Perceived Voluntariness in Decisions about Research

Participation

Charles W. Lidz Ph.D.Center for Mental Health Services ResearchUniversity of Massachusetts Medical School

Paul S. Appelbaum MD (PI)Robert Klitzman MD (Co-I)

Conceptualizing Voluntariness 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

All decisions are influenced Examples

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 do not undercut voluntariness

Confusion Fear Hope, even if

unreasonable

Unless based on external influences

Deception Threats

Intentional Influences Result from deliberate action of another

person Situational constraints generally don’t

make actions involuntary unless someone creates the situation intending to influence Poverty Absence of alternative treatment options Organizational climate

Illegitimate Influences

Intention to influence behavior insufficient unless illegitimate Spouse may have right to exert

influence via pressure/threat Physician generally lacks that right

Alan Wertheimer: legitimacy depends on moral baseline

Causal Influence External, intentional, illegitimate

pressure not enough Must impact decision to limit

voluntariness Pressure may be reprehensible but

irrelevant Individual may successfully resist

influence or may want to act that way any event

Incentives in Research Consents

External, intentional & may affect choice

But generally expand options compared to baseline & so are usually legitimate

Pressures in Research Consents

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

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

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

20 semi-structured interviews each with: 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

Oncology Breast cancer 13 Prostate cancer 15

Total Cancer 28 Substance abuse 31 Other 

Depression/fatigue 17 cardiology 7 HIV vaccine 3 HIV treatment 2

Structured Instruments Demographic data Motivations for participating in research

14 possible motivations Degree of influence rated 1-10

Experience of offers, pressures, or threats 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.

Instruments - 3

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

Motivation % “Yes”

Importance Scores

Lower (1-5)

Importance Scores

Higher (6-10)

The possibility of getting

better care or follow up care80 8 61

Access to treatment you could not get any other way

59 3 47

The availability of free treatment

52 4 20Getting something else for free

4 0 3Having something to occupy your time

12 6 4

Motivations for Participation -2

Motivation % “Yes”

Importance Scores

Lower (1-5)

Importance Scores

Higher (6-10)

Being able to stay in the hospital [for a longer time]

7 1 5

How seriously you need help for your condition

81 6 63

Advice from your doctor or nurse

37 3 29Advice from other people 26 4 19Your trust in the people doing the research study

70 9 42

Motivations for Participation -3

Motivation % “Yes”

Importance Scores

Lower (1-5)

Importance ScoresHigher (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 51The belief you’re getting the active drug rather than the placebo

46 1 31

Variation in Motivations Across Groups

Oncology studies – Higher: advice from their doctors or

nurses; desire to help others with the same medical condition

Substance abuse studies – 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

Factor 1 – “Help and trust” 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”

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

Categories Offers - 31 respondents (35%) Pressures - 3 respondents (3%) Threats – None (0%)

Impact 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

Example of Pressures -2

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

Example of Pressures -3

Can cut both ways AA sponsor pressured subject

not to enroll Enrolled anyway

10/10 on voluntariness 1/10 on degree of influence

Offers Can Be Important Out-of-work subject agrees to

substance abuse treatment study $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

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)

Range 0-5 (less to more coercion) 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

Greater perceived coercion associated with higher importance ratings for: helping others advice from your doctor or nurse presence of an offer

Voluntariness Ladder

Range 1-10 (less to more voluntariness) 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 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 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 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