HSRE Lect15 Skinner
Transcript of HSRE Lect15 Skinner
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Ethics in Health Services Research
Ann Skinner, MSW
Johns Hopkins University
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Section A
Overview
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Belmont Report Principles
Respect for persons−
Individuals should be treated as autonomous agents
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People with diminished autonomy are entitled to
protection
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Belmont Report Principles
Beneficence−
Do no harm
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Maximize possible benefits and minimize possible harms
Justice−
The benefits of the research should accrue to those who
bear the burden of participation
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Impetus for the Belmont Report
Medical experiments conducted by Nazi physicians in the1930s and early 1940s
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Lack of autonomy
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Inhumane treatment−
Research findings intended for others
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Nuremberg Code
Nuremberg Code, 1947−
Informed consent without coercion
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Human experiments based on animal research
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Expected results should justify the research Nuremberg Code, 1947
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Scientists must be qualified
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Physical/mental suffering avoided−
No expectation of disability or death from the research
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Declaration of Helsinki
Declaration of Helsinki (drafted 1953, adopted 1964)−
Ethical principles for “therapeutic”
and “non-therapeutic”
research
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Other Events
The Milgram Study (published 1963)−
Deception
The Tuskegee Study (started 1932, exposed 1972, stopped
1973)−
Informed consent
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Physical harm
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Deception
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Events after Tuskegee
1974—National Research Act−
Institutional review boards
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Informed consent
1979—The Belmont Report 1981—Code of Federal Regulations
1991—Common Rule
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Federal Oversight
Office of Human Research Protections−
Structure and function of IRBs
Food and Drug Administration
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New drugs and devices
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Section B
Human Subjects Protection Program
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Objectives of Human Subjects Protections Program
Risks balanced by benefits Minimize risks of harms
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Types of Harms
Drug side effects
Adverse surgical outcomes
Physical
Injury Emotional distress Anxiety
Relapse
Psychological
Precipitation of depression
Arrest, prosecution Legal
Civil or criminal liability
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Embarrassment
Ostracism
Stigma Loss of status
Social
Retribution
Loss of job or income Loss of insurance/insurability
Reduced employability
Economic
Financial loss
Types of Harms
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Harm Reduction of Risk of Harm
Many unpleasant side effects
Frequent monitoring, long-term follow-up
Distress from questions aboutsuicide
Eliminate sensitive questionsWarn about sensitive items and ability notto answerMake counselor available
Embarrassment from questionsabout relations with co-workers Anonymous participationConfidentiality protections
Prosecution for illegal activities
Confidentiality protectionsDelete questionsCertificate of Confidentiality
Harm/Reduction of Risk of Harm
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Types of Benefits
Direct benefits—research subject gets something fromparticipation that he/she would not get otherwise
Examples—access to medical care information from a blood
test, chance to talk about an important issue, learn a new skill
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Types of Benefits
Societal benefits−
Contribution to basic scientific knowledge
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Development of new product, technique
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Information for decision-making
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Harm
Reduction of Risk
Likely DirectBenefit
Likely SocietyBenefit
Many unpleasantside effects fromstudy drugs
Frequent monitoring
Long-term follow-up
Access to a new drugtreatment
Access to medical care
Referrals for other healthproblems
Low—drug similar toexisting drugs and nobetter side effects
Moderate—moreeffective, fewer sideeffects
High—new drug Distress fromquestions aboutsuicide
Eliminate sensitive questions
Warn about sensitive items andability not to answer
Make counselor available
Chance to talk aboutproblem
Access to counseling
Embarrassmentfrom questionsabout relationswith co-workers
Anonymous participation
Confidentiality protections
Chance to talk
Prosecution forillegal activities
Confidentiality protections
Delete questions
Certificate of Confidentiality
Chance to talk
Low—questions don’tdirectly addresshypotheses
Moderate—will helpexplain importantcontributoryrelationships
High—questions directlymeasure independent ordependent variables andwill advance scientificknowledge
Harm/Reduction of Risk of Harm
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Section C
Informed Consent and Vulnerable Populations
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Informed Consent
Process−
Recruitment
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Explanation of research
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Confirmation of understanding−
Documentation of agreement
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Elements of Informed Consent
Who is doing the research Purpose
Procedures
Duration of participation
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Elements of Informed Consent
Risks or discomforts Anticipated benefits
Confidentiality protections
Assurance of voluntary participation
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Privacy and Confidentiality
Privacy—limited access to an individual and to informationabout that person
Confidentiality—how access to and use of private
information is structured
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Potential Breaches of Confidentiality
During data collection−
Knowledge of participation
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Overhearing interviews
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Access to names, identifiers Data protection during and after analysis
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Identifying information
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Paper storage−
Computer security
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Vulnerable Subjects
Ability to give informed consent−
Children—assent and parental permission
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Cognitively impaired—determination of ability to give
consent, proxies−
Comatose or unconscious patients—proxies
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l bl b
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Vulnerable Subjects
Justice (equitable distribution of risks, benefits)−
Women
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Elderly
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Racial/ethnic minorities−
Economically disadvantaged
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Terminally ill people
I i i l R i B d
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Institutional Review Board
At least five members At least one non-scientist
At least one person unaffiliated with organization
Experts in areas of research conducted by organization
T f R i
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Types of Review
Exempt—no risk −
Determination made by IRB chair
Expedited review—minimal risk
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Complete review by IRB chair or one designated member Full committee review—greater than minimal risk
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All committee members conduct review
C i i f A l
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Criteria for Approval
Risks to subjects are minimized Risks are reasonable in relation to any anticipated benefits
Selection of subjects is equitable
Informed consent will be sought Informed consent will be appropriately documented
Privacy is protected
When appropriate, safety monitoring is provided Appropriate safeguards are in place if vulnerable subjects are
involved
W i hi th S i
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Weighing the Science
A poorly designed study will not answer the researchquestion/hypotheses and is therefore unlikely to have a
benefit
A well-designed but high risk study that addresses a minor
issue is likely to have benefits of less weight than the risks
C ti i R i
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Continuing Review
At least once a year Review for . . .
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Any adverse events or problems
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Any changes in the risk/benefit balance−
Any changes in procedures
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Section D
Health Insurance Portability and Accountability (HIPAA)
HIPAA P i R l
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HIPAA Privacy Rule
Health Insurance Portability and Accountability Act of 1996 Privacy regulations effective April 14, 2003
New, specific rights to individuals about their health
information
Requires covered entities to use and disclose protected
health information only in permitted ways
P t t d H lth I f ti (PHI)
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Protected Health Information (PHI)
About an individual’s health, treatment, billing/payment forservices
About people who are alive or deceased
In any form—paper, electronic, recorded, spoken
Examples of PHI
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Examples of PHI
Patient visit for health problem treatment−
Name, address, phone number
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Diagnosis
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Department and doctor names−
Test results
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Billing data
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Any linking identifiers
Examples of PHI
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Examples of PHI
Research subject−
Name, address, etc.
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Results of tests performed as part of trial
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Questionnaire responses
Covered Entity
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Covered Entity
Providers that transmit PHI electronically Health plans
Clearinghouses that receive PHI
Examples—Johns Hopkins School of Medicine, Johns HopkinsHospital, Johns Hopkins Health Plan
JHSPH is a “hybrid entity”
PHI from a Covered Entity Can Be Used in Research When
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PHI from a Covered Entity Can Be Used in Research When . . .
Authorization is obtained from study subject or . . . A waiver is obtained from IRB or privacy board
Authorization
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Authorization
What information will be used/collected Who will use/disclose information
Why information is needed and how used
Who from outside will see information That information may not be protected if shared with others
When authorization ends
Ability to cancel permission
Waivers
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Waivers
Waiver of authorization−
Minimal risk to privacy
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Adequate protection of identifiers
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Plan to destroy identifiers
Waivers
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Waivers
Waiver of authorization−
Assurance that . . .
Research cannot be conducted without waiver AND
Research cannot be conducted without PHI Partial waiver of authorization to undertake recruitment