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This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this site.
Copyright 2006, The Johns Hopkins University and Holly Taylor. All rights reserved. Use of these materials permitted only in accordance with license rights granted. Materials provided “AS IS”; no representations or warranties provided. User assumes all responsibility for use, and all liability related thereto, and must independently review all materials for accuracy and efficacy. May contain materials owned by others. User is responsible for obtaining permissions for use from third parties as needed.
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Assessment of Risks and Benefits
Holly Taylor, MPH, PhDJohns Hopkins University
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Framework for Ethical Analysis
Beneficence– Moral requirements
• Do no harm• Maximize benefits/minimize harms
– Practical applications• Study design• Assessment of risks and benefits
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Topics to be Covered
Principle of beneficenceStudy design– What is research?Assessment of risks and benefits– Risks– Benefits– Balancing
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Section A
Principle of Beneficence
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Definition/Theory
Central to health professionsDifferent views of beneficence– Frankena– Beauchamp and Childress
Continued 6
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Definition/Theory
Beauchamp and Childress formulation
Continued 7
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Definition/Theory
Principle of utility– Beneficence at core– Maximizing principleEthic of care– Relationships
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Principle of Beneficence
Applied to research ethics– Study design
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Section B
What is Research?
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What is Research?
“Research—a systematic investigation including research development, testing, and evaluation designed to contribute to generalizable knowledge.”
Source: 45 CFR § 46.102 (e) Continued 11
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What is Research?
“Human subject—a living individual about whom an investigator conducting research obtains . . .– (1) data through intervention or
interaction with the individual, or– (2) identifiable private information.”
Source: 45 CFR § 46.102 (f) Continued 12
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What is Research?
Distinguishing research from practice
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Research vs. Practice
1. What is the goal of the investigator?– Local or generalizable
2. Is there intent to publish the results?– Journal requirements
Continued 14
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Research vs. Practice
3. How did the investigator come to know/interact with the patient/client?
– Stranger?4. Will usual care be changed or manipulated?
Continued 15
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Research vs. Practice
5. How novel is the care or intervention?– Does it deviate from standard practice?
6. Will there be systematic data collection?
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Research vs. Quality Assurance
Criteria 1– “Initiative should be regulated by research
regulations if the majority of patients are not expected to benefit directly from the knowledge to be gained.”
Source: Casarett, Karlawish, Sugarman. JAMA, 2000, 283 (17): 2275-80 Continued 17
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Research vs. Quality Assurance
Criteria 2– “If the majority of patients are likely to
benefit from knowledge to be gained, initiative should be reviewed and regulated as research if participants would be subjected to additional risks or burdens beyond the usual clinical practice to make its results generalizable.”
Source: Casarett, Karlawish, Sugarman (2000). JAMA, 283 (17): 2275-80 Continued 18
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Research vs. Quality Assurance
Source: Casarett, Karlawish, Sugarman. JAMA 2000 283 (17): 2275-80) 19
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Research?
If activity is determined to be research:– Federal guidelines apply– Must be reviewed by an IRB
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Section C
Assessment of Risks and Benefits
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IRB Responsibility
Risks to subjects are minimizedRisks to subjects are reasonable in relation to the anticipated benefits, if any, to subjects, and the importance of the knowledge that may be reasonably be expected to result
Source: 45 CFR § 46.111 22
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Risk Concepts
Risk—probability and magnitude of some future occurrence of harmHarm—injury, setback to interestsRisk assessment
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Risk Concepts
Continued 24
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Risk Concepts
Uncertainty—lack of predictabilityRisk perception—perceptions based on personal experience/attitudes/psychologyRelative risk
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Risk Concepts
Minimal risk—“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research is not greater in and of itself than those encountered during daily life or during the performance of routine physical and psychological examinations or tests.”
Source: 45 CFR 46.102(I) Continued 26
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Risk Concepts
Minimal RiskImplications for . . .– Consent – Enrollment of vulnerable populations
Continued 27
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Risk Concepts
Minimal RiskTherapeutic vs. non-therapeutic
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Individual Risk
Physical– Bodily injury– Healthy volunteer vs. patient– Early testing– Delay– Related to RCT
Continued 29
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Individual Risk
Psychological– Stress, discomfort– Disclosure of medical information– Deception
Continued 30
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Used with permission of New Life Community Church of Stafford: http://www.new-life.net/milgram.htm 31
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Milgram Experiment
“I observed a mature and initially poised businessman enter the laboratory smiling and confident. Within 20 minutes he was reduced to a twitching, stuttering wreck, who was rapidly approaching a point of nervous collapse.”
Source: Faden and Beauchamp (1986). A History and Theory of Informed Consent 32
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Individual Risk
InconvenienceWrongs to personhood
Continued 33
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Individual Risk
Individual Risk—Social RisksRisks to reputation/stigma– Breaches of confidentialityEconomic
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Community Risk
Readings“Community”– Ethnic/tribal– Immigrants– Marginalized group– Minority group– Extended family– Religious group
Continued 35
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Community Risk
Community Risk—Social RisksStigmaEconomicExploitation
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Section D
Benefits
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Benefits
Concept– Something of value related to
health/welfare
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Possible Benefits
Individual BenefitPhysical– Medical– “Inclusion” Benefit
• Lantos• Peppercorn, et al.
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Individual Benefit
Psychological– Hope– AltruismKinshipSocial
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Individual Benefit
Economic– Access to medical care– Monetary
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Possible Benefits
Financial CompensationConcerns
Source: Dickert and Grady (1999). NEJM 341(3): 198-203 Continued 42
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Possible Benefits
Financial CompensationModels– Market– Wage-payment– Reimbursement
Source: Dickert and Grady (1999). NEJM 341(3): 198-203 43
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Benefits
Community Benefit– Medical– Material
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Balancing Risks and Benefits
Goals– Minimize risk– Maximize benefit
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Section E
Case Example: Research in the Emergency Room
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Research in ER
Will patients with severe head trauma benefit from anti-oxidant therapy? Investigators wish to study whether the drug polyethlyene glycol-superoxide dismutase (PEG-SOD) will limit the degree of brain injury suffered by head trauma patientsTo date, data from animal models and limited human trials demonstrate a possible benefit
Source: Karlawish and Hall (1996). Am J Respir Crit Care Med, 153: 499-5-6 Continued 47
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Research in ER
The study design will randomize patients to receive either one of two possible doses of PEG-SOD or placeboGiven the circumstances of the patients’injuries, they are typically unable to give informed consent
Source: Karlawish and Hall (1996). Am J Respir Crit Care Med, 153: 499-5-6 Continued 48
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Research in ER
Furthermore, if the patients are to benefit from PEG-SOD, the investigators must administer the drug expeditiously, within two hours of presentation to hospital
Source: Karlawish and Hall (1996). Am J Respir Crit Care Med, 153: 499-5-6 Continued 49
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Research in ER
Consider risks and benefits– Individual– Group
Continued 50
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Research in ER
Consider alternative methods of consent– Surrogate– Deferred– Waiver
Continued 51
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Research in ER
Consider alternative methods of consent– 1996 waiver
• Life threatening situation• Available treatment unproven• Valid scientific data necessary
Continued 52
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Research in ER
Consider alternative methods of consent– 1996 waiver
• Obtaining consent not feasible • Participation holds out potential for
direct benefit• Research could not be carried out
without waiver
Continued 53
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Research in ERConsider alternative methods of consent– 1996 waiver
• Investigator will try and reach decision-maker
• IRB approved• Protections• Subject notified ASAP
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