informed consent for pediatric leukemia research : clinician perspectives

Informed Consent for Pediatric Leukemia ResearchClinician Perspectives

Chris Simon, Ph.D.

Michelle Eder, M.A.

Pauline Raiz, B.S.

Stephen Zyzanski, Ph.D.

Rebecca Pentz, Ph.D.

Eric D. Kodish, M.D.

Rainbow Center for Pediatric Ethics, Department ofPediatrics, Rainbow Babies and Children’s Hospitalof University Hospitals of Cleveland, Cleveland,Ohio.

Supported in part by Rainbow Babies and Chil-dren’s Hospital Board of Trustees and the NationalCancer Institute–funded study Informed Consent inthe Children’s Cancer Group (R01 CA83267).

The authors thank the clinicians who participatedin this study; without their efforts, this articlewould not be possible. They also thank the Chil-dren’s Oncology Group for its support.

Address for reprints: Eric D. Kodish, M.D., RainbowBabies and Children’s Hospital, Department of Pe-diatric Hematology/Oncology, RBC 310, 11100 Eu-clid Avenue, Cleveland, OH 44106; Fax: (216) 844-5431; E-mail: [email protected]

Received October 19, 2000; accepted April 24,2001.

BACKGROUND. Good, fully informed consent is critical to the ethical conduct of

clinical cancer research. The authors examined clinician perspectives on informed

consent for pediatric research by surveying clinicians at five major medical centers

that routinely enroll patients in Children’s Cancer Group studies.

METHODS. Building on a pilot study, a questionnaire was designed to elicit clini-

cians’ general opinions, approaches, and suggestions related to informed consent

in pediatric leukemia trials. Questionnaires were mailed to 132 clinicians. Eighty-

nine questionnaires were returned, along with 13 nonparticipant forms notifying

us of the clinician’s inability to participate because of a lack of experience in

pediatric informed consent. The response rate was 75%.

RESULTS. Providing information so that families can decide about study entry was

ranked as the most important goal of the informed consent process, whereas

parents’ state of shock was rated the most significant obstacle to good informed

consent. Clinicians cited high levels of parental comprehension of key aspects of

clinical research studies and reported information overload and increased anxiety

as effects of the informed consent process on parents. Several key items were

associated with clinicians’ gender, race, and professional experience. Finally, one

open-ended question yielded 126 suggestions for how to improve the informed

consent process that were grouped into 10 meaningful categories.

CONCLUSIONS. Clinicians report a range of approaches, opinions, concerns, and

suggestions for improving the informed consent process. The article proposes that

their views and suggestions be integrated with those of parents and patients in

attempts to survey and improve informed consent in pediatric oncology. Cancer

2001;92:691–700. © 2001 American Cancer Society.

KEYWORDS: informed consent, pediatric oncology, clinician perspectives, clinicaltrials.

Few clinicians would disagree that good, fully informed consent iscritical to the ethical conduct of clinical cancer research.1,2 Far less

consensus, however, accompanies attempts to define “good” and“fully informed.” Significant questions remain about how to deliverthe right amount of information to parents with different back-grounds and needs to help meet—and not hinder—their decisionmaking, and how to sensitively negotiate the clinical imperative toheal children with the scientific impulse to study them. Psychologic,social, and other issues complicate the picture: parents and cliniciansinteract around the topic of clinical trials amidst tremendous emo-tional stress;3 complex social and cultural expectations;4 potentialliteracy and language barriers;5,6 technically complicated treatmentplans and protocols; time-related pressures to discuss and decideabout research; myriad, sometimes conflicting resources (clinical,Internet-based, lay counseling); and, typically, amid busy schedules,

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© 2001 American Cancer Society

FIGURE 1. General clinician questionnaire.

692 CANCER August 1, 2001 / Volume 92 / Number 3

relentless pagers and telephones, and other obliga-tions. These and other factors combine to make theinformed consent process a fully “social situation”7,8

whose ethical dimensions—what to tell parents, when,and how—are shot through with factors such as lan-guage, cultural expectations, popular media, and therespective demographics of parents and clinicians.Describing this tapestry from the perspectives of thosedirectly involved in informed consent is the first steptoward eliminating its flaws and irregularities; clini-cians drawing on their “insider knowledge” of in-formed consent present a unique opportunity in thisregard.

The current paper reflects on a questionnairecompleted by 89 clinicians who reported personal in-volvement in informed consent conferences for pedi-

FIGURE 1 (continued)

FIGURE 1 (continued)

Informed Consent: Clinician Perspectives/Simon et al. 693

atric leukemia clinical trials. Building on a pilot studyconducted among both clinicians and parents in-volved in informed consent,9 this questionnaire wasadministered as part of a larger study (Children’s Can-cer Group [CCG]-S9901) designed to understand theinformed consent process for leukemia trials at fivemajor institutions in the United States. Whereas thelarger study aims to detail 125 informed consent cases,the questionnaire reported here was designed to gleanmore general data that are not patient specific. Spe-cifically, the questionnaire asks clinicians to look be-yond the variability that different clinical situationsmay present and to draw on their general experiencewith and opinions about informed consent for pedi-atric leukemia clinical trials. The questionnaire thusserves as a background to CCG-S9901, as well as asource of data that can stand independently of thelarger study.

METHODSData collection involved mailing out questionnaires to132 clinicians at five U.S. institutions participating inCCG-S9901, each of which routinely enrolls patients inChildren’s Cancer Group leukemia studies (Fig. 1).These institutions were Rainbow Babies and Chil-dren’s Hospital of University Hospitals of Cleveland inCleveland, Ohio; Children’s Hospital of Philadelphiain Philadelphia, Pennsylvania; Children’s HospitalMedical Center in Cincinnati, Ohio; Children Hospitalof Los Angeles in Los Angeles, California; and, M.D.Anderson Cancer Center in Houston, Texas.

Complete, up-to-date departmental lists were ob-tained from each institution so that questionnairescould be personally addressed to clinicians. Eachmailed package contained a questionnaire, a coverletter explaining the purpose of the study and assuringconfidentiality, and a “blue form” that encouragedclinicians without any experience in pediatric in-formed consent to notify us of their inability to par-ticipate in the study. Thirteen of these nonparticipantforms were returned to us, and a total of 30 question-naires were not accounted for by the retrieval dead-line. Therefore, the final sample consists of 89 com-pleted questionnaires. A response rate of 75% of thetotal number of eligible clinicians was achieved.

Questionnaires were administered and retrievedin the following three stages spanning 12 weeks: 1)initial mailing of questionnaire, 2) mailing of reminderletter, and 3) personal contact from research associate.

Data AnalysisThe questionnaire contained 23 items. Responses toquantitative, closed-ended questions were enteredinto an Microsoft Access database and validated for

data integrity. The data were converted from Mi-crosoft Access and loaded into a SAS database. Afterdropping 8 poorly distributed items and convertingothers to dichotomous variables, frequency distribu-tions were calculated for all variables based on thesample of 89 respondents. To aid in interpreting thedistributions, greater emphasis was placed on modalresponses and those occurring to the extremes of thedistribution. Categoric associations between cliniciancharacteristics and selected item outcomes were ex-amined by means of the chi-square statistic. Tests ofassociation between item outcomes and cliniciancharacteristics were performed for only three cliniciancharacteristics: gender, race, and years of experience.

Qualitative data were limited to responses fromone final open-ended question: “How do you think wecan make the informed consent process better? ” Re-sponses to this question were transcribed into Mi-crosoft Word, divided into discrete suggestions, andanalyzed for general categories. The categories pro-duced from this analysis then were ranked accordingto the frequency of the suggestions in each category.

RESULTSDemographic DataAlmost two-thirds (64%) of our 89 respondents areself-reported physicians, 21% are fellows, 12% arenurse practitioners, and 2% are case managers. Fifty-five percent of our respondents were female. Ethnicitywas self-reported as follows: 78% Caucasian or white,12% Asian or Asian American, 2% African American orblack, 2% Latino, and 5% other minorities (Arab, Is-raeli, Indian, Asian-Indian). The mean age of respon-dents was 43 years (range, 29 –75).

Training and Experience in Informed ConsentRespondents averaged 13 years (range, 1– 44 years)involvement in the care of children with cancer, withapproximately half (49%) of clinicians reporting 11 ormore years of experience. Asked to report how theylearned to discuss informed consent for pediatric can-cer research, 84% of clinicians cited “informal trainingthrough observation of mentors,” 14% cited both for-mal and informal training, and 2% cited only a formaltraining program.

Clinicians also were asked if their attitudes towardinformed consent have changed as they have gainedprofessional experience (Fig. 2). Using a Likert scale,we found that greater than half (56%) of cliniciansreported that they have grown more detail-oriented indiscussions of informed consent, whereas 26% re-ported being less concerned about details, and 18%rated themselves as unchanged. In contrast, 46% ofclinicians felt that their approach to informed consent


has grown neither more nor less directive as they havegained professional experience, whereas only 24% feltthey have grown more directive, and 30% reportedhaving grown less directive. Greater than half (51%) ofclinicians reported that they allocate more time todiscussing research as they have gained experience,whereas only 10% claimed they take less time.

Goals of Informed ConsentClinicians were asked to rank their opinion of thegoals of the informed consent process. Ranks given byall 89 clinicians, for each of 5 goals, were added toobtain a summary score. Scoring the highest overallmean ranking (4.01), the most important goal of in-formed consent for leukemia clinical trials was “toprovide information so that families can decide aboutstudy entry.” The next highest mean ranking (3.9) was“to explain the disease and its treatment, ” followed by“to protect the rights of subjects in clinical research”(3.1) and “to document risks and benefits (2.8).” Thelowest mean ranked goal (1.3) was “to encourage fam-ilies to give consent.” Those who selected explainingthe disease and its treatment as most important werealso more likely to have 10 or fewer years of profes-sional experience (chi-square 5 4.15; P , 0.05). Theother goals did not show an association with years ofprofessional experience.

Approaches to Informed ConsentClinicians were asked to select from a series of state-ments the one that best describes the way they ap-proach informed consent discussions with parents.

Thirty-four percent of clinicians chose “I tell familiesabout the CCG study and suggest that their child willbenefit from our knowledge based on previous stud-ies” (emphasis in original instrument). Twenty-eightpercent of clinicians selected “I tell families about theCCG study and suggest that other children will benefitfrom what we learn in the current study,” with lessexperienced clinicians more frequently choosing thisoption (chi-square 5 5.48; P , 0.05). Years of experi-ence showed no association with the other options inthis item.

Twenty-four percent chose “I describe the CCGstudy without any attempt to influence their deci-sion.” Of the respondents who selected this item,three-quarters (75%) were female (chi-square 5 4.1; P, 0.05). The least popular approach, selected by 14%of clinicians, was “I explain the disease and its treat-ment and recommend that the child go on the CCGstudy.” Three-quarters (75%) of the respondentschoosing this approach were male (chi-square 5 5.2; P, 0.05).

Eighty-four percent of clinicians (n 5 75) reportedthe belief that “current patients receive direct benefitfrom participation in CCG studies.” Notably, whenasked to describe the way they approach informedconsent discussions with parents, only 16% of these 75clinicians also stated that they recommend to parentsthat their child should go on a research study. Greaterconsistency was evident among the 16% of clinicianswho stated that they did not believe current patientsreceive direct benefit from participation in CCG stud-ies: none of these clinicians reported an approach that

FIGURE 2. Changes in attitudes about

informed consent with professional ex-

perience. Clinician responses to three

questions about how their attitudes

about informed consent have changed

as they have gained professional expe-

rience.


included recommending to parents that their childrengo on a research study.

Clinicians also were asked to rate on a five-pointscale how detailed they are in explaining researchprotocols (Fig. 3). Sixty-three percent of clinicians re-ported being either more than moderately or verydetailed. Twenty-eight percent reported being moder-ately detailed, and 9% said they were either minimallydetailed or not detailed. A second five-point scaleasked clinicians to rank how directive they are inrecommending a research study (Fig. 3). Forty-twopercent of clinicians reported an approach of interme-diate directiveness, 30% reported favoring a minimallydirective or nondirective approach, and 28% said thatthey are more than moderately directive or very di-rective.

Asked to specify the youngest age at which theythink a child should be included in a discussion ofinformed consent, clinicians felt on average that pa-tients should be at least 11 years old (range, 4 –18). Arelated question asked clinicians to specify at whichage they think a child should be involved in making adecision about participation in research. The meanage reported here was 13 years (range, 6 –19).

Perceived Comprehension and Effects of InformedConsent on ParentsAsked to consider how well parents comprehend arandomized clinical research study at the time parentsdecide whether or not their child should participate,clinicians cited fairly high levels of comprehension

(Table 1). Clinicians reported on average that 70% ormore parents understand such facets of informed con-sent as the right to withdraw from the clinical trial,that data about their child would be handled confi-dentially, that their child would be randomly assignedto a particular arm of the study, and that parents canchoose between standard treatment and study partic-ipation. “The meaning of randomization” scoredsomewhat lower, with clinicians reporting that 62% ofparents on average understand the meaning of theconcept.

Strikingly, many clinicians (48% and 65%, respec-tively) identified anxiety and information overloadamong parents as effects of the informed consentprocess, although 44% of clinicians also reported thatthe informed consent process leaves parents feelingmore in control of their situation than before.

When asked “who usually makes the decisionabout whether a young child with cancer enters a CCGstudy,” 93% of clinicians identified the child’s parents.Four percent identified themselves, and the rest said“someone else” decides.

Perceived Obstacles to Good Informed ConsentWe asked clinicians to rank what they perceived as themajor obstacles to good informed consent in pediatricleukemia trials. “Parents state of shock after a newdiagnosis for their child” received the highest meanranking (4.3). “Requirements mandated by Institu-tional Review Boards” scored lowest (mean, 1.7). Scor-ing in between were “clinical urgency to begin therapy

FIGURE 3. Level of detail and direc-

tiveness used in explaining research

protocol. Clinician responses to the

questions “in explaining the research

protocol, how detailed is the information

you share?” and “how directive are you

when you recommend a CCG study?”


before a consent decision is made” (3.1), “length ofand language used in the consent document” (2.9),and “the complexity of CCG study designs” (3.0). Sig-nificantly, complexity of study design was selected asthe most important obstacle by 39% of minority re-spondents as opposed to 9% of white respondents(chi-square 5 8.96; P , 0.05). Rankings of the otherobstacles were not related to ethnic status.

Suggestions for ImprovementThe questionnaire contained one final open-endedquestion that asked “How do you think we can makethe informed consent process better?” This questionwas answered by 61 of the 89 clinicians who returneda questionnaire, with a total of 126 suggestions beingoffered. As shown in Table 2, the responses fell into 10main categories, many of which correspond with theobstacles discussed above. The category with the mostsuggestions related to simplifying the informationgiven during the informed consent process (23%). Cli-nicians suggested three major ways to simplify in-formed consent information: 1) using visual aids (“Usestate-of-the-art technologies, including standardizedvideos for common themes, preprinted visual aids”),2) simplifying the language used (“Write and speak inlay language and simple sentences”), and 3) providingless information (“There is just so much informationfor a family to take in at a time when all they can thinkof is ‘my child has cancer.’ If less info could be accept-able, it would be great.”)

The second most frequently cited recommenda-tion pertained to the timing of the informed consentdiscussion (21%). One subsection of this category in-cludes statements about separating the discussion ofresearch from the diagnosis/general treatment discus-

sion (“I think that the informed consent discussionneeds to take place over two separate meetings—firstso families can get over the shock of a new diagnosis ofcancer and then a second meeting to actually discussthe study.”) Suggestions referring to the need for morethan one discussion about the research itself formanother subsection in this category.

Another recurrent theme concerned allowing par-ents/patients more time to make a decision aboutparticipation in a clinical trial (15%). Many of thereplies falling into this category also stressed the needto start therapy before requiring parents to decideabout research. For example, one clinician com-mented that “It is exceedingly difficult in the ‘heat ofthe moment’—the need to initiate therapy—for theparents to ‘get up to speed’ regarding treatment alter-natives. They are forced to rely on the judgment of thephysician. The need to begin therapy is a coerciveforce driving parental and physician decisions.” An-other clinician argued that “The bureaucratic insis-tence on obtaining ‘informed consent’ for a complexstudy at the time of diagnosis, even when the experi-mental part of the treatment is later, is absurd, infu-riating, and counterproductive. I hope that the resultsof these studies will eventually convince our regula-tors to drop that requirement.” These types of state-ments reiterate clinicians’ ranking of “parents ‘state ofshock’ after a new diagnosis for their child” and “clin-ical urgency to begin therapy before a consent deci-sion is made” as the two main obstacles to good in-formed consent.

Another prominent category identifies the needfor good communication between physicians and pa-tients/parents (8%), including the value of under-standing the informational needs of different parentsand patients. One clinician stated, “If we could iden-

TABLE 1Clinician Assessment of Parental Comprehension of InformedConsent Issuesa

Issue Mean percentage

That they have the right to withdraw from the clinical trialat any time 76

That data collected about their child will be handledconfidentially 76

That they can choose between standard treatment andclinical trial participation 71

That their child will be randomly assigned to a particulararm of the study if they participate 70

The meaning of randomization 62

a Clinician responses to the question “please consider how well parents comprehend a randomized

Children’s Cancer Group clinical research protocol at the time they decide whether or not their child

should participate. At that time, what percentage of parents do you think understand . . . ”.

TABLE 2126 Suggestions for Improving the Informed Consent Processa

Category Frequency Percentage

Simplify information 29 23%Timing of discussion 27 21%Removing time constraints for decision making 19 15%Physician/patient–parent communication 10 8%Improving consent document 9 7%Formal training 7 6%Providing translated consent documents 6 5%Discussion of risks 4 3%Including child in informed consent process 3 2%Other 12 10%Totals 126 100%

a Clinician responses to the question “how do you think we can make the informed consent process

better?”


tify characteristics of the parents to be able to under-stand their education level, intellectual ability, emo-tional state, and the processes they use to makedecisions, we could tailor the informed consent pro-cess to individual patients and families. Although allpatients (if age appropriate) and families should un-derstand basic requirements of consent, how one ex-plains this, and when, would benefit from understand-ing the above.”

Seven percent of clinicians recommended changesto the consent document as a way to improve the in-formed consent process. For instance, one clinician’sresponse was “have single sided form with boxes fordecision makers to initial that they understand what hasbeen stated, e.g., ‘I understand that my child (or I) will berandomized to the treatment arm or the control arm, Iunderstand that my child (or I) can withdraw at anytime.’ Doing the above may ensure that decision makersand/or child/patient understands and that physician hasaddressed the issues—provided an ‘informed’ consent.”Six percent of clinicians suggested formal training as ameans to improving the informed consent process. Anexample of this type of suggestion is “Have training forstaff regarding how to obtain an informed consent. Thegoal would be to make certain the study was presentedin a way that the families can understand what the studyis about, can separate disease and treatment issues fromthe study, and can truly make an informed decision.”

Five percent of clinicians pointed out the need forforeign language versions of the consent materials, and3% provided suggestions relating to the discussion ofrisks. For example, one respondent’s recommendationfor improving the informed consent process was to“clarify the difference between the risks of study partic-ipation and the risks of therapy for cancer.” Other clini-cians proposed limiting the discussion of side effects tothose that are most common. Several clinicians (2%)suggested including the child/patient in the informedconsent process. Finally, 10% of clinicians made sugges-tions that were highly variable and did not fit into any ofthe above categories. Examples of suggestions falling inthis “other” category are: “simplify study protocols—nomore than one to two differences per arm” and “workwith institutional review boards to focus on consent as apractice to protect the patient’s interests, not those ofthe hospital.”

DISCUSSIONThe purpose of this study was to conduct a multisitesurvey of clinicians’ general attitudes and feelings to-ward informed consent for pediatric cancer research.Comprising a range of ages, ethnic backgrounds, andprofessional roles, most of these clinicians reportedlyengage the subtleties of informed consent equipped

with skills learned informally; only 14 (16%) clinicianscited a formal training program as a resource forlearning how to discuss clinical research and obtaininformed consent. Although low, this figure is an in-crease over our earlier study, which showed that norespondents in a sample of 23 clinicians reported for-mal education in informed consent for pediatric can-cer.9 Clinicians also included in their open-endedsuggestions a call for formal training in conductinginformed consent discussions.

Perceptions of change add complexity to this pic-ture. Far from remaining static, individual approachesto informed consent, clinicians tell us, may shift ascareers develop and clinicians grow seasoned. Our lessexperienced respondents reported opinions and ap-proaches about informed consent that sometimes dif-fered from those of their more experienced colleagues.For example, clinicians with 10 or fewer years of ex-perience were more likely to respond that explainingthe disease and its treatment is the most importantgoal of informed consent, when compared with theresponses of more experienced clinicians. Less expe-rienced clinicians were also more likely to place moreimportance on suggesting to parents that other chil-dren would benefit from current research. These datasuggest that our efforts to understand and improveinformed consent also should take into account howthe process is rooted in the trajectories of professionallife and changing sensitivities to ethical requirements.

This study suggests that gender and ethnicity alsoimpact opinions and approaches to informed consentfor pediatric cancer research. Male clinicians, for exam-ple, were more likely than female clinicians to reportrecommending to parents that they enroll their child ona clinical trial. Female clinicians, conversely, more fre-quently report no attempt to influence parents’ deci-sions concerning entry into a clinical trial. Ethnicity maybe a significant variable in the ranking of obstacles toinformed consent. Minority clinicians were more likelyto select “complexity of study design” as the most im-portant obstacle to informed consent, compared withtheir white/Caucasian counterparts. Clinician demo-graphics are likely to influence the nature of the in-formed consent process, potentially reflecting wider so-ciodemographic and class differences.

Of particular interest to practicing oncologists andethicists may be the finding that many (84%) of ourrespondents cite the belief that current patients ben-efit directly from participation in clinical trials,whereas only a few (16%) of these clinicians say theyactually recommend to parents that their child enrollin a clinical research trial. This belief also contrastssharply with the finding that clinicians ranked “toencourage families to give consent” as the least im-


portant goal of the informed consent process. Put intoperspective, this parsing of belief and practice maystem from a conflict between clinicians’ notions of an“inclusion benefit”10,11 and a perceived need to re-main neutral and unbiased in the presentation of theresearch option to parents. This conflict may add alayer of moral tension to the informed consent effortsof many clinicians.12 However, given significant vari-ations in reports about the degree to which clinicianssay they recommend clinical trials,9 further researchwill be required to gauge the extent of this conflict.

Clinicians entertain various, sometimes contra-dictory, goals for informed consent discussions. Forexample, whereas some clinicians rank “explainingthe disease and its treatment” as one of the mostimportant goals of informed consent, many cliniciansalso suggest improving informed consent discussionsby separating the disease and its treatment from dis-cussion about the research. This may reflect the diffi-culties clinicians face when attempting to balancetheir roles as caregivers and clinical investigators. Al-ternatively, clinicians may think that explaining thedisease and its treatment is of prime importance. Theymay wish to have a completely separate discussionthat focuses just on the disease and its treatment.

Clinicians’ opinions and assumptions about par-ents who participate in informed consent discussionsare clearly important; they may inform how and whyclinicians communicate certain details and leave asideothers. In this light, most clinicians report perceivingparents, and not themselves, as the key decision mak-ers regarding the offer to enroll a child on a researchtrial. They say that parents are negatively influencedby factors that come into play both before and afterissues of research participation are discussed withthem. Clinicians point to “state-of-shock” and thepressure to begin therapy as constraints that are in-troduced into the informed consent process by thesequencing of clinical events. Conversely, they singleout heightened anxiety and information overload aseffects of the informed consent process. Our qualita-tive data contain suggestions to remedy this situation.Clinicians recommend giving parents more time todecide about trial participation by 1) delaying consentdiscussions until randomization occurs and/or theshock of diagnosis has lessened, and 2) allowing treat-ment to begin before parents are required to make adecision about research participation. In fact, currentconsent guidelines for CCG-1991, a new leukemiastudy, will attempt to address this issue.13 Cliniciansalso suggest limiting the amount and complexity ofinformation given to parents during informed consentdiscussions to help prevent information overload.

Strikingly, clinicians credit most parents with gain-

ing control and comprehension through the informedconsent process. Despite recognizing the impact of anx-iety and information overload, clinicians rate parents’levels of comprehension relatively high—in contrastwith findings that show much lower comprehensionlevels for parents involved in informed consent. For ex-ample, Wiley et al.14 cite a “knowledge deficit” for bothacceptors and decliners of clinical trials. Harth andThong15 show that only 45% of their sample of parentsknew that they had the right to withdraw their child fromthe research study, and van Stuijvenberg and her col-leagues16 report that 50% of parents in their study un-derstood the “random assignment procedure” for clini-cal research. These studies suggest that clinicians may beoverestimating parental comprehension.

The generalizability of our findings are limited asa result of the questionnaire being administered atonly five sites, although these were selected on thebasis of their expertise and ongoing involvement ininformed consent for pediatric leukemia research. Asecond constraint is related to the common method-ologic observation that there may exist a gap betweenwhat people say they do and what they actually do, aphenomenon that potentially compromises the valid-ity of all surveys when they are not administered inconjunction with actual observation of practices.17 Anassessment of the degree to which this phenomenonhas affected our questionnaire will be possible oncethe “real-time” findings of our broader study, CCG-S9901, are fully collected and analyzed. Finally, thedata presented in this article are drawn exclusivelyfrom clinicians and do not include the complex andinformative perspectives of parents involved in in-formed consent. Direct observation of consent pro-cesses, case specific clinician questionnaires, and in-depth interviews with parents, however, are beingconducted as part of our larger study on informedconsent in pediatric oncology settings (CCG-S9901).

In conclusion, clinicians report concern or dissat-isfaction with aspects of informed consent that par-ents, by comparison, seem far more satisfied with.9,16

This discordance is undoubtedly rooted in a variety offactors that set apart the experiences of clinicians andparents whose children have leukemia, not least ofwhich may be the simple fact that practicing cliniciansparticipate in many more informed consent interac-tions than most parents. Although care should betaken not to diminish the validity of parents’ perspec-tives on this account, clinicians provide a veteran per-spective that should be integrated in attempts tosurvey and improve the complex world of informedconsent in pediatric oncology.


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informed consent for pediatric leukemia research : clinician perspectives

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