Ethical and Legal Considerations in Molecular Medicine

If your genetic material is taken as part of a medical procedure, can you ask for it back? Who owns it? If that material is used to develop commercially available medications, should you be compensated?

Ethical and legal issues abound in all fields of medicine. While molecular medicine shares some concerns with other disciplines, it also faces unique challenges. Below we’ll lay out some of these complex ethical issues, recognizing that universally accepted solutions will not be easy, if possible at all.

Where Ethics and Laws Come Into Play in Molecular Medicine

Informed Consent

Healthcare professionals have a legal and ethical duty to ensure a patient understands both the potential risks and benefits of an intervention, as well as alternative options. The patient must be of sound mind and capable of understanding these implications.

The Right Not to Know

Individuals can now have their genome sequenced, and millions have taken advantage of the opportunity, enabling them to learn their likelihood of developing certain diseases and conditions. Yet not everyone wishes to know what their DNA reveals, opting to exercise the “right not to know.” This remains controversial, since these genetic findings could adversely affect their health. The scientific community is still debating whether those opting out should be encouraged to reconsider.

Privacy and Confidentiality

In genomics research and other types of medical and scientific studies, protecting the privacy of participants is paramount. Laws like HIPAA are designed for this purpose. Yet, for interventions to be broadly beneficial, research data must also be shared widely. This presents an ethical conundrum not exclusive to molecular medicine.

Considerations of Molecular Epidemiology

Epidemiology studies health risks of populations by examining individuals, requiring epidemiologists to balance individual and societal needs. This can create challenges for molecular epidemiologists, who must share information in a way that respects individual and collective rights. The growing number and variety of studies in molecular epidemiology only makes establishing ethical standards more complex.

Ownership of Tissue Samples and Other Genetic Material

The landmark case Moore v. Regents of the University of California helped define the rights of individuals whose genetic material has been used for commercial purposes.

In 1976, doctors removed the spleen of a leukemia patient and used material from the organ to patent a cell line contracted for commercial therapeutic purposes. The patient sued and, after some legal back and forth, was determined to be the owner of his own genetic sample, having only consented to the spleen’s removal, not its use for profit. The case continues to resonate as genetic research becomes more prevalent and sophisticated.

Equality of Access

New treatments for disease may be developed and made widely available, but cost and other factors can limit accessibility across economic classes and regions. While revenue from such treatments fuels ongoing research, high costs can also put them out of reach for many, raising fundamental ethical questions.

Research Practices

Ethics are a major concern in medical research, which often involves living human and animal subjects. Human subjects who have a personal stake in their participation — whether they suffer from the disease being researched or know someone who does — may be eager to become involved, but it’s crucial not to exploit them because of their need. Subjects must know all risks and consent wholeheartedly.

The FDA and other governmental agencies have established regulations that govern the treatment and protection of human research participants. The Animal Welfare Act, enforced by the USDA, is the primary source of guidance for animal research. Debate over the moral implications of this type of research persists.

Stigmatization

If a genetic predisposition is attributed to a specific demographic group (e.g., one ethnicity is determined to be more likely to develop a given disease), members may face negative attention. While it’s important for at-risk people to understand their circumstances, stigmatization can result.

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Sources:
https://www.acpjournals.org/doi/10.7326/M22-0743
https://www.spandidos-publications.com/ijmm
https://link.springer.com/referenceworkentry/10.1007/978-1-4614-4800-6_43