Increased scrutiny of research practices is coming at a time when advances in genomic science depend on collecting massive amounts of data for analysis, the authors observed. To obtain large numbers of samples, improve the reliability of findings, and achieve greater efficiency, genome scientists around the world have begun pooling biospecimens and data from previous studies. The Science commentary notes that current U.S. federal policies or laws regarding human subjects' protection or privacy of health information do not apply to studies using only coded samples and data. At the same time, other federal policies mandate data sharing and strongly encourage researchers to deposit their study data in public repositories such as the database of Genotypes and Phenotypes (dbGaP), a public access resource maintained by the National Institutes of Health.
The authors added that many disease-specific and general-purpose biorepositories have attracted many participants who have signed blanket informed consents for a broad range of potential purposes. Although a U.S. survey showed that more than 90 percent of respondents would be willing to have their samples and health data placed in a research biobank, their views on blanket consents were divided: 48 percent preferred one-time blanket consent, and 42 percent wanted the chance to re-consent for each new use of their data. Policy disagreement continues, the authors said. Some policy advisors want stronger regulations, but other s believe an opt-out model is better. In an opt-out, consent for research use of clinical samples (with personal identifiers removed) is presumed unless denied.
What's missing from research policy and practice, in many cases, is knowledge and consideration of participants' viewpoints and values, and participants' desire to be notified and to give permission for sharing of their data
|Contact: Leila Gray|
University of Washington