More ethics in the laboratory, please! Scientists’ perspectives on ethics in the preclinical phase

In recent years there have been calls to improve ethics in preclinical research. Promoting ethics in preclinical research should consider the perspectives of scientists. Our study aims to explore researchers’ perspectives on ethics in the preclinical phase. Using interviews and focus groups, we collected views on ethical issues in preclinical research from experienced (<i>n</i> = 11) and early-stage researchers (ESRs) (<i>n</i> = 14) working in a gene therapy and regenerative medicine consortium. A recurring theme among ESRs was the impact of health-related preclinical research on climate change. They highlighted the importance of strengthening ethics in relations within the scientific community. Experienced researchers were focused on technicalities of methods used in preclinical research. They stressed the need for more safeguards to protect the sensitive personal data they work with. Both groups drew attention to the importance of the social context of research and its social impact. They agreed that it is important to be socially responsible – to be aware of and be sensitive to the needs and views of society. This study helps to identify key ethical challenges and, when combined with more data, can ultimately lead to informed and evidence-based improvements to existing regulations.

近年来，学界呼吁加强临床前研究的伦理规范建设。推进临床前研究伦理建设，应充分考量科研人员的视角。本研究旨在探究科研人员对临床前研究阶段伦理问题的看法。本研究采用访谈与焦点小组讨论的方法，从某基因治疗与再生医学联盟中招募的资深科研人员（n=11）与早期阶段科研人员（Early-stage Researchers, ESRs，n=14）处，收集了他们对临床前研究伦理问题的相关观点。早期阶段科研人员反复提及的核心议题为健康相关临床前研究对气候变化的影响，他们着重强调了加强科研共同体内部关系伦理建设的必要性。资深科研人员则更聚焦于临床前研究所用方法的技术细节，他们呼吁增设更多保护措施，以妥善保护研究过程中涉及的敏感个人数据。两组科研人员均强调了研究的社会语境与社会影响的重要性，双方一致认同科研人员需承担社会责任——即充分认知并关切社会的需求与诉求。本研究有助于明确当前临床前研究面临的核心伦理挑战，若结合更多后续数据，最终可推动现有监管体系在充分知情且基于实证的前提下得到优化完善。