Points of contention: Qualitative research identifying where researchers and research ethics committees disagree about consent waivers for secondary research with tissue and data

• Published in: PloS one 2020-08, Vol.15 (8), p.e0235618-e0235618
• Main Authors: Ballantyne, Angela, Moore, Andrew, Bartholomew, Karen, Aagaard, Nic
• Format: Article
• Language: English
• Subjects: Behavior; Ethical aspects; Medical research; Medicine and Health Sciences; People and places; Research and Analysis Methods; Research ethics; Research scientists; Science Policy
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0235618

This is a multi-method, in-depth, three part qualitative study exploring the regulation and practice of secondary research with tissue and data in a high-income country. We explore and compare the perspectives of researchers, research ethics committees (RECs) and other relevant professionals (e.g. pathologists and clinicians). We focus on points of contention because they demonstrate misalignment between the expectations, values and assumptions of these stakeholders. This is a multi-method study using observational research, focus groups and interviews with 42 participants (conducted 2016-2017) and analyzed using thematic analysis. This research highlights ways in which RECs and researchers may be talking past each other, resulting in confusion and frustration. These finding provide a platform for realignment of the expectations of RECs and researchers, which could contribute to making research ethics review more effective.