Attitudes and Preferences Regarding Data Sharing of Genomic Research Using Biobanked Specimens among HIV-Infected Individuals
A growing body of clinical research is dependent on prospectively collecting and storing biological specimens for genomic analysis. In particular, studies which collect clinical specimens of HIV-infected individuals for future genomic analyses are increasingly common. Genomic data sharing policies, which call for rapid public and controlled access release of all generated DNA data, govern the use of this emerging data. However, little is known about the attitudes of HIV-infected individuals regarding genomic data-sharing. Additionally, advances in science raise concern about the privacy of research participants and have led to the creation of controlled access, or restricted, scientific databases. We have argued that all data sharing decisions involve an unavoidable trade-off between protecting privacy and advancing research, and as individuals may vary in their judgments about this trade-off, decisions about DNA data release ought to be made by research participants during the informed consent process. Prior work has shown that individuals are generally willing to participate in genomic data sharing, but this work has been primarily done in healthy volunteers. Due to the stigma associated with HIV disease, it is unclear if HIV-infected individuals would have similar opinions in regards to data sharing. In particular, no prior research has evaluated the willingness of HIV-infected individuals to participate in studies collecting and storing specimens for genomic analysis. Through focus groups, this pilot study explores HIV-infected individuals’ informational attitudes, needs, and decision-making about participating in genomic research and DNA data sharing.
Project Personnel: Janet Butel, M.D., Ph.D., Principal Investigator, Amy McGuire, J.D., Ph.D., Co-Principal Investigator, Elizabeth Chiao, M.D., M.P.H., Co-Investigator, Melody Slashinski, M.P.H., Ph.D., Co-Investigator
Supported by: 5P30AI036211-18 CFAR Ethics Supplement, National Institute of Allergy and Infectious Disease, NIH
Ethics of Consent for the Public Release of Potentially Identifiable DNA Data
This study assessed the impact of data sharing on an individual’s willingness to participate in a genomic study and how broadly one was willing to share their genomic information. Model experimental informed consent documents were developed and refined through pilot studies. The consent documents varied in how much control the participant had in deciding how broadly to share their genomic information, ranging from no control (i.e., agree to participate and agree to broad data sharing) to more specific control (i.e., agree to participate and specify level of desired sharing, broad, restricted, or none). Actual genomic research participants were randomized to receive one of the three experimental consent documents and their initial data sharing decisions were captured. Participants were debriefed about the randomized consent study, and were provided an opportunity to change their data sharing decisions. Along with this intervention impact assessment, some participants were surveyed and interviewed to explore their attitudes and judgments about sharing genome sequence information in scientific databases, both publicly accessible and restricted. Although most participants agreed to share their genomic information publicly, many raised privacy and other concerns about doing so, and a substantial minority preferred not to have this information publicly available.
Project Personnel: Amy McGuire, J.D., Ph.D., Principal Investigator,
Supported by: R01HG004333, National Human Genome Research Institute, NIH
Preliminary Survey of Attitudes to Release of Genetic Information
This project explored patients’ attitudes, needs, and decision-making about participating in genomic sequencing research through focus group studies, with a particular focus on their desired level of control over public data release. The results of this project led to the development of model informed consent documents, which were empirically tested as a randomized intervention in a subsequent funded study (R01-HG004333).
Project Personnel: Amy McGuire, J.D., Ph.D., Co-Principal Investigator, Alica Goldman, M.D., Co-Principal Investigator
Supported by: Baylor College of Medicine Basic & Collaborative Research Program, supported by the Gillson Longenbaugh Foundation and the ARCO Foundation Young Teach-Investigator Award
Leading Responsible Change in Genomic Research
This project developed a conceptual model to identify data release options that could be incorporated into a model informed consent document. This conceptual model was informed by focus groups with research participants and led to the creation of three types of informed consent documents that were tested in a pilot focus group study (BCM Basic & Clinical Collaborative Research Project Award) and which were used later in a lager, randomized study (R01-HG004333).
Project Personnel: Amy McGuire, J.D., Ph.D., Principal Investigator
Supported by: Greenwall Foundation Faculty Scholars Program
Ethical, Legal, and Social Dimensions of Human Microbiome Research
At the outset of the Human Microbiome Project, the NIH solicited projects coinciding with the HMP to identify and examine the ethical, legal and social implications of this research. We conducted interviews with HMP participants and scientists conducting the HMP in order to understand their perspectives on what ethical or social issues arise in this type of research. The project culminated in an interdisciplinary meeting presenting empirical data with representative stakeholders, including scientists, bioethicists, and policy makers, to inform the development of ethically sound strategies to manage these issues in future research. Many of the identified ELSI issues are not specific to human microbiome research, and are largely similar to issues facing genomics research more generally, such as adequacy of informed consent, and broad sharing of individualized genomic information often accompanied by personal-level protected health information.
Project Personnel: Amy McGuire, J.D., Ph.D., Principal Investigator, Sheryl McCurdy, Ph.D., Co-Investigator
Supported by: R01HG004853, National Human Genome Research Institute, NIH
Human Microbiome in Pediatric Abdominal Pain and Intestinal Inflammation
This demonstration project explores the microbiome of pediatric patients with abdominal pain and intestinal inflammation. Co-Investigator, Dr. Amy McGuire, led the effective management of the ethical, legal, and social issues identified during the course of the study.
Project Personnel: James Versalovic, Ph.D., Principal Investigator, Amy McGuire, J.D., Ph.D., Co-Investigator
Supported by: UH3DK083990, National Institute of Diabetes and Digestive Kidney Disease, NIH
Publications Related to Genome and Human Microbiome Research
McGuire AL, Colgrove J, Whitney SN, Diaz CM, Bustillos D, Versalovic J. Ethical, Legal, and Social Considerations in Conducting the Human Microbiome Project. Genome Research 18(12), 2008: 1861-1865.
Achenbaum LS, O’Doherty KC, McGuire AL. Ethical, Legal, and Social Dimensions of Human Microbiome Research. Springer Encyclopedia of Metagenomics (Submitted).
Gevers D, Knight R, Petrosino JF, Huang K, McGuire AL, Birren BW, Nelson KE, White O, Methe BA, Huttenhower C. The Human Microbiome Project: A Community Resource for the Healthy Human Microbiome. PLoS Biology 10(8), 2012:e1001377.
McGuire AL, Achenbaum LS, Whitney SN, Slashinski MJ, Versalovic J, Keitel WA, McCurdy S. Perspectives on Human Microbiome Research Ethics. Journal of Empirical Research on Human Research Ethics. 7(3), 2012: 1-14.
Slashinski MJ, McCurdy SA, Achenbaum LS, Whitney SL, McGuire AL. “Snake-oil,” “Quack Medicine,” and “Industrially Cultured Organisms:” Biovalue and the Commercialization of Human Microbiome Research. BCM Medical Ethics 13, 2012: 28.
The Human Microbiome Project Consortium. [Collaborator] A framework for human microbiome research. Nature 486, 2012:215-221.
The Human Microbiome Project Consortium. [Collaborator] Structure, function and diversity of the healthy human microbiome. Nature 486, 2012:207-214.
Achenbaum, LS, O’Doherty, KC, McGuire, AL. Ethical, legal and social dimensions of human microbiome research. In Karen E. Nelson (Ed.), Encyclopedia of Metagenomics: Springer Reference (www.springerreference.com). Springer-Verlag Berlin Heidelberg, 0. DOI: 10.1007/SpringerReference_303407 2012-08-15 13:13:06 UTC (available at: http://www.springerreference.com/docs/html/chapterdbid/303407.html).
McGuire AL, Gibbs RA. No Longer De-Identified. Science 312, 2006: 370-371.
McGuire AL, Gibbs RA. Meeting the growing demands of genetic research. Journal of Law, Medicine & Ethics 34(4), 2006: 809-812.
McGuire AL, Hamilton J, Lunstroth R, Goldman A, McCullough LB. DNA data sharing: Research participants’ perspectives. Genet. Med. 2008; 10(1):46-53.
McGuire AL. Identifiability of DNA Data: The Need for Consistent Federal Policy (Peer Commentary). American Journal of Bioethics 8(10), 2008: 75-76.
McGuire AL, Basford M, Dressler LG, Fullerton SM, Koenig BA, Li R, et al. Ethical and Practical Challenges of Sharing Data from Genome-Wide Association Studies: the eMERGE Consortium Experience. Genome Research 21(7), 2011:1001-1007.
McGuire AL, Oliver JM, Slashinski MJ, Graves JL, Wang T, Kelly PA, Fisher W, Lau CC, Goss J, Okcu M, Treadwell-Deering D, Goldman AM, Noebels JL, Hilsenbeck SG. To share or not to share: A randomized trial of consent for data sharing in genome research. Genet Med. 2011; 13(11):948-955.
Oliver JM, Slashinski MJ, Wang T, Kelly PA, Hilsenbeck SG, McGuire AL. Balancing the risks and benefits of genomic data sharing: Genome research participants’ perspectives. Public Health Genomics 2012; 15(2):106-114.
Oliver JM, Slashinski, MJ, Wang T, Kelly PA, Hilsenbeck SG, McGuire AL. Understanding of and satisfaction with participation and data sharing in genomic research. In Progress.
Gymrek M, McGuire AL, Golan D, Halperin E, Erlich Y. Identifying Personal Genomes by Surname Inference. Science 339, 2012: 321-324.
Meet Our Team
The Center for Medical Ethics and Health Policy team is led by Director Amy L. McGuire, J.D., Ph.D.