Iltis Ana S, Wall Anji, Lesandrini Jason, Rangel Erica K, Chibnall John T
Saint Louis University, St Louis, MO 63103, USA.
J Empir Res Hum Res Ethics. 2009 Mar;4(1):37-41. doi: 10.1525/jer.2009.4.1.37.
REGULATIONS AND POLICIES GOVERNING research, codes of ethics, and the research ethics literature reflect the need to provide special protections to vulnerable research participants. Nevertheless, there is disagreement about who is vulnerable and why, what protections are appropriate, and when to disallow research involving vulnerable persons. The Common Rule (CR) governs much of the human research conducted in the United States and the Office for Human Research Protections (OHRP) oversees much of this research. The CR requires special protections for pregnant women, fetuses, neonates, prisoners, and children. Although it also requires that researchers employ "additional safeguards" to protect other vulnerable persons, it does not define vulnerability or identify appropriate "safeguards." Very little is known about how OHRP interprets the "additional safeguards" requirement. We examined all letters of determination posted on the OHRP website between July 1, 2000 and December 31, 2006 (n = 636) to study the extent to which OHRP addressed, in its audits and investigations, the requirement to protect vulnerable persons. The letters did not reveal guidance on understanding vulnerability, determining whether a study includes vulnerable persons or protecting vulnerable participants. If institutions and investigators are to fulfill the ethical obligation to provide appropriate safeguards when conducting research on vulnerable persons, they must develop and implement mechanisms to identify and address vulnerability.
有关研究的法规和政策、伦理准则以及研究伦理文献都反映出有必要为易受伤害的研究参与者提供特殊保护。然而，对于谁是易受伤害者以及原因、何种保护措施恰当以及何时应禁止涉及易受伤害者的研究，存在不同意见。《共同规则》（CR）适用于美国开展的大部分人体研究，而人类研究保护办公室（OHRP）负责监督其中的大部分研究。《共同规则》要求对孕妇、胎儿、新生儿、囚犯和儿童给予特殊保护。虽然它还要求研究人员采取“额外保障措施”以保护其他易受伤害者，但并未对易受伤害性进行定义，也未确定适当的“保障措施”。对于OHRP如何解释“额外保障措施”要求，人们知之甚少。我们审查了2000年7月1日至2006年12月31日期间张贴在OHRP网站上的所有判定函（n = 636），以研究OHRP在其审计和调查中落实保护易受伤害者要求的程度。这些信函并未就理解易受伤害性、确定一项研究是否包括易受伤害者或保护易受伤害参与者提供指导。如果机构和研究人员要履行在对易受伤害者进行研究时提供适当保障措施的伦理义务，他们必须制定并实施识别和应对易受伤害性的机制。
