Skip Navigation LinksHome > March 2003 - Volume 98 - Issue 3 > Do They Understand? (Part I): Parental Consent for Children...
Anesthesiology:
Clinical Investigations

Do They Understand? (Part I): Parental Consent for Children Participating in Clinical Anesthesia and Surgery Research

Tait, Alan R. Ph.D.*; Voepel-Lewis, Terri M.S.N., R.N.†; Malviya, Shobha M.D.*

Free Access
Article Outline
Collapse Box

Author Information

Collapse Box

Abstract

Background: Central to the tenet of informed consent is the quality of disclosure of information by the investigator and the understanding thereof by the research subject or his or her surrogate. This study was designed to measure parents’ understanding of the elements of informed consent for clinical studies in which their children had been approached to participate.
Methods: The study sample consisted of 505 parents who had been approached for permission to allow their child to participate in a clinical anesthesia or surgery study. Regardless of whether the parent consented (consenters, n = 411) or declined (nonconsenters, n = 94) to their child's participation in a study, they were interviewed to determine their understanding of 11 elements of consent. Two independent assessors who were familiar with the study protocols scored the parents’ levels of understanding.
Results: Parents perceived their overall understanding of the elements of consent as high (8.7 ± 1.6; 0–10 scale); however, this represented a significant overestimation compared with the assessors’ measures of parental understanding (7.3 ± 1.8;P < 0.0001). Furthermore, consenters had greater understanding than nonconsenters (7.6 ± 1.6 vs. 6.1 ± 1.9;P < 0.001). Several predictors of understanding were identified, including whether the parent consented, education level, clarity of disclosure, child in previous study, age of parent, parent listened to disclosure, and degree to which parent read the consent document. The day on which consent was sought had no impact on the level of understanding.
Conclusions: Parents approached for permission to allow their child to participate in a research study had less than optimal understanding of the elements of consent. As such, investigators must make every effort to enhance understanding and ensure that parents have sufficient information to make informed decisions regarding their child's participation in research studies.
PARENTS are generally considered the proxy decision-makers for their child's participation in clinical research, although the assent of the child (affirmative agreement) may be required for those children considered competent to give it. Because the parents’ role as decision-maker is to protect the interests and safety of the child, it is imperative that they understand the risks, benefits, and consequences of their child's participation as a research subject. In clinical anesthesia, and to a lesser extent, surgery research, consent is often sought just before surgery, a time when the subject and the subject's family may be most anxious. In such a situation, the ability to satisfy the “information element” of consent as described by Beachamp and Childress 1 may be hampered by the unique, often perfunctory, nature of the investigator–subject interaction. Despite this, there is a paucity of information addressing this issue, particularly as it applies to parental decision-making. Although a few studies have addressed understanding of consent for research, none have addressed understanding in a surgical population. 2–4 Therefore, this study was designed to measure parents’ real-time understanding of the elements of informed consent for clinical anesthesia and surgery studies in which their children had been approached to participate.
Back to Top | Article Outline

Materials and Methods

The University of Michigan's Institutional Review Board (Ann Arbor, Michigan) approved this study. The study population included parents or guardians who had been approached to allow their child to participate in 1 of 18 ongoing clinical anesthesia or surgery studies. Disclosure of information for informed consent was presented verbally and in written format by investigators, research nurses, or assistants either on the day(s) before surgery or, in the majority of cases, on the day of surgery. The day on which consent was sought, the time spent disclosing information, and the time allotted for the parents to make a decision were recorded. Regardless of whether the parents had consented to allow their child to participate in one of these studies, the parents were invited to complete an interview and questionnaire. The interview was conducted while the child was in surgery and was designed to determine their understanding of 11 required elements (Title 45. Code of Federal Regulations. Part 46) 5 of the informed consent document. The elements and corresponding interview questions are outlined below.
Study purpose (What is the purpose of the study?)
Protocol (What are the researchers going to do to your child for this study?)
Risks (What are the possible risks or discomforts associated with the study?)
Direct benefits (Describe the possible benefits to your child as a result of this research.)
Indirect benefits (Describe the possible benefits to other children as a result of this research.)
Freedom to withdraw (Could you change your mind about the study once you had agreed to allow your child to participate?)
Alternative treatments or procedures (If you did not allow your child to participate in the study, how would his or her anesthesia and surgery care be different?)
Voluntariness (Was your child's participation in the study voluntary?)
Duration of participation (What is the approximate length of time that your child will be involved in the study?)
Contact (Who can you contact regarding any aspects of your child's involvement in the study?)
Confidentiality (Can you tell me who is allowed to see your child's medical records for this study?)
The questions presented above were adapted from the Deaconess Informed Consent Comprehension Test (DICCT). 6 The interview was presented in a semistructured fashion, and the open-ended responses were written down verbatim by trained research assistants who had no knowledge of the details of the study protocols. Research personnel were allowed to clarify questions and prompt the parents for additional information but were unable to offer any specific details of the study. The parents’ levels of understanding of these individual elements were scored by two assessors who were familiar with all aspects of each study but who were blinded to the parents’ decision to consent or decline their child's participation. Using the format of the DICCT, 6 scores of 2, 1, or 0 were assigned based on whether the parents had complete (correct, complete answer), partial (correct but incomplete answer or “poverty of content”), or no understanding (incorrect or no answer) of each element, respectively. Based on these scores, a composite score was derived and compared with the parents’ perceived level of understanding measured on a 0–10 visual analog scale (VAS; 0 = no understanding, 10 = complete understanding). Because the two scales had different metrics, they were normalized to permit comparisons.
After the interview, the parents completed questionnaires, either while their child was in surgery or, if they preferred, at home. The questionnaire was designed to elicit demographic information, including the child's and parents’ ages, their race, income, parents’ education, and the child's and parents’ previous experience as a research subject. Information regarding the parents’ perceptions of the environment in which consent was sought (e.g., time, privacy) and the clarity and completeness of the information were elicited together with a measure of parental anxiety measured on a 0–10 VAS (10 = extremely anxious). Although there are more comprehensive measures of anxiety, the VAS represents a simple, yet valid means to obtain a global assessment of anxiety. 7,8 Parents also rated their child's health status using a 0–10 VAS (0 = extremely poor health, 10 = extremely healthy). This global measure has been shown to be a valid assessment of health status. 9 Readability of the informed consent documents for each study was analyzed using the Flesch Reading Ease and the Flesch-Kincaid Grade Level tests. 10
Back to Top | Article Outline
Statistical Analysis
Statistical analyses were performed using SPSS® statistical software (SPSS Inc., Chicago, IL). Based on pilot data, the assessors’ scores of understanding for consenters and nonconsenters were 7.3 ± 1.9 (0–10 scale) versus 6.4 ± 1.9, respectively. To detect a difference between groups of at least that large, we would need to study 94 subjects per group (α = 0.05, β = 0.1, two tailed). Descriptive data were analyzed using frequency distributions. Comparisons of parametric data between consenters and nonconsenters were performed using unpaired t tests. Nonparametric comparisons were analyzed using chi-square and Mann–Whitney U tests. Interrater reliability and levels of agreement between the two assessors’ scores of understanding were determined using Spearman correlation coefficients (ρ) and κ statistics, respectively. The κ statistic is a measure of agreement that allows for observer variability and corrects for chance levels of agreement. 11 Kappa values of 0.4 or greater were considered to represent acceptable agreement. Data are expressed as percentages, mean ± SD. Significance was accepted at the 5% level (P < 0.05).
Back to Top | Article Outline

Results

Table 1
Table 1
Image Tools
Five hundred sixty-nine parents whose child had been recruited for 1 of 18 clinical anesthesia (n = 13) or surgery (n = 5) studies were approached for interview and completion of the questionnaire. Of these, 505 parents were enrolled; 411 had consented to allow their child to participate in one of the studies (consenters), and 94 had declined their child's participation (nonconsenters). Of the 64 parents who were not included in this study, 14 declined, 24 were not available to be interviewed, 21 did not complete the questionnaire, 3 had language barriers, and 2 did not remember being approached for a study. The demographics of the study sample are described in table 1. Results showed that nonconsenters were less likely to have completed high school, had children who were significantly younger, and were more likely to have been approached for participation in a therapeutic rather than an observational study.
Table 2
Table 2
Image Tools
Table 3
Table 3
Image Tools
Measures of interrater reliability for scores of understanding between the two assessors revealed excellent correlations. Spearman rank order correlation coefficients and κ values for each core element ranged from 0.82 to 1.0 (P < 0.0001) and from 0.75 to 1.0 (P < 0.0001), respectively. The mean Flesch Reading Ease and Flesch-Kincaid Grade Level indices for the consent forms were 48.2 (range, 36–54.6) and 11.2 (range, 9.9–12), respectively. Table 2 compares the assessors’ measured scores of understanding with the parents’ perceived understanding. The percentages of parents who had complete understanding of each element of consent are described in table 3.
Eighty-four percent of parents believed that the amount of information given was “just right,” and only 13.4% thought that there was “too little” information. In addition, 59.3% of parents rated the clarity of the information as “very clear,” and only 2.1% rated it as “not clear.” There were no significant correlations between understanding and the time taken by the research personnel to disclose information; the time allotted for parents to make their decision; the amount of information given; the timing of consent (i.e., day of surgery vs. day(s) before surgery); parental race or ethnicity; researcher race or ethnicity, gender, appearance (white coat, scrubs, street clothes), and demeanor (friendly, hurried, pushy); whether child had previous surgery; and which parent gave consent.
Table 4
Table 4
Image Tools
However, several factors were shown by univariate analysis to be significantly (P < 0.01) associated with greater understanding. These included older parent or guardian (aged > 30 yr); child's participation in a previous study; parent consented to child's participation; higher education level; anxiety; perceived clarity of information; degree that parents had listened to the researcher; degree parents had read the consent document; and parental perception of the study's importance, risks, and benefits. These factors found to be significant by univariate analysis were subsequently entered into a multiple regression model with stepwise selection. Multivariate analysis of these factors yielded several predictors of parental understanding. Results of these analyses are shown in table 4.
Back to Top | Article Outline

Discussion

The role of the parent or guardian as the proxy decision-maker for his or her child's participation in clinical research is one of protection and, as such, differs from that of the adult subject whose role is one of self-determination. 12 Despite this difference, the information required at disclosure and the understanding thereof is essentially the same. 5 Beauchamp and Childress 1 suggest that one understands “if one has acquired pertinent information and justified, relevant beliefs about the nature and consequences of one's action.” However, some would argue that many subjects or their surrogates are unable to comprehend the relevance of information sufficiently to make an informed decision. 13 The nature of the information presented, for example, including the amount, type, clarity, and difficulty, has been shown to impact the subject's ability to comprehend. 14,15 Furthermore, problems with information processing because of incapacity, language difficulties, time constraints, anxiety, or pain may also hinder understanding of informed consent. Results of this study showed that parents approached for permission to allow their child to participate in a clinical study had inadequate understanding of the research. Furthermore, poor understanding was associated with lower education and clarity of information, and although not surprising, it reinforces the need for information to be disclosed at a level consistent with those attributes.
Although there are some data regarding understanding of consent by adult subjects, 16–18 there are few data regarding understanding by parents acting as proxies for their children in research. 19 Postlethwaite et al.2 measured understanding and ease of decision-making among parents and children involved in a growth hormone trial. Even though 70% of parents reported no difficulty in making their decision, only 30% had understanding that was rated as very good. In another study, van Stuijvenberg et al.4 showed that only 45% of parents approached for permission to enroll their child in a randomized, placebo-controlled trial were aware of five of six major trial characteristics (i.e., study aim, freedom to withdraw, risks, randomization, reasons for signing, chance of placebo). Snowdon et al.3 showed that parents of neonates enrolled in a randomized trial had poor understanding of the nature of the trial, and many had no perception that randomization would occur. These data suggest that inadequate understanding may jeopardize the ability of the parent to protect the child's interests.
Results of this study showed that parents approached for permission to allow their child to participate in a clinical study had inadequate understanding of the elements of informed consent, particularly with respect to those elements that they perceived to be important to them. In a previous study, parents ranked the risks, benefits to their child, and the protocol as the three most important elements that they believed they needed to understand before making a decision regarding their child's participation in a research study. 20 In this study, 70, 57.4, and 52.7% had complete understanding of these three elements, respectively. Furthermore, nonconsenters had less understanding of these elements than consenters. Although this finding may suggest that improved comprehension may improve consent rates, it may also reflect “early closure” by parents who had already made up their mind to decline participation and were uninterested in any further information.
Federal regulations require that consent forms be written “in a language understandable to the subject (or authorized representative).”5 However, although the general recommendation is that consent forms be written at an eighth grade reading level, several studies suggest that this is rarely accomplished. In a review of surgical consent forms, Grudner 21 found that the majority of forms were written at the level of a scientific journal. Other studies show reading levels between eleventh and sixteenth grade. 22,23 In our study, the Flesch-Kincaid readability index of the informed consent documents ranged from a tenth to twelfth grade level. Although we realize that these consent forms did not comply with the readability guidelines, we believed it important to measure understanding as an index of what appears to occur in the real world.
Consent for studies involving surgical populations is unique because consent is often sought on the day of surgery. Although some would argue that consent sought at this time is potentially coercive, studies suggest that consent obtained on the day of surgery is appropriate. 24–26 Furthermore, this study showed that the time taken to disclose information to the parents, the time allotted for them to make a decision, and the day on which consent was sought had no apparent impact on anxiety or understanding. This latter observation is similar to that of Elfant et al., 18 who showed that patients given consent information several days before endoscopic surgery had similar understanding as those given information just before surgery. Despite this, anesthesiologists should make every effort to ensure that the environment in which consent is sought is a private area conducive to decision-making. 27
In our study, understanding was strongly associated with the perceived clarity of information and the degree to which the parent(s) listened to the disclosure by the investigator. In a study by Muss et al., 14 understanding of chemotherapy regimens by cancer patients was greatly enhanced by the clarity of information. These findings fit nicely with the concept that consent should be an interactive process between researcher and subject involving disclosure, discussion, and understanding. 19
It was interesting to note that understanding was significantly better when a nonphysician investigator provided information. Although we were unable to identify factors related to the interaction that may have explained this difference, a similar finding was observed by Muss et al.14 regarding understanding of risks associated with chemotherapy regimens. The reason for this is unclear, although one may speculate that the physicians present the information at a level above that of a layperson.
A few points regarding the design of this study merit discussion. Previous studies addressing issues of informed consent in anesthesia have been based on sham studies. 24,28 Although these types of studies may be easier to conduct, they do not reflect the real-life situation. For example, the anxiety of having a child participate in a sham study may be different from that of a real study with real risks and benefits and, so too, the levels of understanding and decision-making. With this in mind, we believed it important to evaluate the parents’ understanding of real studies. Although participation in more than one study is not generally advocated, this caveat may be waived if the investigators agree that the second study presents minimal risk, will not harm the subjects, and will not influence the study outcomes, as was the case in our study. Furthermore, although parents were required to consent to both studies, the subjects were technically different, i.e., the child for the initial study and the parent for this study.
We deliberately based our measures of understanding on several studies so that we could examine understanding in the context of different risks and benefits. As such, one could argue that there was no standardization of consent documents used in this study. However, we should note that all consent documents used in this study followed the standard University of Michigan's Institutional Review Board template and included all elements of disclosure. Furthermore, all research personnel are trained to obtain informed consent in a standardized fashion.
It should also be noted that this study represents the experiences of subjects at one institution and, as such, may not be generalizable to all research centers. However, in our department, all research personnel involved with subject recruitment are required to complete the National Institutes of Health's and University of Michigan's web-based training program for research involving human subjects, receive on-the-job training, and undergo periodic quality assessment by investigators and senior research personnel. Furthermore, to reduce any bias attributed to the disclosure style of one person, understanding was based on disclosure of information by several different trained researchers. Based on these factors, it is likely that our findings would be similar to those experienced at most large pediatric research centers.
This study is the first to identify predictors of parental understanding of informed consent and, as such, will be useful in developing strategies to improve understanding for research subjects and their proxies. Results showed that parents of children recruited for anesthesia and surgery studies had less than optimal understanding of the elements of informed consent. Several factors, including lower education level, inattention to the researcher, and unclear information, were associated with poor comprehension. Of note for anesthesia research was the fact that subjects recruited on the day of surgery had similar understanding to those recruited on the previous day(s). Because the role of the parents is to protect the child from any perceived research-related risks, a lack of understanding of the elements of consent may jeopardize the parents’ ability to accurately weigh the benefits and risks. As such, these results not only have important implications for this population of children but also for all children involved in clinical research. Because consent without understanding has ethical and legal implications, investigators must make every effort to enhance understanding so the rights of the research subject are protected and preserved.
The authors thank Angela Robinson, B.S., Mark Erber, B.S.N., Michael Brown, B.S., Janelle Marshall (undergraduate), Sarah Earle (undergraduate), and Nina Osak (undergraduate) (all from the Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan) for help with data collection, patient recruitment, and follow-up review.
Back to Top | Article Outline

References

1. Beauchamp TL, Childress JF: Principles of Biomedical Ethics, 4th edition. New York, Oxford University Press, 1994, pp 120–88

2. Postlethwaite RJ, Reynolds JM, Wood AJ, Evans JHC, Lewis MA, Eminson DM: Recruiting patients to clinical trials: Lessons from studies of growth hormone treatment in renal failure. Arch Dis Child 1995; 73: 30–5

3. Snowdon C, Garcia J, Elbourne D: Making sense of randomization: Responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997; 45: 1337–55

4. van Stuijvenberg M, Suur MH, de Vos S, Tjiang GC, Steyerberg EW, Derksen-Lubsen G, Moll HA: Informed consent, parental awareness, and reasons for participating in a randomised controlled study. Arch Dis Child 1998; 79: 120–5

5. Department of Health and Human Services: Protection of Human Subjects. Code of Federal Regulations. Washington, DC, US Department of Health and Human Services, Title 45, Part 46, 1991

6. Miller CK, O'Donnell DC, Searight HR, Barbarash RA: The Deaconess Informed Consent Comprehension Test: An assessment tool for clinical research subjects. Pharmacotherapy 1996; 16: 872–8

7. Folstein M, Lauria R: Reliability, validity and clinical application of the visual analogue mood scale. Psychol Med 1973; 3: 479–86

8. Cella D, Perry S: Reliability and concurrent validity of three visual analogue mood scales. Psychol Reports 1986; 59: 827–33

9. Fayers PM, Sprangers MAG: Understanding self-rated health. Lancet 2002; 359: 187–8

10. Flesch R: A new readability yardstick. J Appl Psychol 1948; 32: 2211–23

11. Fleiss JL: Statistical Methods for Rates and Proportions, 2nd edition. New York, John Wiley & Sons, 1981, pp 212–37

12. Denham EJ, Nelson RM: Self-determination is not an appropriate model for understanding parental permission and child assent. Anesth Analg 2002; 94: 1049–51

13. Schultz AL, Pardee GP, Ensinck JW: Are research subjects really informed? West J Med 1975; 123: 76–80

14. Muss HB, White DR, Michielutte R, Richards F, Cooper MR, Williams S, Stuart JJ, Spurr CL: Written informed consent in patients with breast cancer. Cancer 1979; 43: 1549–56

15. Silva MC, Sorrell JM: Enhancing comprehension of information for informed consent: A review of empirical research. IRB 1988; 10: 1–5

16. Bergler JH, Pennington AC, Metcalfe M, Freis ED: Informed consent: How much does the patient understand? Clin Pharmacol Ther 1980; 27: 435–40

17. Robinson G, Merav A: Informed consent: Recall by patients tested postoperatively. Ann Thorac Surg 1976; 22: 209–12

18. Elfant AB, Korn C, Mendez L, Pello MJ, Peikin SR: Recall of informed consent after endoscopic procedures. Dis Colon Rectum 1995; 38: 1–3

19. Erb TO, Schulman SR, Sugarman J: Permission and assent for clinical research in pediatric anesthesia. Anesth Analg 2002; 94: 1155–60

20. Tait AR, Voepel-Lewis T, Robinson A, Malviya S: Priorities for disclosure of the elements of informed consent for research: A comparison between parents and investigators. Paediatr Anaesth 2001; 12: 332–6

21. Grundner TM: On the readability of surgical consent forms. N Engl J Med 1980; 302: 900–2

22. Murgatroyd RJ, Cooper RM: Readability of informed consent forms. Am J Hosp Pharm 1991; 48: 2651–2

23. Tarnowski KJ, Allen DM, Mayhall C, Kelly PA: Readability of pediatric biomedical research informed consent forms. Pediatrics 1990; 85: 58–62

24. Maltby JR, Eagle CJ: Informed consent for clinical anaesthesia research. Can J Anaesth 1993; 40: 891–6

25. Tait AR, Voepel-Lewis T, Siewert M, Malviya S: Factors that influence parents’ decisions to consent to their child's participation in clinical anesthesia research. Anesth Analg 1998; 86: 50–3

26. Dorantes DM, Tait AR, Naughton NN: Informed consent for obstetric anesthesia research: Factors that influence parturients’ decisions to participate. Anesth Analg 2000; 91: 369–73

27. Waisel DB, Truog RD: Informed consent. A nesthesiology 1997; 87: 968–78

28. Mingus ML, Levitan SA, Bradford CN, Eisenkraft JB: Surgical patients’ attitudes regarding participation in clinical anesthesia research. Anesth Analg 1996; 82: 332–7

Cited By:

This article has been cited 37 time(s).

American Journal of Critical Care
Asking for Parents' Permission to Enroll Their Child Into A Clinical Trial: Best Practices
Lebet, R; Fineman, LD; Faustino, EVS; Curley, MAQ
American Journal of Critical Care, 22(4): 351-356.
10.4037/ajcc2013352
CrossRef
Mayo Clinic Proceedings
Protocol Understanding and Anxiety in Perioperative Clinical Trial Patients Approached for Consent on the Day of Surgery
Chludzinski, A; Irani, C; Mascha, EJ; Kurz, A; Devereaux, PJ; Sessler, DI
Mayo Clinic Proceedings, 88(5): 446-454.
10.1016/j.mayocp.2012.12.014
CrossRef
Pediatric Blood & Cancer
Parental informed consent in pediatric cancer trials: A population-based survey in Germany
Petersen, I; Spix, C; Kaatsch, P; Graf, N; Janka, G; Kollek, R
Pediatric Blood & Cancer, 60(3): 446-450.
10.1002/pbc.24330
CrossRef
Archives of Internal Medicine
Patient Comprehension of an Interactive, Computer-Based Information Program for Cardiac Catheterization A Comparison With Standard Information
Tait, AR; Voepel-Lewis, T; Moscucci, M; Brennan-Martinez, CM; Levine, R
Archives of Internal Medicine, 169(): 1907-1914.

Pediatrics
Factors that influence parents' assessments of the risks and benefits of research involving their children
Tait, AR; Voepel-Lewis, T; Malviya, S
Pediatrics, 113(4): 727-732.

Archives of Pediatrics & Adolescent Medicine
Improving the readability and processability of a pediatric informed consent document - Effects on parents' understanding
Tait, AR; Voepel-Lewis, T; Malviya, SH; Philipson, SJ
Archives of Pediatrics & Adolescent Medicine, 159(4): 347-352.

Journal of Pediatrics
Children are not small adults: Documentation of assent for research involving children
Ungar, D; Joffe, S; Kodish, E
Journal of Pediatrics, 149(1): S31-S33.
10.1016/j.jpeds.2006.04.048
CrossRef
Pediatric Blood & Cancer
When Too Much Is Just Enough: What Do Oncologists Tell Parents?
Berg, SL
Pediatric Blood & Cancer, 52(4): 437-438.
10.1002/pbc.21871
CrossRef
Journal of Medical Ethics
A questionnaire on factors influencing children's assent and dissent to non-therapeutic research
Wolthers, OD
Journal of Medical Ethics, 32(5): 292-297.
10.1136/jme.2004.010579
CrossRef
Journal of Pediatrics
Parental opinions about clinical research
Morris, MC; Besner, D; Vazquez, H; Nelson, RM; Fischbach, RL
Journal of Pediatrics, 151(5): 532-537.
10.1016/j.jpeds.2007.04.032
CrossRef
Lancet
Clinical trials in children
Caldwell, PHY; Murphy, SB; Butow, PN; Craig, JC
Lancet, 364(): 803-811.

Archives of Pediatrics & Adolescent Medicine
Weighing the Risks and Benefits of Pediatric Research A Risky Business
Tait, AR
Archives of Pediatrics & Adolescent Medicine, 164(6): 579-581.

Cochrane Database of Systematic Reviews
Audio-visual presentation of information for informed consent for participation in clinical trials
Ryan, RE; Prictor, MJ; McLaughlin, KJ; Hill, SJ
Cochrane Database of Systematic Reviews, (1): -.
ARTN CD003717
CrossRef
American Journal of Orthodontics and Dentofacial Orthopedics
Informed consent recall and comprehension in orthodontics: Traditional vs improved readability and processability methods
Kang, EY; Fields, HW; Kiyak, A; Beck, FM; Firestone, AR
American Journal of Orthodontics and Dentofacial Orthopedics, 136(4): -.
ARTN 488.e1
CrossRef
Archives of Disease in Childhood
Parental consent in paediatric clinical research
Chappuy, H; Doz, F; Blanche, S; Gentet, JC; Pons, G; Treluyer, JM
Archives of Disease in Childhood, 91(2): 112-116.
10.1136/adc.2005.076141
CrossRef
Oncologist
Ethical challenges in cancer research in children
Berg, SL
Oncologist, 12(): 1336-1343.
10.1634/theoncologist.12-11-1336
CrossRef
Journal of Law Medicine & Ethics
Incidental findings in genetics research using archived DNA
Clayton, EW
Journal of Law Medicine & Ethics, 36(2): 286-+.

Qualitative Health Research
The role familiarity with science and medicine plays in parents' decision making about enrolling a child in vaccine research
Chantler, TEA; Lees, A; Moxon, ER; Mant, D; Pollard, AJ; Fiztpatrick, R
Qualitative Health Research, 17(3): 311-322.
10.1177/1049732306298561
CrossRef
Contemporary Clinical Trials
The role of the consent document in informed consent for pediatric leukemia trials
Hazen, RA; Drotar, D; Kodish, E
Contemporary Clinical Trials, 28(4): 401-408.
10.1016/j.cct.2006.10.011
CrossRef
Social Science & Medicine
Risk perception and decision processes underlying informed consent to research participation
Reynolds, WW; Nelson, RM
Social Science & Medicine, 65(): 2105-2115.
10.1016/j.socscimed.2007.06.021
CrossRef
Archives of Pediatrics & Adolescent Medicine
Empirical data and the acceptability of research risk - A commentary on the charitable participation standard
Reynolds, WW; Nelson, RM
Archives of Pediatrics & Adolescent Medicine, 162(1): 88-90.

Journal of the American Academy of Child and Adolescent Psychiatry
Research knowledge among parents of children participating in a randomized clinical trial
Vitiello, B; Aman, MG; Scahill, L; McCracken, JT; McDougle, CJ; Tierney, E; Davies, M; Arnold, LE
Journal of the American Academy of Child and Adolescent Psychiatry, 44(2): 145-149.

Intensive Care Medicine
Illness severity and parental permission for clinical research in a pediatric ICU population
Hulst, JM; Peters, JWB; van den Bos, A; Joosten, KFM; van Goudoever, JB; Zimmermann, LJI; Tibboel, D
Intensive Care Medicine, 31(6): 880-884.
10.1007/s00134-005-2647-8
CrossRef
Journal of the American Academy of Child and Adolescent Psychiatry
Research knowledge among the participants in the Treatment for Adolescents with Depression Study (TADS)
Vitiello, B; Kratochvil, CJ; Silva, S; Curry, J; Reinecke, M; Pathak, S; Waslick, B; Hughes, CW; Prentice, ED; May, DE; March, JS
Journal of the American Academy of Child and Adolescent Psychiatry, 46(): 1642-1650.
10.1097/chi.0b013e318153f8c7
CrossRef
International Journal of Nursing Studies
The quality of parental consent for research with children: A prospective repeated measure self-report survey
Franck, LS; Winter, I; Oulton, K
International Journal of Nursing Studies, 44(4): 525-533.
10.1016/j.ijnurstu.2006.03.014
CrossRef
Bmc Medical Ethics
How do parents experience being asked to enter a child in a randomised controlled trial?
Shilling, V; Young, B
Bmc Medical Ethics, 10(): -.
ARTN 1
CrossRef
Journal of Child and Adolescent Psychopharmacology
Report of an Initial Pilot Study on the Feasibility of Using the MacArthur Competence Assessment Tool for Clinical Research in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
Koelch, M; Prestel, A; Singer, H; Schulze, U; Fegert, JM
Journal of Child and Adolescent Psychopharmacology, 20(1): 63-67.
10.1089/cap.2008.0114
CrossRef
Therapie
Consent in paediatric clinical trials
Chappuy, H
Therapie, 59(4): 421-429.

Anesthesia and Analgesia
Presenting research information to children: A tale of two methods
Tait, AR; Voepel-Lewis, T; Malviya, S
Anesthesia and Analgesia, 105(2): 358-364.
10.1213/01.ane.0000270326.44507.11
CrossRef
Journal of Medical Ethics
Children in health research: a matter of trust
Woodgate, RL; Edwards, M
Journal of Medical Ethics, 36(4): 211-216.
10.1136/jme.2009.031609
CrossRef
Jama Pediatrics
Informing the Uninformed Optimizing the Consent Message Using a Fractional Factorial Design
Tait, AR; Voepel-Lewis, T; Nair, VN; Narisetty, NN; Fagerlin, A
Jama Pediatrics, 167(7): 640-646.
10.1001/jamapediatrics.2013.1385
CrossRef
European Journal of Pediatrics
Educational Paper: Ethical aspects of clinical research with minors
Bos, W; Tromp, K; Tibboel, D; Pinxten, W
European Journal of Pediatrics, 172(7): 859-866.
10.1007/s00431-012-1856-8
CrossRef
Journal of the American Medical Informatics Association
Evaluation of a prototype interactive consent program for pediatric clinical trials: a pilot study
Tait, AR; Voepel-Lewis, T; McGonegal, M; Levine, R
Journal of the American Medical Informatics Association, 19(): E43-E45.
10.1136/amiajnl-2011-000253
CrossRef
Anesthesiology
Participation of Children in Clinical Research: Factors that Influence a Parent's Decision to Consent
Tait, AR; Voepel-Lewis, T; Malviya, S
Anesthesiology, 99(4): 819-825.

PDF (233)
Anesthesiology
Child Assent and Parental Permission: A Comment on Tait's “Do They Understand?”
Nelson, RM; Reynolds, WW
Anesthesiology, 98(3): 597-598.

PDF (85)
The Clinical Journal of Pain
Parents' Understanding of Information Regarding Their Child's Postoperative Pain Management
Tait, AR; Voepel-Lewis, T; Snyder, RM; Malviya, S
The Clinical Journal of Pain, 24(7): 572-577.
10.1097/AJP.0b013e31816b7cdf
PDF (111) | CrossRef
Current Opinion in Psychiatry
Ethical issues in psychopharmacology of children and adolescents
Koelch, M; Schnoor, K; Fegert, JM
Current Opinion in Psychiatry, 21(6): 598-605.
10.1097/YCO.0b013e328314b776
PDF (140) | CrossRef
Back to Top | Article Outline

© 2003 American Society of Anesthesiologists, Inc.

Publication of an advertisement in Anesthesiology Online does not constitute endorsement by the American Society of Anesthesiologists, Inc. or Lippincott Williams & Wilkins, Inc. of the product or service being advertised.
Login

Article Tools

Images

Share