Mammel K A, Kaplan D W
Department of Pediatrics, University of Colorado Health Sciences Center, Denver, Colorado, USA.
J Adolesc Health. 1995 Nov;17(5):323-30. doi: 10.1016/1054-139x(95)00176-s.
A national survey of institutional review boards (IRBs) was conducted to determine: (1) the current practices of IRBs concerning consent for adolescent minors; and (2) the existence of support for changes in the federal regulations for research on adolescents.
Six hundred surveys were mailed in two waves to all IRB chairs in the United States, with the exception of highly specialized institutions. The survey consisted of three sections. Section 1 assessed demographic data, such as institution type; presence of personnel trained in adolescent health; and number of protocols involving adolescents reviewed annually. Section 2 presented a series of twelve scenarios for which respondents stated whether their IRB would waive parental consent under present federal regulations. These scenarios varied the sensitivity of information and procedural invasiveness, and ranged from simple satisfaction surveys to experimental drug treatment for AIDS. Section 3 assessed whether respondents would recommend changes in current federal regulations that would enable adolescent minors to provide their own consent to research participation. To this end, respondents indicated whether minor consent alone is sufficient or if parental consent should be required for 10 general research categories that paralleled the level of invasiveness of the scenarios presented in Section 2.
Two hundred and thirty-three surveys (39%) were returned and 183 (30%) were fully scorable. Within group comparisons for IRBs were conducted using Chi-square statistics. Seventy percent of respondent IRBs required parental consent for all research on minors, and IRBs reviewing more than 10 adolescent protocols per year were less likely to require parental consent (p < .01). Responses did not differ by institution type or presence of personnel trained in adolescent health. Fifty-two percent of respondent IRBs required parental consent for a simple satisfaction survey, and only 29% of IRBs would waive parental consent for an anonymous HIV seroprevalence study. Over one-half of IRBs supported changes in regulations that would enable minors to provide informed self-consent for seven of 10 general research categories: anonymous surveys (supported by 93%), research involving sensitive material if nothing more than survey (89%) or venipuncture (53%) were involved, and research on diseases for which minors may consent to treatment including survey (93%), venipuncture (68%), or medication approved for use in pediatric patients (57%).
Even though IRBs practice under the same federal regulations there is a broad spectrum of interpretation. Considerable support exists for changing the guidelines for certain categories of research involving adolescents. Federal regulations need to be clarified for meaningful and necessary research on adolescents to take place.
开展一项针对机构审查委员会（IRB）的全国性调查，以确定：（1）IRB目前在青少年未成年人同意方面的做法；（2）是否存在对联邦青少年研究法规变革的支持。
除高度专业化机构外，分两波向美国所有IRB主席邮寄了600份调查问卷。该调查包括三个部分。第1部分评估人口统计学数据，如机构类型；是否有接受过青少年健康培训的人员；以及每年审查的涉及青少年的方案数量。第2部分给出了一系列12个场景，受访者需说明其IRB在现行联邦法规下是否会免除家长同意。这些场景在信息敏感性和程序侵入性方面各不相同，范围从简单的满意度调查到艾滋病实验性药物治疗。第3部分评估受访者是否会建议改变现行联邦法规，以使青少年未成年人能够自行同意参与研究。为此，受访者需表明仅未成年人同意是否足够，或者对于与第2部分所呈现场景的侵入性程度相当的10个一般研究类别，是否需要家长同意。
共收回233份调查问卷（39%），其中183份（30%）可完全计分。对IRB进行组内比较时使用卡方统计。70%的受访IRB要求对所有未成年人研究都获得家长同意，而每年审查超过10个青少年方案的IRB要求家长同意的可能性较小（p <.01）。回答在机构类型或是否有接受过青少年健康培训的人员方面没有差异。52%的受访IRB要求对简单的满意度调查获得家长同意，只有29%的IRB会免除对匿名HIV血清流行率研究的家长同意。超过一半的IRB支持对法规进行修改，以使未成年人能够就10个一般研究类别中的7类自行提供知情同意：匿名调查（93%支持）、仅涉及调查（89%）或静脉穿刺（53%）的涉及敏感材料的研究，以及未成年人可能同意治疗（包括调查（93%）、静脉穿刺（68%）或已批准用于儿科患者的药物（57%））的疾病研究。
尽管IRB依据相同的联邦法规开展工作，但仍存在广泛的解读差异。对于改变某些涉及青少年的研究类别的指导方针存在相当多的支持。需要对联邦法规进行澄清，以便能够开展有意义且必要的青少年研究。
