More Related Content Similar to Dugosh.pptx (20) Dugosh.pptx1. ©Treatment Research Institute, 2012
12/9/2022
Issues Surrounding Informed Consent to
Research with Substance Abusing
Participants
Karen L. Dugosh, Ph.D.
Treatment Research Institute
Philadelphia, PA ©Treatment Research Institute, 2012
2. ©Treatment Research Institute, 2012
12/9/2022
Overview
• This presentation will:
• Provide a brief history of informed consent
• Review the primary tenets of informed consent
• Discuss ways in which the informed consent
process may be compromised among substance
abusers
3. ©Treatment Research Institute, 2012
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Introduction
• Many important medical and behavioral
advancements required research on humans
• Frequently conducted with marginal and highly
vulnerable populations
• Revelations of unethical investigations heightened
public awareness of the potential for research
misconduct
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Nazi Medical Experiments (1942-1945)
• Experimental Surgery - Ravensbrook
• Sterilization Research - Auschwitz
• Typhus Experiments - Buchenwald
• Poison Experiments - Buchenwald
• Sea Water Experiments - Dachau
• High Altitude Experiments - Dachau
• Hypothermia Experiments - Dachau
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Tuskegee Syphilis Experiment (1932-1972)
• Longest non-therapeutic experiment on human
beings in medical history
• U.S. Public Health Service (PHS)
• 399 black men in the late stages of syphilis
• Never told what disease they were suffering from or
of its seriousness
• 28 died directly of syphilis, 100 of complications, 40
wives infected, & 19 of their children born with
congenital syphilis
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Nuremberg Code
• Adopted by UN General Assembly in 1948
• First international document to provide guidelines on
research ethics
• Made voluntary consent a requirement in clinical
research studies
• Emphasized that consent can be voluntary only if
participants:
• 1) are able to consent
• 2) are free from coercion
• 3) comprehend all risks and benefits
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Helsinki Declaration
• Established in 1964 at the 18th World Medical
Assembly in Helsinki, Finland
• World Medical Association adopted a set of
principles to guide physicians on ethical
considerations related to biomedical research
• Emphasized the distinction between medical care
that directly benefits the patient and research which
may have no direct benefit
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Belmont Report (1979)
• National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
• Set forth three principles underlying ethical conduct
of research:
• Respect for Persons
• Recognizing autonomy and dignity
• Beneficence
• Protection from harm by maximizing benefits
and minimizing risks
• Justice
• Fair distribution of benefits and burdens
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Basic Principles of Informed Consent
• Intelligent
• Must be capable of understanding
• Knowing
• Must be understood and retained
• Voluntary
• Must be autonomous
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Vulnerabilities
• Intrinsic
• Attributes of the individual that limit capacity or
freedoms
• Extrinsic
• Situational factors that may limit capacity or
freedoms
• Relational
• Occur as a result of the a relationship with
another individual or group
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Intelligence
• Refers to one’s intrinsic capacity to understand,
appreciate, and express a choice
• May be compromised in substance abusers due to a
host of factors
• Severe neurological effects of chronic drug use
• Traumatic brain injury
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Knowingness
• Refers to one’s accurate understanding and
appreciation of the study and their involvement
• Substance abusers may experience impaired
attention, cognition, or recall as a result of:
• Acute intoxication or withdrawal
• Long term effects of drug use on the brain
• Developmental and environmental factors
• Limited education, poor nutrition, and
comorbid health and mental health problems
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Consent recall
• Rounsaville et al. (2008)
• Examined consent recall among marijuana users
• Presented consent information and tested
participants on recall
• 55% correctly answered all four multiple choice
questions
• Kiluk et al. (2010)
• Immediate recall related to intelligence, attention,
educational attainment
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Consent recall
• Festinger, Dugosh et al., 2007
• Examined consent recall among substance abusing
offenders
• Tested delayed (2 week post-consent) recall of
consent information
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Consent recall
Question
(# of items)
% Totally
Correct
% Partially
Correct
Mean % Correct
(SD)
Purpose of study (2) 0 16 8 (19)
Duration of participation (1) 72 N/A 70 (46)
Compensation (7) 2 96 40 (26)
Group assignment (1) 69 N/A 68 (47)
Random assignment (1) 58 N/A 56 (50)
Potential benefits (4) 0 46 15 (19)
Potential risks (3) 0 25 8 (18)
Declining participation (1) 90 N/A 88 (32)
Study rights and protections (5) 0 0 0 (0)
HIPAA (3) 0 4 2 (9)
16. ©Treatment Research Institute, 2012
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Consent recall
Question
(# of items)
% Totally
Correct
% Partially
Correct
Mean % Correct
(SD)
Purpose of study (2) 0 16 8 (19)
Duration of participation (1) 72 N/A 70 (46)
Compensation (7) 2 96 40 (26)
Group assignment (1) 69 N/A 68 (47)
Random assignment (1) 58 N/A 56 (50)
Potential benefits (4) 0 46 15 (19)
Potential risks (3) 0 25 8 (18)
Declining participation (1) 90 N/A 88 (32)
Study rights and protections (5) 0 0 0 (0)
HIPAA (3) 0 4 2 (9)
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Consent recall
• Overall, clients recalled only 34% of information on
average just two weeks post-consent
• Replicated in several subsequent trials (Festinger,
Dugosh, et al., 2009, 2011)
• Delayed recall related to intelligence, reading level,
memory, and attention
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Researcher perceptions of
understanding (Dugosh, Festinger, et al., 2014)
• Conducted web-based survey to evaluate NIDA-
and NIAAA-funded researchers’ perceptions about
consent recall (n = 233)
48%
15%
37%
Type of research
Behavioral Biomedical Both
20%
8%
66%
11%
Prisoners
Pregnant women
Low SES
Cognitively impaired
Special Populations
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Researcher perceptions of
understanding (Dugosh, Festinger, et al., 2014)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Very Important Somewhat Important Somwhat Unimportant Not Important
How important is it for participants to remember their
consent information throughout the course of a study?
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Researcher perceptions of
understanding (Dugosh, Festinger, et al., 2014)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Methods and Procedures Safeguards and Protections Risks Benefits
How important is it for participants to remember the
following areas covered in the consent process?
Very Important
Somewhat Important
Somwhat Unimportant
Not Important
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Researcher perceptions of
understanding (Dugosh, Festinger, et al., 2014)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Methods and Procedures Safeguards and Protections Risks Benefits
How well do you think participants remember information
in each of the following areas?
Completely
Moderately
Slightly
Not at all
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Voluntariness
• Participation free from coercion and undue influence
• Substance abusers often have certain situational
factors that may interfere with their ability to make
autonomous decisions
• Often recruited from settings that are implicitly
coercive (e.g., inpatient units, detoxification
facilities, prisons)
• May perceive, correctly or incorrectly, that
cooperation is essential for their well being
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12/9/2022
Drug Court Participants
(Dugosh, Festinger, et al., 2014)
Item Not at all A little
More
than a
little
A lot
I felt like I was talked into entering the study 91% (124) 9% (12) 1% (1) --
It was entirely my choice to enter the study (reverse scored) 93% (128) 6% (8) 1% (1) --
I thought it would look bad to my case manager if I did not enter the study 89% (122) 9% (12) 2% (3)
I felt the judge would like it if I entered the study 50% (68) 26% (36) 7% (9) 18%(24)
I entered the study even though I did not want to 94% (129) 5% (7) 1% (1) --
I felt that I could not say ‘no’ to entering the study 88% (120) 6% (8) 4% (6) 2% (3)
I felt that entering the study would help my court case 57% (78) 23% (31) 11% (15) 10% (13)
I thought it would look bad to my counselor if I did not enter the study 87% (119) 8% (11) 4% (5) 1% (2)
I felt that I could not say no to being in the study because of the money 69% (94) 18% (24) 7% (10) 7% (9)
I entered the study because I though it would please my attorney 96% (132) 2% (3) 1% (1) 1% (1)
It would have created problems with my family if I chose not to participate 98% (134) 2% (3) -- --
It would have created problems between me and other people in the
program if I chose not to participate
99% (136) 1% (1) -- --
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Voluntariness and payment
• Widely held belief that providing monetary
incentives to substance abusers is an undue
influence
• Lower SES, lower educational attainment
• Address this by providing gift card payments, non-
monetary goods and services
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Conclusions
• Substance abusers present unique challenges
related to informed consent to research
• Problems may be magnified in genetics research
• Fortunately, there are empirically-validated
techniques and tools available to help improve
informed consent among substance using
participants
Editor's Notes After the Belmont Report was established, DHHS and FDA revised their regulations for studies that involved human participants and informed consent emerged as the cornerstone for human subject protections 20% did not understand that participation was voluntary 2 weeks later 2 weeks later 2 weeks later 2 weeks later 2 weeks later 2 weeks later 2 weeks later 2 weeks later