Informed consent, genetic testing

The plaintiffs are not claiming that the patent is invalid. Rather, relying on theories implicit in Moore, they seek to use informed consent liability doctrines to ensure low-cost genetic screening and testing for Canavan disease. The lawsuit is based on what I will call a breach of covenant, not a breach of promise. The term breach of covenant is appropriate, despite the contractual view in some of the literature (Schuck, 1994), because the relationship between the parties was not contractual. Breach of promise implies that their agreement was contractual in nature, which creates doctrinal problems (Palmer, 1989). 

Before a person has a genetic test, it is important that he or she understands the testing procedure, the benefits and limitations of the test, and the possible consequences of the test results. The process of educating a person about the test and obtaining permission is called informed consent. 

It is important for people considering genetic testing to know whether the test is available on a clinical or research basis. Clinical and research testing both involve a process of informed consent in which patients learn about the testing procedure, the risks and benefits of the test, and the potential consequences of testing. 

Results of genetic tests must be protected from any third party access unless free and informed consent is given. DNA banking allows family and clinical information as well as genetic material to be a resource for other researchers however, removal of the subject s and family s identity is important. Any potential harm must be disclosed to the REB as well as how it will be dealt with. For example, information about an individual s susceptibility to disease may provoke anxiety, particularly if effective therapy or prevention is not available. 

G. Geller, J. R, Botkin, M. J. Green,N. Press, B. B. Biesecker, B. Wilfond, et al. 1997. Genetic testing for susceptibility to adult-onset cancer The process and content of informed consent. Journal of the American Medical Association 277 1467-1474. 

Recommendations to guide pediatricians should be developed and genetic information should be used to improve drug therapy only. It is necessary to obtain appropriate informed parental consent, pay attention to protect confidentiality and identity of subjects, and minimize potential risk. Additionally, the test... 

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