Perspectives of research ethics committee members on human challenge studies in the development of vaccines against COVID-19: a mixed methods study.

Pan, Zihan; Chu, Hongling; Zhang, Yu; Hong, Xue; Liang, Lijun; Zhao, Wenzhi; Chen, Yahong; Song, Chunli

BACKGROUND Vaccines are considered the most effective protection against the coronavirus disease 2019 (COVID-19). Human Challenge Studies can help to shorten the development process of vaccines. The reviewers' opinions from research ethics committees (REC) play an essential gate-keeping role in determining whether a clinical trial can be conducted or not. METHODS A convergent mixed-methods study was conducted in a leading general hospital in China. A total of 58 REC members from the institution were invited to participate in an online questionnaire survey. According to the result of the quantitative survey, 15 of these REC members were purposefully selected to participate in qualitative interviews further. Quantitative data were analyzed using descriptive statistical techniques, and thematic analysis was used to analyze the qualitative data. Findings from the quantitative and qualitative analyses were synthesized to deeply illustrate the attitudes, views, and suggestions of REC members on human challenge studies to develop COVID-19 vaccination. RESULTS The response rate of the online questionnaire was 62% (36/58), and 15 of the respondents were interviewed. All participants deemed that the human challenge study should provide compensation to its participants and that sufficiently informed consent is necessary. The human challenge study was disagreed with by 38.9% of participants. The key points of concern raised were representativeness and fairness of participant selection, benefit, and risk, vulnerable groups, compensation to participants, informed consent, and general view on human challenge studies. CONCLUSIONS Human challenge studies helped accelerate the development of vaccines for disease control to a certain extent, but the bottom line of medical ethics should not have been broken. At any time, the rights and interests of research participants should come first.