Department of Social Medicine, School of Medicine, University of North Carolina at Chapel Hill, 333 South Columbia Street, Rm 347 MacNider, Chapel Hill, NC 2799-7240, USA.
Am J Med Sci. 2011 Oct;342(4):267-72. doi: 10.1097/MAJ.0b013e31822a6c47.
For as long as the federal regulations governing human subjects research have existed, the practice of informed consent has been attacked as culturally biased, legalistic, ritualistic and unevenly enforced. Its focus on meeting the regulatory requirements is seen as undermining a truly ethical process that produces informed and voluntary participation in medical research. Recent changes in the clinical translational research enterprise, with large scale genomic and other data sharing made possible by advanced bioinformatic technologies, may further challenge this goal. Study participants are asked to consent to future studies with unspecified aims, broad data sharing policies and ongoing uncertainties regarding confidentiality protections and the potential benefit of incidental genomic research findings. Because more research is conducted under these new conditions, the very nature of the researcher-subject relationship is shifting and will require new governance mechanisms to promote the original goals of informed consent.
只要联邦法规管理人类主体研究存在，知情同意的实践就一直受到攻击，被认为是文化偏见、法律主义、仪式主义和执行不均等。它对满足监管要求的关注被视为破坏了一个真正的伦理过程，该过程产生了在医学研究中知情和自愿的参与。最近临床转化研究企业的变化，由于先进的生物信息学技术使得大规模基因组和其他数据共享成为可能，可能会进一步挑战这一目标。研究参与者被要求同意未来的研究，这些研究的目的不明确，数据共享政策广泛，并且关于保密性保护和偶然发现的基因组研究结果的潜在益处存在持续的不确定性。由于更多的研究是在这些新的条件下进行的，研究人员与研究对象之间的关系的本质正在发生变化，这将需要新的治理机制来促进知情同意的最初目标。
