Promoting Ethical Payment in Human Infection Challenge Studies

Area of Science:

• Medical Ethics
• Infectious Disease Research
• Clinical Trial Design

Background:

• Human infection challenge studies (HICS) are crucial for developing interventions against emerging infectious diseases like SARS-CoV-2.
• Ethical considerations surrounding participant remuneration in HICS require careful examination to ensure fairness and prevent undue influence.
• Existing frameworks for clinical research payment can be adapted for HICS, but specific factors need particular attention.

Purpose of the Study:

• To address ethical questions regarding the appropriate payment for participants in SARS-CoV-2 human infection challenge studies (HICS).
• To adapt existing ethical payment frameworks for the unique context of HICS.
• To develop a systematic approach for assessing ethically justifiable payment amounts in SARS-CoV-2 HICS.

Main Methods:

• Convening a multidisciplinary working group to discuss ethical payment issues for SARS-CoV-2 HICS.
• Applying a standard ethical payment framework (reimbursement, compensation, incentives) to HICS.
• Identifying and analyzing salient factors specific to HICS, including confinement, risk, and participant trust.
• Developing a payment worksheet to guide ethical assessment of remuneration.

Main Results:

• The established ethical payment framework for clinical research is applicable to HICS.
• Key factors influencing payment decisions in SARS-CoV-2 HICS include confinement duration, anticipated discomfort, perceived risks, participant motivations, and trust.
• A practical tool (payment worksheet) has been created to assist in determining justifiable payment levels.

Conclusions:

• Ethically justifiable payment for SARS-CoV-2 HICS participants can be determined using a structured approach.
• Balancing participant welfare with research recruitment and retention is essential.
• The developed framework and worksheet provide guidance for sponsors, researchers, and ethics reviewers in setting fair compensation for HICS participants.