Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD, 20892-1156, USA,
Theor Med Bioeth. 2014 Apr;35(2):157-73. doi: 10.1007/s11017-014-9285-5.
Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as "nonbeneficial" research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual's behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness-treat like cases alike-imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent?
研究和干预措施有时会为受试者提供潜在的利益补偿他们所面临的风险。而我称之为“非有益”的研究，则不会为受试者提供潜在的利益补偿。这些研究和干预措施有可能利用受试者为他人谋取利益，当研究人员招募那些无法表示知情同意的个体时，这种担忧尤为突出。美国人类受试者研究法规试图通过为无法表示同意的受试者进行非有益研究提供严格保护来解决这一问题。通常情况下，无法表示同意的人类，如儿童，只有在研究风险较低且有可能收集到具有足够价值的信息以证明风险合理时，才能参与非有益研究，即合适的替代同意者代表个人表示同意。相比之下，美国对非人类灵长类动物进行非有益研究的法规并不包括这些保护措施，尽管这些动物也涉及无法表示同意且面临为他人谋取利益的风险的受试者。这种监管保护措施的差异是否合理？或者公平原则——对类似情况一视同仁——是否意味着对非人类灵长类动物进行非有益研究的法规应包括与适用于无法表示同意的人类进行非有益研究的法规类似的保护措施？
