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1 Informed consent Bernard Lo, M.D. August 13, 2009.

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1 1 Informed consent Bernard Lo, M.D. August 13, 2009

2 2 Anyone doing project using  Existing data?  Medical records  Previous research dataset  Existing biological materials?  Using genomic analyses?

3 Questions for audience  After signing consent forms, do most participants understand key features of study?  Do IRB modifications improve consent? 3

4 4 Outline for today  What does informed and voluntary consent require?  How can consent be improved?  What are exceptions to consent?  Why are some exceptions problematic?

5 Why is consent needed?  Compared to clinical care  Risks and benefits uncertain  Risk/benefit balance less favorable  Purpose is not to benefit participants 5

6 Rationale for informed consent  Respect for values and choices of subjects  Deter research with unacceptable risks 6

7 7 Federal requirements for research  Review by IRB  Risks / benefits acceptable  Risks must be minimized

8 8 Federal requirements for research  Informed and voluntary consent  Concerns about undue inducement if payment  Exceptions to consent Not capable of consent (children, adults who lack decision-making capacity) Impracticable to obtain consent

9 9 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

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11 11 What must researchers disclose?  Nature and purpose of research  Research procedures, risks, benefits  Unforeseeable risks  Participation voluntary, may discontinue  IRB template

12 12 Why is informed consent difficult?

13 13 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

14 14 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

15 15 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

16 16 How can informed consent be enhanced?  Empirical studies  Spend more time talking to participants  Questions and feedback  Shorter, simpler consent forms  Multimedia -- mixed evidence

17 17 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

18 18 How can informed consent be enhanced?  Focus on comprehension by participant, not consent forms  Administer questionnaire to ensure appreciation of key aspects of study

19 19 What should participants comprehend?

20 20 What should participants comprehend?  Could still get HIV  Don’t know whether intervention works  May not get active intervention  Keep using condoms every time

21 21 What should participants comprehend?  May refuse to participate  May withdraw from study

22 22 Questions?

23 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 24 Voluntary and free consent  Historical concerns  Prisoners, institutionalized persons  Excluded from research

25 25 Voluntary and free consent  Undue influence  Coercion = threat  Threat to discharge from clinic  Unspoken concerns in students, employees, patients of investigator

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27 Research participants who may lack decision-making capacity  Persons receiving CPR, ICU care  Severe dementia  Severe psychiatric illness  Children 27

28 28 Research participants who may lack decision-making capacity  Not appreciate risks  Not able to refuse  Might be subjected to risks that competent persons would refuse

29 Options if lack decision-making capacity  Exclude from trials  But lack evidence safety and effectiveness of treatments  Additional protections 29

30 30 Research participants who may lack decision-making capacity  Formal assessment of decision-making capacity  Permission from surrogate  Assent of participant

31 31 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

32 32

33 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? 33

34 Ethical rationale for exception from consent  Very low risk  No physical risks  Confidentiality the main risk  Cannot be breached if not identifiable  Benefits of research >> risks 34

35 Ethical rationale for exception from consent  Impracticable to get consent  Could not carry out important study  No one would or should object if asked  Leftover tubes of blood  Cancer tisssue 35

36 36 IRB approval for exception to consent 1. Not human subjects research  No IRB review  Self-certification form 2. Exempt from human subjects regulations  Exempt form reviewed at CHR 3. Qualifies for waiver

37 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 37

38 What is human subjects research?  Data and materials are coded but researcher cannot access keys to code  None of 18 HIPAA identifiers  Code may be retained by database or biobank 38

39 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 39

40 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 40

41 41 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

42 42 Questions?

43 Questions for audience May research be carried out on de- identified materials without consent?  Whole genomic sequence?  Derive new hESC line from “abandoned” frozen embryos? 43

44 How are embryos different from other tissue?  Some believe embryos are persons  Emotional and symbolic significance  Some may prefer to discard rather than donate for research 44

45 Exception to consent not justified  Some donors known to object  Even if no physical risk, not identifiable  Materials considered sensitive, have symbolic value  Object to certain types of research  Respect minority of donors who have strong objections 45

46 Use of reproductive materials without consent  Legally permissible  Ethically problematic 46

47 Concerns about whole genome sequencing  Subject may consider information very personal, may not want others to know  Even if identity not explicitly known 47

48 Concerns about whole genome sequencing  De-identified sample may be re- identified  Genomic sequence widely shared  Confidentiality may be breached 48

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50 50 Re-identification in whole genomic sequencing  Reference samples in forensic databases  DOJ has 7.3 million profiles  STRs at 13 locations  Full genome sequence identifies these STRs  Re-identification low probability, high impact

51 51 Re-identification in whole genomic sequencing  Reference samples with SNPs at recreation genomics companies  Companies not subject to HIPAA  If bankrupt, confidentiality agreements voided

52 52 What are the ethical dilemmas?  When materials collected, whole genome sequencing not envisaged  Donors not consider this possibility  If donors had been told, would they object?

53 Options  Re-consent participants?  Selection bias in sample  Make research much more difficult  Strict security and confidentiality safeguards  How share sequence with other researchers? 53

54 Take home message  Consent is important but challenging  Important exceptions to consent justified  But some exceptions problematic 54

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57 57 Genome-wide association studies  Specimens and clinical data in biobanks  General consent for “research” at time of surgery  Consent for “cancer” or “genetics” research  Researchers get anonymized materials without consent

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