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Ethics in Health Services Research
Ann Skinner, MSW
Johns Hopkins University
Section A
Overview
Belmont Report Principles
Respect for persons
Individuals should be treated as autonomous agents
People with diminished autonomy are entitled to
protection
Belmont Report Principles
Beneficence
Do no harm
Maximize possible benefits and minimize possible harms
Justice
The benefits of the research should accrue to those who
bear the burden of participation
Impetus for the Belmont Report
Medical experiments conducted by Nazi physicians in the
1930s and early 1940s
Lack of autonomy
Inhumane treatment
Research findings intended for others
Nuremberg Code
Nuremberg Code, 1947
Informed consent without coercion
Human experiments based on animal research
Expected results should justify the research
Nuremberg Code, 1947
Scientists must be qualified
Physical/mental suffering avoided
No expectation of disability or death from the research
Declaration of Helsinki
Declaration of Helsinki (drafted 1953, adopted 1964)
Ethical principles for therapeutic and non-therapeutic
research
Other Events
The Milgram Study (published 1963)
Deception
The Tuskegee Study (started 1932, exposed 1972, stopped
1973)
Informed consent
Physical harm
Deception
Events after Tuskegee
1974National Research Act
Institutional review boards
Informed consent
1979The Belmont Report
1981Code of Federal Regulations
1991Common Rule
10
Federal Oversight
Office of Human Research Protections
Structure and function of IRBs
Food and Drug Administration
New drugs and devices
11
Section B
Human Subjects Protection Program
Objectives of Human Subjects Protections Program
Risks balanced by benefits
Minimize risks of harms
13
Types of Harms
Physical
Psychological
Legal
Drug side effects
Adverse surgical outcomes
Injury
Emotional distress
Anxiety
Relapse
Precipitation of depression
Arrest, prosecution
Civil or criminal liability
14
Types of Harms
Social
Economic
Embarrassment
Ostracism
Stigma
Loss of status
Retribution
Loss of job or income
Loss of insurance/insurability
Reduced employability
Financial loss
15
Harm/Reduction of Risk of Harm
Harm
Many unpleasant side effects
Distress from questions about
suicide
Reduction of Risk of Harm
Frequent monitoring, long-term follow-up
Eliminate sensitive questions
Warn about sensitive items and ability not
to answer
Make counselor available
Embarrassment from questions Anonymous participation
about relations with co-workers Confidentiality protections
Prosecution for illegal activities Confidentiality protections
Delete questions
Certificate of Confidentiality
16
Types of Benefits
Direct benefitsresearch subject gets something from
participation that he/she would not get otherwise
Examplesaccess to medical care information from a blood
test, chance to talk about an important issue, learn a new skill
17
Types of Benefits
Societal benefits
Contribution to basic scientific knowledge
Development of new product, technique
Information for decision-making
18
Harm/Reduction of Risk of Harm
Harm
Many unpleasant
side effects from
study drugs
Reduction of Risk
Frequent monitoring
Likely Direct
Benefit
Access to a new drug
treatment
Long-term follow-up
Likely Society
Benefit
Lowdrug similar to
existing drugs and no
better side effects
Access to medical care
Referrals for other health
problems
Distress from
questions about
suicide
Embarrassment
from questions
about relations
with co-workers
Prosecution for
illegal activities
Eliminate sensitive questions
Chance to talk about
problem
Warn about sensitive items and
Access to counseling
ability not to answer
Make counselor available
Anonymous participation
Chance to talk
Moderatemore
effective, fewer side
effects
Highnew drug
Lowquestions dont
directly address
hypotheses
Moderatewill help
explain important
contributory
relationships
Confidentiality protections
Confidentiality protections
Delete questions
Chance to talk
Highquestions directly
measure independent or
dependent variables and
will advance scientific
knowledge
Certificate of Confidentiality
19
Section C
Informed Consent and Vulnerable Populations
Informed Consent
Process
Recruitment
Explanation of research
Confirmation of understanding
Documentation of agreement
21
Elements of Informed Consent
Who is doing the research
Purpose
Procedures
Duration of participation
22
Elements of Informed Consent
Risks or discomforts
Anticipated benefits
Confidentiality protections
Assurance of voluntary participation
23
Privacy and Confidentiality
Privacylimited access to an individual and to information
about that person
Confidentialityhow access to and use of private
information is structured
24
Potential Breaches of Confidentiality
During data collection
Knowledge of participation
Overhearing interviews
Access to names, identifiers
Data protection during and after analysis
Identifying information
Paper storage
Computer security
25
Vulnerable Subjects
Ability to give informed consent
Childrenassent and parental permission
Cognitively impaireddetermination of ability to give
consent, proxies
Comatose or unconscious patientsproxies
26
Vulnerable Subjects
Voluntary consent/absence of coercion
Prisoners
Students
Employees
Heightened risk
Pregnant women
Sick people
27
Vulnerable Subjects
Justice (equitable distribution of risks, benefits)
Women
Elderly
Racial/ethnic minorities
Economically disadvantaged
Terminally ill people
28
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
29
Types of Review
Exemptno risk
Determination made by IRB chair
Expedited reviewminimal risk
Complete review by IRB chair or one designated member
Full committee reviewgreater than minimal risk
All committee members conduct review
30
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
31
Weighing the Science
A poorly designed study will not answer the research
question/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
32
Continuing Review
At least once a year
Review for . . .
Any adverse events or problems
Any changes in the risk/benefit balance
Any changes in procedures
33
Section D
Health Insurance Portability and Accountability (HIPAA)
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
35
Protected Health Information (PHI)
About an individuals health, treatment, billing/payment for
services
About people who are alive or deceased
In any formpaper, electronic, recorded, spoken
36
Examples of PHI
Patient visit for health problem treatment
Name, address, phone number
Diagnosis
Department and doctor names
Test results
Billing data
Any linking identifiers
37
Examples of PHI
Research subject
Name, address, etc.
Results of tests performed as part of trial
Questionnaire responses
38
Covered Entity
Providers that transmit PHI electronically
Health plans
Clearinghouses that receive PHI
ExamplesJohns Hopkins School of Medicine, Johns Hopkins
Hospital, Johns Hopkins Health Plan
JHSPH is a hybrid entity
39
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
40
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
41
Waivers
Waiver of authorization
Minimal risk to privacy
Adequate protection of identifiers
Plan to destroy identifiers
42
Waivers
Waiver of authorization
Assurance that . . .
X Research cannot be conducted without waiver AND
X Research cannot be conducted without PHI
Partial waiver of authorization to undertake recruitment
43
