Consent and assent in the adolescent and young adult with cancer Conrad Fernandez MD, FRCPC Pediatric Hematologist/Oncolog...
Case scenario <ul><li>16 yr old with WBC 299,000, pain, fever presents to ER. </li></ul><ul><li>Admitted to ICU with media...
Case scenario <ul><li>How many have encountered such a patient? </li></ul><ul><li>How many have enrolled them on study? </...
For those who remain standing – this is your destination : “Pillars of Heaven” in the Eagle nebula http://hubblesite.org/ ...
Objectives  <ul><li>Provide a definition of assent and consent </li></ul><ul><li>Understand challenges to consent/assent i...
Who are we talking about? <ul><li>Adolescents/Young Adults (AYA) -  Inconsistently defined ages 14-30 yr. of whom only 5% ...
Principles <ul><li>Western Ethical ideal: respect for persons  </li></ul><ul><li>Respect autonomy (independence) </li></ul...
Defining the concepts <ul><li>Consent requirements :  </li></ul><ul><li>Adequate, understandable information </li></ul><ul...
Defining the concepts <ul><li>Assent : A child’s affirmative agreement to participate (without meeting all of the full con...
Defining the concepts <ul><li>Assent should not be equated with fully informed consent.  </li></ul><ul><li>It should be un...
Defining the concepts <ul><li>Assent is important as it:  </li></ul><ul><li>Reminds us that the adolescent/child must be t...
Defining the concepts - challenges <ul><li>Who is required to provide assent? </li></ul><ul><li>CFR fails to specify what ...
Dissent and should we respect it? <ul><li>Dissent – persistent refusal of assent </li></ul><ul><li>When is it ethically bi...
Dissent and should we respect it? <ul><li>We must be cautious that we do not accept assent and dismiss dissent based solel...
AYA Priorities <ul><li>“ For the adolescent with cancer, the problem is often not survival in the future, but survival in ...
Adolescent Development Stages <ul><li>Erikson </li></ul><ul><li>(Age 12-20 yrs Identity vs. Role confusion)  </li></ul><ul...
Adolescent development <ul><li>Time of significant emotional and physical change </li></ul><ul><li>Three main themes to be...
Challenges to autonomy <ul><li>Autonomy –  The ability to think for oneself. To do what is morally reasonable for its own ...
Challenges to independence <ul><li>Parents (for adolescents):  </li></ul><ul><ul><li>Often stay at bedside in hospital </l...
Challenges to sexuality/body image <ul><li>Multiple physical and sexual changes that are anticipated and normalized within...
Challenges to sexuality/body image <ul><li>Physical changes : alopecia, weight, scars, mucositis, central lines, AVN, acti...
17 yr old young man <ul><li>Grade 12, dating 17 yr old for 1 year </li></ul><ul><li>Parents divorced, joint custody agreem...
Future fertility <ul><li>Adolescents rate fertility as a low quality of life priority during treatment  </li></ul><ul><li>...
Consent : Future fertility <ul><li>Most post pubertal males can bank sperm </li></ul><ul><li>One third use it within a dec...
Consent : Future fertility <ul><ul><li>Storing sperm gives AYA patients future autonomy in choosing to start a family. </l...
Consent : Future fertility <ul><ul><li>Consent #2 – Delayed disposition of the gamete </li></ul></ul><ul><ul><li>Lots of u...
Research in AYA patients
Case scenario <ul><li>16 yr old with WBC 299,000, pain, fever presents to ER. </li></ul><ul><li>Admitted to ICU with media...
Considerations that inform AYA involvement in research <ul><li>What do adult participants understand? </li></ul><ul><li>Th...
What do parents understand about research for their child? <ul><li>Aims of the study – 75% </li></ul><ul><li>Potential Ris...
What do parents understand about research for their child? <ul><li>25-50% do not understand randomization  (or that their ...
Understanding by adults in  Phase I trials  <ul><li>72% of patients with advanced cancer correctly interpreted that a drug...
Conclusions <ul><li>In general, despite well intentioned researchers and being considered “competent” adults,  many resear...
Therapeutic misconception <ul><li>Many subjects systematically misinterpret the risk/benefit ratio of participating in res...
Therapeutic misconception <ul><li>The primary aim of clinical medicine is to provide optimal care for individuals. </li></...
Factors that support  Therapeutic Misconception <ul><li>Both clinical and research options presented at time of diagnosis ...
Therapeutic misconception <ul><li>Applebaum et al IRB 2004 </li></ul><ul><li>Adults (18-82  yrs of age, multiple research ...
Therapeutic misconception <ul><li>Who is at risk for TM? </li></ul><ul><li>Participants who are at risk for death  </li></...
Therapeutic misconception compounded in AYA <ul><li>Core duties of informed consent:  </li></ul><ul><ul><li>Voluntariness ...
Therapeutic misconception compounded in AYA <ul><li>How might this be reduced? </li></ul><ul><li>Appropriate iterative inf...
Medical decision-making <ul><li>Young people  (aged 9-25 yr) tend to defer to parental wishes. </li></ul><ul><ul><li>Coerc...
Decision-making by adolescents  <ul><li>Multi site study (US and Canada) </li></ul><ul><li>n= 409 parents, 86 AYA </li></u...
Decision-making by adolescents and parents for  taking part  in research  AYAs with cancer Parents of child with cancer I ...
Decision-making by adolescents and parents for  declining  research  AYAs with cancer Parents of child with cancer I did n...
Problems in Consent/Assent in Pediatric Oncology  10/14/10
Problems with the regulatory framework <ul><li>1. All or nothing approach – either accorded veto power if able to assent o...
Problems with the regulatory framework <ul><li>2. No guidance as to what constitutes meaningful dissent or assent.  </li><...
Problems with the regulatory framework <ul><li>3. Ignore the fact that clinical research exists along a spectrum of comple...
Problems with the regulatory framework <ul><li>4. In an effort to draw clear lines for decision making – regulators see ch...
Problems with the regulatory framework <ul><li>5. Acknowledging veto power of dissent may interfere with parent’s role in ...
Guidelines for Assent/Consent  COG task force on assent <ul><li>Researchers should respect children by honoring their  dev...
Specific Recommendations  Assent <ul><li>Provision of information to children </li></ul><ul><li>Developmentally appropriat...
Specific Recommendations Assent <ul><li>Inclusion of children in decision-making process </li></ul><ul><li>Assent should o...
Specific Recommendations Assent <ul><li>Integration of family decision-making </li></ul><ul><li>Rather than separate paren...
Specific Recommendations Assent <ul><li>Assent as a process over time </li></ul><ul><li>Continue to educate child and fami...
Specific Recommendations Assent <ul><li>Determining capacity to assent </li></ul><ul><li>Consider age, maturity, psycholog...
Conclusions <ul><li>Consent must always be obtained from competent participants – legal competency age (may be) different ...
Conclusions <ul><li>The assent process must be documented by researcher including description of why assent might not have...
Conclusions <ul><li>Consent is a process that continues throughout the duration of the research study. </li></ul><ul><li>I...
Conclusions <ul><li>Assent/consent exists upon a continuum of developmental issues and context including complexity of res...
Discussion
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Informed Consent for the Treatment of Adolescents and Young Adults with Cancer

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Author: Conrad Fernandez, MD., IWK Health Centre, Halifax, NS

Presented at the 2010 Texas Adolescent and Young Adult Oncology Conference hosted by Methodist Healthcare-San Antonio in October 2010

Published in: Education, Health & Medicine
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Informed Consent for the Treatment of Adolescents and Young Adults with Cancer

  1. 1. Consent and assent in the adolescent and young adult with cancer Conrad Fernandez MD, FRCPC Pediatric Hematologist/Oncologist Professor Pediatrics Departments of Pediatrics and Bioethics Halifax, NS, Canada
  2. 2. Case scenario <ul><li>16 yr old with WBC 299,000, pain, fever presents to ER. </li></ul><ul><li>Admitted to ICU with mediastinal mass and tumor lysis syndrome. </li></ul><ul><li>Bone marrow shows T cell ALL, CNS positive. </li></ul><ul><li>Family approached with consent for treatment and research (CCG 1961 – 4 arm randomized study). Start tomorrow! </li></ul>
  3. 3. Case scenario <ul><li>How many have encountered such a patient? </li></ul><ul><li>How many have enrolled them on study? </li></ul><ul><li>How many feel that they had fully informed consent of parents? </li></ul><ul><li>How many attempted to get assent of the child? </li></ul><ul><li>How many thought the assent was valid? </li></ul>
  4. 4. For those who remain standing – this is your destination : “Pillars of Heaven” in the Eagle nebula http://hubblesite.org/ newscenter/newsdesk/ archive/releases/ 1995/44/image/a                                                                                                      
  5. 5. Objectives <ul><li>Provide a definition of assent and consent </li></ul><ul><li>Understand challenges to consent/assent in AYA development </li></ul><ul><li>Understand consent/assent challenges in research in AYA populations </li></ul><ul><ul><li>Adults </li></ul></ul><ul><ul><li>Therapeutic misconception </li></ul></ul><ul><ul><li>Decision-making </li></ul></ul><ul><li>Understand problems in the regulatory framework </li></ul><ul><li>Conclusions </li></ul>
  6. 6. Who are we talking about? <ul><li>Adolescents/Young Adults (AYA) - Inconsistently defined ages 14-30 yr. of whom only 5% take part in clinical trials </li></ul><ul><li>Limited improvement in cancer outcomes </li></ul><ul><li>Limited opportunity: to take part in research, studies may not address their unique biology, care in between pediatrics and adult medicine, compliance not well supported, financial pressures, changing social roles </li></ul>
  7. 7. Principles <ul><li>Western Ethical ideal: respect for persons </li></ul><ul><li>Respect autonomy (independence) </li></ul><ul><li>Do no harm (non-malificence) </li></ul><ul><li>Do good (beneficience) </li></ul><ul><li>Justice </li></ul>10/14/10
  8. 8. Defining the concepts <ul><li>Consent requirements : </li></ul><ul><li>Adequate, understandable information </li></ul><ul><li>Capacity to fully assimilate information </li></ul><ul><li>Freedom to participate (voluntariness) </li></ul><ul><li>Freedom to withdraw </li></ul>10/14/10
  9. 9. Defining the concepts <ul><li>Assent : A child’s affirmative agreement to participate (without meeting all of the full consent elements) </li></ul><ul><li>The mere failure to object, absent affirmative agreement, should not be construed as assent. </li></ul><ul><li>Title 45 CFR Part 46.402 </li></ul>10/14/10
  10. 10. Defining the concepts <ul><li>Assent should not be equated with fully informed consent. </li></ul><ul><li>It should be understood in conjunction with parental permission (consent). </li></ul><ul><li>Elements to consider (in affirming assent): </li></ul><ul><li>Knowledge of procedures </li></ul><ul><li>Choice to take part </li></ul><ul><li>Communicaton of that choice </li></ul><ul><li>Awareness of ability to withdraw </li></ul><ul><li>National Commission 1978 </li></ul>10/14/10
  11. 11. Defining the concepts <ul><li>Assent is important as it: </li></ul><ul><li>Reminds us that the adolescent/child must be treated with respect and dignity </li></ul><ul><li>Serves to remind us that children have personal interests and are not to be used for research </li></ul><ul><li>Permits children a role in shared decision-making </li></ul><ul><ul><ul><li>Practice in decision-making </li></ul></ul></ul><ul><ul><ul><li>Teaches skills in decision-making </li></ul></ul></ul><ul><ul><ul><li>Supports self-esteem/reduces anxiety </li></ul></ul></ul><ul><ul><ul><li>Teaches respect for others </li></ul></ul></ul>10/14/10
  12. 12. Defining the concepts - challenges <ul><li>Who is required to provide assent? </li></ul><ul><li>CFR fails to specify what is needed for valid assent </li></ul><ul><li>Poorly understood who is capable </li></ul><ul><li>Debated age or cognitive thresholds </li></ul><ul><li>Debated whether an understanding of altruism is needed </li></ul>10/14/10
  13. 13. Dissent and should we respect it? <ul><li>Dissent – persistent refusal of assent </li></ul><ul><li>When is it ethically binding ? </li></ul><ul><li>Should carry considerable weight when: </li></ul><ul><li>intervention is not essential to welfare or can be safely deferred </li></ul><ul><li>there is no or limited prospect of direct benefit. </li></ul><ul><li>adolescents – as they are able to consider key elements of the research </li></ul>
  14. 14. Dissent and should we respect it? <ul><li>We must be cautious that we do not accept assent and dismiss dissent based solely on what we think as care-givers is the best course of action. </li></ul><ul><li>It also seems reasonable to accept (even if inarticulate) dissent if it bears a plausible and valid relationship to the decision. </li></ul><ul><li>Joffe 2003 </li></ul>
  15. 15. AYA Priorities <ul><li>“ For the adolescent with cancer, the problem is often not survival in the future, but survival in the present .” </li></ul><ul><li>Whyte and Smith 1997 </li></ul>
  16. 16. Adolescent Development Stages <ul><li>Erikson </li></ul><ul><li>(Age 12-20 yrs Identity vs. Role confusion) </li></ul><ul><ul><li>Forming a peer group </li></ul></ul><ul><ul><li>Developing sense of identity </li></ul></ul><ul><li>Piaget </li></ul><ul><li>(Age 12 yr – adulthood) </li></ul><ul><ul><li>Greater capacity for abstract thinking </li></ul></ul><ul><ul><li>Deductive reasoning developing </li></ul></ul><ul><ul><li>Conceptual thinking developing </li></ul></ul>
  17. 17. Adolescent development <ul><li>Time of significant emotional and physical change </li></ul><ul><li>Three main themes to be emphasized: </li></ul><ul><ul><li>Autonomy </li></ul></ul><ul><ul><li>Independence </li></ul></ul><ul><ul><li>Sexuality </li></ul></ul>
  18. 18. Challenges to autonomy <ul><li>Autonomy – The ability to think for oneself. To do what is morally reasonable for its own sake. </li></ul><ul><li>Adolescents </li></ul><ul><ul><li>Diminished capacity: Acute illness, complex information, anxiety, therapy effects </li></ul></ul><ul><li>Parents (for adolescents): </li></ul><ul><ul><li>Consent to treatment – legally to age 18 or 19 </li></ul></ul><ul><ul><li>Highly involved in decision-making day to day </li></ul></ul>
  19. 19. Challenges to independence <ul><li>Parents (for adolescents): </li></ul><ul><ul><li>Often stay at bedside in hospital </li></ul></ul><ul><ul><li>Bring youth to the appointment </li></ul></ul><ul><ul><li>Pay for meds </li></ul></ul><ul><ul><li>Become overly protective </li></ul></ul><ul><ul><li>Hear personal medical details </li></ul></ul><ul><ul><li>Restrict driving/ staying out late </li></ul></ul>
  20. 20. Challenges to sexuality/body image <ul><li>Multiple physical and sexual changes that are anticipated and normalized within peer group </li></ul><ul><li>Society attitudes to physical differences place AYA at risk for psychological adjustment sequela. </li></ul><ul><li>Sexual identity - positive self-esteem and physical attractiveness are key </li></ul><ul><li>Fertility preservation discussions </li></ul>
  21. 21. Challenges to sexuality/body image <ul><li>Physical changes : alopecia, weight, scars, mucositis, central lines, AVN, activity limits </li></ul><ul><li>Sexual health information : peers and health education at school </li></ul><ul><li>Diminished ability and interest in developing interpersonal and intimate relationships </li></ul><ul><ul><li>Loss of opportunity, fatigue, sense of body image, self-esteem, feelings of being different </li></ul></ul>
  22. 22. 17 yr old young man <ul><li>Grade 12, dating 17 yr old for 1 year </li></ul><ul><li>Parents divorced, joint custody agreement </li></ul><ul><li>Diagnosed AML – relapses, dies 8 months </li></ul><ul><li>Sperm cryopreservation at diagnosis </li></ul><ul><li>At relapse, he expresses a wish that his girlfriend is the custodian with the choice to use the sperm in the future. </li></ul>
  23. 23. Future fertility <ul><li>Adolescents rate fertility as a low quality of life priority during treatment </li></ul><ul><li>Adult cancer survivors cite fertility as an important issue. </li></ul><ul><li>No definitive preservation methods for females (considered experimental). </li></ul><ul><li>Consent usually for treatment not prevention. </li></ul>
  24. 24. Consent : Future fertility <ul><li>Most post pubertal males can bank sperm </li></ul><ul><li>One third use it within a decade </li></ul><ul><li>Only half offered </li></ul><ul><li>Barriers – oncologists not asking </li></ul><ul><li>Barriers (age 13-21 yr old respondents) </li></ul><ul><ul><li>Lack of information </li></ul></ul><ul><ul><li>Younger age </li></ul></ul><ul><ul><li>High levels of anxiety – cancer, procedure </li></ul></ul><ul><ul><li>Parental discussion - privacy </li></ul></ul><ul><ul><li>Appropriate materials </li></ul></ul>
  25. 25. Consent : Future fertility <ul><ul><li>Storing sperm gives AYA patients future autonomy in choosing to start a family. </li></ul></ul><ul><ul><li>Adolescents physically able yet not legally competent. </li></ul></ul><ul><ul><li>Consent #1 Immediate (parts a. and b.) </li></ul></ul><ul><ul><li>Decision to initiate fertility-preserving measures </li></ul></ul><ul><ul><li>Decision to participate in experimental methods </li></ul></ul><ul><ul><li>Oocyte, ovarian tissue, embryo cryopreservation </li></ul></ul>
  26. 26. Consent : Future fertility <ul><ul><li>Consent #2 – Delayed disposition of the gamete </li></ul></ul><ul><ul><li>Lots of unknowns : Sperm quality at diagnosis/ after thaw, individual accurate prediction of infertility, who the partner may be, whether he/she is prepared for assisted conception. </li></ul></ul><ul><ul><li>On top of other barriers to consent in AYA patients. </li></ul></ul><ul><ul><li>Usual custodian parents </li></ul></ul><ul><ul><li>Parents not entitled to use as they wish – competing interests: sibling needs donor, research </li></ul></ul>
  27. 27. Research in AYA patients
  28. 28. Case scenario <ul><li>16 yr old with WBC 299,000, pain, fever presents to ER. </li></ul><ul><li>Admitted to ICU with mediastinal mass and tumor lysis syndrome. </li></ul><ul><li>Bone marrow shows T cell ALL, CNS positive. </li></ul><ul><li>Family approached with consent for treatment and research (CCG 1961 – 4 arm randomized study). Start tomorrow! </li></ul>
  29. 29. Considerations that inform AYA involvement in research <ul><li>What do adult participants understand? </li></ul><ul><li>Therapeutic misconception </li></ul><ul><li>Decision-making by adolescents? </li></ul>
  30. 30. What do parents understand about research for their child? <ul><li>Aims of the study – 75% </li></ul><ul><li>Potential Risks – 70% </li></ul><ul><li>Potential benefits – 83% </li></ul><ul><li>Right to withdraw – 73% </li></ul><ul><li>Voluntariness – 84% </li></ul><ul><li>Procedures of the study – 44% </li></ul><ul><li>Alternatives - 53% </li></ul><ul><li>Duration – 39% </li></ul><ul><li>In total, less than 10% understood all the elements! </li></ul><ul><li>Chappuy 2006 </li></ul>
  31. 31. What do parents understand about research for their child? <ul><li>25-50% do not understand randomization (or that their child has been randomized) </li></ul><ul><li>Higher risk for this misunderstanding if: </li></ul><ul><li>Non-English speaking parents, lower social status, phase I research </li></ul>
  32. 32. Understanding by adults in Phase I trials <ul><li>72% of patients with advanced cancer correctly interpreted that a drug would have an effect in “40% of cases like yours” </li></ul><ul><li>14% interpreted that the doctor was 40% confident that it would control the cancer </li></ul><ul><li>3% indicated the drug would reduce the cancer by 40% </li></ul><ul><li>Increased error if: low education or no experience with research </li></ul><ul><li>Weinfurt 2005 </li></ul>
  33. 33. Conclusions <ul><li>In general, despite well intentioned researchers and being considered “competent” adults, many research participants have a poor understanding of consent for research. </li></ul><ul><li>Unlikely AYA participants will fair any better. </li></ul>
  34. 34. Therapeutic misconception <ul><li>Many subjects systematically misinterpret the risk/benefit ratio of participating in research thinking they are being treated as patients rather than subjects of research. </li></ul><ul><li>Stems not from level of information disclosure but of prior beliefs or conceptions about the different roles of research and health care. </li></ul>
  35. 35. Therapeutic misconception <ul><li>The primary aim of clinical medicine is to provide optimal care for individuals. </li></ul><ul><li>- “Do no harm, Do good”. </li></ul><ul><li>The primary aim of research is to answer a question with aim of producing knowledge that will benefit groups of people (not the participant in front of one). </li></ul><ul><li>Clinical research therefore has an inherent </li></ul><ul><li>potential to exploit participants. </li></ul>
  36. 36. Factors that support Therapeutic Misconception <ul><li>Both clinical and research options presented at time of diagnosis </li></ul><ul><li>Setting for research same as clinical </li></ul><ul><li>Same methods/instruments used for clinical care </li></ul><ul><li>Language of research and treatment often conflated </li></ul><ul><li>Ads for recruitment rarely refer to altruism </li></ul>
  37. 37. Therapeutic misconception <ul><li>Applebaum et al IRB 2004 </li></ul><ul><li>Adults (18-82 yrs of age, multiple research types, n = 243) </li></ul><ul><li>31% express inaccurate beliefs regarding the degree of individualization of treatment </li></ul><ul><li>51% express inaccurate beliefs in the likelihood of benefit </li></ul><ul><li>63% in total had some degree of TM </li></ul>
  38. 38. Therapeutic misconception <ul><li>Who is at risk for TM? </li></ul><ul><li>Participants who are at risk for death </li></ul><ul><li>FDA approved drugs for the disorder available outside the trial </li></ul><ul><li>Lower education </li></ul><ul><li>Poor optimism about current medical condition </li></ul><ul><li>Applebaum 2004 </li></ul><ul><li>No direct studies of AYA participants. </li></ul>
  39. 39. Therapeutic misconception compounded in AYA <ul><li>Core duties of informed consent: </li></ul><ul><ul><li>Voluntariness – parents influence decisions, power relationship with health care team, financial incentives to obtain care by taking part in research </li></ul></ul><ul><ul><li>Disclosure adequate – complex information, abstract thinking in development, future vs. current priorities, presumption of best interests, no previous experience, </li></ul></ul>
  40. 40. Therapeutic misconception compounded in AYA <ul><li>How might this be reduced? </li></ul><ul><li>Appropriate iterative information </li></ul><ul><li>Disentangling language </li></ul><ul><li>Paying patients like healthy research participants </li></ul><ul><li>Clarify in the minds of researchers themselves that therapeutic misconception is a risk for both researchers and patients </li></ul><ul><li>Consent by non health care team member </li></ul>
  41. 41. Medical decision-making <ul><li>Young people (aged 9-25 yr) tend to defer to parental wishes. </li></ul><ul><ul><li>Coercion </li></ul></ul><ul><ul><li>In order to avoid family tension </li></ul></ul><ul><ul><li>Out of respect for parents </li></ul></ul><ul><ul><li>In need of parental support </li></ul></ul><ul><ul><li>More likely to withdraw if told explicitly that parents would not be upset </li></ul></ul><ul><ul><li>Rossi 2003 </li></ul></ul>
  42. 42. Decision-making by adolescents <ul><li>Multi site study (US and Canada) </li></ul><ul><li>n= 409 parents, 86 AYA </li></ul><ul><li>Median age of AYA 18 yr (12-22 yrs) </li></ul><ul><li>Mailed questionnaires examining decision-making and preferences for return of results </li></ul><ul><li>Read et al Pediatrics 2010 </li></ul>
  43. 43. Decision-making by adolescents and parents for taking part in research AYAs with cancer Parents of child with cancer I thought it would help me/my child 26% 60% I thought it would help others 67% 85% Not add too much time 14% 13% Pressure from family/friends 16% 3% Not add too much discomfort 19% 20%
  44. 44. Decision-making by adolescents and parents for declining research AYAs with cancer Parents of child with cancer I did not think it would help 18% 13% Too much else to think about 36% 21% Added too much time 45% 13% Added too much discomfort 18% 26% Too risky 0% 13%
  45. 45. Problems in Consent/Assent in Pediatric Oncology 10/14/10
  46. 46. Problems with the regulatory framework <ul><li>1. All or nothing approach – either accorded veto power if able to assent or no formal role. </li></ul><ul><li>Inconsistent with cognitive and moral development as a non-linear trajectory, developmental regression, and/or variability in culture/families. </li></ul>10/14/10
  47. 47. Problems with the regulatory framework <ul><li>2. No guidance as to what constitutes meaningful dissent or assent. </li></ul><ul><li>Not clear if the same elements that are necessary for informed consent are required for assent </li></ul><ul><ul><li>(but at somehow a lesser level). </li></ul></ul>10/14/10
  48. 48. Problems with the regulatory framework <ul><li>3. Ignore the fact that clinical research exists along a spectrum of complexity. </li></ul><ul><li>Need to link continuum of childhood experience and development with ability to understand increasing complexity of research questions. </li></ul>10/14/10
  49. 49. Problems with the regulatory framework <ul><li>4. In an effort to draw clear lines for decision making – regulators see children and parents as separate decision makers. </li></ul><ul><li>Need to recognize interdependence of parents and child. </li></ul>10/14/10
  50. 50. Problems with the regulatory framework <ul><li>5. Acknowledging veto power of dissent may interfere with parent’s role in guiding moral development. </li></ul><ul><li>Need to recognize potential cultural realities where a child’s deference to parental authority is intrinsic to the ethos of that culture. </li></ul>10/14/10
  51. 51. Guidelines for Assent/Consent COG task force on assent <ul><li>Researchers should respect children by honoring their developing autonomy </li></ul><ul><li>Researchers should respect parent’s role their child’s moral development </li></ul><ul><li>Policies should be flexible to recognize wide range of medical, psychological and other contextual circumstances </li></ul><ul><li>Joffe, J Peds 2006 </li></ul>10/14/10
  52. 52. Specific Recommendations Assent <ul><li>Provision of information to children </li></ul><ul><li>Developmentally appropriate </li></ul><ul><li>Purpose </li></ul><ul><li>Incremental procedures </li></ul><ul><li>Risks/benefits </li></ul>10/14/10
  53. 53. Specific Recommendations Assent <ul><li>Inclusion of children in decision-making process </li></ul><ul><li>Assent should only be sought if input is to be honored </li></ul><ul><li>Should solicit input without promise </li></ul><ul><li>Incorporate child’s views </li></ul>10/14/10
  54. 54. Specific Recommendations Assent <ul><li>Integration of family decision-making </li></ul><ul><li>Rather than separate parent’s decision seek to unified decision </li></ul><ul><li>Solicit views in a cultural, developmental, contextual way </li></ul>10/14/10
  55. 55. Specific Recommendations Assent <ul><li>Assent as a process over time </li></ul><ul><li>Continue to educate child and family </li></ul><ul><li>Reconfirm prior to burdensome research specific points or natural decision-making points ie randomization </li></ul>10/14/10
  56. 56. Specific Recommendations Assent <ul><li>Determining capacity to assent </li></ul><ul><li>Consider age, maturity, psychological/ emotional state </li></ul><ul><li>Reasons a child gives for his or her references provide strong evidence of capacity – plausibility </li></ul>10/14/10
  57. 57. Conclusions <ul><li>Consent must always be obtained from competent participants – legal competency age (may be) different from ethical competency age </li></ul><ul><li>Assent must always be obtained from children in a way that is respectful of capacity and context recognizing family, medical, and psychological issues </li></ul>10/14/10
  58. 58. Conclusions <ul><li>The assent process must be documented by researcher including description of why assent might not have been sought. </li></ul><ul><li>There is no regulatory requirement to have an incompetent participant sign a document of assent </li></ul>10/14/10
  59. 59. Conclusions <ul><li>Consent is a process that continues throughout the duration of the research study. </li></ul><ul><li>Incompetent participants who become competent should have their full consent sought. (“re-consent” at age 18 yr) </li></ul>10/14/10
  60. 60. Conclusions <ul><li>Assent/consent exists upon a continuum of developmental issues and context including complexity of research, severity of illness and emotional acuity. </li></ul><ul><li>A requirement for a blanket consent intervention focused on an age or time point in the study fails to recognize this continuum. </li></ul>10/14/10
  61. 61. Discussion

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