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: jean.ruiz@ors.ubc.ca

Kirsten Bell•Ph: 604 827 5310 •Email: kirsten.bell@ors.ubc.ca•Generally available on Wednesdays