Elks M L
Division of Endocrinology, Texas Tech University Health Sciences Center, Lubbock 79430.
J Lab Clin Med. 1993 Aug;122(2):130-6.
Institutional review boards for the use of human subjects in scientific studies were initially established to focus on protection of human subjects from the risks of research. It has become evident in recent years, however, that it is also important to protect the rights of individuals to have access to the benefits of research participation. These include, but are not limited to, certain experimental drugs or treatments, closer monitoring, free care or direct remuneration, and societal benefits of results of studies on specific populations. Researchers, so long sensitized by their respective institutional review boards to the need for protection of the subjects, now must also focus on the added burden of efforts to include individuals and the increased efforts it may take to protect the safety and rights of certain populations, including patients with AIDS, women, minorities, children, and the elderly. Additional care must be taken to design appropriate studies, recruit an appropriate spectrum of the population, craft a complete yet understandable and nondeterent informed consent form, and make efforts to assure that participants are informed.
科学研究中使用人类受试者的机构审查委员会最初设立的目的是专注于保护人类受试者免受研究风险。然而，近年来已经很明显，保护个人获得参与研究益处的权利也很重要。这些益处包括但不限于某些实验药物或治疗、更密切的监测、免费护理或直接报酬，以及针对特定人群的研究结果所带来的社会益处。研究人员长期以来已被各自的机构审查委员会提醒要保护受试者，但现在他们还必须关注纳入个体所带来的额外负担，以及为保护某些人群（包括艾滋病患者、妇女、少数群体、儿童和老年人）的安全和权利可能需要付出的更多努力。必须格外小心地设计合适的研究、招募合适范围的人群、精心制定一份完整但易懂且不具威慑力的知情同意书，并努力确保参与者得到充分告知。
