Privacy and confidentiality of genetic information: what rules for the new science?

This review covers the ethical, legal, and policy issues associated with the generation and dissemination of genetic information. First, conceptual issues, such as the definition of terms and the description of two modes of analysis, are addressed. Research findings on public attitudes toward privacy and genetics and other factors relevant to policy making are also reviewed. Second, the example of genetic research is used to highlight the importance of attention to the intrinsic harms associated with violations of genetic privacy. Subtopics include national databases and biobanks, gene brokers, and pharmacogenomics. Third, the example of insurer access to genetic information is used to highlight the importance of attention to discrimination and other instrumental harms associated with failures of regulation. Fourth, a summary of the preceding sections leads into an outline of a program for realizing the benefits of the new science in a manner that affirms rather than erodes privacy and other important values.

Ethical and legal implications of pharmacogenomics.

Pharmacogenomics is the application of genomics technology to the discovery and development of drugs. A greater understanding of the way in which individuals with a particular genotype respond to a drug allows manufacturers to identify population subgroups that will benefit most from a particular drug. The increasing emphasis on pharmacogenomics is likely to raise ethical and legal questions regarding, among other things, the design of research studies, the construction of clinical trials and the pricing of drugs.

Ethical guidelines for medical research on workers.

Federal regulations protecting research subjects make special provisions for individuals who are subject to coercion or undue influence. Because they are subject to coercion and undue influence, workers should be considered vulnerable subjects of research. A series of ethical guidelines are proposed for medical research on workers that seek to safeguard the rights of workers and maintain the scientific integrity of research. In general, the guidelines emphasize that participation must be voluntary and knowing, that the confidentiality of medical information must be protected, and that the benefits of the research to the participants must be maximized while the risks are minimized.

Genetic testing, genetic medicine, and managed care.

As modern human genetics moves from the research setting to the clinical setting, it will encounter the managed care system. Issues of cost, access, and quality of care will affect the availability and nature of genetic testing, genetic counseling, and genetic therapies. This Article will explore such issues as professional education, coverage of genetic services, privacy and confidentiality, and liability. It will conclude with a series of recommendations for the practice of genetic medicine in the age of managed care.

Genetic privacy and confidentiality: why they are so hard to protect.

Author notes that widespread concerns have been raised about protecting genetic privacy and confidentiality in insurance and employment. He argues that effective protections are difficult because complicated issues, such as the right of access to health care, are invariably implicated.

A proposed revision of the ACOEM Code of Ethics. American College of Occupational and Environmental Medicine.

The 1993 revision of the American College of Occupational and Environmental Medicine (ACOEM) Code of Ethical Conduct is insufficiently demanding of physicians in important areas, such as conflicts of interest, reporting unethical or incompetent colleagues, and confidentiality of medical information. The International Commission on Occupational Health's International Code of Ethics, drafted for all occupational health professionals worldwide, does not apply well to American legal and economic relationships. The best way to revise the 1993 ACOEM Code is to incorporate key provisions of the American Occupational Medical Association's 1976 Code. A proposed revised ACOEM Code is presented combining elements of the 1993 ACOEM and 1976 AOMA Codes. The resulting code is a clearer description of individual standards of conduct and group ideals.

Are cancer patients subject to employment discrimination?

We sought to determine whether patients undergoing treatment for cancer had experienced discrimination in employment and, if so, how that discrimination was manifested. We also sought to determine what variables affected the rate of discrimination, including age, gender, occupation, and employer size. We surveyed 422 patients diagnosed with cancer who were being treated at an acute-care, comprehensive cancer center in Houston, Texas, or were being followed after therapy. Whereas 76% of respondents indicated that they were working at the time of diagnosis and 82% said that they wanted to work full- or part-time, only 56% were working at the time of the study. Type of occupation was the main determinant of whether individuals were employed after diagnosis. The study documents self-reported discrimination in employment on the basis of cancer. Additional research is needed to determined the measures, including legal recourse, necessary to enable cancer patients to obtain and continue work.

Health hazards among working children in Texas.

This report represents the first attempt to assemble existing data from a variety of sources regarding children less than 18 years of age in the work force in Texas. These data include the frequency of detected violations of child labor laws, reports of injuries to the Texas Workers' Compensation Commission, and work-related deaths as ascertained from death certificates. More than 1,000 minors were detected as being illegally employed in Texas each year since 1986 and nearly 1,100 work-related injuries in children 18 years of age and younger were reported to the Texas Workers' Compensation Commission in 1991. A review of Texas death certificates from 1980 to 1990 revealed 125 work-related fatalities among children. The leading cause of death was motor vehicle injuries, followed by injuries from machinery (usually agricultural machinery). The magnitude and severity of occupational illnesses in working children are unknown. Because of physiologic differences in size, metabolism, and absorption, children may be especially susceptible to work-related injury and illness. Health and safety data on working children in Texas, as in most other places, are fragmented and incomplete. These data are needed to identify children at high risk of injuries and illnesses, to target prevention programs, and to identify areas for additional legislation. More rigorous enforcement of current legislation is also needed.

Genetic testing: employability, insurability, and health reform.

Presently, 85%-90% of individuals with private health insurance are covered under group health insurance, with most covered through employment. Under virtually any system of health care reform likely to be enacted in the near future, employers will continue to play a major role in the funding of private health care. As costs of health care are increasing dramatically, employers and insurance carriers are examining alternatives for controlling health care expenditures. Not all consumers of health care are equal in their rates of consumption. Tremendous savings could be realized by parties responsible for paying for health care if the most expensive (or potentially most expensive) health care users could be identified and their costs shifted to another payer. Genetic testing could play a major role in predictive health screening to identify individuals with the potential for developing cancer. This prospect raises three major problems regarding employability and insurability. First, individuals could be subject to discrimination in employment, with the responsibility for their health coverage shifted to the public sector. Second, privacy and confidentiality could be compromised through the compilation, storage, and release of non-job-related, sensitive medical information. Third, the fear of employment discrimination through employer access to medical records generated in the clinical setting might discourage at-risk individuals from undergoing medically indicated genetic testing. This report reviews these issues and emphasizes that these concerns must be addressed in the context of health care reform as well as through the interpretation of existing legal proscriptions on employment discrimination.

Taking the patient's view of health reform.

To many, health reform seems to consist entirely of enormous changes in how the nation's medical bills will be paid. In reality, sweeping social changes will also accompany reform, including new ways of obtaining a patient's medical history and an end to traditional barriers to health care access. Changes must be made in the nonfinancial elements of the U.S. health system for reform to make a positive difference in patients' lives.