Patenaude Johane, Grant Andrew M, Xhignesse Marianne, Leblanc Frédéric, Courteau Josiane
Department of Surgery, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada.
J Gen Intern Med. 2008 Jan;23 Suppl 1(Suppl 1):27-31. doi: 10.1007/s11606-007-0410-2.
Various stakeholders can have differing opinions regarding ethical review when introducing new procedures with patients.
This pilot study examines the way in which Research Ethics Boards (REBs; Institutional Review Boards) and clinical biochemists (CBs; laboratory medicine specialists) differ in their interpretation of what is research and what should be considered common practice versus innovation versus experimentation when introducing new procedures with patients. It also explores whether these groups agree on who is responsible for the ethical review of new procedures.
A validated case scenario for the introduction of a new diagnostic test into clinical practice was sent to CBs and REBs across Canada. Participants were asked to determine whether the scenario constituted research; whether the test procedure should be considered as experimental, innovative, or commonly accepted care; and whether the project required approval by a REB and, if not, who should be responsible for ethical review.
Results showed 81% of 37 CBs and 52% of 27 REBs identified the scenario as research. Responsibility for ethical review was assigned to REBs by 44% of REBs and 54% of CBs. Of all participants, 53% classified the test procedure as 'innovative', 8% as 'experimental', whereas 17% classified it as 'commonly accepted'.
This pilot study indicates a substantial variation in the ethical assessment of innovation in clinical care. This suggests the need to further elaborate on the types of innovation in health care and categorize the nature of the risks associated with each.
在将新程序引入患者治疗过程中，不同利益相关者对于伦理审查可能存在不同观点。
本试点研究考察了研究伦理委员会（REBs；机构审查委员会）和临床生物化学家（CBs；检验医学专家）在对何为研究以及在将新程序引入患者治疗时，哪些应被视为常规做法、创新做法或实验做法的理解上存在的差异。研究还探讨了这些群体在谁应对新程序进行伦理审查这一问题上是否达成一致。
向加拿大各地的临床生物化学家及研究伦理委员会发送了一份经过验证的关于将一项新诊断测试引入临床实践的案例。参与者被要求确定该案例是否构成研究；测试程序应被视为实验性、创新性还是普遍接受的治疗方法；该项目是否需要研究伦理委员会的批准，如果不需要，谁应负责伦理审查。
结果显示，37名临床生物化学家中的81%以及27名研究伦理委员会成员中的52%将该案例认定为研究。44%的研究伦理委员会成员和54%的临床生物化学家将伦理审查责任归于研究伦理委员会。在所有参与者中，53%将测试程序归类为“创新”，8%归类为“实验”，而17%将其归类为“普遍接受”。
本试点研究表明，临床护理创新的伦理评估存在很大差异。这表明有必要进一步阐述医疗保健创新的类型，并对与之相关的各类风险的性质进行分类。
