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The potential for various violation of individual rights looms large
in the
issues of government storage, use and sharing of newborn DNA with
corporate and other researchers. At stake are human rights,
Fourth Amendment rights, privacy rights, parent rights, DNA property
rights, human subject rights and patient rights.
Research using baby DNA includes, but is not limited to, the
development of additional newborn screening tests (test development),
research into newborn and adult-onset medical conditions, the impact of
environmental
pollutants, and analysis of genetic variation in the human population.
Parents find research on their children without their consent to be
highly objectionable,
according to research reported by Dr. Sharon Kardia at the September
2009 forum on dried blood spots and privacy:
"You’ll see over and over again that research use should
require explicit informed consent, even if the bloodspots are
deidentified, that 80 percent supported the option for consent or to
limit the kinds of research for which blood spots could be used, and
that the goals of the research or consent for research are necessarily
related...."
"They’ll say, OK, I don’t mind if you ask me, if you tell me what it’s
going to be used for, if I know it’s going to benefit people, if you
make the research transparent so I can know and be associated with that
research finding, like my child did something good. I’ve done something
good. If you keep me informed when you use it...."
"So, my conclusion is that we’re in serious need of community awareness
building and that in Michigan, I’ve warned our department of health
that I think we’re sitting on a ticking time bomb with our own
biotrust
that was launched in June of 2009. I think it’s also time for us to
explore seriously the potential for online dynamic interactive systems
of information flow between people, researchers and government and that
includes consent in real time..."
"And I think we have a serious image problem as researchers. They
associate us with the government. They do not make a distinction. I
could be the FBI...."
Research is not and never should be considered an obligation of
existing on planet earth. Not all research is good. Some research would
be considered downright objectionable to everyone, or to an individual
or to a group of people. The Navajo tribe has made genetic research
illegal, according to comments made at the December 2009 forum.
Deidentification/Anonymization of Samples
State health departments and other organizations and corporations
supportive of research using newborn
DNA often claim that de-identification or anonymization of the
newborn's blood specimen is sufficient to
warrant research without parent consent. It is essential that
individuals and parents first realize that de-identifcation is not
anonymization. Then parents must realize what researchers and privacy
experts know: anonymization is not possible.
Dr. Fleischmann describes de-identification at the September 2009
forum, showing clearly that the specimen is still quite identifiable:
"We can also de-identify blood spots, separate them from their
identifiers, but code them and have a master code that can be held by
what some call an honest broker, a person who could break the code in a
very specific or critical need occurred, if something that we needed to
know or if we wanted to talk to a family about something that’s been
learned, we could relink. But the researcher would not have that code,
would not have that ability to re-link. Those samples would be truly
de-identified."
Dr. Fleischmann also discusses anonymization as an option, saying,
"We can make blood spots
truly anonymous. That is to say, we can
separate the blood from all identifiers and maintain no possibility of
re-linkage. This would result in absolutely no risk to any individual
or family." However, Ann Cavoukian, Ph.D,
Information & Privacy Commissioner of Ontario, noted in a 2005
presentation on genetic privacy:
"It
is impossible to completely anonymize DNA since there is always a means
to identifying the tissue or the sample."
Others concur. Steven Hirschfield, MD, Ph.D, from the National
Institute of Child Health and Human Development at the National
Institutes of Health, in a PowerPoint for a May 10, 2007 presentation
at the Newborn Screening and Genetic Testing Symposium of the
Association of Public Health Laboratories, wrote,
"Genomic data is the ultimate identifier: what is not
identifiable now is plausible to be so in the future."
Even if the blood spots could be fully anonymized and never
reidentified, parents have a right to
protect their children's privacy and DNA property rights, as well as
the child's right to not
become a subject of research. They also have the right to refuse to
have their child participate in research where the findings may be used
in a manner contrary to their belief system. In addition, due to the
hereditary
nature of human genetics, genetic research on the
child also reveals a certain amount of genetic information on the
parents of the child. Thus, parents also have a right to not
become subjects of research through research on their children.
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