Data and tissue research without patient consent: A qualitative study of the views of research ethics committees in New Zealand.

PURPOSE: Secondary use of clinical tissue and data is an increasingly important platform for health research. Many jurisdictions allow research ethics committees (RECs) or institutional review boards (IRBs) the flexibility to waive the requirement for patient consent for secondary research. But most RECs/IRBs conduct their meetings "behind closed doors" and their decision-making processes are opaque to researchers and academics. The purpose of this study was to assess how New Zealand RECs weigh the potentially competing goals of enabling research and protecting patients' rights.

METHODS: We used a participatory observation approach involving observation sessions (3), focus groups (4), and individual interviews (2) with members of the national-level health and disability ethics committees (HDECs) in 2016.

RESULTS: Twenty-four HDEC members participated (75% participation rate). Participants described the core ethical issues as consent, public benefit, and potential harms (to both collectives and individuals). Participants felt the weight of responsibility in waiving patients' right to consent. Time pressure and a lack of specificity in the guidelines resulted in increased anxiety and stress. Participants' comments demonstrate multiple different methods for defining and assessing public benefit.

CONCLUSION: IRB/REC members have rich experience of moral reasoning regarding research ethics, especially in areas where the official guidance is underdeveloped. Their insights can contribute to the academic literature and suggest improvements in the review process and in ethical regulation and guidelines.