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Background
Pharmacogenetics is a rapidly expanding field with expectations of applications to human health. There has been mounting fear on the possible misuse of genetic information derived from genetic research and through that an intrusion on the privacy of an individual (Rothenberg & Terry, 2002). This concern about the misuse of genetic information and intrusion into the privacy of individuals has led to the development of safeguards to prevent such misuse, which has implications not just on current research, but on pharmacogenetic testing involving tests that may be developed in the future (Hamyas et al, 2004).
Issues
In the United Kingdom the collecting of material including genetic material for research and testing is governed by the Human Tissue Act 2004 (HT Act). The HT Act makes it mandatory for those involved in the removal, storage and use of human tissues, which includes human cells to have a license, as these are licensable activities. The HT Act also makes the retention of human material of tissues and cells for DNA analyses without the consent of the concerned individual an offence under DNA ‘theft’. These regulations of the HT Act impact reflect the importance of pharmacogenetics being a licensed activity and the role of the consent of the individual in any current tests and tests that may be developed in the future (Human Tissue Authority, 2004).
The enrolment of subjects for pharmacogenetic testing is a documented process, which usually involves the creation of two separate documents consisting of the drug research protocol and the pharmacogenetic sampling protocol and informed consent from the research subject has to be sought and received for both the protocols. The informed consent document for pharmacogenetic sampling has necessarily to give appropriate information for the subject to make the informed decision on the donation of genetic material that is founded on the merits and risks of the aims and procedures alone (Anderson et al 2002).
According to Anderson et al 2002, p.284, informed consent is “how potential research subjects make a judgment about the contribution that their involvement in the research can make, relative to the risks or benefits to them as individuals.” This makes the judgement to participate in potential testing hinge on the quality of the information provided to the concerned individual. This quality is provided when the all relevant information is provided to the concerned individual including the information on sample storage; sample replication, which includes the creation of immortalized sample lines, and/pr the provision of the samples to third parties, which include investigators and commercial entities, for any collaborative studies.
The information given should also include the clear plans drawn up for sample destruction or depletion, particularly with regards to protecting the individual from any intrusion into the privacy of the individual (Anderson et al 2002).
Two issues for the use of genetic material for future tests emerge from the regulations on the use of genetic material for pharmacogenetic testing. The use of the genetic material for any testing purposes is limited to the consent of the subject based on the information of the objectives and the procedures of the testing. This means unless the subject has been informed of the extension of the objectives of the current research into any future testing purposes, the genetic material cannot be used, even if the subject has consented to the use of genetic material in the current research objectives and procedures.
The second issue is that genetic material cannot be stored indefinitely and has to be destroyed or depleted according the definite plans on sample storage as informed to the subject and agreed to by the subject in the interests of the privacy of the subject. These issues thus lay large hurdles and act as preventive measures in the use of collected material in pharmacogenetics tests that may develop some time in the future.
Literary References
Anderson, D. C., Gomez-Mancillai, B., Spears, B. B., Barnes, D. M. Cheeseman, K., Shaw, P. M., Friedman, J., McCarthy, A., Brazell, C., Ray, S. C., McHale, D., Hashimoto, L., Sandbrink, R., Watson, M. L., Salerno, R. A., Cohen, N. & Lister, C. E. 2002, ‘Elements of informed consent for pharmacogenetic research; perspective of the pharmacogenetics working group’, The Pharmacogenomics Journal, vol.2, pp.284-292.
Hamyas, A., Madden, K. K., Nogee, L. M., Trusgnich, M. A., Wegner, D. J., Heins, H. B. & Cole, F. S. 2004, ‘Informed Consent for Genetic Research’, Archives of Pediatrics & Adolescent Medicine, vol.158, no.6, pp.551-555.
Human Tissue Authority. 2004, ‘Human Tissue Act’. Web.
Rothenberg, K. H. & Terry, S. F. 2002, ‘HUMAN GENETICS: Before It’s Too Late Addressing Fear of Genetic Information’, Science, vol.297, no.5579, pp.196-197.
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