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臨床試驗(yàn)受試者選擇多樣和公平性，弱勢群體的保護(hù)越發(fā)得到重視。一起來看看FDA是如何對此進(jìn)行解釋的。

問題8.45 :出于知情同意目的，F(xiàn)DA法規(guī)如何定義“弱勢”臨床試驗(yàn)對象？IRB在評估弱勢人群方面的角色如何？以及獲得弱勢群體知情同意有哪些法規(guī)？尤其是，弱勢群體具有哪些特征？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法規(guī)沒有定義“弱勢群體”一詞，盡管它們確實(shí)定義了相關(guān)和相關(guān)術(shù)語，例如“法定代表人”，“兒童”，“” “家庭成員”、“被監(jiān)護(hù)人”和“監(jiān)護(hù)人”。Part50中D子章節(jié)確實(shí)繼續(xù)討論了在臨床試驗(yàn)對兒童的額外保障措施。FDA regulations do not necessarily define the term “vulnerable,” even though they do define related and relevant terms such as “l(fā)egally 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批準(zhǔn)的標(biāo)準(zhǔn)之一（56.111-IRB批準(zhǔn)研究的標(biāo)準(zhǔn)-公平選擇受試者）向 IRB施壓，對研究的審查和批準(zhǔn)時(shí)給對弱勢群體特殊需求給予特殊考量，盡管它這樣做很廣泛?！霸谧鞒鲞@一評估時(shí)[即公平選擇受試者]，IRB應(yīng)考慮研究的目的和進(jìn)行研究的環(huán)境，特別是 認(rèn)識(shí)到研究涉及弱勢群體的特殊問題 ，如兒童、囚犯、孕婦、殘疾人或智障人士 人，或經(jīng)濟(jì)或教育上處于不利地位的人。 當(dāng)IRB確定受試者可能是潛在弱勢人群，IRB必須確保額外的保障措施增加以保護(hù)受試者的權(quán)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月的一次演講中，AngioDynamics的RA / QA / CA副總裁S. Michael Sharp博士，闡述了不同的弱勢的類別，并分享“弱勢”的定義：“那些 相對（或絕對）無法保護(hù)自己的利益的人“（Levine，1986）。Sharp明確了三個(gè)類別， 其中兩個(gè)類別在FDA法規(guī)中直接或間接確定：“依賴”（絕對：囚犯，軍事人員，未成年人;親屬：學(xué)生、雇員、機(jī)構(gòu)化人員、 醫(yī)療依賴人）;和“個(gè)人 屬性“（精神疾病、醫(yī)療無行為能力、 情報(bào)）。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確定了第三類 FDA法規(guī)中似乎沒有完全考慮到的脆弱性（孕婦和經(jīng)濟(jì)之外的處境不利）——“環(huán)境弱勢?！?nbsp;那些受制于環(huán)境弱勢的人包括事故受害者，有急性醫(yī)療必要性或嚴(yán)重醫(yī)療狀況的人，或 貧困的受試者。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.