 |
|
 |
|
 |
 |
|
 |
 |
 |
 |
 |
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ARTICLE |
a Center for Family and Adolescent Research, Oregon Research Institute, Albuquerque, New Mexico
b Department of Psychology, University of Massachusetts, Amherst, Massachusetts
c University of New Mexico Health Sciences Center, Albuquerque, New Mexico
 |
ABSTRACT |
|---|
 TOP ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
|---|
STUDY DESIGN: Adolescents (n = 36) with asthma and their parents reviewed 9 pediatric research protocols, decided whether they would choose to participate, rated the extent they would be responsible for the actual decision, and indicated the ability of family and physician to influence their decisions. Multivariate analyses of variance were used to evaluate differences in perceptions of decision-making authority and sources of influence on the decisions.
RESULTS: Adolescents were less willing to cede decision making authority to parents than parents anticipated. Parents and adolescents acknowledged a greater openness to influence from physicians than from family for above minimal risk studies. Parents were more willing to consider opinions from male adolescents.
CONCLUSIONS: Adolescents desire responsibility for research participation decisions, though parents may not share these views. Physicians’ views on research participation are important to families, especially for above minimal risk studies. Parents may grant more decision-making autonomy to adolescent males than to females. Researchers, physicians, and institutions play a key role in facilitating the ethical enrollment of adolescents into biomedical research. Educational, policy, and oversight processes that support both adolescent autonomy and parental responsibility for research participation decision-making in biomedical research are discussed.
Key Words: asthma drug therapy • biomedical research ethics • informed consent • adolescent assent • research participation decision making • adolescent • child • parents • female • humans • male • research support
Abbreviations: FDA—Food and Drug Administration • MANOVA—multivariate analyses of variance
There is considerable ethical and legal ambiguity surrounding the role of adolescents in the decision-making process for research participation. Depending on the nature of the study and the regulations involved, adolescents may have independent responsibility for providing informed consent, they may be asked to provide their assent, or they may be completely excluded from the decision process.1,2 The extent to which adolescents' opinions concerning research participation are actually solicited and honored depend on factors such as family decision-making styles and preferences; beliefs about the importance of adolescent autonomy; perceived risks and benefits of the research study; and perceptions of adolescent judgment, maturity, and cognitive ability.3,4 Some have commented on the reluctance of the medical community and parents to recognize mature children and adolescents as having decision-making capacity. They note that a lack of clarity concerning the rules and confusion about the basis for assent or dissent of a child with developing decision-making ability may limit participation in research decisions.5,6 For example, Department of Health and Human Services regulations allow for parental waivers in certain situations, whereas the Food and Drug Administration (FDA) regulations do not.1,2
The degree to which parents and adolescents influence one another and the extent to which they consider the opinions of physicians in the research participation decision-making process have received little empirical attention. Preliminary evidence suggests that both parents and adolescents claim decision-making responsibility for research participation decisions.4 Parents in this study were willing to consider their adolescents' opinions but expected that adolescents would acquiesce to their decision. However, adolescents seemed less amenable to parental influence, and indicated they would not have to follow their parents' wishes. Parents are known to exert greater decision-making control over younger adolescents, especially daughters.7–9 Findings from focus group research on parent-adolescent need for parental consent for research participation found that older adolescents saw significantly less need for parental consent than did their parents for research on sensitive topics, such as sexuality and drug and alcohol use.10
The purpose of the present study was to examine parent and adolescent perceptions of responsibility for adolescent research participation decisions and to examine the role of adolescents, parents, and physicians as sources of decision-making influence. We hypothesized that parents would overestimate their adolescents' willingness to acquiesce to parental decisions, that both parents and adolescents would view physicians as an important source of decision-making influence, and that adolescent boys would have more influence over parents than would adolescent girls.
|
METHODS |
|---|
|
TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
Participants
Parent-adolescent dyads were eligible to participate if the adolescent was between 11 and 18 years of age and had a previous diagnosis of asthma. Only English-speaking families were enrolled.
Measures
Parents completed a 15-item demographic form and a 33-item asthma history questionnaire developed from the Guidelines for the Diagnosis and Management of Asthma11 and also included questions pertaining to the adolescent's current medication regimen. Parents were asked about previous participation in asthma research studies and about the frequency of various asthma procedures that had been completed by the adolescent in the preceding 12 months (eg, spirometry, allergy/skin testing, and venipuncture).
Research Vignettes
Forty consent forms describing previously conducted publicly and privately funded studies from the 1990s and 2000 were obtained from pediatric asthma researchers in the United States and England. Consent forms were obtained in 2 ways. Prominent researchers known to the authors were contacted directly to request copies of their consent forms. Other researchers were identified via a Medline literature review of recently published pediatric asthma studies. Requests for consent forms were made to all of those for whom contact information was available. Specific attempts were made to obtain consent forms for studies that involved varied designs and procedural elements. An expert panel of 8, consisting of physicians, clinical pharmacists, and psychologists with expertise in ethics, pediatric asthma research, or both, evaluated the consent forms and selected a representative sample of 9 studies. The studies were selected based on unanimous ratings of risk and unique protocol design. The 5 minimal risk protocols included: a 1-month study examining the impact of an approved asthma medication on participants' ability to learn in school; a 3-year study monitoring symptoms of adolescents with mild-to-severe asthma; an 18-month evaluation of 3 educational methods for helping adolescents control asthma; a 1-day study examining the use of using high resolution computer tomography in asthma research; and a 36-hour observational study evaluating nitric oxide and cortisol levels during an overnight hospital stay. The 4 above minimal risk studies included: a 15-week clinical trial comparing 2 FDA-approved medications using a double-blind, double-dummy placebo crossover design; a 26-week medication trial examining fixed versus as-needed dosing for an established asthma medication; a 5-year clinical trial comparing 2 non-FDA-approved medications versus placebo; and a 4-month study involving methacholine challenge to evaluate the use of sputum induction findings for asthma treatment.12
Key information for each of the selected protocols was extracted from the consent form and rewritten into a 1-page standardized research vignette format. Each included an informative study title, a brief statement of the reason for the study, and details of the length and time required for participation. To facilitate presentation of multiple vignettes, procedures were summarized in bullet format. Risks of the procedures were described in an earlier part of the study and were available to participants during presentation of the vignettes. The medication trials included a description of medications and their known risks/adverse effects. A description of study incentives was included at the end of each vignette. See Table 1 for a sample vignette.
|
The 9 vignettes describing the research protocols were then presented to participants. Alternate presentation orders were established for each parent-adolescent dyad using a standard Latin square design procedure. For each of the 9 research vignettes, adolescents and parents were asked an identical series of 12 questions. Respondents were asked for a dichotomous (yes or no) response concerning their willingness to enroll in the research protocol described in each vignette. The remaining questions were evaluated on a 7-point Likert scale. In addition to willingness to participate, the questions asked about perceptions of the other family member's (parent or adolescent) willingness to participate, perceptions of responsibility for the participation decision, influence of family member and physician views on their decisions, and their overall evaluation of the risks, benefits, discomfort, hassle, and appropriateness of compensation offered for participation in the protocol. Previously published findings from this set of questions include data comparing family members' willingness to participate in each of the protocols12 and perceptions of fair compensation for participation.14 The results presented here compare parent and adolescent perceptions of family member authority and influence versus physician influence on the research participation decision.
Data Analyses
Data were analyzed using 2 separate full-factorial multivariate analyses of variance (MANOVA). The first set of analyses compared parent and adolescent perceptions of responsibility for the research participation decision. The second set of analyses compared parent and adolescent perceptions of the influence of family members versus physicians on research participation decisions. Preliminary analyses examining adolescent age and gender effects indicated that age was not significantly related to the dependent measures. However, adolescent gender was retained in subsequent analyses of the findings.
To compare parent and adolescent perceptions of responsibility for adolescent research participation decisions, we computed mean scores across the vignettes based on parent responses to the 7-point Likert scale question, "Would your child agree to whatever you thought was best?" and adolescent responses to the question, "Would you have to do what your parent(s) decided?" Separate minimal risk means were computed from parent and adolescent responses to the 5 minimal risk vignettes. Similarly, separate above minimal risk means were computed from parent and adolescent responses to the 4 above minimal risk vignettes. We then conducted a gender x family member x protocol risk level mixed-effects MANOVA on these mean scores. Adolescent gender was the between-participants variable. Risk (minimal or above minimal) and family member (parent or adolescent) were treated as within-participant repeated measure factors.
Perceptions of influence on the research participation decision were evaluated from parent and adolescent responses to 2 questions. Parents responded to the questions, "Could your child's opinion change your mind (about research participation)?" and "Could the opinion of your child's doctor change your mind?" Adolescents responded to the questions, "Could your parent's opinion change your mind?" and "Could your doctor's opinion change your mind?" A gender x protocol risk x family member x influence source mixed-effects MANOVA was conducted with adolescent gender as the between-participants variable and protocol risk (minimal or above minimal), family member (parent or adolescent), and influence source (family or physician) as the repeated measures.
To ensure that participants' evaluations of the level of protocol risk matched those of the expert panel, we also conducted a protocol risk (minimal or above minimal) by family member (parent or adolescent) analysis of variance and the question, "How risky is this study to you?" (Parents responded to the question, "How risky is this study for your child?")
|
RESULTS |
|---|
|
TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
|
Findings revealed significant differences in the perception of decision-making responsibility between parents and adolescents. Across all of the research vignettes, parents anticipated that adolescents would yield to their decisions, whereas adolescents reported significantly less willingness to yield to parental decisions concerning research participation (P = .022).
Concerning perceptions of influence on the research decision, results revealed significant main effects for family member, protocol risk, and influence source, with no significant effects for gender. Overall, parents reported greater willingness than adolescents to change their minds about research participation based on outside opinion (P = .003; parent mean: 4.83; adolescent mean: 3.84). The significant protocol risk effect indicated that both parents and adolescents were more open to outside influence on above minimal risk studies than on minimal risk studies (P = .041; above minimal risk mean: 4.53; minimal risk mean: 4.15). The findings also revealed that, overall, parents and adolescents could be more influenced in their decision by a physician than by a family member (P = .028; physician mean: 4.56; family member mean: 4.12).
Three significant interaction effects were also observed. First, both parents and adolescents were more likely to accept outside influence on the participation decision for above minimal risk studies when the adolescent was female. When the adolescent was male or the study was minimal risk, both parents and adolescents were less likely to accept outside opinions (P = .028). Figure 1 depicts this significant protocol risk by adolescent gender effect.
|
|
|
|
DISCUSSION |
|---|
|
TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
The young adolescents in this sample expressed a relative unwillingness to cede decision-making authority to parents, although parents believed their adolescents would be agreeable to and comply with parental wishes. This is consistent with our earlier research,4 verifying a preference among adolescents for greater decision-making autonomy in asthma research. Moreover, this finding corresponds with current psychological perspectives on adolescent development of emotional and behavioral autonomy. Although parents exert considerable control over young adolescents, especially girls,7–9 as they mature, older adolescents assume greater responsibility for decisions affecting their personal life and perceive themselves as more capable of resisting social influence in decision-making situations.9,15,16 That even young adolescents report a desire to exercise autonomy in research-related decisions, such as those presented in this study, may reflect a special value placed on matters of personal control over health behaviors, particularly when they involve the use of medications with unpleasant adverse effects or uncomfortable medical procedures.
Although there is a growing consensus among scholars that children ought to have more input into research participation decision-making, principally for nonbeneficial research,17,18 our data suggest that parents do not necessarily share this view. Parents have already voiced concerns about health care policies that protect adolescent confidentiality.19 If they believe research decisions are primarily in their purview, parents are likely to voice dissent with attempts to enhance research decision-making autonomy for children and adolescents. Differences of opinion among family members may also create ethical quandaries for investigators enrolling adolescents in research, particularly for girls, because adolescent boys seem to be granted more autonomy by parents to make research decisions.
The likeliest scenario for disagreement is one in which the adolescent desires to participate and the parent prefers to decline. This is particularly true for above minimal risk studies. We have demonstrated elsewhere12 that adolescents are more willing to enroll in above minimal risk asthma research than parents are willing to permit their enrollment. Were adolescents to obtain greater autonomy in research participation decision-making, enrollment in these studies might proceed more quickly. However, the ability of adolescents to appropriately weigh research risks and benefits in the context of an actual clinical trial has not yet been empirically established, although it has been demonstrated in analog vignette studies.20 As data accumulates on the desire, ability, and process by which adolescents may exercise autonomy in research participation decision-making, the issue of parental versus adolescent rights in these decisions may emerge at the forefront of the discussion, with the courts as ultimate arbiters. Clarifying the perspectives of family members helps to explain the potential legal and ethical issues at stake.
Our finding concerning the willingness of adolescents and parents to consider the opinions of family members and physicians lends further nuance to the influence of personal versus professional relationships in research participation decisions. In general, parents reported more willingness than adolescents to be influenced by others in asthma research participation decisions. Both parents and adolescents acknowledged a greater openness to input from others when considering above minimal risk rather than minimal risk studies, and both groups also acknowledged that physician's views would be more persuasive than family members' views. However, there were important clarifications to these findings. Physician influence would be strongest when considering participation in above minimal risk asthma studies. Moreover, physicians would have the greatest influence on both parents and adolescents when the adolescent was female.
Overall, these findings demonstrate the importance of physician recommendations for parent and adolescent decision-making. Both parents and adolescents recognized the increase risk associated with protocols rated by our experts as above minimal risk, and they also reported greater interest in physician's views of these studies. This suggests that families may feel less able to appropriately judge the risks and benefits of above minimal risk studies and will look to their personal physicians for guidance. Many above minimal risk studies offer little direct benefit to participants, and participants can be expected to conflate research with medical care, a process well documented as the therapeutic misconception.21,22 Thus, physician guidance may be particularly important in clarifying the purpose of and limits to the benefits of research participation. Commentators have identified a number of complex considerations related to the ethical involvement of physicians in research participation decisions, including limitations in professional integrity, conflicts of interest, and disparities of social power that may operate to limit participant autonomy and inappropriately influence participant decision-making.23–26 Nonetheless, our findings highlight that physician guidance is important to families contemplating research participation. Although no data directly address physician influence, trust in physicians has been identified as an important factor in some research participation decisions4,27 and the physician as advisor may be especially important to adolescents as they begin to exercise greater independence from parents on both medical and research participation decisions.
Thus, physicians can be expected to play a key role in research decisions concerning adolescents. In recognition of this important role, steps can be taken by researchers, physicians, and institutions to facilitate the ethical enrollment of adolescents into biomedical research. Researchers can establish methods of physician dialogue with adolescents that enhance adolescent knowledge and appreciation of research participation, whereas simultaneously preserving and respecting their developing autonomy. Individual physicians can reflect on their own multiple roles within an institution, carefully considering conflicts of interest that may influence their behavior toward potential research participants. Institutions can take a proactive approach in each of these areas, incorporating education on developmental issues in research participation decision-making into ongoing research ethics training programs, establishing policy guidance related to potential conflicts of interest, creating a research culture that values participant autonomy in decision-making, and ensuring appropriate oversight. Taken together, these measures can provide an important ethical foundation for the enrollment of all participants into biomedical research and facilitate the appropriate involvement of adolescents in research participation decision-making.
There are several limitations to this research that should be noted. Participants evaluated only asthma protocols. Responses to protocols related to other diseases, especially for research related to terminal rather than chronic illnesses, may be different. Our sample was relatively small, and recruitment occurred from a single medical site and did not include all racial groups. Participants located in other geographical regions and from other cultural backgrounds may have responded differently. Finally, these data represent participants' beliefs about their own behaviors in a research setting; they do not measure actual behaviors. Further research examining actual research decision-making processes in families is needed to more fully explain family and physician influences on parent and adolescent research participation decisions.
|
ACKNOWLEDGMENTS |
|---|
|
FOOTNOTES |
|---|
Address correspondence to Janet Brody, PhD, Center for Family and Adolescent Research, Oregon Research Institute, 2700 Yale SE, Suite 200, Albuquerque, NM 87106. E-mail: jbrody{at}ori.org
The authors have indicated they have no financial relationships relevant to this article to disclose.
|
REFERENCES |
|---|
|
TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
|---|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
 |
||
|
||
Home | My Pediatrics | Journal Information | Current Issue | Past Issues | Subscriptions & Services | Contact Us Click here for faster international access © 2006 American Academy of Pediatrics. All rights reserved. |
||
|
||
