IRB chairs contacted. Of those responding, 70 percent said that the IRB required parental permission for all minors involved in studies; that is, they did not allow waivers of parental permission for certain kinds of research involving adolescents. IRBs that reviewed more than 10 protocols involving “adolescents” a year were less likely to have this blanket requirement (p. 323). Approximately one-third of the respondents said that their IRB would waive parental permission for a study that involved anonymous testing of adolescents for HIV infection.
A statement to the committee by the Allergy and Asthma Network included observations on the experiences of one office-based researcher, who reported that sponsors often did not provided assent materials and that protocols were “often approved without an assent document being reviewed by the IRB” (White, 2003, p. 7). In this physician’s view, adolescents generally needed a simplified version of the consent document to help them understand the research.
Several studies have documented considerable variability in the practices of IRBs related to informed consent. In a study supported by NIH, researchers surveyed the chairs of nearly 500 IRBs that had conducted at least 10 protocol reviews in 1995 (Bell et al., 1998). More than a third of respondents reported that their IRBs had suspended or terminated a research project; of this group, just over 20 percent of the actions had been based on investigator failure to obtain informed consent. When questioned about their priorities for the initial review of protocols, about 20 percent of IRB chairs indicated that consent forms were a priority and another 11 percent mentioned informed-consent procedures. When questioned about deficiencies in protocols during the initial review, 60 percent of IRB chairs said that excessively technical language in the consent form was often a problem. Less than 10 percent said that they often saw problems with other aspects of consent forms (e.g., understatement of risks or benefits) or with the consent process. More than half, however, said that they sometimes found problems with consent processes that did not “promote comprehension” (p. 62). For multisite studies that originated at another institution, more than half the chairs reported that their IRBs had required modifications in the (model) consent form. Almost 90 percent of the chairs and administrators said that the failure of investigators to provide an acceptable consent form with their initial submission was a problem. “Issues relative to assent procedures” had been encountered by almost 90 percent of the IRB chairs (p. 22).
For the survey just cited, Bell and colleagues (1998) also questioned investigators and administrators associated with 300 IRBs. Among the investigators who reported that they had modified a research protocol in response to IRB concerns, more than three-quarters reported that they had to modify the consent form and one-fifth mentioned that they had to modify the consent process. Responses from investigators questioned about in-