Posted: January 11th, 2024

As genetic testing becomes increasingly prevalent in clinical practice

Or you can choose the topic of malpractice in clinical genetic research: an overview. In recent years, genetic predisposition tests are becoming increasingly popular. Yet, this leaves room for mistakes and other types of malpractice.
As genetic testing becomes increasingly prevalent in clinical practice, so too does the potential for errors and other issues that could lead to malpractice claims. This paper will examine some of the key challenges and considerations around malpractice in the field of clinical genetic research based on a review of recent literature and cases. Specifically, it will discuss reporting of results, expanding liability, duty of care obligations, and privacy/data issues.
Reporting of Results
Accurate reporting and reevaluation of genetic test results over time is crucial given that variant interpretation is ongoing (Kalia et al., 2017). A review of malpractice claims related to genetic testing found that misinterpretation of results and failure to confirm or reanalyze results were common issues (Vears et al., 2016). As more data is collected, results that were initially negative could later be reclassified as positive or variants of unknown significance could be resolved. Proper informed consent and follow-up counseling are also important for managing patient expectations about the evolving nature of results (Vears et al., 2016).
Expanding Liability

There are indications that liability related to the clinical use of genetic information is expanding. A recent lawsuit involved a genetic counselor who failed to detect and properly disclose a patient’s test results, which indicated an increased cancer risk (Kampourakis, 2022). Another involved a lab that did not reanalyze a sample after a variant was reclassified, missing an opportunity for improved patient care (Kampourakis, 2022). As genetic testing becomes more mainstream, we may see more such malpractice claims regarding responsibilities around accurate and timely reporting of results.
Duty of Care Obligations
There is ongoing discussion about what specific duties of care are owed to patients regarding genetic testing. For example, which incidental or secondary findings warrant investigation and disclosure (Kampourakis, 2022; Vears et al., 2016)? As tests reveal increasingly detailed genomic information, delineating the scope of the clinician’s duty becomes more complex. Failure to adhere to accepted standards could open the door to malpractice allegations (Kampourakis, 2022).
Privacy and Data Sharing

Researchers must address privacy issues, data security standards, and informed consent for data sharing (Christofides and O’Doherty, 2016). Genetic data contains highly sensitive personal information, so strict protocols are needed around its collection and use. A data breach or inappropriate sharing of results could understandably lead to legal claims (Christofides and O’Doherty, 2016). Researchers must balance open data practices with strong privacy protections to avoid these types of issues.
Discussion and Conclusion
As the above analysis shows, there are several areas of ongoing discussion and development around malpractice in clinical genetic research. By continuing to examine challenges proactively, establish best practices, and engage stakeholders across disciplines, the research community can help ensure genetic information is used appropriately and risks are mitigated. Some key steps include developing robust systems for accurate, long-term result management; clarifying standards of care; and implementing rigorous privacy safeguards (Vears et al., 2016; Christofides and O’Doherty, 2016; Kampourakis, 2022). With diligence in these areas, the promise of precision medicine through genetic research can be better realized while avoiding issues that could lead to malpractice claims.

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