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
Feb 01, 2016
Research Ethics andResearch Involving Humans
Jean Ruiz, MA Kirsten Bell, PhDResearch Ethics Analyst Research Ethics AnalystOffice of Research Ethics Office of Research Ethics
Overview
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
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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
Reflections:
What are the ethical issues?•Consent•Individual benefit versus societal benefit•Confidentiality•Commercialization
Case Study 2. Nuu-chah-nulth Nation Blood Samples (1983-1985)
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:
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
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Case Study 3. HIV/AIDS in Rakai, Uganda 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:
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 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
Key Principles
1. Voluntary consent 2. For good of society 3. Animal experiments 1st; human experiments 2nd
4. Avoid unnecessary suffering5. Do not conduct if death & debility likely6. Risk commensurate with benefits7. Protect subjects against even remote possibility of harm8. Conducted only by qualified persons9. Subjects should be at liberty to discontinue experiment10. Terminate if becomes apparent that death or debility will
occur
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
Belmont Report (1979)
Key Principles
Principle
1. Respect for persons 2. Beneficence3. Justice
Application
1. Informed consent2. Assessment of risks/benefits3. Fair selection of subjects
Notable in that research ethics guidelines were expanded to cover all research
Canadian Research Ethics Guidelines 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 Respecting autonomy
• Recognizing persons involved in research as participants • Not exercised in isolation but is influenced by a person’s
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 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 Obligation to treat people fairly & equitably Equal access to benefits/equal share of burdens Avoid underprotection & overprotection
KEY RESOURCES Tri Council Policy Statement: Ethical Conduct for Research Involving
Humanshttp://www.pre.ethics.gc.ca/eng/policy-politique/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
Jean Ruiz •Ph: 604 827 5310•Email: [email protected]
Kirsten Bell•Ph: 604 827 5310 •Email: [email protected]•Generally available on Wednesdays