Is Genetic Research An Unethical And Immoral Act?

Introduction

Research in human genetics currently involves the effort to identify the location and function of the roughly 40,000-80,000 genes that make up the human genome, with the aim of developing diagnostic and treatment techniques for a host of hereditary diseases. This research involves unusual risks for subjects due to the close link between biological heritage and individual identity, and the fact that genetic information obtained from one individual usually has implications for family members. How this information is or may be used by social institutions such as employers and insurers also poses risks for prospective subjects. However, in many cases the risks are unknown or there are no clear guidelines for how to address them.

Special Concerns With Genetic Research

Family/Cultural Issues

Genetic information is often considered "special," or different from other kinds of medical information because of its close association with individual identity, which is due in part to the common assumption that genes are determinative of human health and behavior. This assumption creates opportunities for social stigma and discrimination by employers and insurers.

In addition, the fact that genetic information about an individual reveals information about relatives creates new and complex ethical issues, particularly regarding privacy and confidentiality (MacKay, 2003)

Risk Interpretation

Genetic information is in most cases probabilistic, providing information about risks, not definitive diagnoses. The interpretation of genetic risks is a complex process, influenced by numerous factors. For this reason, it is generally agreed that when research involves disclosure of genetic information to subjects, such disclosure should always be accompanied by genetic counseling. (Assessing Genetic Risks, Ch. 4; NSGC and ASCO Position papers, Holtzman and Watson, 2007).

Ethical Conduct Of Genetic Research

Informed Consent

Informed consent is required in all research in which genetic data may be directly or indirectly linked to subjects. Depending on the protocol, the following topics should be considered for inclusion in the consent process and forms. (Some of these topics receive more discussion later in this outline.)

Content Of Consent Process

(IRB Guidebook; MacKay, 2003; Reilly et al., 2007; ASHG Report):

• What is being studied and why

• Why the particular individual or population is being asked to participate

• Who is doing the research, including any commercial partners?

• Procedures involved in participation

• Psychosocial risks: issues of identity, stigma, family stress, guilt, the burden of knowledge, the possibility of unanticipated findings (i.e. false paternity, etc.)

• Benefits of participation: may provide reassurance, create opportunities for preventive interventions or medical treatment, or help others in the future

• Interests of family members: right not to know information about oneself; (arguable) duty of physicians to warn individuals at risk; confidentiality issues

• Confidentiality: how to maintain; who has access to genetic information; limits of confidentiality

• Risks of discrimination from insurers/employers; limits of legal protection

• Circumstances for collection, storage, and future use of genetic samples

• Whether and when research results will be disclosed

• Right of subjects to withdraw themselves from study without penalty

• Costs of participation

Layered Consent

An option for protocols that involve a variety of procedures, including requesting permission for collecting and storing ...