Sandra Soo-Jin Lee, Ph.D

All Publications

• Strategies for recruiting representative samples of Asian Americans for a population-based case-control study. Journal of epidemiology and community health Wong, C. K., Horn-Ross, P. L., Gee, G. C., Shariff-Marco, S., Quach, T., Allen, L., Bautista, R., La Chica, P. Q., Tseng, W., Chang, P., Clarke, C. A., Yang, J., Le, G. M., Canchola, A., Irwin, M. L., Lee, S. S., Gomez, S. L. 2016; 70 (10): 974-982

  Abstract

  Data are limited on effective methods for recruiting persons, especially from ethnically diverse populations, into population-based studies. The goal of this study was to evaluate the variation among and representativeness of controls identified using multiple methods for a population-based case-control study of breast cancer among Asian Americans, Native Hawaiians and Pacific Islanders (AANHPIs) in the San Francisco Bay Area.We used a unique combination of targeted recruitment strategies, including address-based sampling, community-based methods, and internet-based and media-based approaches for recruiting controls, frequency matched on age and ethnicity to a population-based sample of cases. To characterise the participating controls, we compared the distribution of sociodemographic characteristics and cancer risk factors between recruitment sources using χ(2) tests. To ensure that the controls we recruited were representative of the underlying at-risk population, we compared characteristics of the controls, by ethnicity and in aggregate, to data from the California Health Interview Survey (CHIS), and adjusted the relative mix of recruitment strategies throughout the study as needed to achieve representativeness.As expected, controls (n=483) recruited by any single method were not representative. However, when aggregated across methods, controls were largely representative of the underlying source population, as characterised by CHIS, with regard to the characteristics under study, including nativity, education, marital status and body mass index.A multimode approach using targeted recruitment strategies is an effective and feasible alternative to using a single recruitment method in identifying a representative, diverse control sample for population-based studies.

  View details for DOI 10.1136/jech-2015-206905

  View details for PubMedID 27053683

• A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent. Clinical trials Kraft, S. A., Constantine, M., Magnus, D., Porter, K. M., Lee, S. S., Green, M., Kass, N. E., Wilfond, B. S., Cho, M. K. 2016

  Abstract

  Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices.We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms.There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without.Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.

  View details for PubMedID 27625314

• Can Destination Therapy be implemented in children with heart failure? A study of provider perceptions. Pediatric transplantation Char, D. S., Lee, S. S., Ikoku, A. A., Rosenthal, D., Magnus, D. 2016; 20 (6): 819-824

  Abstract

  DT is an established final therapeutic choice in adult patients with severe heart failure who do not meet criteria for cardiac transplantation. Patients are given VADs, without the prospect of care escalation to transplantation. VADs are now established therapy for children and are currently used as a bridge until transplantation can be performed or heart failure improves. For children who present in severe heart failure but do not meet transplantation criteria, the question has emerged whether DT can be offered. This qualitative study aimed to elicit the perspectives of early adopters of DT at one of the few institutions where DT has been provided for children. Responses were recorded and coded and themes extracted using grounded theory. Interviewees discussed: envisioning of the DT candidate; approach to evaluation for DT; contraindications to choosing DT; and concerns about choosing DT. Providers articulated two frameworks for conceptualizing DT: as a long bridge through resolution of problems that would initially contraindicate transplantation or, alternatively, as a true destination instead of transplantation. True destination, however, may not be the lasting concept for long-term VAD use in children given improvement in prognosis for current medical contraindications and improving VAD technology.

  View details for DOI 10.1111/petr.12747

  View details for PubMedID 27357389

• Enacting the molecular imperative: How gene-environment interaction research links bodies and environments in the post-genomic age. Social science & medicine Darling, K. W., Ackerman, S. L., Hiatt, R. H., Lee, S. S., Shim, J. K. 2016; 155: 51-60

  Abstract

  Despite a proclaimed shift from 'nature versus nurture' to 'genes and environment' paradigms within biomedical and genomic science, capturing the environment and identifying gene-environment interactions (GEIs) has remained a challenge. What does 'the environment' mean in the post-genomic age? In this paper, we present qualitative data from a study of 33 principal investigators funded by the U.S. National Institutes of Health to conduct etiological research on three complex diseases (cancer, cardiovascular disease and diabetes). We examine their research practices and perspectives on the environment through the concept of molecularization: the social processes and transformations through which phenomena (diseases, identities, pollution, food, racial/ethnic classifications) are re-defined in terms of their molecular components and described in the language of molecular biology. We show how GEI researchers' expansive conceptualizations of the environment ultimately yield to the imperative to molecularize and personalize the environment. They seek to 'go into the body' and re-work the boundaries between bodies and environments. In the process, they create epistemic hinges to facilitate a turn from efforts to understand social and environmental exposures outside the body, to quantifying their effects inside the body. GEI researchers respond to these emergent imperatives with a mixture of excitement, ambivalence and frustration. We reflect on how GEI researchers struggle to make meaning of molecules in their work, and how they grapple with molecularization as a methodological and rhetorical imperative as well as a process transforming biomedical research practices.

  View details for DOI 10.1016/j.socscimed.2016.03.007

  View details for PubMedID 26994357

  View details for PubMedCentralID PMC4815914

• Accounting for Complexity: Gene-environment Interaction Research and the Moral Economy of Quantification SCIENCE TECHNOLOGY & HUMAN VALUES Ackerman, S. L., Darling, K. W., Lee, S. S., Hiatt, R. A., Shim, J. K. 2016; 41 (2): 194-218

  View details for DOI 10.1177/0162243915595462

  View details for Web of Science ID 000369672500003

• The Role of Patient Perspectives in Clinical Research Ethics and Policy: Response to Open Peer Commentaries on "Patient Perspectives on the Learning Health System". American journal of bioethics Kelley, M., James, C., Alessi Kraft, S., Korngiebel, D., Wijangco, I., Joffe, S., Cho, M. K., Wilfond, B., Lee, S. S. 2016; 16 (2): W7-9

  View details for DOI 10.1080/15265161.2015.1125967

  View details for PubMedID 26832115

• Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making AMERICAN JOURNAL OF BIOETHICS Kelley, M., James, C., Kraft, S. A., Korngiebel, D., Wijangco, I., Rosenthal, E., Joffe, S., Cho, M. K., Wilfond, B., Lee, S. S. 2015; 15 (9): 4-17

  View details for DOI 10.1080/15265161.2015.1062163

  View details for Web of Science ID 000360555700002

• The Biobank as Political Artifact: The Struggle over Race in Categorizing Genetic Difference ANNALS OF THE AMERICAN ACADEMY OF POLITICAL AND SOCIAL SCIENCE Lee, S. S. 2015; 661 (1): 143-159

  View details for DOI 10.1177/0002716215591141

  View details for Web of Science ID 000359724300008

• Attitudes Toward Risk and Informed Consent for Research on Medical Practices A Cross-sectional Survey ANNALS OF INTERNAL MEDICINE Cho, M. K., Magnus, D., Constantine, M., Lee, S. S., Kelley, M., Alessi, S., Korngiebel, D., James, C., Kuwana, E., Gallagher, T. H., Diekema, D., Capron, A. M., Joffe, S., Wilfond, B. S. 2015; 162 (10): 690-?

  View details for DOI 10.7326/M15-0166

  View details for Web of Science ID 000355015200018

  View details for PubMedID 25868119

• Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making. The American journal of bioethics : AJOB Kelley, M., James, C., Alessi Kraft, S., Korngiebel, D., Wijangco, I., Rosenthal, E., Joffe, S., Cho, M. K., Wilfond, B., Lee, S. S. 2015; 15 (9): 4–17

  Abstract

  We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. In general, patients support this research, but worry that participation in research involving randomization may undermine individualized care that acknowledges their unique medical histories. These findings suggest the need for public education on variation in practice among physicians and the need for a collaborative approach to the governance of research on medical practices that addresses core values of trust, transparency, and partnership.

  View details for DOI 10.1080/15265161.2015.1062163

  View details for PubMedID 26305741

• Breathing Race in the Machine: The Surprising Career of the Spirometer from Plantation to Genetics. Medical Anthropology Quarterly Lee, S. S. 2015; 29: 304
• Direct-to-consumer Personal Genetic Testing International Encyclopedia for Social and Behavioral Sciences Lee, S. S. Oxford. 2015; 2nd: 440–45
• Race and Ancestry in the Age of Inclusion: Technique and Meaning in Post-Genomic Science JOURNAL OF HEALTH AND SOCIAL BEHAVIOR Shim, J. K., Ackerman, S. L., Darling, K. W., Hiatt, R. A., Lee, S. S. 2014; 55 (4): 504-518

  Abstract

  This article examines how race and ancestry are taken up in gene-environment interaction (GEI) research on complex diseases such as heart disease, diabetes, and cancer. Using 54 in-depth interviews of 33 scientists and over 200 hours of observation at scientific conferences, we explore how GEI researchers use and interpret race, ethnicity, and ancestry in their work. We find that the use of self-identified race and ethnicity (SIRE) exists alongside ancestry informative markers (AIMs) to ascertain genetic ancestry. Our participants assess the utility of these two techniques in relative terms, downplaying the accuracy and value of SIRE compared to the precision and necessity of AIMs. In doing so, we argue that post-genomic scientists seeking to understand the interactions of genetic and environmental disease determinants actually undermine their ability to do so by valorizing precise characterizations of individuals' genetic ancestry over measurement of the social processes and relations that differentiate social groups.

  View details for DOI 10.1177/0022146514555224

  View details for Web of Science ID 000346697900008

  View details for PubMedID 25378251

  View details for PubMedCentralID PMC4443814

• Protecting Posted Genes: Social Networking and the Limits of GINA AMERICAN JOURNAL OF BIOETHICS Lee, S. S., Borgelt, E. 2014; 14 (11): 32-44

  View details for DOI 10.1080/15265161.2014.957417

  View details for Web of Science ID 000343211500013

• Views of genetics health professionals on the return of genomic results. Journal of genetic counseling Grove, M. E., Wolpert, M. N., Cho, M. K., Lee, S. S., Ormond, K. E. 2014; 23 (4): 531-538

  Abstract

  As exome and whole genome sequencing become clinically available, the potential to receive a large number of clinically relevant but incidental results is a significant challenge in the provision of genomic counseling. We conducted three focus groups of a total of 35 individuals who were members of ASHG and/or NSGC, assessing views towards the return of genomic results. Participants stressed that patient autonomy was primary. There was consensus that a mechanism to return results to the healthcare provider, rather than patient, and to streamline integration into the electronic health record would ensure these results had the maximal impact on patient management. All three focus groups agreed that pharmacogenomic results were reasonable to return and that they were not felt to be stigmatizing. With regard to the return of medically relevant results, there was much debate. Participants had difficulty in consistently assigning specific diseases to 'bins' that were considered obligatory versus optional for disclosure. Consensus was reached regarding the importance of informed consent and pretest counseling visits to clarify what the return of results process would entail. Evidence based professional guidelines should continue to be developed and regularly revised to assist in consistently and appropriately providing genomic results to patients.

  View details for DOI 10.1007/s10897-013-9611-5

  View details for PubMedID 23728783

• Homogeneity and heterogeneity as situational properties: Producing - and moving beyond? - race in post-genomic science SOCIAL STUDIES OF SCIENCE Shim, J. K., Darling, K. W., Lappe, M. D., Thomson, L. K., Lee, S. S., Hiatt, R. A., Ackerman, S. L. 2014; 44 (4): 579-599

  View details for DOI 10.1177/0306312714531522

  View details for Web of Science ID 000342792500006

• The time is ripe for an ethics of entrepreneurship. Nature biotechnology Scott, C. T., Borgelt, E. L., Lee, S. S. 2014; 32 (4): 316-318

  View details for DOI 10.1038/nbt.2867

  View details for PubMedID 24714474

• Genetics and Racial Minorities International Encyclopedia of Social and Behavior Sciences Lee, S. S. 2014; 2nd
• Race, Risk, and Recreation in Personal Genomics: The Limits of Play MEDICAL ANTHROPOLOGY QUARTERLY Lee, S. S. 2013; 27 (4): 550-569

  Abstract

  Despite the mantra that genetics has moved beyond race, the burgeoning industry of genetic ancestry reveals how genetics has offered new technology through which individuals can link to intersections in time and space in complex ways that recapitulate understandings of racial order, origins, and group membership. This article focuses on the trope of "recreation" asserted in the marketing of ancestry genetic tests and examines the suggestion of self-discovery through the recovery of lost kin. Themes of recreation and re-creation paradoxically suggest both passivity of self-revelation and the power to re-act and re-create one's self in light of a different, more enlightened future. Direct-to-consumer personal genetics testing companies play guardian to this consumer play, providing tailored genetic scripts and highlighting how consumers might use their information. This article critically examines the play with concepts of ancestry, ethnicity, and genetic variation and their implications for public understanding of the relationship between race and genetics.

  View details for DOI 10.1111/maq.12059

  View details for Web of Science ID 000332039800005

  View details for PubMedID 24214161

• Reflections on the cost of "low-cost" whole genome sequencing: framing the health policy debate. PLoS biology Caulfield, T., Evans, J., McGuire, A., McCabe, C., Bubela, T., Cook-Deegan, R., Fishman, J., Hogarth, S., Miller, F. A., Ravitsky, V., Biesecker, B., Borry, P., Cho, M. K., Carroll, J. C., Etchegary, H., Joly, Y., Kato, K., Lee, S. S., Rothenberg, K., Sankar, P., Szego, M. J., Ossorio, P., Pullman, D., Rousseau, F., Ungar, W. J., Wilson, B. 2013; 11 (11)

  Abstract

  The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.

  View details for DOI 10.1371/journal.pbio.1001699

  View details for PubMedID 24223516

• Reflections on the Cost of "Low-Cost" Whole Genome Sequencing: Framing the Health Policy Debate PLOS BIOLOGY Caulfield, T., Evans, J., McGuire, A., McCabe, C., Bubela, T., Cook-Deegan, R., Fishman, J., Hogarth, S., Miller, F. A., Ravitsky, V., Biesecker, B., Borry, P., Cho, M. K., Carroll, J. C., Etchegary, H., Joly, Y., Kato, K., Lee, S. S., Rothenberg, K., Sankar, P., Szego, M. J., Ossorio, P., Pullman, D., Rousseau, F., Ungar, W. J., Wilson, B. 2013; 11 (11)

  View details for DOI 10.1371/journal.pbio.1001699

  View details for Web of Science ID 000330352200001

  View details for PubMedID 24223516

• American DNA The Politics of Potentiality in a Genomic Age CURRENT ANTHROPOLOGY Lee, S. S. 2013; 54: S77-S86

  View details for DOI 10.1086/670970

  View details for Web of Science ID 000324739800009

• Personal genome testing in medical education: student experiences with genotyping in the classroom GENOME MEDICINE Vernez, S. L., Salari, K., Ormond, K. E., Lee, S. S. 2013; 5

  View details for DOI 10.1186/gm428

  View details for Web of Science ID 000319861100001

• Attitudes towards Social Networking and Sharing Behaviors among Consumers of Direct-to-Consumer Personal Genomics. Journal of personalized medicine Lee, S. S., Vernez, S. L., Ormond, K. E., Granovetter, M. 2013; 3 (4): 275-287

  Abstract

  Little is known about how consumers of direct-to-consumer personal genetic services share personal genetic risk information. In an age of ubiquitous online networking and rapid development of social networking tools, understanding how consumers share personal genetic risk assessments is critical in the development of appropriate and effective policies. This exploratory study investigates how consumers share personal genetic information and attitudes towards social networking behaviors.Adult participants aged 23 to 72 years old who purchased direct-to-consumer genetic testing from a personal genomics company were administered a web-based survey regarding their sharing activities and social networking behaviors related to their personal genetic test results.80 participants completed the survey; of those, 45% shared results on Facebook and 50.9% reported meeting or reconnecting with more than 10 other individuals through the sharing of their personal genetic information. For help interpreting test results, 70.4% turned to Internet websites and online sources, compared to 22.7% who consulted their healthcare providers. Amongst participants, 51.8% reported that they believe the privacy of their personal genetic information would be breached in the future.Consumers actively utilize online social networking tools to help them share and interpret their personal genetic information. These findings suggest a need for careful consideration of policy recommendations in light of the current ambiguity of regulation and oversight of consumer initiated sharing activities.

  View details for DOI 10.3390/jpm3040275

  View details for PubMedID 25562728

  View details for PubMedCentralID PMC4251386

• The Political Economy of Personalized Medicine, Health Disparities, and Race Anthropology of Race: Genes, Biology, Culture Lee, S. S. School of Advanced Research. 2013
• Customers or research participants?: Guidance for research practices in commercialization of personal genomics GENETICS IN MEDICINE Tobin, S. L., Cho, M. K., Lee, S. S., Magnus, D. C., Allyse, M., Ormond, K. E., Garrison, N. A. 2012; 14 (10): 833-835

  View details for DOI 10.1038/gim.2012.64

  View details for Web of Science ID 000309645900001

  View details for PubMedID 22699154

• Informational risk, institutional review, and autonomy in the proposed changes to the common rule. IRB Allyse, M., Karkazis, K., Lee, S. S., Tobin, S. L., Greely, H. T., Cho, M. K., Magnus, D. 2012; 34 (3): 17-19

  View details for PubMedID 22830179

• Assessing the Pedagogical Goals of Self-Testing in Evaluating the Consultation Needs of Different Student Populations AMERICAN JOURNAL OF BIOETHICS Lee, S. S., Vernez, S. 2012; 12 (4): 41-43

  View details for DOI 10.1080/15265161.2012.656815

  View details for Web of Science ID 000302916400015

  View details for PubMedID 22452476

• Lessons Learned From the US Public Health Service Syphilis Study at Tuskegee: Incorporating a Discourse on Relationships Into the Ethics of Research Participation Among Asian Americans ETHICS & BEHAVIOR Lee, S. S. 2012; 22 (6): 489-492

  View details for DOI 10.1080/10508422.2012.730002

  View details for Web of Science ID 000311692600010

• Secondary uses and the governance of de-identified data: Lessons from the human genome diversity panel BMC MEDICAL ETHICS Fullerton, S. M., Lee, S. S. 2011; 12

  Abstract

  Recent changes to regulatory guidance in the US and Europe have complicated oversight of secondary research by rendering most uses of de-identified data exempt from human subjects oversight. To identify the implications of such guidelines for harms to participants and communities, this paper explores the secondary uses of one de-identified DNA sample collection with limited oversight: the Human Genome Diversity Project (HGDP)-Centre d'Etude du Polymorphisme Humain, Fondation Jean Dausset (CEPH) Human Genome Diversity Panel.Using a combination of keyword and cited reference search, we identified English-language scientific articles published between 2002 and 2009 that reported analysis of HGDP Diversity Panel samples and/or data. We then reviewed each article to identify the specific research use to which the samples and/or data was applied. Secondary uses were categorized according to the type and kind of research supported by the collection.A wide variety of secondary uses were identified from 148 peer-reviewed articles. While the vast majority of these uses were consistent with the original intent of the collection, a minority of published reports described research whose primary findings could be regarded as controversial, objectionable, or potentially stigmatizing in their interpretation.We conclude that potential risks to participants and communities cannot be wholly eliminated by anonymization of individual data and suggest that explicit review of proposed secondary uses, by a Data Access Committee or similar internal oversight body with suitable stakeholder representation, should be a required component of the trustworthy governance of any repository of data or specimens.

  View details for DOI 10.1186/1472-6939-12-16

  View details for Web of Science ID 000295886100001

  View details for PubMedID 21943371

• The Illusive Gold Standard in Genetic Ancestry Testing SCIENCE Lee, S. S., Bolnick, D. A., Duster, T., Ossorio, P., Tallbear, K. 2009; 325 (5936): 38-39

  View details for DOI 10.1126/science.1173038

  View details for Web of Science ID 000267594000022

  View details for PubMedID 19574373

• MEDICINE Racing Forward: The Genomics and Personalized Medicine Act SCIENCE Lee, S. S., Mudaliar, A. 2009; 323 (5912): 342-342

  View details for DOI 10.1126/science.1165768

  View details for Web of Science ID 000262481400022

  View details for PubMedID 19150830

• Research 2.0: Social Networking and Direct-To-Consumer (DTC) Genomics AMERICAN JOURNAL OF BIOETHICS Lee, S. S., Crawley, L. 2009; 9 (6-7): 35-44

  Abstract

  The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information (PGI) direct-to-consumers. Companies such as 23andme (Mountain View, CA) and Navigenics (Foster City, CA) are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social networking business ventures that market the science of the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information--openly sharing of data with all interested parties, not just the biomedical researcher--for the purposes of pooling data (increasing statistical power) and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis.

  View details for DOI 10.1080/15265160902874452

  View details for Web of Science ID 000267493100013

  View details for PubMedID 19998112

• Race and ancestry in biomedical research: exploring the challenges GENOME MEDICINE Caulfield, T., Fullerton, S. M., Ali-Khan, S. E., Arbour, L., Burchard, E. G., Cooper, R. S., Hardy, B., Harry, S., Hyde-Lay, R., Kahn, J., Kittles, R., Koenig, B. A., Lee, S. S., Malinowski, M., Ravitsky, V., Sankar, P., Scherer, S. W., Seguin, B., Shickle, D., Suarez-Kurtz, G., Daar, A. S. 2009; 1

  View details for DOI 10.1186/gm8

  View details for Web of Science ID 000208627000008

• Pharmacogenomics and the Challenge of Health Disparities PUBLIC HEALTH GENOMICS Lee, S. S. 2009; 12 (3): 170-179

  Abstract

  This paper examines emerging technologies and recent research on population differences in pharmacogenomics and the perspectives of scientists, community advocates, policymakers, and social critics on the use of race as a proxy for genetic variation. The discussion focuses on how recent developments in genomic science impact social understandings of racial difference and the public health goal to eliminate ongoing health disparities among racially identified groups. This paper examines how factors such as governmental policies--requiring the use of racial and ethnic categories in genetic research and increasing interest in identifying untapped racial market niches by the pharmaceutical and biotechnology industries--and weak governmental oversight of race-based therapeutics converge to create an 'infrastructure of racialization' that may alter the vision of personalized medicine that has been so highly anticipated. This paper argues that significant public investment in pharmacogenomics requires careful consideration of the emerging discourse that tethers racial justice to notions of racial biology and discusses the social and ethical implications for the pendulum shift towards a geneticization of race in drug development.

  View details for DOI 10.1159/000189630

  View details for Web of Science ID 000263585600007

  View details for PubMedID 19204420

• Response to Open Peer Commentaries on "Research 2.0: Social Networking and Direct-to-Consumer Personal Genomics" AMERICAN JOURNAL OF BIOETHICS Lee, S. S., Crawley, L. 2009; 9 (6-7): W1-W3

  View details for DOI 10.1080/15265160902967009

  View details for Web of Science ID 000267493100043

  View details for PubMedID 19998097

• Race and ancestry in biomedical research: exploring the challenges Genome Medicine Caulfield, T., Stephanie M Fullerton, Sarah E Ali-Khan, Laura Arbour, Esteban G. Burchard, Richard S. Cooper, Billie-Jo Hardy, Simrat Harry, Robyn Hyde-Lay, Jonathan Kahn, Rick Kittles, Barbara A. Koenig, Sandra S-J Lee, Michael Malinowski, Vardit Ravitsky, Pamela Sankar, Stephen W Scherer, Beatrice Seguin, Darrn Shickle, Guilherme Suarez-Kurtz, Abdallah S Daar 2009; 1 (1): 8-16
• The ethics of characterizing difference: guiding principles on using racial categories in human genetics GENOME BIOLOGY Lee, S. S., Mountain, J., Koenig, B., Altman, R., Brown, M., Camarillo, A., Cavalli-Sforza, L., Cho, M., Eberhardt, J., Feldman, M., Ford, R., Greely, H., King, R., Markus, H., Satz, D., Snipp, M., Steele, C., Underhill, P. 2008; 9 (7)

  Abstract

  We are a multidisciplinary group of Stanford faculty who propose ten principles to guide the use of racial and ethnic categories when characterizing group differences in research into human genetic variation.

  View details for DOI 10.1186/gb-2008-9-7-404

  View details for Web of Science ID 000258773600005

  View details for PubMedID 18638359

  View details for PubMedCentralID PMC2530857

• Revisiting Race in a Genomic Age. New Brunswick: Rutgers University Press. Koenig, B., Lee SS, Richardson S 2008
• The ethical implications of stratifying by race in pharmacogenomics CLINICAL PHARMACOLOGY & THERAPEUTICS Lee, S. 2007; 81 (1): 122-125

  Abstract

  Many predict that pharmacogenomics is poised to deliver on the promises of the genomic revolution in ushering an era of personalized medicine. However, questions have emerged over whether the field will deliver a truly individualized medicine or if population-based therapies that build on conventional notions of racial biology will prevail. At the heart of this issue is the challenge of knowing which axes of stratification are appropriate in identifying population differences and to what extent is race and/or ethnicity an appropriate method of comparison in studies of genetic variation. These questions make plain that in addition to the development of technical tools to identify salient gene variants associated with drug response, serious consideration over how best to characterize populations in human genetic variation research must be given in order to realize the putative benefits of tailored therapeutics.

  View details for DOI 10.1038/sj.clpt.6100020

  View details for Web of Science ID 000242874200028

  View details for PubMedID 17186010

• Biobanks of a 'racial kind': mining for difference in the new genetics PATTERNS OF PREJUDICE Lee, S. S. 2006; 40 (4-5): 443-460

  View details for DOI 10.1080/00313220601020163

  View details for Web of Science ID 000243150500009

• Identifying ?Race? in the New Genetics: Bio-Banks of a Kind Patterns of Prejudice Lee, S. 2006; 40 (4): 443-460
• Racializing drug design: implications of pharmacogenomics for health disparities. American journal of public health Lee, S. S. 2005; 95 (12): 2133-2138

  Abstract

  Current practices of using "race" in pharmacogenomics research demands consideration of the ethical and social implications for understandings of group difference and for efforts to eliminate health disparities. This discussion focuses on an "infrastructure of racialization" created by current trajectories of research on genetic differences among racially identified groups, the use of race as a proxy for risk in clinical practice, and increasing interest in new market niches by the pharmaceutical industry. The confluence of these factors has resulted in the conflation of genes, disease, and race. I argue that public investment in pharmacogenomics requires careful consideration of current inequities in health status and social and ethical concerns over reifying race and issues of distributive justice.

  View details for PubMedID 16257939

• The Meanings of Race in the New Genomics The Social Contributions to Health, Difference and Inequality: The Social Medicine Reader 2nd Edition Lee, S., Mountain J, Koenig BA 2005
• Personalized Medicine and Pharmacogenomics: Ethical and Social Challenges Personalized Medicine Lee, S. 2005; 2 (1): 29-35
• The Politics of Hope: Dreaming in a Genomic Age Science Lee, S. 2005; 313: 1888-1889
• Genetic research and health disparities JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Sankar, P., Cho, M. K., Condit, C. M., Hunt, L. M., Koenig, B., Marshall, P., Lee, S. S., Spicer, P. 2004; 291 (24): 2985-2989

  Abstract

  Alleviating health disparities in the United States is a goal with broad support. Medical research undertaken to achieve this goal typically adopts the well-established perspective that racial discrimination and poverty are the major contributors to unequal health status. However, the suggestion is increasingly made that genetic research also has a significant role to play in alleviating this problem, which likely overstates the importance of genetics as a factor in health disparities. Overemphasis on genetics as a major explanatory factor in health disparities could lead researchers to miss factors that contribute to disparities more substantially and may also reinforce racial stereotyping, which may contribute to disparities in the first place. Arguments that promote genetics research as a way to help alleviate health disparities are augmented by several factors, including research funding initiatives and the distinct demographic patterns of health disparities in the United States.

  View details for Web of Science ID 000222184600028

  View details for PubMedID 15213210

• Paradoxes of Difference PLoS Biology Lee, S. 2004; 2 (9): 263
• Race, distributive justice and the promise of pharmacogenomics: ethical considerations. American journal of pharmacogenomics Lee, S. S. 2003; 3 (6): 385-392

  Abstract

  Pharmacogenomics has emerged in the popular press as a key vehicle ushering in a new era of personalized medicine. Often described in utopian terms, gene-sequencing technology is predicted to result in the creation of a new line of therapeutics tailored to individual genetic signatures. In the absence of cost-effective, ubiquitous genome scanning tests, it may be more accurate to describe the next wave of genomic medicine as population-based rather than one focused on individual differences. Although the completion of the Human Genome Project seemed to confirm the fallacy of a genetic basis of 'race', the use of race in understanding human genetic variation has become a central focal point in the development of tools in genomic research in medicine. Despite the often repeated statement that humans share 99.9% of their genetic makeup, the growing number of privately and publicly funded cell repositories collecting DNA samples from racially identified populations reflects the increasing salience of the relationship between race and genes. Research on the ethical implications of identifying race in pharmacogenomics research has thus far, been fairly limited. As the field surges ahead, it is critical to examine the use of race in pharmacogenomics research and its attendant benefits and potential harm to individuals and groups.

  View details for PubMedID 14672519

• The meanings of "race" in the new genomics: implications for health disparities research. Yale journal of health policy, law, and ethics Lee, S. S., Mountain, J., Koenig, B. A. 2001; 1: 33-75

  View details for PubMedID 12669320