Table 1.

Targeted Ethical Criteria for Phase I Healthy Volunteer Trials

Criteria	Definition	Significance for phase I healthy volunteer trials
Translational science value	Clinical research should be designed to ensure that results are as accurate and informative as possible for clinical populations.	Phase I healthy volunteer clinical trials should be designed, particularly regarding key demographic factors such as age and sex, to include participants who can provide externally valid information about the safety and tolerability of novel therapies.
Fair opportunity and burden sharing	Participants for clinical trials should be recruited and selected through processes that grant people a fair opportunity to participate and that aim to distribute the risks and burdens of participation equitably.	Participants for phase I healthy volunteer trials should be recruited and selected according to transparently communicated criteria, on the basis of wide outreach, and using relevant scientific bases. Disadvantaged minority group members and underserved communities should not be disproportionately targeted for enrollment.
Fair compensation for service	When offered, clinical trial compensation should be commensurate with the requirements of participation and disbursed in a timely manner.	Phase I healthy volunteer compensation amounts and payment schedules should adequately reflect the substantial time, inconvenience, and body-monitoring activities required of participants, as well as the management of expected adverse events.
Experiential welfare	Research-related harms should be minimized and the psychological, emotional, and physical well-being of participants supported, particularly, but not only, while they are confined to an in-patient or residential clinic.	Phase I clinic environments should be structured and maintained in keeping with high participant welfare standards. The frequency and invasiveness of medical procedures as well as restrictions on participant activities should be minimized and scientifically well justified.
Enhanced voice and recourse	Study participants should have meaningful opportunities to express concerns regarding their experiences in clinical trials and have direct recourse for wrongful treatment or harms incurred through trial participation.	Healthy volunteers should be invited and incentivized to participate in efforts to improve phase I trials through community engagement or other mechanisms. Provision of recourse for wrongs or harms experienced during trial participation should be mandated and accessible for participants. Procedures for reporting and responding to research complaints should be formalized, as should protection from reprisal.