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Recruitment of Healthy Recruitment of Healthy Volunteers: Volunteers:
Research Ethics under Research Ethics under PressurePressure
INSIGHT Toronto October 24 INSIGHT Toronto October 24 20062006
Michael Goodyear
Department of Medicine, Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax NS
Learning ObjectivesLearning Objectives
• I: A Culture of SafetyI: A Culture of Safety
• II: What Motivates Volunteers?II: What Motivates Volunteers?
• III: Why Volunteers are VulnerableIII: Why Volunteers are Vulnerable
• IV: Role of Financial IncentivesIV: Role of Financial Incentives
• V: Adverse Risk-Benefit RatioV: Adverse Risk-Benefit Ratio
• VI: Defining the Ethical ProblemVI: Defining the Ethical Problem
SummarySummary
Part IPart I
A Culture of SafetyA Culture of Safety
A Healthy Volunteer
Died
Ellen RocheEllen Roche
“What's the worst that can happen to me? …I die, and it's for the babies.“New York Times, 28 Nov 1999
Jesse Jesse GelsingerGelsinger
TGN1412TGN1412
Hell of human guinea pigsHow the drug trial horror unfoldedBy MICHAEL SEAMARK, Daily Mail 17th March 2006
We saw human guinea pigs explodeVictims tearing at shirtsBy NICK PARKER, EMMA MORTON and JACQUI THORNTON 16th March 2006
Ryan, Gangrene
Khan, EyewitnessPlacebo
Elephant Man and Girlfriend
Oedema
A Culture of A Culture of SafetySafety
“The demand for human subjects is at an all time high, and the competition for human subjects for research participation is equally great. Investigators must take care to not respond to this competitive environment … The temptation to entice subjects with a large amount of money is a natural reaction to such conditions; however, the protection of human subjects must come first”Tishler CL, Bartholomae S: The recruitment of normal healthy volunteers: A review of the literature on the use of financial incentivesJ Clin Pharmacol 2002; 42: 365-375
Part IIPart II
What Motivates What Motivates Volunteers?Volunteers?
What Motivates What Motivates Volunteers?Volunteers?
• AltruismAltruism– DiseaseDisease– SocietySociety
• CuriosityCuriosity
• Medical Care (where not available)Medical Care (where not available)
• MoneyMoney
• Other incentivesOther incentives
Walter Reed Experimenting on
Yellow FeverCuba, 1898
$100 in Gold
Additional $100 in Case of Death
Research related injuryInformed Consent re
risk
Allied Research International is always recruiting for normal healthy study Allied Research International is always recruiting for normal healthy study participants for our phase I and bioequivalence studies. We conduct our participants for our phase I and bioequivalence studies. We conduct our studies in a cheerful, safe, and respectful environment. Our meals are second studies in a cheerful, safe, and respectful environment. Our meals are second to none and to none and …now with 100% more …now with 100% more pool tablespool tables!!
$950
Part IIIPart III
Why Volunteers are Why Volunteers are VulnerableVulnerable
Why Volunteers are Why Volunteers are VulnerableVulnerable
• Economically DisadvantagedEconomically Disadvantaged
• High Incidence of PsychopathologyHigh Incidence of Psychopathology– Up to 50%Up to 50%
Part IVPart IV
Role of Financial Role of Financial IncentivesIncentives
Role of Financial Role of Financial IncentivesIncentives
Difficult to assessDifficult to assess– Subjective and RelationalSubjective and Relational
– Degree of riskDegree of risk– Risk taking behaviourRisk taking behaviour– Personal valuesPersonal values– Amount of moneyAmount of money
Role of Financial Role of Financial IncentivesIncentives
• Incentives compromise autonomyIncentives compromise autonomy
• Unpaid volunteers believe there Unpaid volunteers believe there should not be paymentsshould not be payments
• Voluntariness becomes occupationVoluntariness becomes occupation
• Repeat or professional volunteersRepeat or professional volunteers
• Problems of Justice, GeneralisabilityProblems of Justice, Generalisability
Part VPart V
Adverse Risk-Benefit RatioAdverse Risk-Benefit Ratio
Adverse Risk-Adverse Risk-Benefit RatioBenefit Ratio
• Essentially no benefitEssentially no benefit
• (Social obligation)(Social obligation)
Part VIPart VI
Defining the Ethical Defining the Ethical ProblemProblem
Defining the Ethical Defining the Ethical ProblemProblem
DisadvantagedDisadvantaged
PopulationsPopulations
Require Require
Special Special
ProtectionProtectionBelmont
CFR
FDA, OHRP
Healthy Research Healthy Research VolunteersVolunteers
OHRP – IRB GuidebookOHRP – IRB Guidebook
Chapter VI: Special Classes of Subjects:Chapter VI: Special Classes of Subjects:– ““Volunteers for whom Volunteers for whom no therapeutic benefitno therapeutic benefit
can result from participation in research should, can result from participation in research should, therefore, be exposed to therefore, be exposed to risks that are risks that are minimizedminimized to the greatest extent possible.” to the greatest extent possible.”
– “…“…IRBs must ensure that any IRBs must ensure that any monetary monetary paymentspayments to subjects are to subjects are not not so great as to so great as to constitute an constitute an undue inducementundue inducement. …. …Payments should be commensurate with time, Payments should be commensurate with time, discomfort, and risk involved.”discomfort, and risk involved.”
VulnerableVulnerable PopulationsPopulations
21 CFR 56.111 (b)21 CFR 56.111 (b)
Criteria for IRB Approval of Research:Criteria for IRB Approval of Research:
“ “When some or all of the subjects, such as children, When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally prisoners, pregnant women, handicapped, or mentally disabled persons, or disabled persons, or economically or educationally economically or educationally disadvantageddisadvantaged persons, are likely to be persons, are likely to be vulnerable vulnerable to coercion or undue influenceto coercion or undue influence additional additional safeguardssafeguards have been included in the study to have been included in the study to protect the rights and welfare of these subjects."protect the rights and welfare of these subjects."
Defining the Ethical Defining the Ethical ProblemProblem
Risk/Benefit
Vulnerability
SummarySummary
Summary I/IISummary I/II
• Volunteers are HarmedVolunteers are Harmed
• Are largely Motivated by Financial Are largely Motivated by Financial IncentiveIncentive
• Are Economically DisadvantagedAre Economically Disadvantaged
• Have Increased VulnerabilityHave Increased Vulnerability
• Have Compromised VoluntarinessHave Compromised Voluntariness
• Have Adverse Risk-benefit Have Adverse Risk-benefit Considerations Considerations
Summary II/IISummary II/II
Experimentation with Normal Experimentation with Normal Healthy Volunteers Requires Healthy Volunteers Requires
AA
High Degree of Review and High Degree of Review and OversightOversight
AcknowledgementsAcknowledgements
Dr Janice Parente, Ethica Clinical Research