Research Ethics and Research Involving Humans

1. Research Ethics andResearch Involving Humans Jean Ruiz, MA Kirsten Bell, PhD Research Ethics Analyst Research Ethics Analyst Office of Research Ethics Office of Research Ethics

2. Overview • Case Studies • Key Tensions in Research Ethics • Development of Research Ethics Codes • Human Research Ethics Guidelines in Canada

3. Case Study 1. HeLa Henrietta Lacks 1920-1951 Footer Text

4. HeLa • 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 Footer Text

5. Reflections: • What are the ethical issues? • Consent • Individual benefit versus societal benefit • Confidentiality • Commercialization

6. 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

7. 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 Footer Text

8. 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

9. 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?

10. 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

11. Emergence of Research Ethics Codes

12. 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

13. Key Principles • Voluntary consent • For good of society • Animal experiments 1st; human experiments 2nd • Avoid unnecessary suffering • Do not conduct if death & debility likely • Risk commensurate with benefits • Protect subjects against even remote possibility of harm • Conducted only by qualified persons • Subjects should be at liberty to discontinue experiment • Terminate if becomes apparent that death or debility will occur

14. Belmont Report (1979) • 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

15. Key Principles Principle Application Informed consent Assessment of risks/benefits Fair selection of subjects • Respect for persons • Beneficence • Justice • Notable in that research ethics guidelines were expanded to cover all research

16. 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

17. 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

18. 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

19. Principle 3. Justice • Obligation to treat people fairly & equitably • Equal access to benefits/equal share of burdens • Avoid underprotection & overprotection

20. 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/

21. 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