Ethical considerations in the collection of genetic data from critically ill patients: what do published studies reveal about potential directions for empirical ethics research?
Zehnbauer, Barbara Ann, 1952-
Freeman, Bradley D.
Kennedy, Carie R.
Frankel, Hans L.
Clarridge, Brian R.
Iverson, Ellen F.
The pharmacogenomics journal 2010 Apr ; 10(2): 77-85
Critical illness trials involving genetic data collection are increasingly commonplace and pose challenges not encountered in less acute settings, related in part to the precipitous, severe and incapacitating nature of the diseases involved. We performed a systematic literature review to understand the nature of such studies conducted to date, and to consider, from an ethical perspective, potential barriers to future investigations. We identified 79 trials enrolling 24 499 subjects. Median (interquartile range) number of participants per study was 263 (116.75-430.75). Of these individuals, 16 269 (66.4%) were Caucasian, 1327 (5.4%) were African American, 1707 (7.0%) were Asian Pacific Islanders and 139 (0.6%) were Latino. For 5020 participants (20.5%), ethnicity was not reported. Forty-eight studies (60.8%) recruited subjects from single centers and all studies examined a relatively small number of genetic markers. Technological advances have rendered it feasible to conduct clinical studies using high-density genome-wide scanning. It will be necessary for future critical illness trials using these approaches to be of greater scope and complexity than those so far reported. Empirical research into issues related to greater ethnic inclusivity, accuracy of substituted judgment and specimen stewardship may be essential for enabling the conduct of such trials.
Permanent LinkFind Full Text at Georgetown University Library
Full Text from Publisher
Showing items related by title, author, creator and subject.
Hull, Sara Chandros; Sharp, Richard R.; Botkin, Jeffrey R.; Brown, Mark; Hughes, Mark; Sugarman, Jeremy; Schwinn, Debra; Sankar, Pamela; Bolcic-Jankovic, Dragana; Clarridge, Brian R.; Wilfond, Benjamin S. (2008-10)It is unclear whether the regulatory distinction between non-identifiable and identifiable information--information used to determine informed consent practices for the use of clinically derived samples for genetic ...
Ethical and Practical Challenges of Sharing Data From Genome-Wide Association Studies: The eMERGE Consortium Experience McGuire, Amy L; Basford, Melissa; Dressler, Lynn G; Fullerton, Stephanie M; Koenig, Barbara A; Li, Rongling; McCarty, Cathy A; Ramos, Erin; Smith, Maureen E; Somkin, Carol P; Waudby, Carol; Wolf, Wendy A; Clayton, Ellen Wright (2011-07)In 2007, the National Human Genome Research Institute (NHGRI) established the Electronic MEdical Records and GEnomics (eMERGE) Consortium (www.gwas.net) to develop, disseminate, and apply approaches to research that combine ...