Research Ethics and
Research Involving Humans
Jean Ruiz, MA
Kirsten Bell, PhD
Research Ethics Analyst Research Ethics Analyst
Office of Research Ethics Office of Research Ethics
Overview
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Case Studies
Key Tensions in Research Ethics
Development of Research Ethics Codes
Human Research Ethics Guidelines in Canada
Case Study 1. HeLa
Henrietta Lacks 1920-1951
4/13/2015
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HeLa
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Standard diagnostic test reveals cervical cancer (1951)
Cancer cells are removed for research purposes without consent
George Gey created the first immortal cell line, and they were widely
shared
Creation of the cell line generated an increase in medical and
biological research, including a vaccine for polio, cancer research,
AIDS research, among others
The identity of Henrietta Lacks remained confidential until the 1970s
After her identity was known, the family found out for the first time
that Henrietta Lack’s cells were still “alive.”
The family was approached to give blood for research
The Lacks family did not have access to health care
4/13/2015
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Reflections:
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What are the ethical issues?
•Consent
•Individual benefit versus societal benefit
•Confidentiality
•Commercialization
Case Study 2. Nuu-chah-nulth Nation Blood
Samples (1983-1985)
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UBC medical genetics researcher Dr.
Richard Ward
883 subjects provided blood
samples for arthritis study
Samples were used without consent
for genetic analysis
Results suggested that the
territorial origin was contrary to the
group’s own understanding
Blood and documents returned to
UBC in 2004
Reflections:
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What are the ethical issues?
• Research deviation – Researcher does something
different than what was consented to
• Erodes trust and creates a general distrust of
research
• Psychological repercussions - disruption of group
values
4/13/2015
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Case Study 3. HIV/AIDS in Rakai, Uganda
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Goal of study to understand risk factors connected with
heterosexual HIV transmission
Identified 415 couples in which one partner was HIV+ and
other not
Followed them prospectively for 30 months
90 of HIV- partners seroconverted over period of study
No treatment offered for HIV+ participants (e.g. ARV) or
co-morbid STDs
It was left up to HIV+ partner to determine whether their
status was disclosed to their partner
Reflections:
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What are the ethical issues?
• Differing standard of care – study couldn’t have
been conducted in North America
• HIV status – different disclosure laws
• Exploitation – taking advantage of differing social,
political & economic conditions?
Key tensions in research ethics
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Balancing scientific concerns with research ethics
• Most scientifically valid approach isn’t always most
ethical
Individual rights vs. public benefit
Inclusion vs. exploitation
International settings
• Should ethics guidelines apply universally?
New technologies (e.g. genomics, internet)
• Are challenging prevailing norms around research
ethics
Emergence of Research Ethics Codes
Nuremberg Code (1947)
Specific to medical
experiments
 Emerged from Nazi war crimes
trial
 Revelations about
experiments conducted on
prisoners in concentration
camps
 Such research could only take
place in context where broader
human rights were
systematically abrogated
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Key Principles
Voluntary consent
2. For good of society
3. Animal experiments 1st; human experiments 2nd
4. Avoid unnecessary suffering
5. Do not conduct if death & debility likely
6. Risk commensurate with benefits
7. Protect subjects against even remote possibility of harm
8. Conducted only by qualified persons
9. Subjects should be at liberty to discontinue experiment
10. Terminate if becomes apparent that death or debility will
occur
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Belmont Report (1979)
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Created in wake of outcry
over Tuskegee Syphilis
study (1932-1972)
US Department of Public
Health funded study to
document natural history
of syphilis
Followed 399 black share
croppers in Alabama with
syphilis
Key Principles
Principle
Respect for persons
Beneficence
Justice
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Application
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Informed consent
Assessment of risks/benefits
Fair selection of subjects
Notable in that research ethics guidelines were
expanded to cover all research
Canadian Research Ethics Guidelines
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Tri Council Policy Statement: Ethical Conduct for Research
Involving Humans (TCPS 2)
Overarching Canadian policy framework for research
involving human participants
1st TCPS came out in 1998
Revised version released in December 2010
Three Core Principles: Respect for Persons, Concerns for
Welfare, and Justice
Principle 1. Respect for Persons
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Respecting autonomy
• Recognizing persons involved in research as participants
• Not exercised in isolation but is influenced by a person’s
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connections
Free and Informed consent
Accountability and transparency
Protecting those with developing/diminished autonomy
• Youth, cognitive impairment, other mental health issues or
illness
Principle 2. Concern for Welfare
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Consideration of the impact on physical, mental, and
spiritual health, as well as participants’ physical,
economic and social circumstances
Privacy and control of information
Consider risks & potential benefits of research
Welfare of group
Principle 3. Justice
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Obligation to treat people fairly & equitably
Equal access to benefits/equal share of burdens
Avoid underprotection & overprotection
KEY RESOURCES
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Tri Council Policy Statement: Ethical Conduct for Research Involving
Humanshttp://www.pre.ethics.gc.ca/eng/policypolitique/initiatives/tcps2-eptc2/Default/
Emmanuel, Wendler & Grady (2000) What makes clinical research
ethical, JAMA, 283: 2701-2711.
Course in Human Research Participant Protection
http://www.chrpp.ca
Network of Networks: Online Good Clinical Practice (GCP) Training
http://www.citiprogram.org
The Lab: Avoiding Research Misconduct http://ori.hhs.gov/TheLab/
CONTACT DETAILS
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Jean Ruiz
• Ph: 604 827 5310
• Email: jean.ruiz@ors.ubc.ca
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Kirsten Bell
• Ph: 604 827 5310
• Email: kirsten.bell@ors.ubc.ca
• Generally available on Wednesdays