Genetic studies involving the long term storage and study of human samples hold great promise for medical research—but they also pose new threats to individuals such as uninsurability, unemployability, and discrimination, say a team of researchers in this week's PLoS Medicine.
Matthias Wjst (Institute of Genetic Medicine, Bozen, Italy) and colleagues argue that the traditional informed consent process—in which the researcher counsels potential study participants about the risks and benefits of taking part in a study—may no longer be appropriate when dealing with long-term studies using biological materials.
"In current practice," say the authors, "the only moment when a person is really able to make a choice about participating in clinical research is when they sign the informed consent form." But they argue that there is a major problem with asking participants to sign this form as a "once-and-for-all decision"—a biological sample collected from a study participant for one study today might feasibly be of use in a future study several years down the line. New genetic information that is obtained from these later studies, if released, could lead to "uninsurability, unemployability, discrimination, and the breakdown of family relationships by unintentionally demonstrating missing or unknown relatedness."
"Informed consent should be seen as an ongoing process between researcher and participant, and not just as a once-and- for-all decision," say Wjst and colleagues.
They argue that any research following the initial storage of samples needs to be explained to the participants so that they can give their feedback. The authors suggest that such communications could involve both conventional channels—face-to face meetings, group meetings, and letters—as well as newer electronic communications—such as e-mail alerts, online chat rooms, and blogs.
Citation: Mascalzoni D, Hicks A, Pramstaller P, Wjst M (2008) Informed consent in the genomics era. PLoS Med 5(9): e192. doi:10.1371/journal.pmed.0050192
IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE PUBLISHED PAPER: http://medicine.plosjournals.org/perlserv/?request=get-document&doi:10.1371/journal.pmed.0050192
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SUMMARY IN ITALIAN: http://www.plos.org/press/plme-05-09-wjst-italian.pdf
SUMMARY IN GERMAN: http://www.plos.org/press/plme-05-09-wjst-german.doc
CONTACT:
Matthias Wjst
GSF Natl Res Ctr Envir Health
EPI/MOLEPI
Ingolstädter Landstr.1
Munich-Neuherberg, Bavaria 85764
Germany
+498931873206
m@wjst.de
Tobacco control makes economic sense
In this week's PLoS Medicine, Kelley Lee (London School of Hygiene & Tropical Medicine, London UK) highlights the history of research on the economics of tobacco control. She also discusses a research article by Stanton Glantz and colleagues, published last month in PLoS Medicine (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0050178), which reported that investment in tobacco control programs leads to substantial savings in health care expenditures.
Citation: Lee K (2008) Tobacco control yields clear dividends for health and wealth. PLoS Med 5(9): e189. doi:10.1371/journal.pmed.0050189 IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE PUBLISHED PAPER: http://medicine.plosjournals.org/perlserv/?request=get-document&doi:10.1371/journal.pmed.0050189 PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-05-09-lee.pdf
CONTACT:
Kelley Lee
London School of Hygiene & Tropical Medicine
Centre on Global Change and Health
Room LG41, Keppel Street
London, WC1E 7HT
United Kingdom
44 20 7927 2037
44 20 7927 2946 (fax)
kelley.lee@lshtm.ac.uk
Journal
PLoS Medicine