, along with several other federal and private, national and international organizations, is currently engaged in a research effort known as the Human Genome Project (HGP). This project is designed to characterize the human genome and the genomes of selected model organisms. The HGP has several interrelated goals: the determination of the complete nucleotide sequence of human DNA and the DNA of several model organisms, the development of new technologies to make sustained high throughput DNA sequencing efficient, accurate and cost effective, the exploration of human genome sequence variation, the development of technologies for interpreting the function of DNA sequence, the identification and analysis of related ethical, legal, and social issues, and research training. The knowledge and technologies that will become available as a result of accomplishing these goals will: serve as a resource for studies of gene structure and function, promote research into the genetic aspects of human growth, development, and variability, increase the understanding of genetic contributions to human diseases and disorders, and inform clinical and health policies related to genetics. This understanding will lead to insights into new ways of dealing with health and disease, including new prevention, diagnostic and treatment options. It will also help to elucidate more clearly the interaction between genes and the environment in the development of disease. Knowing the entire sequence of the human genome and understanding more about genetic variation among individuals and groups will, however, raise questions about how this information will be interpreted and used by individuals, families, and society. As the Human Genome Project draws closer to the completion of the first human DNA sequence, researchers are focusing increasing attention on the discovery of variations found in the DNA sequences of individuals. The identification, classification, quantification and analysis of these sequence variations is expected to constitute one of the most powerful, and direct, approaches to the study of a wide range of important biological questions. It will allow researchers to identify genetic contributions to many common diseases and disorders, such as diabetes, depression, heart disease, deafness and hearing impairment, and some forms of cancer, and will provide the basis for studying how sequence variation influences gene function in human growth and development and in the development of disease. To stimulate research in this area, in January 1998, NHGRI and seventeen other NIH Institutes and Centers released an RFA, Methods for Discovering and Scoring Single Nucleotide Polymorphisms (SNPs) (http://www.nhgri.nih.gov:80/Grant_info/Funding/RFA/rfa-hg-98-001.html). To facilitate discovery of DNA sequence variation, the NHGRI has coordinated the assembly of a DNA Polymorphism Discovery Resource of anonymous samples from 450 U.S. residents with ancestry from all the major regions of the world. This initial resource was set up solely for the purpose of the initial discovery of human variation. Therefore, no medical, phenotypic, or demographic information was linked to individual samples. A second activity, the Environmental Genome Project, was also begun in 1998. A program of the National Institute of Environmental Health Sciences, its overarching goal is to understand the impact and interaction of environmental exposures on human disease, which will allow more precise identification of the environmental agents that cause disease and the true risks of exposure. A third related activity was the 1999 release of RFA GM-99-004, "Pharmacogenetic Research Network and Database (http://www.nih.gov/nigms/funding/pharmacogenetics.html)" sponsored by the NIGMS and a number of other NIH Institutes. This RFA was designed to solicit applications to study functional variation in genes and proteins that play essential roles in individual drug responses and to make predictions about phenotypic responses based on genotypic make-up. In addition to these and other federally-sponsored activities, broad and vigorous efforts to discover human variation are also proceeding in the private sector. The research into sequence variation that will result from these and other similar initiatives, will raise a number of ethical, legal, and social issues. These include: how to design and conduct this research, not only in a scientifically sound, but also an ethical manner, how to interpret and use this information, whether and how to integrate this information into clinical settings, and what impact this information will have in non-clinical and research settings. Many of these issues may be of special concern to individuals from diverse communities, including those who traditionally have not been involved in genetic research, as researchers, research participants, or policy makers. Questions have already been raised concerning the inclusion of members of these populations in early genetic studies and whether the under-representation or, in some cases, the over-representation of these populations have led to an increase in stigmatization and discrimination in employment, health care, insurance, or in society more broadly. These issues may become even more acute if research into human genetic variation reveals data on the interactions between genotype, disease, and traditional, socially-constructed concepts of race, ethnicity and culture. This RFA is designed to solicit applications that will begin to address the ethical, legal, and social issues being raised as this research moves forward. Research Scope The goal of this RFA is to solicit applications for studies that will identify, explore and begin to address the ethical, legal and social issues that may arise in the course of research on human DNA sequence variation and in the use of the information that may result from this research. The ways in which this new information will interact with cultural and socioeconomic factors and concepts of race, ethnicity and culture are of particular interest. Research topics that may be appropriately addressed in applications responding to this RFA could include, but are not limited to the following broad areas. Examples of possible research questions are provided, but are designed only to help clarify the areas of research, and are not, in any sense, exhaustive or exclusive. (1) Strategies for Conduct of Sequence Variation Research: Exploration of the ethical, legal and social issues surrounding the design and implementation of basic and applied research into sequence variation. Research questions might include: o What are the most effective strategies for involving various groups in the development and conduct of genetic variation research? o What mechanisms could be utilized to ensure that the research that is conducted in these areas is culturally sensitive and relevant and that the needs for privacy and confidentiality of information about individuals and groups are considered? o How should populations be identified for participation in research? o What issues should be considered in designing informed consent protocols that address the concerns of both the group and the individual group member? o What ELSI issues will arise if research suggests an association between individual or group genetic variation and phenotype, including health or illness states, and how can these issues best be addressed? (2) Concepts of Race, Ethnicity, and Culture: Examination of the ways in which the discovery of DNA polymorphisms may interact with current concepts of race, ethnicity and culture. Research questions might include: o How will individuals and groups respond to potential challenges to or validations of their racial, ethnic or cultural self-identification, based on new genetic information? o What impact will the discovery of information on genetic variation have on the current categories (as defined by the government) of race and ethnicity? o Will the discovery of patterns of DNA polymorphisms affect the concepts of race and ethnicity that are used by genetic, anthropological and other health and social sciences researchers? o How will this newly discovered information influence the development, prioritization, and conceptual framework of future research questions and protocols? (3) Interpretation and Use of Information on Sequence Variation: Exploration of the ways in which the interpretation and use of the information that results from this research might be influenced by current concepts of race, ethnicity or culture or by socioeconomic status. Research questions might include: o Will individuals from diverse populations be more or less vulnerable to various forms of stigmatization and discrimination as a result of the availability of information on sequence variation? o How will diverse communities be affected by the potential commercialization and patenting of DNA sequence variation information? o Are there ways to minimize harm to individuals and groups, while maximizing possible benefits? o What strategies could be employed to educate the public about the meaning and interpretation of information about genetic variation? (4) Potential Uses of Information on Sequence Variation in Clinical Settings: Exploration of how the information that may result from research into sequence variation may influence access to and use of genetic and other health services by various groups. Research questions might include: o What strategies can be used to ensure that the information that may result from sequence variation research is used appropriately in health care settings? o How will individuals with diverse cultural and socioeconomic backgrounds perceive the development of genetic tests and treatments that are designed for use in specific socially or geographically defined populations, in which a particular DNA sequence variation is prevalent? o How will these perceptions influence the use of these new technologies? o Are there strategies to increase the likelihood that diverse communities will benefit from health information and services derived from sequence variation research? o What strategies could be utilized to educate health professionals how to interpret and use information obtained through sequence variation research? The research design should be appropriate to the nature of the project(s) proposed and the discipline(s) involved. Projects that use the interpretive methods traditional to the humanities, law, and the social sciences are encouraged. The formation of interdisciplinary research teams involving social science/ELSI researchers and researchers engaged in sequence variation studies is highly desirable. It is essential that applicants address the full range of perspectives on each issue they elect to investigate in a responsible, scholarly, and balanced manner, with the goal of advancing scholarship, achieving better understanding, and developing useful recommendations. SPECIAL REQUIREMENTS In order to increase the scope and pace of the research, the NIH will organize a consortium of studies. Such an arrangement will allow researchers to compare findings on issues common to all the projects, to reduce duplication of effort, and to promote sharing of information. To facilitate such coordination, grantee workshops will be arranged on an annual basis in the Bethesda area. The initial meeting of the consortium will take place shortly after the grants are funded. Funds for travel to these meetings for up to two investigators (the PI and one other) per year should be included in the requested budget. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by June 15, 1999, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 NIH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Elizabeth Thomson, R.N., M.S., C.G.C. Ethical, Legal, and Social Implications Research National Human Genome Research Institute 38 Library Drive, MSC 6050, Room 617 Bethesda, MD 20892-6050 Telephone: (301) 402-4997 FAX: (301) 402-1950 Email: et22s@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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. 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) To expedite the review process, at the time of submission, two additional copies of the application must be sent to: Rudy Pozzatti, Ph.D. Office of Scientific Review National Human Genome Research Institute 38 Library Drive, Room 609, MSC 6050 Bethesda, MD 20892-6050 Telephone: (301) 402-0838 FAX: (301) 480-2770 Email: pozzattr@exchange.nih.gov Applications must be received by August 31, 1999. If an application is received after that date, it will be returned to the applicant without review. 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. CSR will also not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of previously reviewed applications with substantial revisions. Such applications must include an "Introduction to the Revised Application" in which the response to the previous summary statement is made. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the participating Institutes. Incomplete applications will be returned to the applicant by CSR without further consideration. If the application is not responsive to the RFA, Institute staff will contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with other unsolicited applications at the next review cycle. 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 NHGRI, in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which only those applications deemed to have the highest scientific merit (generally the top half of the applications under review) will be discussed, assigned a priority score, and receive a written critique of their application. The second level of review will be by the National Advisory Council for Human Genome Research and other National Advisory Councils as assigned. 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 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that 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. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. Other review criteria will include: o The adequacy of plans for both the recruitment and retention of subjects. o The adequacy of the proposed informed consent process and the protections for human participants, particularly the risks that may be posed to groups as well as individuals. Schedule Letter of Intent Receipt Date: June 15, 1999 Application Receipt Date: August 31, 1999 Peer Review Date: November 1999 Council Review: February 2000 Earliest Anticipated Start Date: April 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review), o responsiveness of the proposed project to achieve the goals of this RFA, o balance among projects to respond to the questions included in this RFA, and o availability of funds INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elizabeth Thomson, R.N., M.S., C.G.C. Ethical, Legal, and Social Implications Research National Human Genome Research Institute 38 Library Drive, MSC 6050, Room 617 Bethesda, MD 20892-6050 Telephone: (301) 402-4997 FAX: (301) 402-1950 Email: et22s@nih.gov Amy M. Donahue, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS 400C Rockville, MD 20892 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: amy_donahue@nih.gov Michael E. McClure, Ph.D. Organs and Systems Toxicology Branch National Institute of Environmental Health Sciences 111 T.W. Alexander Drive (Courier-79 T.W. Alexander Drive) P.O. Box 12233, Mail Drop EC-23 Building 4401, Room 3417 Research Triangle Park, NC 27709 Telephone: (919) 541-5327 FAX: (919) 541-5064 Email: mm461n@nih.gov Rochelle M. Long, Ph.D. Pharmacology, Physiology, and Biological Chemistry Division National Institute of General Medical Sciences Building 45, Room 2AS.49H Bethesda, MD 20892-6200 Telephone: (301) 594-1826 Fax: (301) 480-2802 Email: rochelle_long@nih.gov Direct inquiries regarding fiscal matters to: Ms. Jean Cahill Division of Extramural Research National Human Genome Research Institute 38 Library Drive, MSC 6050, Room 613 Bethesda, MD 20892-6050 Telephone: (301) 402-1733 Fax: (301) 402-1951 Email: jc166o@nih.gov Ms. Sherry Dennison Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS 400C Rockville, MD 20892 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: Sherry_Dennison@nih.gov Mr. David Mineo Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MDEC-22 111 T.W. Alexander Drive, East Campus Research Triangle Park, NC 27709 Telephone: (919) 541-1373 Fax: (919) 541-2860 Email: mineo@niehs.nih.gov Ms. Antoinette Holland Grants Administration Branch National Institute of General Medical Sciences Building 45, Room 2AN.50B Bethesda, MD 20892-6200 Telephone: (301) 594-5132 Fax: (301) 480-3423 Email: hollanda@nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172, (NHGRI), No. 93.173 (NIDCD), Nos. 93.113, 93.854 and 93.242 (NIEHS), and Nos. 93.859 and 93.862 (NIGMS). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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. REFERENCES Department of Health and Human Services. Healthy People DHHS Publication No. PHS 91-50212, 1991. Collins, F.S., A. Patrinos, E. Jordan et al. "New Goals for the U.S. Human Genome Project: 1998-2003." SCIENCE. October 1998, 282: 682-689. Collins, F.S., L.D. Brooks, and A. Chakravarti. "A DNA Polymorphism Discovery Resource for Research on Human Genetic Variation." Genome Research. December 1998, 8:1229-1231 Collins, F.S., M.S. Guyer and A. Chakravarti. "Variations on a Theme: Cataloging Human DNA Sequence Variation." SCIENCE. November 1997, 278: 1580-1581. Foster, M.S., A.J. Eisenbraun and T.H. Carter. "Communal discourse as a supplement to informed consent for genetic research." Nature Genetics. November 1997, 17: 277-279. Foster, M.S., D. Bernsten and T.H. Carter. "A Model Agreement for Genetic Research in Socially Identifiable Populations." Am. J. Hum. Genetics. 1998, 63: 696-702. Freeman, H.P. "The Meaning of Race in Science--Considerations for Cancer Research." CANCER. January 1998, 82(1): 219-225. Jackson, F. "Concerns and Priorities in Genetic Studies: Insights from Recent African American Biohistory." Seton Hall Law Review. 1997, 27(3): 951-970. Juengst, E.T. "Human Genetics 98: Ethical Issues in Genetics. Group Identity and Human Diversity: Keeping Biology Straight from Culture." Am. J. Hum. Genetics. 1998, 63: 673-677. RFA: HG-98-001 "Methods for Discovering and Scoring Single Nucleotide Polymorphisms" NIH GUIDE, January 9, 1998. Schafer, A.J. and J.R. Hawkins. "DNA Variation and the Future of Human Genetics." Nature Biotechnology. January 1998, 16: 33-39.

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