Bridging The Divide Between Genomic Science And
Bridging the Divide betweenGenomic Science andIndigenous PeoplesBette Jacobs, Jason Roffenbender, Jeff Collmann, Kate Cherry,LeManuel Lee Bitsói, Kim Bassett, and Charles H. Evans, Jr.The new science of genomics endeavors tochart the genomes of individuals around theworld, with the dual goals of understandingthe role genetic factors play in human health andsolving problems of disease and disability. Fromthe perspective of indigenous peoples and developing countries, the promises and perils of genomicscience appear against a backdrop of global healthdisparity and political vulnerability. These conditions pose a dilemma for many communities whenattempting to decide about participating in genomicresearch or any other biomedical research. Genomicresearch offers the possibility of improved technologies for managing the acute and chronic diseases thatplague their members. Yet, the history of biomedicalresearch among people in indigenous and developingnations offers salient examples of unethical practice,misuse of data and failed promises. This dilemmacreates risks for communities who decide either toparticipate or not to participate in genomic scienceresearch. Some argue that the history of poor scientific practice justifies refusal to join genomic researchprojects. Others argue that disease poses such greatthreats to the well-being of people in indigenouscommunities and developing nations that not participating in genomic research risks irrevocableharm. Thus, some communities particularly amongindigenous peoples have declined to participate assubjects in genomic research.1 At the same time, theyhave begun developing new policies, procedures, andpractices for engaging with the scientific communitythat offer opportunities to bridge the gap betweengenomic science and indigenous communities and/or developing countries. From the perspective ofthe ethical, social, and legal issues facing genomicresearch, bridging the gap between indigenous people and genomic scientists offers lessons and modelsfor conducting genomic research for the world community as a whole, particularly for vulnerable andhigh risk populations.Bette Jacobs, Ph.D., is the Distinguished Professor and Co-Founder of the Georgetown University O’Neill Health Law Institute.Dr. Jacobs served for ten years as Dean of Georgetown School of Nursing and Health Studies. She is an enrolled member ofCherokee Nation and active leader in minority advancement organizations. Dr Jacobs holds a Ph.D. from the University of Texas,M.S. in public health nursing, and B.S. in nursing from California State University. Jason Roffenbender, M.S., is a ResearchAssistant for the O’Neill Institute at Georgetown University. Mr. Roffenbender earned an M.S. in physiology and biophysics fromGeorgetown University. Jeff Collmann, Ph.D., M.A., is the Center Director at the Disease Prevention and Health Outcomesand Associate Professor at the School of Nursing & Health Studies at Georgetown University. Dr. Collmann holds a Ph.D. fromAdelaide University (1980) in Australia and was a Post-doctoral Fellow at University of Tennessee from 1987-1990. He also holdsa M.A. (Econ.) from the University of Manchester, U.K. (1975), and a B.A. from Lehigh University (1970) in Bethlehem, PA. KateCherry worked as a Research Assistant for the O’Neill Institute from 2007 to 2009. Ms. Cherry earned a B.A. in Public Policyfrom Duke University. LeManuel Bitsoí, Ed.D., M.Ed., is an enrolled member of the Navajo Nation, and former Post-doctoralFellow in the O’Neill Institute. Dr. Bitsóí earned a bachelor of science degree from the University of New Mexico (1995) and amaster of education degree from Harvard University (1998). In 2007, he earned a doctorate from the University of Pennsylvania,where he conducted his doctoral dissertation research on the conditions that encourage and discourage American Indians frompursuing higher education. Kim Bassett worked as a Research Assistant for the O’Neill Institute from 2007 to 2009. Ms. Bassettearned a B.S. in International Health from Georgetown University. Charles H. Evans, Jr., M.D., Ph.D., is the former Chair ofthe Department of Human Science at the School of Nursing & Health Studies at Georgetown University Medical Center. He earnedan M.D. and a Ph.D. in microbiology from the University of Virginia, and a B.S. in Biology from Union College.684journal of law, medicine & ethics
Jacobs, Roffenbender, Collmann, Cherry, Bitsói, Bassett, and Evans, Jr.Articulating the DilemmaThe Personalized Healthcare Initiative, Department ofHealth and Human Services, and the O’Neill Institutefor National and Global Health Law at GeorgetownUniversity jointly sponsored a colloquium entitled“Developing a Framework to Guide Genomic DataSharing and Reciprocal Benefits to Developing Countries and Indigenous Peoples,” held at GeorgetownUniversity on January 7-8, 2009, to promote and emulate collaborative discourse among the diverse constituencies contributing to the global discussion aboutgenomic science.2 The colloquium included thoughtleaders from developing countries, indigenous peoples, genomic science, genomic medicine and globalhealth, most of whom have participated in the international debate about genomics, indigenous peoples,and developing countries for many years.(HGDP), the National Geographic Genographic Project, and others.3 From this perspective, the struggle ofindigenous peoples worldwide to achieve recognitionof their sovereignty and rights of self-determinationinforms the discussion about biomedical research,particularly when scientific investigators act in unethical ways. The Navajo offer a case in point.Case One: Moratorium on Genetic ResearchStudies within the Jurisdiction of the NavajoNationIn 2002, the Navajo Nation Council passed a moratorium banning all research activities involving genetics and genomics until amendment of the NavajoNation Health Research Code. The purpose of theNavajo Nation Health Research Code is to “set forththe conditions under which investigators, physicians,From the perspective of the ethical, social, and legal issues facing genomicresearch, bridging the gap between indigenous people and genomic scientistsoffers lessons and models for conducting genomic research for the worldcommunity as a whole, particularly for vulnerable and high risk populations.The colloquium posed the question of how to assurethat people in indigenous and developing nations realize the benefits from their participation in genomicresearch. Indigenous nations and developing countries share a history of underdevelopment and colonialexploitation that has often left their peoples politicallyand economically marginalized. People in these communities suffer disproportionately from both infectious diseases such as HIV/AIDS, malaria, and diarrhea and chronic illnesses such as diabetes and heartdisease. Personalized medicine promises dramaticimprovements in treatment for these illnesses throughhealth care tailored to the genotype of individualpatients. Yet, genomic science has just begun to collectthe data necessary to support personalized medicineand requires some degree of participation by all theworld’s people to succeed in its objectives, includingpeople in indigenous and developing nations.Spokespersons from indigenous communitiesasserted, however, that genomic investigators shouldnot presume that all communities would agree to participate in the research. Indeed, indigenous organizations such as the United Nations Working Group onIndigenous Peoples and many indigenous communities have already decided not to participate in genomicresearch citing negative experiences with earlier projects such as the Human Genome Diversity Projectresearchers and others may perform health and healthrelated activities within the territorial jurisdiction ofthe Navajo Nation.”4 The Code aims to “ensure that allpersons within the territorial jurisdiction of the NavajoNation are free from unreasonable harmful, intrusive, ill-conceived or otherwise offensive research andinvestigation procedures.”5 The moratorium currentlyin place within the Navajo Nation does not indicatethat the Navajo Nation government is entirely opposedto the possibility of participating in future genetic andgenomic research studies to benefit its citizenry. Themoratorium is not an obstacle, but an opportunity topartner with the Navajo Nation to establish a bilateral,mutually beneficial, and ethical relationship.One opportunity identified in the moratoriumgrows out of the need to develop educational materialsto inform the Navajo public before developing specificpolicy on genetic and genomic studies.6 Participatingin collaboration with the Health and Social ServicesCommittee of the Navajo Nation Council to work onthese educational materials offers a possible avenueto re-establish a partnership between the NavajoNation and biomedical science communities. Previoussocio-medical partnerships with the Navajo outlineimportant lessons learned prior to broaching futureresearch. In his extensive analysis of a tuberculosisresearch study on the Navajo, David Jones notes theglobal health governance fall 2010685
IND EPEND ENTresearchers “depended on the continued cooperationof the Navajo, [and] cultivated their relationship.with great care, celebrating the results of both treatment and research.”7 The promotion of a long-termscientific relationship with the Navajo Nation mustintegrate enduring partnerships on respectful biomedical policy and education, as well as the basic science research itself.Other participants in the colloquium, particularlyspokespersons for developing countries, acknowledgedthe importance of sovereignty and colonial history butexpressed great concern that people from their communities could easily miss benefitting from advancesin personalized medicine as they had missed so manyother technological “revolutions.” Indeed, a “genomicgap” in both scientific research and healthcare alreadyexists between Africa and the developed world thatmay be impossible to close. From this perspective, theglobal community faces a challenge not to let Africa fallfarther behind in genomic science. Mexico offers animportant case study because, as a developing countrywith many indigenous communities, it has faced thequestions of scientific practice and health disparity inthe design and implementation of its National Institute of Genomic Medicine (INMEGEN).8Bridging the DivideAs the colloquium participants discussed these pointsand evaluated their implications for genomic scienceand health care, conversation began to focus on thefundamental importance of engaging indigenous anddeveloping communities in the discussion about, andprocess of, genomic research. They drew attention tohow, over the last two decades, many indigenous communities and scientists around the world have explorednovel community-based research methods that couldbenefit both genomic science and indigenous communities, while also furthering global public health.9These methods entail a model of research in whichscientists and communities develop complex relationships composed of cultural exchange, mutual learning, and respect as well as data and sample collection.Implicit, too, is a new definition of “rigorous scientificresearch,” one that includes both community development and scientific progress as legitimate objectives ofgenomic research. Participants in the Georgetown colloquium identified four processes that warrant specialattention and further support: consulting with localcommunities; negotiating the complexities of consent;training members of local communities in science andhealth care; and training scientists to work with indigenous communities.686Standards for Consulting with Local CommunitiesNational and international organizations have developed standards for scientists to use in consulting withcommunities about the conduct of research. A matrixof guidelines for genomic research with indigenouspopulations presented in Figure I has been constructed based on the principles outlined by RichardSharp and Morris Foster in An Analysis of ResearchGuidelines on the Collection and Use of Human Biological Materials from American Indian and AlaskanNative Communities.10 The categories included in thematrix are divided into five complementary principles: community consultation, sample collection andinformed consent, use and storage of biological materials, prioritization of research uses, and post-researchobligations. Guidelines are individually coded according to the complementary principles based on theirinclusion or exclusion of 15 sub-principles. One axisof the matrix is the 15 sub-principles. The other axisof the matrix represents individual sets of guidelineslisted by organization and year of publication. Thiswork builds on the previous analysis by Sharp andFoster by applying the existing framework to morerecent guidelines for ethical research with Indigenouspopulations. The selection criteria for guidelines islimited to those created by English-speaking countries or international bodies which explicitly addressgenomic research or generally address health researchwith Indigenous populations.The matrix demonstrates the evolution of researchguidelines over time. As late as the mid-1990s, guidelines rarely recommended community consultation.Today all of the recent guidelines published by staterun organizations explain the need for individual andcommunity approval on issues such as secondaryuses of data and withdrawal of samples. The matrixunderscores the importance of explicitly consultingcommunities and individuals in efforts to conductresearch with Indigenous populations. Guidelineshave evolved from showing little emphasis on theenumeration of reciprocal benefits to the point whereall guidelines require benefit sharing with contributing populations. An increasing number also takes aclear position on how to benefit contributing populations when research leads to commercial applications.The overall trend shown in the matrix is a movementtowards guidelines that prescribe mutually beneficialand deeply collaborative research partnerships, manyof which can be categorized within the framework ofparticipatory research.The CIHR Guidelines for Health Research Involving Aboriginal People (CIHR Guidelines) publishedby the Canadian Institutes of Health Research (CIHR)in 2007 present the most comprehensive contributionjournal of law, medicine & ethics
Jacobs, Roffenbender, Collmann, Cherry, Bitsói, Bassett, and Evans, Jr.CIHR22 (2007)UNESCO21 (2005)NIGMS20 (2004)UNESCO19 (2003)NHMRC18 (2003)WHO17 (2002)AMA16 (2001)HIS15 (2001)AIATSIS14 (2000)HGDP13 (1997)UNESCO12 (1997)HUGO Council11 (1996)Figure 1Guidelines for Genomic Research with Indigenous PopulationsCommunityConsultationIn protocol developmentBefore collection of samplesyEmbodies respect forcultural differencesyyyyyyyyyyyFormal community approvalrequiredyyyyyyyyyyyyyyyyyyyyyyyySample Collection andInformed ConsentDone in a culturally sensitivemanneryyyyyyyyyyDiscussion of a collectiveharm (e.g. group discr) as partof inform consent processyyyyyyyyyyyyyyyyyIWCWIW,CW IWDCDIDI,DCDI,DCyyUse and Storage of BiologicalMaterialsPotential uses defined priorto sample collectionProvision for withdrawal ofsamples (IW or CW)IW,CW IW,CWDiscussion of secondary useswith contributors (DI or DC)yDIySecondary uses requirecommunity approvalyyyyyyyIW,CWyIWIW,CWPrioritization of Research UsesShould benefit contributingpopulationyyyyClear position on commercial applicationsyyyyOngoing research updates to yparticipating communitiesyyCommunity review of studyfindings before releaseyyyyyyyyyyPost-Research ObligationsNeed to develop localcapacitiesyyyyyyyyyyyyyyyyY signifies that the sub-principle is included in the indicated guideline(s).global health governance fall 2010687
IND EPEND ENTon this issue to date, and serve as a model for genomicresearch in other countries. The guidelines includethree sections that provide the rationale for developing them, identify and explain the 15 principles uponwhich they rest, and offer examples of how to developand codify research projects with indigenous peoples.Discussing all 15 of the coded sub-principles listed inthe matrix, the guidelines capture the intended spiritof these principles in a comprehensive and concisemanner and represent a checklist of what scientistsshould understand about conducting research withindigenous communities (see below). The CIHRGuidelines address many points of previous disputebetween indigenous communities and biomedical scientists, such as re-consent for multiple uses of samples, acknowledgment of intellectual property rights,protection of indigenous rights in cultural and sacredknowledge as well as recognition of ownership andstewardship of data or biological samples.23 The spiritof the CIHR Guidelines, however, emerges from articles pertaining to the relationship that should developbetween an indigenous community and researchers.Article 1 for example, enjoins researchers to “understand and respect Aboriginal world views, includingresponsibilities to the people that flow from beinggranted access to traditional or sacred knowledge.These should be incorporated into research agreements, to the extent possible.”24 Beyond respect, however, indigenous communities also should be given theoption of a participatory-research approach, have anopportunity to participate in the interpretation of thedata and review the analysis to ensure “accuracy andcultural sensitivity of the interpretation,” and, finally,decide how to acknowledge its participation in projectreports and publications.25 Article 9 states, “Researchshould be of benefit to the community as well as to theresearcher.”26 Given the respective sovereignty of FirstNation, Inuit, and Métis communities in Canada, theseconcerns should be addressed on a community-leveland discussed prior to each research investigation.The CIHR emulated the consultative process forwhich it advocates by engaging in extended consultations and deliberations with Canadian indigenous communities to develop the CIHR Guidelines. In March2004 the CIHR established the Aboriginal EthicsWorking Group (AEWG), an interdisciplinary, multicultural 12-member advisory team composed primarily of Indian, Inuit, and Métis people that eventuallycrafted the Guidelines. The Aboriginal Capacity andDevelopmental Research Environments (ACADRE),a university-based network of academic research communities and First Nation, Inuit, and Métis communities, worked with communities to translate traditionalvalues and ethics into guidance for health researchers.688From these discussions, ACADRE produced a series ofcommissioned background papers that informed thedeliberations of the AEWG. The AEWG met to writethe Guidelines over the course of two years. Uponreceiving a draft from the AEWG, the CIHR EthicsOffice along with the National Council on Ethics inHuman Research conducted workshops and consultations with Aboriginal communities, researchers, andmembers of research ethics boards to obtain feedbackon the draft guidelines. CIHR and its partners electronically posted the document to enable widespreadaccess and awareness, and to solicit comments prior tofinal revision. The draft guidelines were then edited byCIHR Ethics Office, in consultation with Health Canada and Justice Canada, to optimize internal consistency, and to ensure that the draft guidelines reflectedCIHR’s mandate.27 Through these workshops andconsultations, the CIHR Guidelines emerged froma participatory, inclusive, and ongoing process. Theconsultations acknowledge the basic sovereignty andright of self-determination of indigenous peoples asexpressed in United Nations General Assembly Resolution 61/295 within the Declaration on the Rights ofIndigenous Peoples.28Internationally, the Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization, specificallyoutlines
the ethical, social, and legal issues facing genomic research, bridging the gap between indigenous peo-ple and genomic scientists offers lessons and models for conducting genomic research for the world com-munity as a whole, particularly for vulnerable and high risk populations. Bridging the Divide
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GENUS ABS JERSEY DIRECTORY Winter 2020 CONTENTS PROVEN/ GENOMIC SIRE NAME PAGE NO. PROVEN/ GENOMIC SIRE NAME PAGE NO. PROVEN/ GENOMIC SIRE NAME PAGE NO. Genomic CHEESEHEAD 3 Genomic LONESTAR 9 Proven VJ LARI 15 Proven COCHISE 4 Genomic MARIN
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