With Rise of Gene Sequencing, Ethical Puzzles - NYT

August 26, 2012

thical-puzzles.html

Genes Now Tell Doctors Secrets They Can't Utter

By GINA KOLATA

Dr. Arul Chinnaiyan stared at a printout of gene sequences from a man

with cancer, a subject in one of his studies. There, along with the

man's cancer genes, was something unexpected --- genes of the virus that

causes AIDS.

It could have been a sign that the man was infected with H.I.V.; the

only way to tell was further testing. But Dr. Chinnaiyan, who leads the

Center for Translational Pathology at the University of Michigan, was

not able to suggest that to the patient, who had donated his cells on

the condition that he remain anonymous.

In laboratories around the world, genetic researchers using tools that

are ever more sophisticated to peer into the DNA of cells are

increasingly finding things they were not looking for, including

information that could make a big difference to an anonymous donor.

The question of how, when and whether to return genetic results to study

subjects or their families " is one of the thorniest current challenges

in clinical research, " said Dr. Francis , the director of the

National Institutes of Health. " We are living in an awkward interval

where our ability to capture the information often exceeds our ability

to know what to do with it. "

The federal government is hurrying to develop policy options. It has

made the issue a priority, holding meetings and workshops and spending

millions of dollars on research on how to deal with questions unique to

this new genomics era.

The quandaries arise from the conditions that medical research studies

typically set out. Volunteers usually sign forms saying that they agree

only to provide tissue samples, and that they will not be contacted.

Only now have some studies started asking the participants whether they

want to be contacted, but that leads to more questions: What sort of

information should they get? What if the person dies before the study is

completed?

The complications are procedural as well as ethical. Often, the research

labs that make the surprise discoveries are not certified to provide

clinical information to patients. The consent forms the patients signed

were approved by ethics boards, which would have to approve any changes

to the agreements --- if the patients could even be found....

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