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Using Evidence to Face the Challenges of Informed Consent

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Using Evidence to Face the Challenges of Informed Consent Jeremy Sugarman, MD, MPH, MA Phoebe R. Berman Bioethics Institute Department of Medicine – PowerPoint PPT presentation

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Title: Using Evidence to Face the Challenges of Informed Consent


1
Using Evidence to Face the Challenges of Informed
Consent
  • Jeremy Sugarman, MD, MPH, MA
  • Phoebe R. Berman Bioethics Institute
  • Department of Medicine
  • Johns Hopkins University

2
Overview
  • The process of informed consent
  • The empirical imperative
  • Obtaining evidence about informed consent

3
Two Senses of Consent
  • Autonomous authorization
  • Social rules of consent

4
Autonomous Authorization
  • Arises from a littered history
  • Respect for persons/autonomy
  • Liberty interests

5
Social Rules
  • Consent of minors
  • Special forms
  • Witnesses

6
The Process of Informed Consent
  • Threshold
  • Information
  • Consent

7
Informed Consent Process
Threshold
  • Decision-making capacity

8
Informed Consent Process
Threshold
  • Decision-making capacity
  • Voluntariness

9
Informed Consent Process
Information
  • Disclosure

Threshold
  • Decision-making capacity
  • Voluntariness

10
Informed Consent Process
Information
  • Disclosure
  • Understanding

Threshold
  • Decision-making capacity
  • Voluntariness

11
Informed Consent Process
Authorization
  • Indication of agreement
  • Consent forms
  • Consistent with disclosure
  • Readable

Information
  • Disclosure
  • Understanding

Threshold
  • Decision-making capacity
  • Voluntariness

12
An Empirical Imperative
  • Clinical research is predicated on the notion
    that we need data to determine truth and
    facilitate sound decision-making
  • Ironically, methods of clinical research,
    including those designed to protect participants
    such as informed consent, are introduced without
    data regarding safety or efficacy
  • Where relevant we need to evaluate these
    protections as we would any proposed clinical
    intervention

13
Recent and Current Efforts
  • Reviewing the literature
  • ACHRE SIS (Subject Interview Study)
  • Informed consent for umbilical cord blood
    donation
  • Improving informed consent for early phase trials
    in oncology
  • Proxy decision making for research on dementia
  • COINS (Conflict of Interest Notification Study)
  • EQUIC

14
Reviewing the Literature
  • Older persons
  • Adults

15
Older PersonsStructured Literature Review
  • Searches in 10 electronic databases
  • Included primary research data specifically on
    informed consent and involved older persons in
    the sample
  • Articles abstracted

16
Aspects of Consent(99 articles 289 research
questions)
  • ASPECT
  • Recruitment
  • DMC
  • Voluntariness
  • Disclosure
  • Understanding
  • Consent forms
  • Authorization
  • Policies
  • Other
  • N
  • 60
  • 21
  • 6
  • 30
  • 139
  • 7
  • 11
  • 13
  • 2

17
Results
  • Diminished understanding of informed consent
    information was associated with older age and
    fewer years of education
  • Studies of disclosure suggest strategies to
    improve understanding
  • Formats
  • Procedures

18
Recommendations
  • Effective strategies should be considered in the
    design of research
  • Research on aspects of informed consent other
    than understanding ought to be conducted

19
Annotated BibliographyMethods
  • 9 electronic databases (inception-12/97)
  • Inclusion criteria
  • Primary data or systematic review
  • One or more aspects of consent
  • Adults
  • Articles abstracted and entered into a database

20
Annotated BibliographyResults
  • 377 articles
  • 3,173 hypotheses
  • Annotated bibliography assembled
  • Most examine disclosure and understanding

21
Advisory Committee on Human Radiation Experiments
  • Uncover the history of human radiation
    experiments between 1944 and 1974
  • Examine cases of released radiation into the
    environment for research purposes
  • Identify the ethical and scientific standards for
    evaluating these events
  • Make recommendations to ensure that whatever
    wrongdoing may have occurred in the past cannot
    be repeated

22
ACHREs Empirical Projects
  • Review federal agency policies
  • Examine contemporary research documents and
    consent forms
  • Interview patients receiving out-patient medical
    care about their understanding of and attitudes
    towards medical research

23
Methods
  • Part 1 Brief Survey
  • Interviewed 1,882 patients
  • From medical oncology, cardiology, and radiation
    oncology waiting rooms
  • Included 16 hospitals and 5 cities around the
    U.S.
  • To determine beliefs and attitudes about medical
    research and to ask if they were, or ever had
    been, participants in medical research
  • Paid 5.00

24
Methods
  • Part 2 In-Depth Interview
  • Interviewed 103 patients
  • All reported in Brief Survey that they were or
    had been in medical research
  • To determine reasons for joining research and to
    describe their research experiences
  • Paid 25.00

25
DemographicsTotal Respondents 1,882 (Response
rate 94.7)
  • Age gt 59 53
  • White 80
  • African American 16
  • High School Graduates 54
  • College Graduates 25

26
SIS Summary
  • Most patients had very positive attitudes about
    medical research
  • Positive attitudes were more likely to be
    expressed by those who told us that they had
    actual experience in research
  • Although the majority of both white and
    African-American respondents said that patients
    are not pressured into participating and that
    research does not pose unreasonable risks,
    African-American patients still were more likely
    to hold these attitudes than were white patients

27
SIS Summary (continued)
  • There are significant differences between
    patients understanding of different terms used
    to describe research
  • Small amount of discordance between patients
    reports and evidence available from research
    records
  • Some patients chose not to participate in
    research
  • The main reasons why patients decided to
    participate was to advance science and the
    possibility of helping others

28
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29
Early Phase Research
  • Trust plays a major role in participation
  • Patient-subjects are frequently motivated by hope
    for therapeutic benefit along with other reasons

30
  • Theres not a lot that you can control when
    youre sick, so you have to rely on your doctors
    if he suggests that you should go into a
    research project, I think you should really take
    his advice because if you take the time to find
    yourself a good doctor and theyre involved in
    research, they would never steer you wrong.
  • (552244-6)

31
  • I think Ive got the best treatment down there
    at named hospital, I dont think I could get
    any better.
  • (333208-7)

32
  • They know what they are doing. They wouldnt
    have you do this if they didnt know what they
    were doing,
  • (332324-3)

33
EQUIC Study Chairs
  • Phil Lavori, PhD
  • Jeremy Sugarman, MD, MPH, MA

34
Goals
  • Create, field test, and validate an independent,
    real-time measure of the quality of informed
    consent encounters in actual clinical trials
  • Develop specific interventions directed at
    improving the quality of informed consent
  • Test interventions in CSP trials

35
Expert Advisory Committee
  • Membership
  • Paul Appelbaum, MD
  • Marguerite Hayes, MD
  • Robert Pearlman, MD, MPH
  • Findings
  • Independent measurement
  • Results confidential
  • Evaluate IC process and not experience
  • Not-interfere with research process
  • Minimal burden
  • Practical and simple

36
EQUIC-Development Phase
  • Telephone interview after parent study consent
  • Brief Informed Consent Evaluation Protocol
    (BICEP)
  • Substrate for all subsequent EQUIC studies

37
EQUIC-DP Research Team
  • Maryann Boeger, MBA - Program Manager
  • Andres Busette - Research Health Scientist
  • Carole Cain, PhD Interviewer
  • Eric Crawford - Interviewer
  • Robert Edson, MS Statistician
  • Madhulika Gupta, MS Interviewer
  • Phil Lavori, PhD Co-Principal Investigator
  • Patrick Nisco, MA- Interviewer
  • Lee Pickett, MS Interviewer
  • Jeremy Sugarman, MD Co-Principal Investigator
  • Carmen Tumialan-Lynas, MS - Interviewer

38
EQUIC-DP Parent Studies
  • 1. CSP 027 FDG PET
  • 2. CSP 403 Shingles Vaccine
  • 3. CSP 410 FeAST
  • 4. CSP 424 COURAGE
  • 5. CSP 453 HOST
  • 6. CSP 494 PTSD and Women
  • 7. CSP 499 SELECT
  • 8. CSP 719B Latent Prostate

39
EQUIC-DP Participating Sites
  • Site Study Site Study
  • Ann Arbor, MI CSP 424 Melbourne, FL CSP 424
  • Birmingham, AL CSP 403 Minneapolis, MN CSP
    403
  • Buffalo, NY CSP 027 Northport, NY CSP
    403
  • Durham, NC CSP 424 Northport, NY CSP 499
  • Houston, TX CSP 410 Northport, NY CSP
    719B
  • Houston, TX CSP 424 Reno, NV CSP 410
  • Indianapolis, IN CSP 027 Seattle, WA
    CSP 424
  • Lexington, KY CSP 410 St. Louis, MO CSP
    499
  • Mayo Clinic CSP 424 St. Louis, MO CSP 719B
  • 13 VAMCs 1 non-VAMC

40
EQUIC-DP Enrollment
  • Total 632 interviews completed
  • BICEP-1
  • 441 completed
  • 8/21/00-7/31/01
  • BICEP-2
  • 191 completed
  • 8/1/01-7/2/02

41
EQUIC-DPSite Coordinators Reports
  • 100 patient willingness to participate
  • 98.9 no difficulty with process
  • 99.5 no difficulty with call
  • 95.4 no difficulty reaching center
  • 98.4 no interruption of clinic flow
  • 99.2 no other difficulties

42
Degree of Disruption of Parent Study
  • None 66.3
  • Mild 32.8
  • Moderate 1
  • Severe 0

43
Incremental Burden
  • Site coordinators
  • mean 14.2 min (std dev 9.6)
  • Participants
  • mean 10.9 min (std dev 7.8)

44
Mean Timing of Interviews
  • Completion of parent study IC and EQUIC IC 19.8m
    (sd 28.0)
  • EQUIC IC and initiation of call 8.4m (sd 11.7)
  • Duration of call 8.8m (sd 3.6)
  • Interview length 7.7m (sd 2.9)

45
Respondents Reports about Parent Study IC Process
  • 95.1 received just right amount of information
  • 99.3 remember signing consent form
  • 99.8 felt no pressure to consent
  • 98.4 made a good decision to participate
  • 89.1 completely satisfied with the IC process

46
Taking a Deeper Look
  • Verbatim responses to selected items
  • What is the primary purpose of the parent
    study?
  • When can you stop participating in the parent
    study?
  • Coding developed and refined during BICEP-1

47
What is the primary purpose of parent study?
(n191)
  • Code
  • Addresses a research question?
  • Directed at an outcome to ultimately benefit
    others?
  • Directed at an outcome to ultimately benefit
    self?
  • Other?
  • Percent
  • 80
  • 59
  • 6
  • 1

48
When can you stop participating in the Parent
Study
  • Code for clear appreciation of voluntariness
  • Yes
  • No
  • Percent
  • 55
  • 45

49
Reliability of Verbatim Coding
  • 3 interviewers, each coding verbatim responses
    from interviews in BICEP2 and parent studies
    concerning research on a therapy (n42)
  • ICC for coded responses .75
  • Variable components analysis
  • Subjects (true).94
  • Total1.25
  • Residuals (rater).32

50
Lessons
  • BICEP is well-tolerated, by participants and
    staff
  • BICEP imposes minimal burden
  • Verbatim coding is reliable
  • Patients who consent are uniformly satisfied with
    the process, but inspection of verbatims reveals
    considerable room for improvement, especially in
    the therapeutic misconception
  • Innovations have scope to work

51
Next Steps
  • EQUIC-SM (Self-Monitoring)
  • EQUIC-CC (Customized Consent)
  • Explore other uses for BICEP and develop new
    interventions

52
Concluding Comments
  • To do the ethical work assumed in theoretical
    approaches, informed consent must be considered
    as a process that goes well beyond completing
    consent forms
  • There is an emerging database evaluating parts of
    the informed consent process that suggests areas
    warranting attention
  • Informed consent needs to be evaluated rigorously

53
(No Transcript)
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