Balancing Justice and Autonomy in Clinical Research With Healthy Volunteers

Abstract

In clinical research, ethics review generally first examines whether study risks are reasonable in light of benefits provided. Through informed consent, then, prospective subjects consider whether the risk/benefit balance and procedures are reasonable for them. Unique ethics issues emerge in clinical research with healthy volunteers. Certain types of studies only recruit healthy volunteers as participants. Phase 1 studies, for example, including first time in human studies of investigational drugs and vaccines, generally are conducted in healthy volunteers. Although such research carries inherent and often unknown risks, healthy subjects provide the most efficient target population in which to conduct such research, as these volunteers generally are free of concurrent diseases or medications that could confound interpretation of toxicity. Other studies enrolling healthy volunteers often are simply looking for the most scientifically sound population for the study of normal human physiology.

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies

“…[2][3][4][5][6] Over one third of participants in this study experienced no adverse events. Of the 64% of participants who did, the majority (nearly 85%) of adverse events were mild.…”

“…Yet patient advocates, bioethicists, and researchers criticize phase I research because they claim that healthy participants are exposed to high risks of serious harms with no possibility of clinical benefit. [2][3][4][5][6][7] This assumption is obviated when non-oncology phase I research poses few serious risks to participants but is reinforced by episodes such as the TeGenero case in which six healthy individuals in a phase I study experienced life threatening reactions. [8][9][10] Robust studies exist on the risks and clinical benefits of phase I oncology trials that enroll patients with cancer.…”

Evaluation of factors that motivate participants to consent for non-therapeutic trials in India

“…Several studies have observed that a personal approach by skilled clinical trial staff leading to development of a good relationship with study participants during the trial can have a large impact on recruitment of new participants in the study through recommendations from earlier participants, as well as repeat participation in future studies 4 9. Almeida et al 4 reported that ‘word of mouth’ was the source of information in 94.9% participants.…”

Risks of phase I research with healthy participants: A systematic review

“…3,4 Third, payments may result in some individuals regarding repeated research participation as a full-time occupation that might pose high risks and offers few rewards. 5,6 Fourth, some express concern that phase I trials enroll low-income participants who endure high trial risks but have limited access to the medical products they help develop. 6–9 …”