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Consent, Assent and Distributive Justice. © Copyright 2010.

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1 Consent, Assent and Distributive Justice. © Copyright 2010

2 Fundamental confusions Is “assent” merely “consent lite?” When should IRBs demand assent? Can parents override dissent? If so, when? How do children at different ages understand medical research?

3 Confusions rooted in history Paul Ramsey and Richard McCormick had a famous debate in 1970s –Ramsy – Protestant theologian, one of the first bioethicists –McCormick – Jesuit priest, another early bioethicist Ramsey’s early opinions about children in research were a response to Saul Krugman’s controversial hepatitis studies at the Willowbrook State School in NY

4 Ramsey on Willowbrook “Such use of captive populations of children for purely experimental purposes ought to be made legally impossible... stopped by legal acknowledgement of the moral invalidity of parental or legal proxy consent for the child to procedures having no relation to a child’s own diagnosis or treatment.” Ramsey P. Yale University Press

5 Ramsey’s absolutist position “To experiment on children in ways that are not related to them as patients is already a sanitized form of barbarism… We should expect no significant exceptions to this canon of faithfulness to the child.” Ramsey P. Yale University Press

6 McCormick’s response “Ramsey’s position protects the child, but so absolutely that it…all too easily undermines not only the overall good of children but even and eventually of the individual child.”

7 McCormick’s response “The child, when she becomes an adult with children of her own, will – if she has the good of her own children at heart - look back with regret on the trivial experiments that could have been done on her but were not, and that could have improved the lot of her own present children.”

8 McCormick’s response Speaking to herself and of herself as a child, that child-become-parent would, I judge, say: "I would have consented because I ought to have."

9 Stark contrasts Ramsey – focus on consent. Children cannot consent, therefore, children should never be subjects of non-therapeutic research. McCormick – it is not about consent. It is about what every human being ought to choose. We should choose, for children, what they ought to choose for themselves.

10 Bartholome’s mediation Experimental protocols must get IRB review and approval Research must provide significant and essential new knowledge. The knowledge can be obtained only by experimentation involving children. Hastings Center Report

11 Bartholome’s mediation No greater risk or discomfort than would be encountered by the child in his family life. Where possible, a similar experiment must have been performed on adult subjects and been found to be without risk. Informed parental consent is mandatory. Consent of the child obtained by a member of the research team and by an independent subject-representative. Hastings Center Report.1976.

12 Federal regulations Define assent as “a child’s affirmative agreement to participate in research.” Allow the IRB to determine whether assent is required and how assent must be documented. IRB may waive the assent requirement –“if the IRB determines...that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well being of the children, and –is available only in the context of the research.”

13 AAP position paper First draft by William Bartholome in Took ten years to be approved by the Academy. At that time, Bartholome had been diagnosed with inoperable esophageal cancer. In the intro: –“No one is more gratified by this statement than its primary author and champion.” –“The statement embodies Bill Bartholome’s dedication to children.”

14 Four requirements in getting assent Help the patient to a developmentally appropriate understanding of her condition Assess the patient’s understanding Tell patient what to expect with tests and treatment. Solicit an expression of the patient’s willingness to accept the proposed care. AAP Committee on Bioethics

15 Assent, consent, and permission Competent adults can consent Parents cannot “consent” on behalf of their children – they can only give permission. Minors cannot consent – but they can assent or dissent.

16 Bartholome’s objections Objects to three additions to the original draft –Children should not be excluded from decision- making without persuasive reasons. –Impasses between parents and children are rare. –In situations in which the patient will have to receive medical care despite his or her objection, the patient she be told of this fact and not deceived. (Bartholome thought that this was too wishy-washy

17 AAP response to Bartholome “Dr. Bartholome’s views on the issues of the moral status of children are controversial. The ‘qualifications’ that he dislikes in the statement reflect disagreement and uncertainty in an evolving reevaluation in the pediatric community.” Kohrman et al. Pediatrics

18 Should the child have to sign? IRBs should not require that children sign an assent form. Instead, they should require that the responsible investigator complete a note documenting the child’s role in the research decision. Ungar et al. J Peds

19 Should the child have to sign? Should include discussion of the child’s ability to give meaningful assent, and—if judged capable— a statement that the child understands: –what procedures will be carried out (What will they do to me?), –the potential risks and discomforts (Will it hurt?), and –the voluntary nature of research participation (Do I have to?). –It should also state that the child provided affirmative agreement and was under no coercion or undue influence. Ungar et al. J Peds

20 IRBs are not consistent in their requirements for assent 183/224 (84%) IRB chairs completed 30 minute telephone interview –IRBs at pediatric hospitals –Proprietary IRBs –Other randomly selected IRBs Specific questions about assent Whittle et al. Pediatrics

21 58% of IRB chairs would allow this to be done in children who were not capable of giving assent. 42% would not. Imagine that your IRB is asked to review a study of blood clotting in healthy children. There is no benefit to the children who participate. The study involves one clinic visit with a single 10ml blood draw. Should the child’s assent be required? Could the study enroll children too young to assent? Whittle et al. Pediatrics

22 IRBs use different methods for assessing competence to assent Whittle et al. Pediatrics

23 Method for assessing competence to assent Whittle et al. Pediatrics

24 How common are inconsistencies? CF Twin and Sibling Study, 42 sites 31 responded to survey about IRB process Study involved a questionnaire, medical record review, and blood test 24 (79%) required full IRB reviews, –McWilliams et al JAMA 2003

25 How common are inconsistencies? 7 (23%) considered blood draw and medical record review to be minimal risk. 3 (10%) required 4 consent forms (adult, minor, parental, and assent). Ten centers (32%) did not require assent. The specific age range of patients for which assent was required varied considerably among centers years McWilliams et al. JAMA

26 CF Twin and Sibling Study Mean time to approval –expedited review -> 32.3 days (range, 9-72) –full review -> 81.9 days (range, ).

27 Distributive justice Arguments about children’s participation are fundamentally about justice –Without any research, all children will be treated unfairly compared to adults. –With research, the children who are research subjects may bear an unfair share of the burdens of research. –How do we spread the burdens fairly?

28 Research and race Conflicting data Blacks and Hispanics are underrepresented in therapeutic research. Blacks may be overrepresented in non- therapeutic research.

29 Studies showing similar consent rates between Blacks and Non-hispanic whites Wendler et al. PLoS Med

30 Studies showing similar consent rates for Hispanics and non-Hispanic Whites Wendler et al. PLoS Med

31 In pediatric cancer trials The majority of racial/ethnic/age groups are proportionally represented. Pockets of poor representation are noted among the youngest black and Hispanic children, Hispanic females, and particularly white adolescents ages 15 to 19 years. Lund et al. Cancer

32 In all pediatric research (including non-therapeutic research) Compared to census percentages: Black children overrepresented and Hispanic children underrepresented in clinical trials. Both were underrepresented in therapeutic research. Black and Hispanic children were overrepresented in potentially stigmatizing research. Walsh et al. Pediatrics

33 Conflicting data on SES and research participation Some studies show that more educated parents are more likely to participate Some studies show greater participation by less-educated parents. Some show no difference. Van Stuijvenberg et al. Arch Dis Child Harth et al. Soc Sci Med Hoffman et al. Pediatr Cardiol

34 Summary and Conclusions Tension between the lofty goals of research and concerns about the inclusion of children have persisted for fifty years. Can be characterized as tension between “access” and “protection.” Broad agreement about a framework for decisions

35 Framework Studies must not entail much risk. (minimal, minor increase over minimal) Child must be included in decisions when possible. Independent review boards must approve There will always be “gray zones.”

36 Resources Bartholome WG. Informed consent, parental permission, and assent in pediatric practice. Pediatrics Nov;96(5 Pt 1):981-2.Informed consent, parental permission, and assent in pediatric practice Burke W, Diekema DS. Ethical issues arising from the participation of children in genetic research. J Pediatr Jul;149(1 Suppl):S34-8.Ethical issues arising from the participation of children in genetic research McCormick RA. Experimentation in children: sharing in sociality. Hastings Cent Rep Dec;6(6):41-6.Experimentation in children: sharing in sociality Ramsey P. The enforcement of morals: nontherapeutic research on children. Hastings Cent Rep Aug;6(4):21-30.The enforcement of morals: nontherapeutic research on children Ungar D, Joffe S, Kodish E. Children are not small adults: Documentation of assent for research involving children. ©2006 Elsevier Inc. All rights reserved.

37 Resources Walsh C, Ross L. Are Minority Children Under-or Overrepresented in Pediatric Research? Pediatrics Oct;112(4):890-5.Are Minority Children Under-or Overrepresented in Pediatric Research? Wendler DS. Assent in paediatric research: theoretical and practical considerations. J Med Ethics Apr;32(4): Assent in paediatric research: theoretical and practical considerations Wendler D. Is it possible to protect pediatric research subjects without blocking appropriate research? J Pediatr Apr;152(4): Is it possible to protect pediatric research subjects without blocking appropriate research? Whittle A, Shah S, Wilfond B, Gensler G, Wendler D. Institutional review board practices regarding assent in pediatric research. Pediatrics Jun;113(6): Institutional review board practices regarding assent in pediatric research


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