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Research Involving Human Subjects: Ethics, Law and Regulation December 2002 William Beaumont & Alexis St. Martin Beaumont carried out a series of experiments on Alexis St. Martin over a period of many years Was Beaumont a pioneer in ethical research or someone who abused his research subject?
A. what is research?
B. rationale for research ethics review
C. ethical/legal/regulatory framework for human subject research in Canada
D. some major ethical/legal issues in biomedical research
- RCT’s ethically acceptable where expert community in state of honest professional disagreement as to relative merits of two alternatives
- biomedical research governed by law that is primarily directed to other purposes
- some legislation applies almost inadvertently to research
- other legislation re health care deliberately excludes research from its ambit
- role of the common law- consent, negligence, etc.
- Quebec - Civil Code
- Advance Health Care Directives Act
- Access to Information and Protection of Privacy Act
- Hospitals Act
- Human Tissue Act
1. conflicts of interest
2. consent - informed, voluntary
3. confidentiality, access to information
4. scope of acceptable research
5. children, mentally incompetent individuals
6. justice in recruitment of subjects
- fame, publishable results, medical breakthroughs to benefit society
- pharmaceutical companies
- partnerships between academic institutions and corporations
- commercial value of research results
- financial conflicts
- impact of conflicts on informed consent
- membership, operation within institution
- collegiality, concerns about promotion, bringing valuable research funding into institution, etc.
- must be given by person legally capable of making decision
- no coercion/undue influence
- to procedure(s), physician(s) involved
- disclosure/discussion required
1. consent to research with no intended benefit for participants
2. consent to research with intended benefit with participants
Halushka v. U. of Saskatchewan (Sask. C.A. 1965)
- healthy university student paid $50 to participate in anesthetic drug trial, requiring cardiac catheterization
- told test was “nothing to worry about”
- suffered cardiac arrest, residual injuries
Court held: duty of disclosure of investigators at least as great as, if not greater than, duty of ordinary physician/surgeon to patient
- full and frank disclosure
- no “therapeutic privilege”, no waiver
Weiss v. Solomon (Que. Sup. Ct. 1989)
- trial of ophthalmic drops in reducing post-op retinal edema
- fluorescein angiography used to verify effects of drops
- told risks: discomfort, nausea and minor allergic reactions
- patient died from severe allergic reaction
Court held: investigator and REB at fault for failure to warn of all the risks involved in the research
- all risks must be disclosed, even if rare/remote, particularly if serious consequences
- court based decision in part on Helsinki Declaration
- access to data for safety and ethics monitoring
-Health Protection Branch, Health Canada
- periodic review by REB’s
- genetic research
- right to know/right not to know?
- duty/right to inform relatives of their risks?