How voluntary consent may be overlooked in gene editing clinical trials.

Main Article Content

Sharon E. O’Hara, DrPH, MPH, MS Jodi Halpern, MD, PhD

Abstract

In the United States, advocates have successfully fought for accelerated pathways for FDA approval of novel promissory technologies to address severe unmet medical needs. These pathways can blur the distinction between clinical trials as experiments vs. treatment. In addition, a recent focus on developing individual therapeutics through small clinical trials for people with rare diseases has not included early phases to test safety with healthy human volunteers. Rather, the clinical trials are offered as a therapeutic intervention for those with the targeted genetic condition.


This lack of clarity about the distinction between early-in-human trials and treatment is compounded by the unknowns of innovative promissory technologies, impairing the ability of researchers to convey an accurate and thorough picture of the risks and benefits of participation. In addition, researchers are responsible for ensuring that the potential research subject has understood the information provided about the study and for obtaining informed consent, which is considered valid only under conditions where a person makes a voluntary decision about participation. Scientists’ belief that research subjects may not appreciate what is involved in clinical trials and incentives to recruit participants despite this may create a context in which voluntariness is not fully considered.


When physicians recruit their own patients for clinical trials, the dual role of patient care and trial recruitment may create a communicative context that undermines voluntariness. Physicians may be unaware that the patient’s consent is not truly voluntary for several reasons. One is the normalization of their dual role - both scientists and physicians know they are influential in patients’ decisions. Another is when the physician is convinced of the trial intervention’s benefit as a treatment, despite its experimental status.


In this study, we used qualitative interviews to explore whether and how genome editing scientists and physicians are taking care to ensure research subject voluntariness in the face of potentially irresistible enticements to participate in testing unproven interventions. Moreover, we sought to understand whether the connection between one’s professional role and enrollment of clinical trial subjects influenced how scientists and physicians saw the benefits of trial participation as in the subject's best interests.

Keywords: gene editing clinical trials

Article Details

How to Cite
O’HARA, Sharon E.; HALPERN, Jodi. How voluntary consent may be overlooked in gene editing clinical trials.. Medical Research Archives, [S.l.], v. 12, n. 1, jan. 2024. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/5046>. Date accessed: 03 mar. 2024. doi: https://doi.org/10.18103/mra.v12i1.5046.
Section
Research Articles

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