{"id":1702,"date":"2008-09-15T18:00:52","date_gmt":"2008-09-15T16:00:52","guid":{"rendered":"http:\/\/www.wjst.de\/blog\/?p=1702"},"modified":"2009-10-12T19:51:46","modified_gmt":"2009-10-12T17:51:46","slug":"informed-consent-20","status":"publish","type":"post","link":"https:\/\/www.wjst.de\/blog\/sciencesurf\/2008\/09\/informed-consent-20\/","title":{"rendered":"Informed Consent 2.0"},"content":{"rendered":"

PLoS medicine publishes today<\/a> a piece that we wrote already last summer. As we have removed the narrative abstract (PLoS uses keypoints instead of an abstract) here is it – pleading for an update of traditional informed consent.<\/p>\n

\nInformed consent (IC) is a basic requirement for biomedical research. It in-
\ncludes the understanding of risks and benefits of study procedures and the
\nvoluntary agreement to participate under these conditions. Genetic cohort
\nstudies storing biological materials hold great promise for medical research
\nbut also present new problems that are profoundly different from the classical
\nclinical trial for which the IC formula was initially developed. The classical
\nrisk\/benefit analysis of physical harm doesn’t take into account new threats to
\nthe individual like uninsurability, unemployability, genetic discrimination or
\neven disruption of family relationships.
\nWe show here that traditional IC is no longer appropriate when dealing with
\nstudies using biological materials. Traditional IC requires that full disclosure of
\nall relevant information is provided to allow subjects to decide on their par-
\nticipation for a finite time and within a well-defined research protocol. Goals
\nof genomic screening studies, however, may not be well defined a priori and
\nthe subject’s involvement may last indefinitely.
\nAs a solution we are advocating for these kind of studies a close researcher-
\nparticipant partnership. Described by Veatch and others at the late 1980s,
\nsuch a researcher-participant partnership may now be revived for genetic
\nstudies. IC should no more be seen as a once-and-for-all decision but as an
\nongoing process.
\nSeveral authors already suggest an exploratory or participatory process prior
\nto the implementation of a research project that should provide a better un-
\nderstanding of relevant issues. Research following the initial storage of sam-
\nples needs to be likewise announced and explained by new communication
\nchannels such as email broadcasts, websites, blogs and chats. IC in the ge-
\nnomics era should no more be viewed as just signing a legal document at the
\nbeginning of a study, but as a process of communication that involves re-
\nsearchers and participants as partners in an open dialogue, giving new force
\nand meaning to the ethics of current research.\n<\/p><\/blockquote>\n

We have spent considerable space in this paper to explain that genetic data are not being anonymous (as genotyping of retrospectively collected samples is largely justified as samples are being “anonymous” where genotyping may not harm anybody).
\nIn our opinion this is inadequate as genetic data are self-identifying. At least last week we get support also from a group in LA that can identify an individual in pooled! DNA that contributed less than 0.1% of the total genomic DNA.
\nEvents come thick and fast as reported by Science a week ago<\/a> “Genetic privacy. Whole-genome data not anonymous, challenging assumptions”:<\/p>\n

The Wellcome trust has pulled data on about a dozen common diseases, and NIH has pulled data from nine genetic studies off two sites, dbGaP … and CGEMS.\n<\/p><\/blockquote>\n

They can remove the data from a public server but they can’t unmake genotyping, yea, yea.<\/p>\n

Addendum<\/h3>\n

An interview that I have given to Genomeweb<\/a>.<\/p>\n\n

 <\/p>\n

\n CC-BY-NC Science Surf , accessed 21.04.2026<\/span>\n <\/div>","protected":false},"excerpt":{"rendered":"

PLoS medicine publishes today a piece that we wrote already last summer. As we have removed the narrative abstract (PLoS uses keypoints instead of an abstract) here is it – pleading for an update of traditional informed consent.   CC-BY-NC Science Surf , accessed 21.04.2026<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2,5],"tags":[2036,2035,2037,2034],"class_list":["post-1702","post","type-post","status-publish","format-standard","hentry","category-genetics-biology","category-philosophy-of-science","tag-veatch","tag-informed-consent","tag-partnership","tag-revision"],"_links":{"self":[{"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/posts\/1702","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/comments?post=1702"}],"version-history":[{"count":1,"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/posts\/1702\/revisions"}],"predecessor-version":[{"id":3114,"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/posts\/1702\/revisions\/3114"}],"wp:attachment":[{"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/media?parent=1702"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/categories?post=1702"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.wjst.de\/blog\/wp-json\/wp\/v2\/tags?post=1702"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}