Perceived Voluntariness in
Decisions about Research
Participation
Charles W. Lidz Ph.D.
Center for Mental Health Services Research
University of Massachusetts Medical School
Paul S. Appelbaum MD (PI)
Robert Klitzman MD (Co-I)
Conceptualizing Voluntariness
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Our concept is rooted in law of
informed consent
Decisions should reflect the decision
maker autonomous choice rather than
another person’s.
Thus voluntariness is the opposite of
coercion
Voluntariness is compatible
with some types of influences
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All decisions are influenced
Examples
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Psychological state
Opinions of others
Available resources vs. needs
Altruism
Financial & other incentives
Features of Influences that
Undercut Voluntary Choice
External
 Intentional
 Illegitimate
 Casually linked to choice

External Influences
Internal influences
Unless based on
do not undercut
external influences
voluntariness
Confusion
 Fear
 Hope, even if
unreasonable
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Deception
 Threats

Intentional Influences
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Result from deliberate action of another
person
Situational constraints generally don’t make
actions involuntary unless someone creates
the situation intending to influence
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Poverty
Absence of alternative treatment options
Organizational climate
Illegitimate Influences
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Intention to influence behavior
insufficient unless illegitimate
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Spouse may have right to exert influence
via pressure/threat
Physician generally lacks that right
Alan Wertheimer: legitimacy depends
on moral baseline
Causal Influence
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External, intentional, illegitimate
pressure not enough
Must impact decision to limit
voluntariness
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Pressure may be reprehensible but
irrelevant
Individual may successfully resist influence
or may want to act that way any event
Incentives in Research Consents
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External, intentional & may affect
choice
But generally expand options
compared to baseline & so are
usually legitimate
Pressures in Research
Consents
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External, intentional & can be causal
Illegitimate if overwhelm other
considerations and applied by someone
without the right to do so.
Interpersonal or organizational
Applied by researchers or others
Threats in Research Consents
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Declaration of intent to act to a person’s
detriment, contingent on their behavior
External, intentional, can be causal--and
always illegitimate when made by
researcher
But other parties may have right to
make threats, e.g., families
Aims of our Study
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Aimed at developing structured approach to
assessing constraints on voluntariness
Secondary aim: first look at prevalence of
diminished voluntariness in broad range of
subject populations
Greenwall Foundation funded
2 Phases
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20 semi-structured interviews each with:
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Research staff who obtain consent
Recently enrolled subjects
Goal: to develop questionnaires that cover the
territory of impaired voluntariness
88 structured subject interviews with
recently enrolled subjects
Subjects Drawn From Diverse
Studies
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Oncology
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Breast cancer
Prostate cancer
13
15
Total Cancer
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Substance abuse
Other
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Depression/fatigue
cardiology
HIV vaccine
HIV treatment
28
31
17
7
3
2
Structured Instruments
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Demographic data
Motivations for participating in research
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14 possible motivations
Degree of influence rated 1-10
Experience of offers, pressures, or threats
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What happened
Degree of influence rated 1-10
Fairness of influence rated 1-10
Instruments - 2
Modified MacArthur Perceived Coercion Scale (MPCS)
1. I felt free to do what I wanted about signing up for the
research project.
2. I chose to sign up for the research project.
3. It was my idea to sign up for the research project.
4. I had a lot of control over whether I signed up for the
research project.
5. I had more influence than anyone else on whether I
signed up for the research project.
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Instruments - 3
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Modified Voluntariness Ladder
“Now I’d like you to think again about your decision to
enter the research study on _____________. Use the
ladder of numbers below to show me how voluntary
(willing to participate) your decision was. Circle the number
that below best matches your decision, from completely
voluntary (10) to not at all voluntary (1).”
Adapted from Hoyer, et al. Int J Law Psychiatry 2002; 25:93-108.
Motivations for Participation-1
%
“Yes”
Importance
Scores
Lower (1-5)
Importance
Scores
Higher (6-10)
80
8
61
Access to treatment you
could not get any other way
59
3
47
The availability of free
treatment
52
4
20
4
0
3
12
6
4
Motivation
The possibility of getting
better care or follow up care
Getting something else for
free
Having something to occupy
your time
Motivations for Participation -2
%
“Yes”
Importance
Scores
Lower (1-5)
Importance
Scores
Higher (6-10)
7
1
5
How seriously you need help
for your condition
81
6
63
Advice from your doctor or
nurse
37
3
29
Advice from other people
26
4
19
Your trust in the people doing
the research study
70
9
42
Motivation
Being able to stay in the
hospital [for a longer time]
Motivations for Participation -3
%
“Yes”
Importance
Scores
Lower (1-5)
Importance Scores
Higher (6-10)
The reputation of the institution
where the research is being done
76
16
59
Your curiosity about the research
study’s methods/results
60
13
37
Your desire to help other people
[with your condition]
73
12
51
The belief you’re getting the
active drug rather than the
placebo
46
1
31
Motivation
Variation in Motivations Across Groups
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Oncology studies –
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Substance abuse studies –
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Higher: advice from their doctors or nurses;
desire to help others with the same medical
condition
Higher: availability of free treatment; how
seriously respondents needed help for their
condition
No single pattern for all types of studies
Factor Analysis of Motivations
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Factor 1 – “Help and trust”
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possibility of getting better care, access to treatment not
otherwise available, how seriously help was needed, trust
in the people doing the research study, the reputation of
the institution
No significant differences across groups
Factor 2 – “Free treatment”
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free treatment, not getting advice from a doctor or nurse,
and not having altruistic motivations.
Substance abuse group signif. higher
Reports of Constraints on Voluntariness
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Categories
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Offers - 31 respondents (35%)
Pressures - 3 respondents (3%)
Threats – None
(0%)
Impact
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Offers – 26/31 assigned an importance rating in
the lower half of the 1 to 10 scale, with 19 of
those giving it 1; only 1 rated it 10.
Pressures – none in top half of scale
Example of Pressures -1

From medical team
“Initially I didn’t want to, but they
really encouraged me to do it”
 5/10 (lowest score) on voluntariness
ladder
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Example of Pressures -2
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From other people in subject’s life
Boss suggests participation in
substance abuse study
 9/10 on voluntariness, 5/10 on
influence
 5/10 on fairness
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Example of Pressures -3
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Can cut both ways
AA sponsor pressured subject not to
enroll
 Enrolled anyway
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10/10 on voluntariness
 1/10 on degree of influence
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Offers Can Be Important
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Out-of-work subject agrees to
substance abuse treatment study
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$500/yr., 10/10 on importance
Money made risks/discomforts tolerable,
8/10
10/10 on voluntariness, PCS 0/5
Appears influential, but not subjectively
undue--but closest case
Offers Involve More Than
Money
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Availability of free care for people
without insurance, cited in 52 cases
Often rated as highly important in
decision
But almost never seem to affect
perceived voluntariness
Perceived Coercion Scale
(MPCS)
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Range 0-5 (less to more coercion)
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0: 65 respondents
1: 18 respondents
2: 3 respondents
18 of 25 + responses came from a
single question: “It was my idea to sign
up for the research project,” which may
have been misinterpreted in this
context
PCS Scores and Motivations
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Greater perceived coercion associated
with higher importance ratings for:
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helping others
advice from your doctor or nurse
presence of an offer
Voluntariness Ladder
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Range 1-10 (less to more voluntariness)
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73 rated score as 10 (no coercion)
11 rated score as 6-9 (upper half of scale)
1 rated score as 5 (lower half of scale)
No signif. associations with motivations
Possible Areas of Concern
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Although offers were associated with less
perceived coercion on MPCS, as importance
to decision rose, so did MPCS scores
Higher MPCS scores also associated with
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Helping others as motive (perhaps meaning of
“I feel compelled to help”)—is this a problem?
Advice from nurses and doctors—but needs to
be confirmed using other methods
Concluding Thoughts
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Systematic investigation of voluntariness
possible
Additional studies needed to confirm
findings that constraints on voluntariness
uncommon
Might be useful to focus on populations
(e.g., prisoners) and techniques (e.g.,
financial incentives) of particular concern to
policymakers