NEW ORLEANS--Informed consent has historically focused on physical risks, but genetic testing will move informed consent into psychosocial areas, Karen Rothenberg, JD, MPA, Marjorie Cook Professor of Law, University of Maryland School of Law, said at the 21st annual meeting of the American Society of Preventive Oncology (ASPO).
With genetic testing, the informed consent process will need to address such psychosocial risks as changes in self- image, altered family relationships, and possible stigmatization,
Patients must be told the potential benefits of genetic testing but also the uncertainties, she said. For example, for many genetic tests for cancer, the true predictive value is unknown, the risk for misinterpretation is great, the effectiveness of prevention and intervention has not been satisfactorily validated in trials, and the impact of testing on changes in health behavior is unknown.
Physicians must inform their patients that the legal protection of test results is not uniform at this point, said Prof. Rothenberg, who is also director of the Law and Health Care Program at the University of Maryland.
She said that about a dozen states prohibit health insurers from requesting the results of genetic testing, from making coverage conditional on genetic testing, or from considering genetic testing in setting rates. Another 20 states have laws pending.
"The catch is that except for a few states, most laws only protect the genetic test result, not genetic information, such as might be obtained from the family history in the medical record," she stressed.
In addition, states cannot regulate self-funded insurance plans, which constitute about half of all employee-provided insurance, Prof. Rothenberg said. The Health Insurance Portability and Accountability Act of 1996, also called the Kassenbaum/Kennedy law, provides some protection. However, it cannot prohibit insurers from requesting disclosure of genetic information, increasing rates for patients with certain conditions or findings, or excluding from coverage all patients with certain conditions.
Few actual protections exist in the workplace, either, since again most restrictions apply to genetic test results, not genetic information. Employers are generally not prohibited from requesting medical releases, and they can legally attempt to obtain access to information, she said.
Issues of Family Privacy
The area of family privacy is especially controversial now. Issues include the right of the patient and other family members to know or not know test results, the individual's responsibility to share information with family members, reproductive decision making, and genetic testing of children.
"In the informed consent process, there needs to be discussion about family sharing of information," Professor Rothenberg said. "And people need to recognize that having genetic information can change their responsibilities, obligations, even rights."