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From the Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
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Methods. The study population consisted of parents of 505 children who had been approached to participate in 1 of several ongoing clinical studies. Regardless of their decision to allow or decline their child’s participation in a study, parents completed a questionnaire that elicited information regarding their perceptions of the risks and benefits of the study and factors that had influenced their decision.
Results. Factors that influenced positive risk/benefit assessments by the parents included use of a placebo, the designated risk category of the study, the clarity of information given, the parents’ perceptions of the amount of time provided to make a decision, and the amount of privacy afforded them in making a decision. Furthermore, positive risk/benefit assessments were associated with low decisional uncertainty and greater trust in the medical system.
Conclusions. Identification of factors that influence parents’ perceptions of the risks and benefits of a research study is important as a means to optimize the manner in which consent information is disclosed and to ensure that parents and subjects can assess accurately the relative importance of the risks and benefits.
Key Words: pediatric research • risks • benefits
Abbreviations: IRB, Institutional Review Board • NFC, need for cognition
The perception of a study’s risks and benefits is among the most important determinants of a parent’s decision to allow his or her child to participate in a research study.1–3 Indeed, previous research from our department suggests that the risks and direct benefits are the 2 most important elements of consent that parents want to know to make a decision regarding their child’s participation.3 Despite this, our studies showed that although 70% of parents had complete understanding of the risks, only 57.4% had complete understanding of the benefits to their child (direct).4 Furthermore, only 50.5% of children had complete understanding of the risks and 30.4% complete understanding of the benefits to themselves.5 These results are disturbing because a lack of understanding of these core elements of consent may render participants vulnerable to misinterpretation of the risks and benefits and thus threaten their ability to make an informed choice.
This study, therefore, was designed to examine factors that influence parents’ assessments of the risks and benefits of research in which their children are approached to participate. An understanding of these factors will be important to develop strategies to ensure that parents adequately understand the anticipated risks and benefits of research involving their children.
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METHODS |
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The parents completed the questionnaires while their children were in surgery or, if they preferred, at home. Demographic data were collected, including the parents’ age, race/ethnicity, education, and socioeconomic status. In addition, parents were asked to rate their assessments of the risks and benefits (direct and indirect) of the research for which their child had been approached to participate using 0 to 10 visual analog scales (where 10 = high). On the basis of the assessments of risk and direct benefit, a risk/benefit ratio was calculated. Lower risk/benefit ratios represent positive (favorable) risk/benefit assessments, ie, low risk and/or high benefit. Validated visual analog scales (0–10) were also used to measure the child’s health status6 and the parents’ anxiety levels.7,8 Items in the questionnaire were developed to measure several constructs of interest, including trust in the medical system,9,10 decisional uncertainty and effectiveness,11 and altruism.9,10 Decisional uncertainty and effectiveness relate to the state of uncertainty when making choices, particularly those involving risk or uncertain outcomes. Thus, measurement of decisional conflict is important in considering how subjects make decisions about research participation. Individual items in the questionnaire were measured using a 5-point Likert scale of "strongly disagree," "disagree," "neither disagree nor agree," "agree," and "strongly agree." The readability of the consent forms for each of the studies was measured using the Flesch Reading Ease (0–100 scale, where 100 = easiest) and Flesch-Kincaid Grade level tests (grade reading level).12
Statistical Analysis
Statistical analyses were performed using SPSS statistical software (SPSS Inc, Chicago, IL). Descriptive data were analyzed using frequency distributions. Comparisons of parametric data were performed using unpaired t tests. Nonparametric comparisons were analyzed using 
2 and Mann-Whitney U tests. Correlation of independent factors with the assessments of risk/benefit were analyzed using Spearman correlation coefficient (
). Factors that were shown to be significantly associated with the assessment of risk/benefit by bivariate analysis were entered into a multivariate regression model with backward selection. Internal consistency measures of reliability of the survey items were analyzed by determination of Cronbach (coefficient) 
. Cronbach values of 
.7 were considered to represent excellent internal consistency. Data are expressed as percentages, mean ± standard deviation. Significance was accepted at the 5% level (P < .05).
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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30 years of age) assessed the risks as significantly lower than their younger counterparts. Furthermore, parents whose children had previously served as research subjects assessed the risk/benefit as more positive than those with no research experience (P < .05).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Woloshin and Schwartz13 suggested that the manner in which risk/benefit information is presented to patients is an important determinant in their understanding of treatment options. Quantitative information, for example, may be particularly difficult to understand given that low levels of numeracy (quantitative literacy) are common among lay individuals and may be a barrier to the communication and understanding of basic medical data.14,15 For example, in 1 study, only 20% of female veterans could correctly convert 0.1% to 1 in 1000.14 Furthermore, most lay individuals have trouble with probabilistic language, eg, 30% chance of an outcome.13 Studies also show that the format in which data are presented, ie, "framing," is an important determinant of the assessment of risks and benefits.16,17 For example, studies indicate that benefits of treatment options presented in relative rather than absolute terms are preferred by both parents and physicians.16,17 Although our study did not examine differences in the presentation of information, we found that parents who perceived the information as "very clear" and the amount of information as "just right" assessed the risk/benefit as more favorable than those who perceived the information to be unclear, insufficient, or excessive.
The observation that the amount of information provided influenced the parents’ assessment of the risks and benefits suggests that the parents had different "needs for cognition" (NFC). NFC refers to the tendency of an individual to engage in or enjoy thinking.18,19 For example, individuals with high NFC require more information than those with low NFC. Thus, depending on the parent’s NFC, the amount and detail of information provided may have a significant impact on their assessment of the risks and benefits. In our study, parents who perceived that they had been given too much or too little information assessed the risks and benefits more negatively than those who believed that they had received "just the right amount." As such, the amount of information presented to these parents may not have satisfied their NFC.
Understanding of research information is further complicated by the fact that the assessment of research risks and benefits are made under varying levels of decisional uncertainty because many of the outcomes are unknown. Indeed, our results showed that risk/benefit assessments are perceived as more negative among participants with higher levels of uncertainty. In a similar light, we observed that parents who had more trust in the medical system tended to have more positive risk/benefit assessments. Although this is not particularly surprising, it is important and may be particularly relevant for minority populations that have been shown to have less trust in research and the medical system and are less likely to participate in clinical research.20,21 Nonparticipation by specific groups on the basis of cultural, educational, or socioeconomic factors may deny their rights to the bioethical concept of justice, ie, an equal opportunity to share in the risks and benefits of research, and, as such, may create a selection bias.22
In addition to uncertainty, there may be many factors that influence a research participant’s assessment of risks and benefits. Studies of patients who undergo treatment regimens and research have shown associations between the assessments of risks and benefits and the health status of the participant, use of a placebo, vulnerability (eg, age, economically disadvantaged, low literacy levels), and whether rewards are offered as an incentive/remuneration to participate.13,23 In our study, we found no association between risk/benefit assessment and the health status of the child. This observation may have occurred because the majority of our subjects were relatively healthy (American Society of Anesthesiologists’ class I or II); thus, we were unable to examine risk/benefit assessment across a broader range of health statuses. In addition, because none of our studies involved payments to the subjects, we were unable to examine the effect of this variable.
Our finding that the assessment of risk/benefit was similar regardless of when consent was sought (day of surgery vs day[s] before) was interesting given that there is concern (particularly by IRBs) that consent sought on the day of surgery or treatment is potentially coercive.24 A recent study from our department showed that parents’ understanding of the 11 elements of consent were similar regardless of whether consent was sought on the day of surgery or before.4 Although the day on which consent was sought did not seem to influence the assessment of risks and benefits, parents who perceived that they had insufficient time or privacy to make a decision assessed the risk/benefit more negatively. Although all parents were recruited in a similar manner (time allotted for decision-making and area in which consent was sought), this observation seems to be partly a result of stress, because parents who perceived that they had less time or privacy were also more anxious. In a previous study from our department, we observed that parents who exhibited more anxiety had less overall understanding of consent information and were more likely to decline their child’s participation.4 Given that this study showed that the manner in which the researcher presented study information was associated with a more positive risk/benefit assessment, every effort must be made to alleviate any anxiety and present study information in a relaxed, unhurried manner.
The limitations of this study are those inherent in survey research in general: nonresponse and self-report bias. The response rate for this study was high and, as such, should not present a bias. Furthermore, because the questionnaire was completed anonymously, one would expect parents to provide accurate and honest information. Another potential limitation of this study is that although the majority of our measurements were based on previously validated tools, some were developed specifically for this study and, as such, were not validated. All measurement tools, however, exhibited excellent internal consistency reliability (Cronbach .7). Another potential concern is that we based our results on the assessments of risks and benefits for several studies; as such, there was no standardization of the studies themselves or of the informed consent documents. Because we were most interested in identifying factors that influence the assessment of risks and benefits and their consistency under different circumstances, we chose to examine risk/benefit in the context of different study types. Although one could argue that the use of different study types in and of itself might explain some of the differences in risk/benefit assessment, analysis of the risks and benefits by individual study yielded the same trends and differences (albeit not all significant because of some smaller sample sizes). In the same vein, one could argue that the consent documents were also not standardized. However, we should note that all consent documents conformed to the University of Michigan’s IRB template and that consent information for all studies was disclosed in a standardized manner by the same experienced research personnel.
This study has identified several factors that influence the assessment of risks and benefits by parents whose children had been approached to participate in a clinical research study. Some of these factors are intrinsic to the characteristics of the parent/subject (eg, decisional uncertainty) and, as such, may not be readily amenable to intervention. However, other factors, such as the quality of the informed consent document and the environment in which consent is sought, are within our purview to change. Identification of these factors therefore is important as a means to develop strategies to ensure that the presentation of risk/benefit information is not open to misinterpretation and that parents can make informed decisions that fulfill their obligations to protect the interests of their children.
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ACKNOWLEDGMENTS |
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Presented in part at the joint meeting of the Society for Pediatric Anesthesia and the American Academy of Pediatrics Section on Anesthesiology; February 20–23, 2003; Fort Myers, FL.
We are indebted to Mark Erber, BSN, Sarah Earle, and Janelle Marshall for help with subject recruitment, data collection, and follow-up.
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FOOTNOTES |
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Reprint requests to (A.R.T.) Department of Anesthesiology, University of Michigan Health System, Ann Arbor, MI 48109. E-mail: atait{at}umich.edu
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REFERENCES |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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This article has been cited by other articles:
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  D. Wendler and T. Jenkins Children's and Their Parents' Views on Facing Research Risks for the Benefit of Others Arch Pediatr Adolesc Med, January 1, 2008; 162(1): 9 - 14. [Abstract] [Full Text] [PDF]
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 T. E. A. Chantler, A. Lees, E. R. Moxon, D. Mant, A. J. Pollard, and R. Fiztpatrick The Role Familiarity With Science and Medicine Plays in Parents' Decision Making About Enrolling a Child in Vaccine Research Qual Health Res, March 1, 2007; 17(3): 311 - 322. [Abstract] [PDF]
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 K S Hoehn, G Wernovsky, J Rychik, J W Gaynor, T L Spray, C Feudtner, and R M Nelson What factors are important to parents making decisions about neonatal research? Arch. Dis. Child. Fetal Neonatal Ed., May 1, 2005; 90(3): F267 - f269. [Abstract] [Full Text] [PDF]
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A. R. Tait, T. Voepel-Lewis, S. Malviya, and S. J. Philipson Improving the Readability and Processability of a Pediatric Informed Consent Document: Effects on Parents' Understanding Arch Pediatr Adolesc Med, April 1, 2005; 159(4): 347 - 352. [Abstract] [Full Text] [PDF]
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