Gordon Bruce G
Assistant Vice-Chancellor for Regulatory Affairs, Executive Chairman, Institutional Review Boards, and Professor, Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE.
Ochsner J. 2020 Spring;20(1):34-38. doi: 10.31486/toj.19.0079.
The concept of vulnerability is a cornerstone of the theoretical basis and practical application of ethics in human subjects research. Risks to humans participating in research must be minimized; that is, subjects must be offered protection from risks. Vulnerable subjects require additional protections. This paper reviews the ethical and conceptual basis of vulnerability within the context of human subjects research and suggests a basic approach that institutional review boards (IRBs) can use when considering if the research includes adequate safeguards to protect the rights and welfare of subjects who are likely to be vulnerable. Two distinct approaches to describing the features that make a person vulnerable are the categorical approach and the contextual approach. The categorical approach considers certain groups or populations as vulnerable. This approach is not optimal because it does not address persons with multiple vulnerabilities, does not account for variation in the degree of vulnerability within the group based on individual characteristics, and classifies certain persons as vulnerable rather than identifying situations in which individuals might be considered vulnerable. The alternate contextual approach allows for a more nuanced understanding of the nature of the vulnerability than the categorical approach and therefore a more focused approach to safeguards. The IRB is charged with ensuring that additional safeguards to protect the rights and welfare of subjects who are likely to be vulnerable are included in the study under review. To make this determination, the IRB might be advised to consider two questions: (1) is inclusion necessary? and (2) if so, are safeguards adequate? Although vulnerability is often presented as a yes/no consequence related to some characteristic of a group, a more accurate approach is to consider vulnerability as occurring along a spectrum of seriousness and as a consequence of situations and context. With this idea in mind, investigators and IRBs are advised to take a stepwise approach to determining if the study meets the regulatory and ethical admonition to ensure that safeguards protect the rights and welfare of vulnerable subjects.
脆弱性概念是人类受试者研究伦理理论基础和实际应用的基石。参与研究的人类所面临的风险必须降至最低；也就是说，必须为受试者提供风险保护。脆弱受试者需要额外的保护。本文回顾了人类受试者研究背景下脆弱性的伦理和概念基础，并提出了一种基本方法，机构审查委员会（IRB）在考虑某项研究是否包含足够的保障措施以保护可能脆弱的受试者的权利和福利时可以采用。描述使人脆弱的特征有两种不同的方法，即分类法和情境法。分类法将某些群体或人群视为脆弱群体。这种方法并非最佳选择，因为它没有涉及具有多种脆弱性的人，没有考虑到基于个体特征的群体内部脆弱程度差异，并且将某些人归类为脆弱群体，而不是识别个体可能被视为脆弱的情况。另一种情境法比分类法更能细致入微地理解脆弱性的本质，因此在保障措施方面的方法更具针对性。IRB负责确保在正在审查的研究中纳入额外的保障措施，以保护可能脆弱的受试者的权利和福利。为了做出这一决定，建议IRB考虑两个问题：（1）纳入是否必要？（2）如果是，保障措施是否充分？尽管脆弱性通常被呈现为与某个群体的某些特征相关的是/否结果，但更准确的方法是将脆弱性视为沿着严重程度的连续体出现，并且是情况和背景的结果。考虑到这一观点，建议研究者和IRB采取逐步方法来确定研究是否符合监管和伦理要求，以确保保障措施保护脆弱受试者的权利和福利。
