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Gene banks and blanket consent
Academic and industry researchers are understandably excited about the scientific and therapeutic potential presented by gene banks. Emerging areas of research, such as pharmacogenetics, require access to large pools of genetic data, which are of greatest scientific value when linked to identifiable personal information. For example, links between genetic information and health data are required to study geneenvironment interactions effectively.
The ethical challenges that are associated with gene banks have attracted much attention from both academics and policy makers, as highlighted by the UK Human Genetics Commission’s (1999) report. However, the issue of consent is particularly problematic for researchers. A strict application of many countries’ consent laws requires researchers to obtain informed consent for the use of all identifiable genetic information and a fresh consent for new research projects, and to allow participants to withdraw their sample at anytime. Following these legal requirements is tremendously difficult for research involving large gene banks.
This dilemma has been dealt with through the increasing use of “blanket consent”. Although one-time consents simplify the research process, the legal challenges associated with them have been underplayed. Because blanket consents are necessarily vague, they are too general to have much legal weight. Moreover, they do not allow patients to act meaningfully on their continuing right to control their health information. As such, most types of blanket consent fall “far short of true informed consent” (Greely 1999).
Given this legal uncertainty, adopting comprehensive blanket consent policies will require many countries to change their existing consent laws, requiring statutory amendments or legislation. However, creating new consent policy poses several significant challenges. First, there is some evidence that the public would not feel comfortable with a lowering of the legal standard to facilitate research. Indeed, a survey in 2001 of Canadians found that 90% strongly agree (61%) or agree (29%) that genetic information is different and that rules governing access to it should be stricter (Report for the BADMCC 2001). Second, jurisdictional variation in how this consent issue is addressed could add to the challenge of organizing large, multi-site research initiatives. In Canada, for example, the handling of health information is a provincial matter. As such each of the ten provinces will need to craft legislation to address this topic.
Finally, governments need to consider carefully the broader social impact of changing consent law. Is it really time to jettison the well-established autonomy-driven view of consent? What additional safeguards will be needed to make such a change ethically sound?
(Timothy Caulfield, Extraído de Nature Reviews/Genetics)
In paragraph four, the text presents two areas that specify “several significant challenges”. These two general areas are
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