Research consent by adolescent minors and institutional review boards.

PURPOSE

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.

METHODS

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.

RESULTS

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%).

CONCLUSION

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.