NIH Guide: STUDIES OF THE ETHICAL, LEGAL AND SOCIAL IMPLICATIONS OF RESEARCH INTO HUMAN GENETIC VARIATION

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 301/435-0714, 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:

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 þ98: 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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