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Informed consent

Informed consent. Bernard Lo, M.D. August 11 and 12, 2010. Neonatal blood samples. Screen for birth defects Required by law Parental consent not required Later used for research on Preterm birth Environmental levels of pesticides

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Informed consent

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  1. Informed consent Bernard Lo, M.D. August 11 and 12, 2010

  2. Neonatal blood samples • Screen for birth defects • Required by law • Parental consent not required • Later used for research on • Preterm birth • Environmental levels of pesticides • Gene-environment interactions (smoking, folic acid, cleft palate)

  3. Questions for audience • Do regulations permit research be carried out on leftover neonatal spots without consent? • Yes /No / Unsure

  4. Questions for audience • Should regulations permit research be carried out on leftover neonatal spots without consent? • Yes /No / Unsure

  5. Neonatal blood samples • Parents in Texas sued over storage of samples for for research without consent • 2002 Texas law allows opt-out • 5.3 million samples from before 2002 destroyed

  6. Use of neonatal blood spots for research • Permitted under federal regulations • Ethically contested

  7. Outline for today • What does informed and voluntary consent require? • How can consent be improved? • What are exceptions to consent? • Why are some exceptions in regulations ethically problematic?

  8. Why is consent needed? • Research compared to clinical care • Risks and benefits uncertain • Risk/benefit balance less favorable • Purpose is not to benefit participants

  9. Rationale for informed consent • Respect for values and choices of subjects • Deter research with unacceptable risks

  10. Questions for audience • After signing consent forms, do most participants understand key features of study? • Do IRB modifications improve consent?

  11. 1. HIV prevention trial • RCT of diaphragm + gel vs. diaphragm + placebo in women in Africa at risk for HIV infection • Both arms receive free condoms

  12. What must researchers disclose? • Nature and purpose of research • Research procedures, risks, benefits • Unforeseeable risks • Participation voluntary, may discontinue • IRB template

  13. Why is informed consent difficult?

  14. Why is informed consent difficult? • Participants commonly misunderstand • Not understand how RCT differs from clinical care • Believe that study interventions are • Standard therapy • Best treatment for condition • No additional risks • For their personal benefit

  15. Why is informed consent difficult? • Participants commonly misunderstand • Basic features of trial design • May be in control group • Randomization • Therapeutic options restricted by study design rather than individualized for them

  16. Why is informed consent difficult? • Vulnerable participants • Low health literacy, low literacy • Poverty, few options • Cultural context • No informed consent in clinical care • No acknowledgement of medical uncertainty

  17. How can informed consent be enhanced? • Empirical studies • Spend more time talking to participants • Questions and feedback • Shorter, simpler consent forms • Multimedia -- mixed evidence

  18. How can informed consent be enhanced? • Practical suggestions • Take point of view of participant • Use simple language that 8th grader can understand • Explain how RCT differs from clinical care • Invite questions

  19. How can informed consent be enhanced? • Focus on comprehension by participant, not consent forms • Administer questionnaire to ensure appreciation of key aspects of study

  20. What is essential for participants to comprehend?

  21. What is essential for participants to comprehend? • Could still get HIV • Don’t know whether intervention works • May not get active intervention • Keep using condoms every time

  22. What is essential for participants to comprehend? • May refuse to participate • May withdraw from study

  23. Why is voluntary consent difficult? • Hard to say no to persons in power • Defer to husband or father • Relationship to investigator • Student • Employee • Undue monetary influence

  24. Research participants who may lack decision-making capacity • Persons receiving CPR, ICU care • Severe dementia • Severe psychiatric illness • Young children

  25. Concerns about participants who lack decision-making capacity • Not appreciate risks • Not able to refuse • Might be subjected to risks that competent persons would refuse

  26. Options if lack decision-making capacity • Exclude from trials • But lack evidence safety and effectiveness of treatments • Additional protections

  27. Additional protections if lack decision-making capacity • Formal assessment of decision-making capacity • Permission from surrogate • Assent of participant

  28. Additional protections for vulnerable partcipants • Closer monitoring for adverse effects • Subject advocate who can withdraw participant from study • IRB include persons familiar with the condition that impairs capacity • Research advance directives

  29. Questions for audience Without consent, may researcher • Use EMR to study whether patients have worse outcomes if admitted over weekend? • Use leftover cancer tissue to identify prognostic markers?

  30. Ethical rationale for no consent • Very low risk • No physical risks • Confidentiality the main risk • Cannot be breached if not identifiable • Benefits of research >> risks

  31. Ethical rationale for no consent • No one would or should object if asked • Cancer tissue would be discarded • Leftover tubes of blood • Impracticable to get consent • Could not carry out important study

  32. Consent not required • Not human subjects research • No IRB review • Exempt from human subjects regulations • Qualifies for waiver

  33. What is human subjects research? • Interact with person OR • Use identifiable private information • Not human subjects research if data and materials cannot be identified • Examples of tissue from cancer surgery

  34. 1. Not human subjects research • De-identified data and materials • Coded data and materials, researcher cannot access keys to code • None of 18 HIPAA identifiers • Code may be retained by database or biobank

  35. 2. Exempt from federal regulations • Most survey and interview research • Unless subjects can be identified and responses could put respondents at risk • Not if ask about illegal activities, sensitive or private topics

  36. 2. Exempt from federal regulations • Existing data or materials • Publicly available • Existing data or specimens if researcher records information in manner than subjects cannot be identified • Can look at medical records

  37. Studies that require identifiers • Link specimens with clinical records • Prognostic markers in cancer • HER2/neu overexpression = poor prognosis • Trastuzumab effective only in patients who overexpress HER2/neu

  38. 3. Waiver of consent • Minimal risk • Not adversely affect rights and welfare • Could not be practicably carried out • IRB may allow identifiable data to be used without consent • Use identifiers to link different databases

  39. Research with cancer specimens • Not human subjects research if • Completely de-identified • Coded and researcher has no access to key • Can determine prevalence of marker

  40. Neonatal spots • Not human subjects research if • Completely de-identified • Coded and researcher has no access to key • Waiver of consent • Can link spots to medical records

  41. Neonatal spots • Permissible in regulations • Approved by IRBs • But still problematic • New standard is to offer opt-out for research

  42. Questions for audience • Do regulations permit whole genome sequencing on de-identified materials? • Yes /No / Unsure • Should regulations permit whole genome sequencing on de-identified materials? • Yes /No / Unsure

  43. Re-identification in whole genomic sequencing • Reference samples in forensic databases • DOJ has 8.3 million profiles • STRs at 13 locations • Full genome sequence yields DOJ identifiers

  44. Whole genome sequence an overt identifier? • Need access to DOJ database • Is access to DOJ identifiers more secure than access to SSN? • May need to rethink concept of “de-identified” samples

  45. Concerns about whole genome sequencing • Subject may consider information very private and sensitive • Privacy concerns access to information about self • May not want others to access • Even if identity not explicitly known

  46. Concerns about whole genome sequencing • Some donors may object • When giving blanket consent for research, donors did not consider this • If donors had been told, would they object? • Respect donors who have strong objections

  47. Questions for audience • Genetics of criminal behavior • Match DOJ database with neonatal blood spots without consent • Do regulations permit this? • Yes /No / Unsure • Should regulations permit this? • Yes /No / Unsure

  48. Objections to certain research on existing samples • Genetics of criminal and antisocial behavior • Stigmatize vulnerable populations • Undermine individual responsibility • Human evolution • Derivation of embryonic stem cells from IVF embryos

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