JOURNAL OF ADOLESCENT HEALTH 1992;13:640
EDI’TORUiL
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hits and Research on Ado escents We face an interesting dilemma in our efforts to expand the data base on adolescent health. On the one hand, there are forces (typically institutional review boards [IRBs]) which, in their rightful role of protecting minor subjects from potential harm, impose restrictions which preclude involvement of adolescents in research studies. These have included requirements of parental consent for involvement in studies of conditions which we are permitted as clinicians to treat without parental consent; moreover, such boards may actually sit “in loco parentis” in establishing standards of morality, particularly in matters of sexuality. On the other hand, such review boards rarely consider the developmentally relevant issues which may place adolescent subjects at psychological risk. Two cases in point: In the first instance, recent adolescent female victims of familial sexual abuse are being studied longitudinally with periodic sampling of blood and CSF to determine endocrine sequelae of their traumatic experience. From a newspaper report of this study, it is unclear who was asked to give consent for the adolescent’s participation. Likely, it was the parents, so, this calls into question the assumption that parents will act in the best interest of their children. Parents of victims of familial sexual abuse asked to give consent for research on their children within six months of the discovery of the abuse (the admission criterion in this study) are hardly in an emotional position to be objective about the matter. Depending on the circumstances, they are likely to be feeling either guilty or punitive towards the teenager. What about the capacity of the adolescent incest victim, herself, to give consent for her own participation? That, too, is problematic, given the effect of the abuse and the traumatic aftermath of discovery. What is the likely effect of multiple venipunctures and painful lumbar punctures on her feelings about being punished for revealing the abuse or, alternatively, for having kept the secretsor on her feelings of responsibility for a father’s removal from the home, etc? What about the normal control subjects in this study? HOWwere 640 1054-139xi9z&i5.00
the potential risks and benefits explained to parents or adolescents, Zhemselve>? before they consented to participate? In the second study, adolescents under the age of 18 years were recruited to attempt to make illegal purchases of cigarettes at local stores. If successful in making a purchase, they were required to report the illegal sale to the researcher whose goal was to document the ease with which minors are able to purchase cigarettes. These teenagers and their par ents were informed that, in so doing, the subjects would be at risk for arrest. This study raises questions about whether the ends justify the means. Is it ever permissible in a research study to ask an adolescent subject to break the law in the name of a noble goal? The fact that both of these studies had been approved by their respective IRBs calls into question the efficacy of current mechanisms for protection of adolescent subjects. How might the interests of adolescents as research subjects be better protected? A few suggestions: 1) Include a developmental psychologist, pediatrician and/or adolescent medicine specialist on every IRB. 2) Adjust the reading level on informed consent forms to below the 7th grade. 3) Consider changing guidelines to exclude routinely from participation any adolescent who is at risk for emotional trauma, either because of the condition being studied or as a result of the study itself. 4) Educate IRBs concerning statutes which govern provision of medical care to adolescents, so that the same protection of confidentiality may be extended to these patients in the context of their participation in research’ studies. 5) Consider the process of oversight of IRBs. What else? Iris F. Litt, M.D. Editor-In-Chief
0 societyfor Adolescent Medicine, 1%~2 -__.. _ _ Published by Elsevier Science l’ublishing Co., Inc., 655 Avenue of the Amnicas, New York, NY 10010
EDI’TORUiL
__-... -.-I.
hits and Research on Ado escents We face an interesting dilemma in our efforts to expand the data base on adolescent health. On the one hand, there are forces (typically institutional review boards [IRBs]) which, in their rightful role of protecting minor subjects from potential harm, impose restrictions which preclude involvement of adolescents in research studies. These have included requirements of parental consent for involvement in studies of conditions which we are permitted as clinicians to treat without parental consent; moreover, such boards may actually sit “in loco parentis” in establishing standards of morality, particularly in matters of sexuality. On the other hand, such review boards rarely consider the developmentally relevant issues which may place adolescent subjects at psychological risk. Two cases in point: In the first instance, recent adolescent female victims of familial sexual abuse are being studied longitudinally with periodic sampling of blood and CSF to determine endocrine sequelae of their traumatic experience. From a newspaper report of this study, it is unclear who was asked to give consent for the adolescent’s participation. Likely, it was the parents, so, this calls into question the assumption that parents will act in the best interest of their children. Parents of victims of familial sexual abuse asked to give consent for research on their children within six months of the discovery of the abuse (the admission criterion in this study) are hardly in an emotional position to be objective about the matter. Depending on the circumstances, they are likely to be feeling either guilty or punitive towards the teenager. What about the capacity of the adolescent incest victim, herself, to give consent for her own participation? That, too, is problematic, given the effect of the abuse and the traumatic aftermath of discovery. What is the likely effect of multiple venipunctures and painful lumbar punctures on her feelings about being punished for revealing the abuse or, alternatively, for having kept the secretsor on her feelings of responsibility for a father’s removal from the home, etc? What about the normal control subjects in this study? HOWwere 640 1054-139xi9z&i5.00
the potential risks and benefits explained to parents or adolescents, Zhemselve>? before they consented to participate? In the second study, adolescents under the age of 18 years were recruited to attempt to make illegal purchases of cigarettes at local stores. If successful in making a purchase, they were required to report the illegal sale to the researcher whose goal was to document the ease with which minors are able to purchase cigarettes. These teenagers and their par ents were informed that, in so doing, the subjects would be at risk for arrest. This study raises questions about whether the ends justify the means. Is it ever permissible in a research study to ask an adolescent subject to break the law in the name of a noble goal? The fact that both of these studies had been approved by their respective IRBs calls into question the efficacy of current mechanisms for protection of adolescent subjects. How might the interests of adolescents as research subjects be better protected? A few suggestions: 1) Include a developmental psychologist, pediatrician and/or adolescent medicine specialist on every IRB. 2) Adjust the reading level on informed consent forms to below the 7th grade. 3) Consider changing guidelines to exclude routinely from participation any adolescent who is at risk for emotional trauma, either because of the condition being studied or as a result of the study itself. 4) Educate IRBs concerning statutes which govern provision of medical care to adolescents, so that the same protection of confidentiality may be extended to these patients in the context of their participation in research’ studies. 5) Consider the process of oversight of IRBs. What else? Iris F. Litt, M.D. Editor-In-Chief
0 societyfor Adolescent Medicine, 1%~2 -__.. _ _ Published by Elsevier Science l’ublishing Co., Inc., 655 Avenue of the Amnicas, New York, NY 10010
