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PEDIATRIC ANESTHESIA

Permission and Assent for Clinical Research in Pediatric Anesthesia

Thomas O. Erb, MD MHS^*, Scott R. Schulman, MD^*, and Jeremy Sugarman, MD MPH, MA

*Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina; and Departments of Medicine and Philosophy and Center for the Study of Medical Ethics and Humanities, Duke University, Durham, North Carolina

Address correspondence and reprint requests to Scott R. Schulman, MD, Department of Anesthesiology, Box 3094, Duke University Medical Center, Durham, NC 27710. Address e-mail to schul003{at}mc.duke.edu

	Abstract

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IMPLICATIONS: This article discusses the process and specific nature of informed consent for clinical research in pediatric anesthesia. For informed consent to be meaningful, permission from the child’s proxy must be obtained and the child’s assent must be tailored in a manner that is sensitive to the abilities of children.

	Introduction

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Leading national (1–3) and international (4) initiatives have recently been enacted to promote clinical research in children. The primary impetus for these initiatives is a paucity of adequate information to direct safe and appropriate clinical applications of medicinal products in the pediatric population (5). In pediatric anesthesia, research is needed to evaluate drugs and equipment. Most new and current strategies in anesthesia and perioperative treatment must be examined to generate evidence that they are indeed safe and effective. This includes multidisciplinary research involving pediatric anesthesia to ultimately improve the care of the child undergoing surgery (6). With such forces at work, the number of children who participate in research in general and in anesthesia research in particular is likely to increase (6).

Nevertheless, the ethical imperative to foster knowledge about the efficacy and safety of treatments in the pediatric population as a group must be carefully balanced by the ethical imperative to protect and respect each individual pediatric patient (7). In this context, respect includes the ability for both the child and his or her legal representative to exercise free choice without force, fraud, deceit, duress, constraint, or coercion. Although informed consent is a means of ensuring that each competent adult’s autonomy is respected in research, the emotional, cognitive, and socioeconomic conditions of children make it necessary to modify informed consent in an effort to provide similar protection to children participating in research. Such protection is especially important because the incentives to enroll children can be powerful (8). The purpose of this article is to discuss the nature and process of what is typically considered to be informed consent for research in clinical pediatric anesthesia so as to maximize the likelihood that the rights and interests of the participating child are protected while research endeavors proceed so that ultimately children as a group can benefit from therapeutic advances.

	Modifying Informed Consent in Pediatric Research

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Minors are typically presumed to lack adequate decision-making capacity to make most important health-related decisions and to have limited autonomy, thereby making it impossible to obtain meaningful informed consent. The Declaration of Helsinki states the following: "In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever possible the minor child is in fact able to give a consent, the minor’s consent must be obtained in addition to the consent of the minor’s legal guardian" (9). This approach to informed consent protects, to the extent possible, the child’s rights of self-determination, yet privileges respect for the parent’s rights in decision making concerning their child while acknowledging the evolving nature of a child’s capacity to participate.

In the United States, the Department of Health and Human Services provided an amendment to the traditional requirements of informed consent for research involving pediatric subjects, codified as 45 Code of Federal Regulations 46, Subpart D (10), which was also recently endorsed in US Food and Drug Administration regulations (11). In this substitute for individual informed consent, parents or legally authorized representatives (also known as proxies) give permission (agreement for the participation of their child or ward), and children give assent (affirmative agreement to participate in research) (12).

The concept of proxy permission is based on the assumption that the proxy always acts in the best interest of the minor and is capable of providing informed consent. Thus, proxies need to have all relevant information that enables them to safeguard the interests of their child.

The US federal regulations define assent as "a child’s affirmative agreement to participate in research," and "mere failure to object should not, absent affirmative agreement, be construed as assent" (13). It is also the responsibility of institutional review boards (IRBs) to consider "age, psychologic state, and the maturity of the children involved" and to determine whether and how assent must be documented (13). The regulations provide additional protection by requiring that all research proposals involving children submitted to an IRB must be categorized and reviewed according to levels of risk and the possibility of direct benefit to the enrolled children (Table 1). A requirement for an institution to qualify for US federal funding brings much research under the purview of these regulations (14).

	Different Models of Assent

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Assent is different from consent. The US definition of assent (13) simply necessitates the child’s affirmative agreement to participation in research. Under such a definition, assent is limited to a preference for participation, which, unlike informed consent, does not require a demonstration of understanding (18). Furthermore, this definition provides limited guidance concerning the operational meaning of assent (7). In an analysis of research involving subjects incapable of giving informed consent for research, the US National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research describes assent in greater detail: "The standard for ‘assent’ requires that the subject know that procedures will be performed in the research, choose freely to undergo those procedures, communicate this choice unambiguously, and be aware that subjects may withdraw from participation. This standard for assent is intended to require a lesser degree of comprehension of the subject than would generally support informed consent and is not related to judicial determination of incompetency or commitment status" (19). However, this conception of assent was never incorporated into federal regulation.

Nonetheless, assent can be considered as an interactive process between the child and the researcher, involving disclosure, discussion, obtaining a (limited) understanding of the proposed research activity, and determining the child’s preference regarding participation (17). Use of this approach to assent may serve the following purposes: (a) providing information about the proposed research to the minor, (b) establishing shared decision making by the child and the proxy concerning participation together with the proxy, (c) making an assessment of the child’s understanding of the proposed research, and (d) soliciting an expression of the child’s willingness to participate in the proposed research (20,21).

It is obvious that children’s capabilities to give assent depend on their maturation and development. The Committee on Drugs of the American Academy of Pediatrics suggests that assent "should usually be obtained from any child with the intellectual age of seven or more" for participation in nontherapeutic research (i.e., research that does not hold the prospect of direct benefit to the participant) (5). Evidently the age of the child is an important, but not an absolute, criterion. Other attributes, such as the ability to identify benefits and risks of the proposed research endeavor or the ability to reason about consequences regarding participation, need to be considered. In fact, a sliding scale of competence to assent has been proposed to be created to ascertain the child’s comprehension of the proposed research (21).

It is a widely held belief that the child’s involvement in personal health care decision making should increase as the child matures (21–23). How can this increasing autonomy be best acknowledged and respected in children asked to participate in medical research? Various national guidelines have offered different perspectives: whereas the Australian National Health’s and the United Kingdom Medical Research Council’s guidelines prioritize parents’ permission rather than the child’s assent, the US regulations emphasize children’s assent with proxies’ permission (24).

Regardless of which model of assent is used, two practical issues are of utmost importance when obtaining informed consent for the participation of children in research: first, how to provide information about the proposed research, and second, how to ensure that consent (composed of permission and assent) is voluntary.

	Providing Understandable Information

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For informed decision making to occur, it is essential to provide adequate and understandable information to both the child and proxy. Core informational elements of informed consent include detailed information about (a) research procedures, (b) research purposes, (c) anticipated risks and benefits, (d) disclosure of alternative procedures or therapies, and (e) voluntary participation. Both the proxy and the child must be told that they have the opportunity to ask questions and understand that they may withdraw from participating in the research at any time without any effect on their continuing or future medical care.

How much information should be provided? Although requirements of local laws must be fulfilled in obtaining informed consent for medical treatment, the amount and type of information to the extent often provided in medical practice can be inadequate in the research setting. This is partly because research typically occurs in the absence of a common understanding and shared goals; whereas in medical practice the goal is patient centered, in research the goal is the procurement of generalizable knowledge. In giving information, one must be as precise as possible concerning study benefits to minimize therapeutic misconception (25) and make it as clear as possible that the experiment is not primarily devoted to an individual patient’s treatment. In situations in which no benefits are expected for the individual participant, this should be so stated, and even if some benefits are anticipated, the risks of the research must nevertheless be detailed in a manner that is easily appreciable.

For proxy permission, the standard of "the reasonable volunteer" is arguably applicable. This standard requires that "The extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge" (26). Little research has analyzed the understanding that proxies have when giving permission for their children to participate in research. In the few reports that have been published, general understanding of the research process was accurate (27–30), but understanding of the random allocation procedure was poor (27,31).

Determining what information children need for them to give meaningful assent is difficult, given that the paucity of published empirical research reveals conflicting findings. Although several studies have documented that most older children can understand concrete information concerning research procedures, their ability to do so may depend to some extent on the study’s complexity (32). Indeed, analyses of a small number of children enrolled in complex research settings show that understanding is poor in a considerable proportion of children (30,33). In other reports, even children who attained a basic understanding of the research had difficulties understanding and appreciating the positive and negative consequences of it (32,34). In addition, children were unlikely to view research as an activity directed at acquiring generalizable knowledge (35).

It has been argued that for the child to give assent, the presentation must be tailored on the basis of the child’s individual cognitive and emotional development (36). Furthermore, the research project should be explained as clearly as possible, concentrating on the information that is primarily of interest to the child (20). The child should also be able to discern the difference between routine management and the proposed research project, including the distinction between tests and interventions solely connected to the research protocol and those necessary for routine care. In addition, in an attempt to provide children with better information on which to base their decisions concerning participation, potential risks and potential benefits of the research must be made very explicit (32).

In most cases, to ensure clarity both for the persons obtaining and for those giving consent, relevant information should also be provided in written form. This should be done in a way that avoids creating consent forms that are not readily comprehensible (37). Indeed, much of the medical terminology often used by health care professionals can be avoided without adversely affecting the content of the consent/assent/permission form. It has been suggested that such documents be written at a sixth grade reading level (38). Assent may be documented on specific assent forms (39), on the consent (proxy permission) form, or in the patient’s chart on the basis of the local practices of the IRB’s requirements. However, there are no recent reviews on the present practice used for assent forms.

Special attention must be paid to obtaining consent for research with disabled children and with those who speak foreign languages. The capability of the disabled child to comprehend information about a research endeavor may be vastly different (e.g., deviation from the child’s chronological age or understanding about his or her circumstances may be greater compared with inexperienced children of similar age and development). Assessment of comprehension is critical, but this too may elude common evaluation techniques (40). Similarly, language and culture may confront the researcher with additional challenges in obtaining valid permission and assent (30). A written translation of the consent form that has been back-translated to ensure accuracy before approval by the IRB is an important step in preparing to obtain consent in different languages. To minimize communication difficulties, efforts should be made to use professional interpreters, although the presence of interpreters may further increase the already complicated researcher/participant/proxy relationship (41).

It is the investigator’s or their representative’s responsibility to ascertain that both the child and the proxy have attained an understanding of the essential information that has been disclosed. It is important not to underemphasize the importance of engaging in a conversation in which patients and proxies ask questions, given that in pediatric anesthesia, both the child and the proxy will probably often have only vague concepts about anesthesia in general and research in anesthesia in particular.

	Voluntary Participation

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Participation in research is voluntary only if the decision to do so is free of undue influence and the subject feels free to stop at any time. Undue influence includes manipulation of a subject’s decision through the controlling influence of a close relative or an offer of an excessive, inappropriate, or improper reward to obtain compliance (26). This is of special relevance in children because they are particularly vulnerable to undue influence. Children’s tendency to defer to authority figures can result in a lack of assertiveness in proclaiming their personal choices (20). In this context, reticence may be a behavioral manifestation of minors who have concerns about research participation, and such a response may represent a strong negative conviction on the minor’s part. Accordingly, investigators must be sensitive to reticence. Given the minor’s inclination to defer to parents or physicians, attempts to compel minors to assent to research that does not hold out the prospect of direct medical benefit to them are disrespectful and clearly inappropriate.

Why do parents volunteer their children for research? Tait et al. (42) investigated parents who were asked to consent to anesthesia research and showed that the perception of the usefulness of the intervention along with minimal risk to the child were the most important factors for granting permission. This is consistent with findings in studies not related to anesthesia (27,43), in which altruistic reasons led to participation.

Results concerning a feeling of pressure to participate in research are conflicting. Whereas in some studies none of the proxies, regardless of whether or not they gave consent, felt pressure (28,42), in another study as many as 25% of those giving consent reported that they felt obliged to give permission (27). In a setting of neonatal controlled trials, approximately one-third of the parents stated that the responsible physician should have advised them about participation (43). It is notable that concerns of a social-filter effect in parents giving permission for research (that is, that parents volunteering their children were socially disadvantaged and emotionally vulnerable compared with nonvolunteering parents), as previously suggested by Harth and Thong (44), were not confirmed in more recent studies (28,43).

Empirical data analyzing children’s voluntariness to participate in research are scarce. In a series of hypothetical psychological studies, Abramovitch et al. (32) observed little evidence that prior permission from the proxy influenced children’s decisions regarding participation. However, the children’s willingness to withdraw from a continuing experiment was affected by instructions from the experimenter. Only if the child wants to withdraw and, in addition, is given active permission by the experimenter will the child be likely to withdraw. To empower children to freely state their choice once the study has begun, Abramovitch et al. (32) suggest that experimenters be explicit about the possibility of stopping while the study is in progress. In the context of a medical experiment, Ondrusek et al. (33) found that children’s actual freedom to act on the understanding that it is permissible to withdraw from participation is indeed limited.

Voluntary participation is also made possible by requesting it under the appropriate circumstances. Thus, the location and timing of request also influence the manner in which children and their proxy deal with the information provided. This is particularly important for anesthesia research. Consultation in a private setting has been advocated for research involving adults undergoing same-day surgical procedures (45); however, there are currently no data regarding this issue in pediatric anesthesia research. Nevertheless, research in children and adolescents suggests that emotional factors are more closely related to understanding participation in research than age or cognitive development, stressing the need to provide environments that decrease anxiety and increase this group’s feeling of control (46).

Approaching the patient and the proxy for enrollment in a research project shortly after the patient’s admission to the hospital may also be experienced as stressful because it adds unexpected tasks at a time when anesthesia and surgery are imminent. Time for reflection or consultation in such settings is insufficient for many individuals. Conversely, approaching patients and proxies before admission, when no professional relationship has been established between the anesthesia team and the patient and proxy, may be problematic as well because this could be perceived as a violation of privacy and confidentiality (47).

There is no consensus on how this issue should best be handled in pediatric anesthesia research. However, the recruitment for clinical research studies of children scheduled for ambulatory procedures is highly successful when consent is obtained on the day of or the day before surgery (42,48). When queried, nonconsenting parents stated that the opportunity to consult with the pediatrician or surgeon and more time to decide would positively influence their decision to participate in future studies. Furthermore, the majority of parents who gave consent for clinical anesthesia research on the morning of surgery indicated their preference for enrollment a few days before admission. In addition, approximately 40% stated that they would have preferred being first approached by their surgeon (49). The results of this survey challenge the suggestion, previously made, that the factor of timing for obtaining consent in pediatric anesthesia research might be offset by paying special attention to the formal process requesting informed consent on the day of admission (50). Given the lack of empirical data obtained in children, investigations are needed to determine when to optimally inform children about pediatric anesthesia research.

	Summary

Top Abstract Introduction Modifying Informed Consent in... Different Models of Assent Providing Understandable... Voluntary Participation Summary References

 
Informed consent for participation in research with children must be modified by using proxy permission and assent of the child. Requests must be tailored in a manner that enables the proxy to safeguard the interests of the child and, of equal importance, also enables the child to give meaningful assent. To increase the likelihood that the rights and interests of children participating in clinical research are protected, the person requesting consent must engage in a conversation that covers the specific needs of both the proxy and the child. Congruent with parental preferences regarding consent for clinical studies in pediatric anesthesia, the optimal time to obtain consent for clinical research in pediatric anesthesia might be well in advance of admission to the hospital, yet further empirical data are needed to develop optimal methods of obtaining informed and voluntary permission and assent in this setting.

	Acknowledgments

 
Supported exclusively by institutional assistance.

	References

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