THE studies presented by Tait et al . 1,2in their articles in this issue of Anesthesiology build on their previous work 3,4and contribute to the literature on child assent and parental permission for research participation. At the same time, their work illustrates the problems associated with assessing the meaning and function of assent and permission for research participation.
Unlike many empirical studies on assent and permission that assess participants’ understanding of the elements of consent and assent through the use of hypothetical research scenarios, 5,6Tait et al . collect data from subjects who are deciding whether to participate in actual research studies. The authors evaluate participants’ understanding of a fixed set of 11 elements of informed consent for parents and 8 elements of “disclosure” for children. In each case, understanding of an individual element is assessed on a 3-point scale indicating whether the answer is correct and complete, correct but incomplete, or incomplete or no answer. The eight elements on which children are assessed (and which overlap with the parental informed consent elements) are understanding of: study purpose, protocol, risks, direct benefits, indirect benefits, freedom to withdraw, alternative treatments or procedures, and voluntariness. The authors report percentages of those parents and children who had a complete understanding of each element and find that parents have an “inadequate understanding of the research” and that children (particularly those below the age of 11) have a “limited understanding of the elements of disclosure.” These findings are similar to those reported by other informed consent researchers 7; however, the literature on this topic suffers from inconsistency with regard to how understanding of the elements of informed consent is defined and measured.
One of the conclusions drawn by Tait et al . is that “every attempt should be made to ensure that the subject has sufficient information and understanding to formulate a preference for participation.” Clearly, the principle of respect mandates that such an attempt is made; however, there are important additional implications of these findings that should be explored.
The authors raise but do not explore further the implications of their findings for the adequacy of parental permission. If many of the parents interviewed had an “inadequate” understanding of the research for which they granted permission for their children to participate in, are they doing a sub-standard job of protecting their children from harm? How are we to interpret the apparent discrepancy between the parents’ subjective perception of adequate information and understanding, and the raters’“objective” assessment of inadequate understanding? The method used to assess the parents’ understanding relies on short-term recall. If we assume the parent was initially told the information, the failure to recall the information may indicate either a lack of initial understanding or a lack of perceived importance. Parental misinformation, misunderstanding, or the relative unimportance of the information may each be a sufficient explanation of the failure to recall the information; however, we can not know why parents have such a poor understanding of the elements of consent from the data collected in this study.
More fundamentally, one can question whether an objective or subjective standard should be used to judge the adequacy of parental permission. In a previous study, 3the authors found that parents prioritized elements of consent differently than investigators. Because parents can give a correct answer in the current study and still be judged to have “poverty of content,” it may be possible that parents understand enough about the research to make an informed decision, in line with their perceptions, but could still be judged deficient in their knowledge by the assessors. Assuming that an institutional review board (IRB) determines that the balance of risks and benefits is such that presentation of the research to the parent of an eligible child is appropriate, would a subjective standard of parental permission be sufficient to assure that the child is adequately protected? Relying on a subjective standard of parental permission, of course, assumes the adequacy of IRB review to protect a child from inappropriate risks—an assumption that may or may not be warranted in any given instance.
The method used to determine the adequacy of the children's assent raises a more fundamental issue, beyond asking whether a subjective or objective standard should be used to determine the adequacy of a child's assent. The finding that children younger than eleven years of age have an inadequate understanding of a fixed, albeit limited, set of informational elements could be cited as support for waiving younger children's assent based on lack of capacity. If we view assent as comparable to consent, as it appears the authors do by evaluating children on eight of the same elements for which they evaluate adults, then it appears we must interpret the finding that young children “have limited understanding of the elements of disclosure” to mean that these children do not possess the capacity to assent. Such a conclusion would be, in our judgment, unfortunate. If children of whatever age are perceived to lack the capacity to assent, the opportunity to have their assent valued when asked to participate in a research study may be absent. If this is the case, young children who may be quite capable of meaningfully dissenting from a study may never be given the opportunity to do so. Whether a child is able to achieve “complete” understanding of the “core elements of disclosure” may be very different than whether the child has the capacity to meaningfully assent (or dissent) to participate in a research study.
The studies done by Tait et al . demonstrate why it is important that we examine child assent and parental permission together, not as separate, independent processes. After reading these two articles, 1,2one might reasonably conclude that children younger than 11 years of age lack the capacity to assent, and perhaps, that a significant proportion of their parents (especially the less educated ones; see table 4 1) are unable to adequately protect their children from potential harm. We do not believe that this conclusion would be warranted, however. What we do believe these findings demonstrate, though, is that informed consent does not adequately serve as a model for both parental permission and child assent. Rather than judging children against a standard set of elements of informed consent and calling that “assent,” perhaps assent should be understood differently at different developmental levels. A “complete” understanding of each of the eight elements of informed consent examined by the authors may be neither necessary nor reasonable for a child to be able to meaningfully assent to participate in research. In addition, more research must be done to explore how parents approach making a decision to permit a child's research participation.
We agree that efforts should be made to ensure that parents and children have sufficient information and understanding to formulate a preference for research participation. However, if assent functions differently depending on one's developmental level, sufficient information should be allowed to vary with age, maturity, and so forth. If one uses findings such as those in the articles presented here to establish an age below which the capacity to assent is deemed inadequate, one may fail to ask the child's preference regarding participation. By assuming lack of capacity, the potential arises to dishonor and disregard a child's meaningful dissent when he or she wishes not to participate in research that is not necessary for his or her personal benefit.
This Editorial View accompanies the following articles: Tait A, Voepel-Lewis T, Malviya S: Do they understand? (Part I) Parental consent for children participating in clinical anesthesia and surgery research 2003, 98:603–8; and Tait A, Voepel-Lewis T, Malviya S: Do they understand? (Part II) Assent for children participating in clinical anesthesia and surgery research 2003. Anesthesiology 2003; 98:609–14.