Should medical researchers inform anonymous donors about
important genetic findings? A recent
article entitled “Genes Now Tell Doctors Secrets They Can’t Utter” investigates
such questions. With constantly improving technological resources, medical studies
are increasingly discovering unsolicited, yet significant, information about
study participants. Though some data may
be trivial where the patient is concerned, studies frequently ascertain
knowledge about potentially life-threatening diseases including AIDS and
various forms of cancer. While it might
seem that researchers should immediately attempt to contact research patients
or their families to notify them about risks of disease, signed consent forms
often indicate that those who donate tissue samples will not be contacted. These documents have been analyzed and
approved by ethics boards, and thus overturning a legal agreement can involve
extensive bureaucratic procedures.
While many research institutes are
now amending their paperwork to ask volunteers whether or not they wish to be
contacted regarding noteworthy findings, constructing ethical guidelines has
proven to be no easy task. Often
information is acquired years after samples were first collected. Laboratories do not have funds to track down
participants who may or may not want to hear about potential diseases. Furthermore, if patients have died, the
question arises of whether or not family members should be contacted as they
may be at risk as well. Often findings
may have consequences that pertain to many relatives and may be relevant in
family planning. But matters are even
more complicated in families with divorces or separations. Because consent forms do not address how
participants’ families should be regarded, the ethical debate cannot be easily
solved.
One case in which confidentiality
was breached occurred when researchers at the National Human Genome Research
Institute, after consulting their ethics committee, chose to inform a young
woman with a family history of breast cancer that she did not have the
associated gene mutation. This
divergence from protocol was approved so as to prevent the woman from having
her breasts removed out of fear of cancer.
While this success story highlights
a positive outcome of contacting anonymous participants about genetic risks,
not all cases work out so favorably. One
of the problems is that research institutes cannot contact anonymous volunteers
to ask if they want to be informed about significant information without
implying there is something of concern.
Additionally, experimental data is never absolutely certain. Thus many researchers feel that such matters
are not in their control, and they prefer to not even attempt to approach their
ethics committees with inquiries.
Sometimes it is difficult to gage the severity of a risk based on
limited genetic evidence. Other findings
regarding potentially significant treatment or prevention methods can raise
even more ambivalence about how to proceed.
While in some cases, the obligation to inform a participant may be
obvious, most circumstances are far from clear-cut.
The U.S. government has already
begun conducting research to explore the effects of contacting at-risk
anonymous study participants. However,
for the time being, laboratories continue to face these ethical dilemmas. I think that most research volunteers, even
if anonymous, would want to know about potentially life-threatening
diseases. Thus it seems morally
appropriate to breach contracts to inform patients (or their families if the
patient is deceased) of pertinent genetic information. Though a chance few individuals may object to
receiving unsolicited insights into their genomes, this knowledge will not kill
them. Withholding such information on
the other hand could have deathly consequences.
Hopefully, consent forms will soon be amended to include more precise
information about patient preferences.
Nevertheless, even if law does not yet require it, research institutes
do have an obligation to tell patients if they discover a significant risk of
disease.
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