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American Journal of Epidemiology
Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2019. This
work is written by (a) US Government employee(s) and is in the public domain in the US.
Vol. 188, No. 7
DOI: 10.1093/aje/kwz062
Advance Access publication:
April 24, 2019
Special Article
Genomic Research and American Indian Tribal Communities in Oklahoma:
Learning From Past Research Misconduct and Building Future Trusting
Partnerships
Jennifer Q. Chadwick*, Kenneth C. Copeland, Dannielle E. Branam, Julie A. Erb-Alvarez, Sohail
I. Khan, Michael T. Peercy, Mark E. Rogers, Bobby R. Saunkeah, Jeanie B. Tryggestad, and David
F. Wharton
*Correspondence to Jennifer Chadwick, University of Oklahoma Health Science Center, 1200 North Children’s Avenue, Suite 4D,
Oklahoma City, OK 73104 (e-mail: jennifer-chadwick@ouhsc.edu).
Initially submitted August 9, 2018; accepted for publication March 4, 2019.
Research misconduct and consequential harms have been inflicteduponAmericanIndian/Alaska Native communi-
ties for decades. To protect their people and culture and to retain oversight over research, many Native communities
have established tribal health research and institutional review boards. The Treatment Options for Type 2 Diabetes in
Adolescents and Youth (TODAY) Study showcases a successful, trusting research collaboration with tribal nations and
academic investigators in Oklahoma. In 2006, the TODAY Study investigators proposed a modification of the study pro-
tocol to collect biological specimens from participants for genomic analyses and indefinite storage. Partnering American
Indian tribal nations elected not to participate in the genomics collection and repository proposal. Reasons included
1) protection of cultural values, 2) concerns regarding community anonymity, 3) a potential threat to tribal services eligi-
bility, 4) broad informed consent language, and 5) vague definitions of data access and usage. The nations believed the
proposed genomics analyses presented a risk of harm to their people and nations without clear benefit. Since the 2006
proposal and the advancement of genomics research, many tribal communities in Oklahoma, appreciating the potential
benefits of genomic research, are developing policies regarding oversight of/access to data and biological specimens
to mitigate risks and provide members and communities with opportunities to participate in safe and meaningful geno-
mic research.
American Indian research; American Indians; collaborative research; genomic research
Abbreviations: IRB, institutional review board; TODAY, Treatment Options for Type 2 Diabetes in Adolescents and Youth.
Historically, American Indians have endured higher inci-
dences of chronic diseases and greater health disparities
than other minority populations (1,2). From 1995 to 2006,
based on a cross-sectional analysis of data from the Behavioral
Risk Factor Surveillance System, national health statistics indi-
cated that diabetes in American Indians increased by 26.9%
and that the prevalences of obesity and diabetes among Ameri-
can Indian youth were higher than those in any other ethnic
group in the United States (3). Because of the alarming increase
in the prevalence of obesity and diabetes in this population, it
became imperative for American Indian communities to aggres-
sively address issues of diabetes prevention, research, and treat-
ment (4,5).
In 2002, the institutional review boards (IRBs) of the Cher-
okee Nation, the Chickasaw Nation, and the Choctaw Nation
of Oklahoma, the Oklahoma City Area Indian Health Service
IRB, and the Absentee Shawnee Tribal Research Board part-
nered with the investigators of the Treatment Options for
Type 2 Diabetes in Adolescents and Youth (TODAY) Study
(6), a National Institutes of Health–supported pediatric diabe-
tes treatment trial designed to determine optimal treatment for
youth with type 2 diabetes (7). This collaboration was an effort
to maximize American Indian participant recruitment and to
monitor study execution, while also providing surveillance
and counsel for all TODAY Study publications (6). After
16 years, the TODAY Study’s Native American research
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partnership continues to be an exceptional example of an
effective research collaborative model.
In 2006, the TODAY Study investigators proposed a proto-
col modification that would allow for the collection of biological
specimens from all study participants for genomic analyses,
with remaining samples to be stored indefinitely in a National
Institutes of Health–sponsored repository. The TODAY Study’s
partnering American Indian IRBs were notified regarding the
proposed modification. After thorough deliberation, all 4 Amer-
ican Indian IRBs and the Absentee Shawnee Tribal Research
Board elected not to approve the protocol modification that
would have allowed for the collection and storage of these bio-
logical specimens. The purpose of this report is to delineate the
reasons why the TODAY Study’s American Indian partners
elected not to participate in the proposed genomic research col-
laboration portion of the TODAY Study and to describe their
present efforts to participate in future genomic and biorepository
research opportunities.
RESEARCH MISTRUST AND ETHICAL MISCONDUCT
American Indians have experienced great historical trauma
related to social, economic, cultural, and political injustices (8,9).
Research suggests that these injustices have contributed to higher
incidences of heart disease, cancer, obesity, and diabetes in
American Indian communities (2,3). Centuries of deception and
injustices by government agencies and researchers have resulted
in native communities’developing a deep-rooted mistrust and
fear of biomedical research. Research harm has included absent,
inappropriate, or insufficiently specific informed consent; misin-
terpretation of data; misrepresentation of tribal culture; breaches
of privacy; mishandling of biological samples; false representa-
tion; and, in some cases, medical malpractice (10–14). Often
American Indians were allegedly subjected to research without
regard for potential harm to individuals or their communities.
Some researchers would enter American Indian communities,
collect data, depart without community engagement, and then
publish negative findings from their research, inflicting harmful
imprints on the communities’social, economic, and cultural sys-
tems (12–15).
American Indians’trepidations regarding research are long-
standing and well-founded, including their concerns related to
genomic research. In the past, some researchers have gathered
blood samples from American Indian participants without ade-
quate informed consent and/or conducted and published geno-
mic analyses without tribal approval (13,16). The most recent
incident of research injustice, which was highly publicized,
involved the Havasupai tribe, a small tribal nation located in Ari-
zona’s Grand Canyon (17). The tribe asserts that researchers
from Arizona State University unethically collected and ana-
lyzed data and biological specimens, including samples for
genomic studies not described in the informed consent docu-
ment, and then shared the samples with other researchers, all
without seeking guidance and approval from tribal leaders (13,
18). These infractions occurred for decades until a tribal member
happened upon some of the results during a scientificpresenta-
tion. It is believed that around 23 publications were circulated
without official Havasupai tribal approval (18). The Havasupai
tribe perceived some of the published data to be disparaging,
and believed it harmed their people and culture by contradicting
the tribe’s creation beliefs and linking tribal members and fami-
lies to schizophrenia and inbreeding genomic markers (13,18).
AMERICAN INDIAN RESEARCH OVERSIGHT
Oklahoma is home to 38 federally registered tribes, including
the Cherokee Nation, the Chickasaw Nation, the Choctaw
Nation of Oklahoma, and the Absentee Shawnee Tribe (17). As
sovereign nations, tribes have the unquestioned legal right and
authority to govern their people, including the right to approve
and monitor research conducted within their nations (19–21).
Believing that academic research review boards do not, and can-
not, adequately assess the tribal community and cultural harm
committed in recent years, many tribes and nations have devel-
oped their own research review practices in order to protect their
people and communities from harm (22–24). In the 1990s, the
Oklahoma City Area Indian Health Service developed an IRB
to assure the protection of American Indians from potential
research harms; this board currently provides research protec-
tion support to numerous tribal communities. In addition to
the Oklahoma City Area Indian Health Service, many tribal
nations have created tribal health research boards and/or tribe-
led IRBs. The first Oklahoma American Indian tribe to create
a registered IRB was the Cherokee Nation. The Chickasaw
Nation and Choctaw Nation of Oklahoma soon followed with
their own registered IRBs, and the Absentee Shawnee Tribe cre-
ated a tribal research board. Currently there are approximately
28 tribal IRBs nationally registered with the US Department of
Health and Human Services’Office for Human Research Pro-
tections (25).
In addition to providing ethical protection, tribal review boards
also ensure that the research is of value to the tribal community
(24,26). Many tribes will only consider research that aims to
address tribally identified concerns. Protocols must specify all
potential benefits and risks, not only for the individual but also
for the tribal community and nation. Many current tribal IRBs
require that the tribal nation and researcher agree beforehand on
who will own the study data. Presently some tribes only allow re-
searchers access to the data for the duration of the study and
require that, once the study concludes, the data be returned to the
tribal nation. Finally, most tribes require all presentations and
publications generated from the study’sdatatobereviewedby
the tribal IRB before the research can be presented or published
(24,26).
TODAY STUDY GENOMIC RESEARCH
In 2006 (Figure 1), only 3 years after the Havasupai tribe
uncovered what they deemed unethical genomic research prac-
tices in their community, the TODAY Study investigators sub-
mitted to the American Indian partnering IRBs a protocol
modification seeking to collect genomic biological specimens
from TODAY Study participants for analyses and storage of
additional samples in a repository (13,27). The participants
were given the option to donate genomic biological specimens
without affecting their overall study participation.
The study’s investigators believed that collection of genomic
samples would aid in future research related to the development
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of undiscovered diagnostic tests, treatments, and possible pre-
vention of diseases, especially diabetes; however, there was no
specified clinical use for the samples. The biological specimens
would first be analyzed by TODAY Study investigators and
then, if consent was provided by the participants, stored indefi-
nitely at the National Institute of Diabetes and Digestive and
Kidney Diseases Central Repository for future research studies
(27). The proposed modification was approved by all of the
study’s participating academic IRBs. However, after careful
deliberation, all 5 partnering American Indian research boards
elected not to participate in the TODAY Study’s collection of
genomic biological specimens or the repository. Each tribal na-
tion’s decision was made independently; however, many com-
mon concerns were raised.
One issue raised was whether the scientificbenefits of the
genomic testing and repositoryparticipationoutweighedthe
risks to the individual participants and tribal culture. The collec-
tion of biological specimens for genomic analyses provided no
direct, immediate benefit to the participant and/or the tribe; any
potential, yet-to-be-determined benefit might be due to future
medical advances. Consent form wording stated that if a geno-
mic abnormality were to be discovered, individuals would not
be notified of the results, nor would any genetic education or
counseling be provided. Some tribal IRBs felt very strongly
that participants should be notified of abnormalities or, if poten-
tially beneficial information was discovered, genetic counseling
should be made available.
The tribes concluded that participating in the study would
yield little to no immediate or direct benefit; however, the risks of
participation appeared to be numerous. First, the tribes noted that
many American Indian people hold strong cultural values, be-
liefs, and concerns related to the collection, treatment, and
destruction of biological specimens. Also, maintaining confi-
dentiality and anonymity in small tribal communities can be
difficult or impossible. Losing anonymity places study partici-
pants and their family members at greater risk of being identified
personally. In some cases, the discovery of genomic abnormali-
ties might affect families personally or socially and/or impact
their ability to obtain future employment, housing, and/or health
benefits (28–31).
For some American Indians, tribal membership is declared by
the tribe/nation, in agreement with the US Bureau of Indian Af-
fairs, through approved documented ancestry (32). The TODAY
Study’s partnering IRBs were concerned that agreeing to open-
ended consent for genomic analyses might lead to questions
regarding an individual’s family and tribal lineage, possibly re-
sulting in termination of the person’s eligibility for services. Con-
sidering these risks and the fact that the proposed genomic tests
would be conducted on a vulnerable population (children), the
IRBs believed participation would pose a greater-than-minimal
risk to study participants (33).
The tribes did consider the potential, yet-to-be-discovered
benefits of genomic analysis and repository storage of biologi-
cal specimens (i.e., clinical utility and the possibility of gene-
specific therapy or prevention, particularly for diabetes); how-
ever, they held great concerns regarding the safeguards needed
to allow such an endeavor (34–36). Since the supplementary
research analyses were yet to be determined, it was unknown
whether the future analyses might include cultural/racial identi-
fication, mental health genetic markers, and other genetic cod-
ing analyses. After reviewing other tribes’experiences with
similar research analyses, the tribal partners felt that the unfore-
seen benefits of medical advances did not outweigh the risks to
their people and culture.
Another concern was that the proposed protocol modifica-
tionfailedtoallowanavenueinwhichsomeone’sconsentto
participate could be withdrawn at a later date. After the samples
were deidentified, the TODAY Study’s researchers would be
unable to identify and dispose of particular samples if a partici-
pant or tribe later wished to withdraw their consent for partici-
pation. In addition, the repository, by design, would store
samples for an undetermined length of time and could be used
for a myriad of research purposes. Allowing never-ending, irre-
versible consent for members’genomic samples to be used for
undefined research concerned the tribal IRBs, making it impos-
sible to monitor access to and usage of the biological specimens
and to approve subsequent analyses. Some tribal IRBs also
noted that use of tribal members’genomic samples for future
proposed studies would require separate and individual tribal
leadership approval at that time.
Struggling with these issues, some tribal IRBs elected to
make a few, yet short-lived allowances. It is important to note
that the partnering American Indian IRBs weighed their con-
cerns against a participant’s inherent right to make his/her
own independent, informed decisions. They considered allow-
ing participants the opportunity to be approached for consent
for genomic sampling for the TODAY Study’s analyses only,
15th–18th
Centuries
Colonization of the Americas introduced new diseases
and epidemics to the American Indians, including the
spread of smallpox and measles
19th
Century
Medical professionals inaccurately associated the cause
of a tuberculosis outbreak with American Indian culture
Early
1900s
Removal of upper and lower eyelids to treat trachoma in
American Indian patients
1950s
Alaska Natives given radiosotopes for research purposes,
including pregnant and lactating women, without known
benefit to subjects
1970s
Study examined sociological effects of alcohol on a
Native community—data reported in the press in a
stigmatizing and disparaging manner
US medical facilities sterilized American Indian females
without their knowledge or consent, in some cases
under threats of loss of benefits
1990s First American Indian tribal research board formed to
help reduce incidence of research injustices
2003
Havasupai Tribe became aware of genetic research
practices that included inadequate consent procedures
and improper use of genetic samples
2006
Treatment Options for Type 2 Diabetes in Adolescents
and Youth (TODAY) Study proposed to partner with tribal
nations to collect and store genomic samples for future,
undetermined studies
2019
Within trusting research relationships, some Oklahoma
tribes have cautiously begun participating in beneficial
genomic research
Figure 1. Historical timeline of research misconduct and development
of distrust between medical researchers and Native Americans and their
relationship to the formation of tribal research boards (8–15,24).
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followed by sample destruction at the conclusion of the study
and without allowing repository storage. For a short period of
time (6 months), the Choctaw Nation of Oklahoma IRB did
approve giving their members the opportunity to consent
regarding the TODAY Study genomic analyses only, without
allowing repository storage of the samples. However, after
reconsideration, the Choctaw Nation of Oklahoma IRB, still
uncomfortable with the possible risks, rescinded its approval.
The Oklahoma Area Indian Health Service IRB, which sup-
ports tribal nations and their views, also approved participa-
tion in the repository if all of the partnering tribes approved
the collection of the genomic samples. When all of the tribal
IRBs rejected the modification, the Oklahoma Area Indian
Health Service IRB withdrew its approval. In the end, the
tribal IRBs felt that potential risks to both the individual and
the tribal community, particularly regarding the repository,
outweighed the potential scientificbenefit and took prece-
dence over an individual’s right to decide.
CONSIDERATIONS FOR FUTURE GENOMIC RESEARCH
The partnering Oklahoma American Indian IRBs and tribal
research board concur that since 2006, the TODAY Study in-
vestigators’proposed genomic-research protocol modification
has prompted them to explore developing guidelines regarding
genomic studies and biorepositories. Understanding the possi-
ble advances in genomic research and their potential benefits
in the identification and treatment of many diseases, including
diabetes, tribal nations have a desire to ensure that their people
have opportunities to contribute to, and participate in, innova-
tive yet culturally appropriate research. Even though many of
the concerns raised by the partnering American Indian tribal
nations in 2006 have not been fully resolved, they believe that
through education and advocacy, both nationally and locally,
they are now prepared to consider genomic studies and biore-
pository research partnerships (37–42).
Aware of successful genomic research partnerships, like the
Northwest-Alaska Pharmacogenomics Research Network and
the National Congress of American Indians’American Indian
& Alaska Native Genetics Resource Center (supported by the
National Human Genome Research Institute), Oklahoma tribal
nations have made efforts to build similar partnerships in terms
of trusting genomic research allies (43). The Chickasaw Nation
recently partnered with the University of Oklahoma on another
project supported by the National Human Genome Research
Institute—the Center on American Indian and Alaska Native
Genomic Research—in an effort to understand implications of
genomic research and to develop a program to educate the com-
munity regarding the benefits of participating in research (44).
Tribes from Oklahoma are also engaging in national conversa-
tions regarding ethical genomic research, including the National
Congress of American Indians and the Precision Medicine Initia-
tive’s“All of Us”research program, and are actively partnering
with the National Institutes of Health’s Tribal Health Research
Office by serving on the Tribal Advisory Committee (39–42).
Drawing from recent experiences and the national dialogue
regarding ethically appropriate genomic research, Oklahoma
tribal health boards/IRBs have implemented new strategies
(Figure 2) to allow their members safe access to innovative
research, including review of each study proposal on its own
merits in the context of a study investigator’s prior research
work and relationships with tribal communities. Such new pro-
posals often now require a formal contract/agreement with the
investigator and the institution before research can be approved
by the tribal nation(s). These contracts usually specify tribal
ownership of study data, the expectations of the research part-
nership, and a limitation on data analyses.
Learning from past research injustices, most tribal boards in
Oklahoma now require that all study consent forms include a
date on which consent and use of protected health information
expires; after the expiration date, researchers must seek IRB
reapproval for continued use of and access to protected health
information. Requiring a date of expiration also provides the
tribe with an estimated duration of time inwhich their research
oversight will be needed and assurance that the research data
will be analyzed and results reported in a timely manner.
Additionally, the proposal and consent form must specifically
and clearly state the disease to be studied and how genomic
samples will be utilized. The proposal and consent form must
also explicitly describe all secondary uses of the specimens,
storage, security, and the time frame after which samples will
be destroyed or returned to the tribal nation. Furthermore, if a
secondary researcher unaffiliated with the original proposal is
interested in analyzing the biological specimens, a separate
research agreement must be made with the new investigator
and new IRB review and approval is required.
Recently, for example, the Chickasaw and Choctaw Nations
of Oklahoma completed a study with investigators from the
University of Oklahoma Health Science Center that included
Previous
Trusting
Relationship
With
Investigator Clear
Understanding
of Expectations
in Partnership,
Including Data
and Specimen
Ownership
Explicit
Description of
Usage, Storage,
and Security of
Specimens
Clearly State
Study Intent and
Utilization of
Samples in
Consent
Document
Projected Time
of Completion
and Agreement
for Return or
Destruction of
Data/Samples
Continuous
Communications
Throughout the
Project’s
Duration
Figure 2. Guidelines Oklahoma American Indian tribes consider
when approached to partner with medical researchers on biological
genomic research.
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Genomic Research With Oklahoma Tribes 1209
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genomic analyses (45). Parameters were defined and followed
that included allowing analyses of deidentified samples for
DNA methylation and for developing a tribe-approved adjudi-
cation process in order to safeguard data for future quality assur-
ance analyses (45). The Chickasaw and Choctaw Nations
believed their experience with the TODAY Study and other
tribal genomic research experiences prepared them to under-
stand the value of genomic research and specific research
parameters needed to address their nations’ethical concerns.
As tribal nations in Oklahoma have developed internal poli-
cies regarding genomic research, many are beginning to rec-
ognize certain educational deficits within their communities
with regard to genomic research (42,44). To address these
needs, some tribal nations have now partnered with academic
investigators to analyze and address their knowledge and
needs through questionnaires regarding genomic research.
For example, the Cherokee Nation recently partnered with in-
vestigators at the University of Oklahoma on a pilot study to
assess their community’s understanding of and openness to
genomics research (42). The Chickasaw Nation is also expand-
ing their understanding of community members’research
concerns and goals through the distribution of community
assessment questionnaires (44).
It is important to note that even with these new strategies and
polices, the TODAY Study’s American Indian partners have
still not approved participation in the genomic portion of the
TODAY Study, believing that many of their initial concerns
have not yet been resolved completely. Regarding genomic
research in general, some Oklahoma American Indian research
boards remain hesitant, believing that many of their nations’
concerns, some of which are described in this paper, have yet
to be addressed and that their communities still are not being
provided with adequate institutional respect. American Indians’
unique and long-standing institutionalized research-related
trauma, if not acknowledged and addressed by research
professionals and institutions, may continue to deter tribal
people and communities from being fully engaged in the
potentially transformative benefits of cutting-edge research,
including genomic research.
CONCLUSION
In 2006, the TODAY Study’s Native American partnering
IRBs and health boards elected not to participate in the study’s
proposed optional genomic analyses and biorepository storage
(27), based on each tribal nation/IRB’s sovereign right to make
research decisions in the best interest of its nation and members
(20,21). Previous incidences of researchers’abuse of commu-
nity trust and use of improper consent procedures played a role
in the TODAY Study’s Native American partners’decision to
not participate in the study’s genomic research, as did a myriad
of other ethical questions and possible unforeseen ramifications
of genomic analyses and biorepositories. After years of building
tribal/academic collaborations, fostering bidirectional commu-
nication, and establishing policies and procedures, genomic
research with American Indian communities in Oklahoma is
now cautiously emerging (37–45).
ACKNOWLEDGMENTS
Author affiliations: Department of Pediatrics, Section of
Diabetes and Endocrinology, University of Oklahoma
Health Sciences Center, Oklahoma City, Oklahoma
(Jennifer Q. Chadwick, Kenneth C. Copeland, Jeanie B.
Tryggestad); Heath Services Authority, Choctaw Nation of
Oklahoma, Durant, Oklahoma (Dannielle E. Branam, David
F. Wharton); Oklahoma City Area Indian Health Service,
Oklahoma City, Oklahoma (Julie A. Erb-Alvarez);
Department of Health Research, Cherokee Nation,
Tahlequah, Oklahoma (Sohail I. Khan); Department of
Health, Division of Research and Public Health, The
Chickasaw Nation, Ada, Oklahoma (Michael T. Peercy,
Bobby R. Saunkeah); and Tribal Health System, Absentee
Shawnee Tribe, Shawnee, Oklahoma (Mark E. Rogers).
This work was supported by funding from the National
Institute of Diabetes and Digestive and Kidney Diseases and
the Office of the Director, National Institutes of Health
(grants U01-DK61212, U01-DK61230, U01-DK61239,
U01-DK61242, and U01-DK61254); by funding from the
National Center for Research Resources General Clinical
Research Centers Program (grants M01-RR00036
(Washington University School of Medicine), M01-
RR00043-45 (Children’s Hospital Los Angeles), M01-
RR00069 (University of Colorado Denver), M01-RR00084
(Children’s Hospital of Pittsburgh), M01-RR01066
(Massachusetts General Hospital), M01-RR00125 (Yale
University), and M01-RR14467 (University of Oklahoma
Health Sciences Center)); and by National Center for
Research Resources Clinical and Translational Science
Awards (grants UL1-RR024134 (Children’s Hospital of
Philadelphia), UL1-RR024139 (Yale University),
UL1-RR024153 (Children’s Hospital of Pittsburgh),
UL1-RR024989 (Case Western Reserve University), UL1-
RR024992 (Washington University in St. Louis),
UL1-RR025758 (Massachusetts General Hospital), and
UL1-RR025780 (University of Colorado Denver)).
We gratefully acknowledge the participation and guidance
of the American Indian partners associated with the clinical
center located at the University of Oklahoma Health
Sciences Center, including members of the Absentee
Shawnee Tribe, the Cherokee Nation, the Chickasaw Nation,
and the Choctaw Nation of Oklahoma, and the Oklahoma
City Area Indian Health Service.
The following individuals and institutions constitute the
TODAY Study Group (an asterisk (*) indicates a principal
investigator or director): clinical centers—Baylor College
of Medicine: S. McKay*, M. Haymond*, B. Anderson,
C. Bush, S. Gunn, H. Holden, S. M. Jones, G. Jeha,
S. McGirk, S. Thamotharan; Case Western Reserve
University: L. Cuttler*, E. Abrams, T. Casey, W. Dahms
(deceased), C. Ievers-Landis, B. Kaminski, M. Koontz,
S. MacLeish, P. McGuigan, S. Narasimhan; Children’s
Hospital Los Angeles: M. Geffner*, V. Barraza, N. Chang,
B. Conrad, D. Dreimane, S. Estrada, L. Fisher, E. Fleury-
Milfort, S. Hernandez, B. Hollen, F. Kaufman, E. Law,
V. Mansilla, D. Miller, C. Muñoz, R. Ortiz, A. Ward,
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K. Wexler, Y. K. Xu, P. Yasuda; Children’s Hospital of
Philadelphia: L. Levitt Katz*, R. Berkowitz, S. Boyd,
B. Johnson, J. Kaplan, C. Keating, C. Lassiter, T. Lipman,
G. McGinley, H. McKnight, B. Schwartzman, S. Willi;
Children’s Hospital of Pittsburgh: S. Arslanian*, F. Bacha,
S. Foster, B. Galvin, T. Hannon, A. Kriska, I. Libman,
M. Marcus, K. Porter, T. Songer, E. Venditti; Columbia
University Medical Center: R. Goland*, D. Gallagher,
P. Kringas, N. Leibel, D. Ng, M. Ovalles, D. Seidman; Joslin
Diabetes Center: L. Laffel*, A. Goebel-Fabbri, M. Hall,
L. Higgins, J. Keady, M. Malloy, K. Milaszewski, L.
Rasbach; Massachusetts General Hospital: D. M. Nathan*,
A. Angelescu, L. Bissett, C. Ciccarelli, L. Delahanty,
V. Goldman, O. Hardy, M. Larkin, L. Levitsky,
R. McEachern, D. Norman, D. Nwosu, S. Park-Bennett,
D. Richards, N. Sherry, B. Steiner; Saint Louis University:
S. Tollefsen*, S. Carnes, D. Dempsher, D. Flomo,
T. Whelan, B. Wolff; State University of New York Upstate
Medical University: R. Weinstock*, D. Bowerman,
S. Bristol, J. Bulger, J. Hartsig, R. Izquierdo, J. Kearns,
R. Saletsky, P. Trief; University of Colorado Denver:
P. Zeitler* (Steering Committee Chair), N. Abramson,
A. Bradhurst, N. Celona-Jacobs, J. Higgins, M. M. Kelsey,
G. Klingensmith, K. Nadeau, T. Witten; University of
Oklahoma Health Sciences Center: K. Copeland* (Steering
Committee Vice-Chair), E. Boss, R. Brown, J. Chadwick,
L. Chalmers, S. Chernausek, A. Hebensperger, C. Macha,
R. Newgent, A. Nordyke, D. Olson, T. Poulsen, L. Pratt,
J. Preske, J. Schanuel, S. Sternlof; University of Texas
Health Science Center at San Antonio: J. Lynch*,
N. Amodei, R. Barajas, C. Cody, D. Hale, J. Hernandez,
C. Ibarra, E. Morales, S. Rivera, G. Rupert, A. Wauters;
Washington University in St. Louis: N. White*, A. Arbeláez,
D. Flomo, J. Jones, T. Jones, M. Sadler, M. Tanner,
A. Timpson, R. Welch; Yale University: S. Caprio*,
M. Grey, C. Guandalini, S. Lavietes, P. Rose, A. Syme,
W. Tamborlane; Coordinating Center—George
Washington University Biostatistics Center: K. Hirst*,
S. Edelstein, P. Feit, N. Grover, C. Long, L. Pyle; Project
Office—National Institute of Diabetes and Digestive and
Kidney Diseases: B. Linder*; central units—Central Blood
Laboratory (Northwest Lipid Research Laboratories,
University of Washington): S. M. Marcovina*, J. Harting;
DEXA Reading Center (University of California at San
Francisco): J. Shepherd*, B. Fan, L. Marquez, M. Sherman, J.
Wang; Diet Assessment Center (University of South Carolina):
M. Nichols*, E. Mayer-Davis, Y. Liu; Echocardiogram
Reading Center (Johns Hopkins University):J.Lima*,S.
Gidding, J. Puccella, E. Ricketts; Fundus Photography
Reading Center (University of Wisconsin):R.Danis*,A.
Domalpally, A. Goulding, S. Neill, P. Vargo; Lifestyle
Program Core (Washington University):D.Wilfley*, D.
Aldrich-Rasche, K. Franklin, C. Massmann, D. O’Brien, J.
Patterson, T. Tibbs, D. Van Buren; other centers—Hospital
for Sick Children (Toronto, Ontario, Canada):M.Palmert;
MedStar Health Research Institute (Washington, DC):R.
Ratner; Texas Tech University Health Sciences Center:D.
Dremaine; University of Florida: J. Silverstein.
The content of this article is solely the responsibility of the
authors and does not necessarily represent the official views
of the National Institutes of Health. The opinions expressed
in this paper are those of the authors and do not necessarily
reflect the views of the respective Tribes or the Indian Health
Service.
Conflict of interest: none declared.
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