临床试验受试者选择多样和公平性，弱势群体的保护越发得到重视。一起来看看FDA是如何对此进行解释的。

问题8.45 :出于知情同意目的，FDA法规如何定义“弱势”临床试验对象？IRB在评估弱势人群方面的角色如何？以及获得弱势群体知情同意有哪些法规？尤其是，弱势群体具有哪些特征？For the purposes of informed consent, how do FDA regulations define a “vulnerable” clinical trial subject, what is the IRB’s role in determining vulnerability, and what special provisions do these regulations establish for obtaining the informed consent of vulnerable subjects? Specifically, what characteristics are considered to make a subject vulnerable?

FDA法规没有定义“弱势群体”一词，尽管它们确实定义了相关和相关术语，例如“法定代表人”，“儿童”，“” “家庭成员”、“被监护人”和“监护人”。Part50中D子章节确实继续讨论了在临床试验对儿童的额外保障措施。FDA regulations do not necessarily define the term “vulnerable,” even though they do define related and relevant terms such as “legally authorized representative,” “children,” “family member,” “ward,” and “guardian.”Part 50, Subpart D does go on to discuss additional safeguards for children in clinical trials.

IRB批准的标准之一（56.111-IRB批准研究的标准-公平选择受试者）向 IRB施压，对研究的审查和批准时给对弱势群体特殊需求给予特殊考量，尽管它这样做很广泛。“在作出这一评估时[即公平选择受试者]，IRB应考虑研究的目的和进行研究的环境，特别是 认识到研究涉及弱势群体的特殊问题 ，如儿童、囚犯、孕妇、残疾人或智障人士 人，或经济或教育上处于不利地位的人。 当IRB确定受试者可能是潜在弱势人群，IRB必须确保额外的保障措施增加以保护受试者的权利和福利。 One criterion for IRB approval (56.111-Criteria for IRB approval of research-Equitable selection of subjects) puts the burden on IRBs to consider the special needs of vulnerable populations in their review and approval of research, although it does so broadly. “In making this assessment [that the selection of subjects is equitable] the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons.” When the IRB determines that subjects may be potentially vulnerable, the IRB must ensure additional safeguards have been added to protect the rights and welfare of subjects.

在2010年6月的一次演讲中，AngioDynamics的RA / QA / CA副总裁S. Michael Sharp博士，阐述了不同的弱势的类别，并分享“弱势”的定义：“那些 相对（或绝对）无法保护自己的利益的人“（Levine，1986）。Sharp明确了三个类别， 其中两个类别在FDA法规中直接或间接确定：“依赖”（绝对：囚犯，军事人员，未成年人;亲属：学生、雇员、机构化人员、 医疗依赖人）;和“个人 属性“（精神疾病、医疗无行为能力、 情报）。At a presentation in June 2010, S. Michael Sharp, Ph.D., vice president of RA/QA/CA for AngioDynamics, explored different categories of vulnerability, and shared a definition of “vulnerable”: “those who are relatively (or absolutely) incapable of protecting their own interests” (Levine, 1986). Sharp identified three categories of vulnerability, two of which seem to be identified directly or indirectly in FDA regulations: “dependency” (absolute: prisoners, military personnel, minors未成年人; relative: students, employees, institutionalized persons, medically dependent persons); and “personal attributes” (mental illness, medical incapacitation, intelligence).

但Sharp确定了第三类 FDA法规中似乎没有完全考虑到的脆弱性（孕妇和经济之外的处境不利）——“环境弱势。“ 那些受制于环境弱势的人包括事故受害者，有急性医疗必要性或严重医疗状况的人，或 贫困的受试者。But Sharp identified a third category of vulnerability that does not seem to be accounted for fully in FDA regulations (outside of pregnant woman and economically disadvantaged)—“circumstantial vulnerability.” Those subject to circumstantial vulnerability include accident victims, those with an acute medical necessity or serious medical condition, or subjects who are impoverished.