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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 ma...
Beaumont (1785-1853)
Had a 2 year apprenticeship with a country doctor
Enlisted as a surgeon’s mate in 1812. Briefly left ...
St. Martin (1803?-1880)
June 6, 1822 – St. Martin, a French-Canadian working for
the American Fur Company, was accidentall...
The Experiments
First experiment in May, 1823?
– Administering a cathartic by pouring it in
Literally hundreds between 182...
The Relationship
1825 – Beaumont carried out experiments from May-
August then St. Martin “returned to Canada … without
ob...
The Relationship
1832 – In October, St. Martin returns.
– The two sign a contract binding St. Martin to “obey,
suffer & co...
The Relationship
1833 – A new contract is signed, for 2 years
at $200 a year
Shortly afterward, Beaumont advances St. Mart...
Beaumont as Medical Ethics
Pioneer?
Beecher (1970) credits Beaumont with producing the
“oldest American code” concerning h...
Some Issues
When did Beaumont take St. Martin into his home?
– Beaumont tells us it was before he began using St. Martin a...
Outline
A. what is research?
B. rationale for research ethics review
C. ethical/legal/regulatory framework
for human subje...
What is Research?
sometimes difficult to distinguish research
from therapy:
– often carried out simultaneously
– investiga...
Research and/or Therapy?
Why is the distinction important?
– determines whether particular set of regulations
or research ...
What is Human Subject
Research?
“the generation of data about persons,
through intervention or otherwise, that goes
beyond...
Rationale For Research Ethics
Review
part of crucial system of checks and
balances
safeguard rights and well-being of rese...
Rationale For Research Ethics
Review
inherent tension between primary aims of
research and treatment
when patients partici...
Research Codes and Guidelines
primary purpose - to protect the physical
well-being, dignity and integrity of
individuals w...
Historical Context
will be covered in future session
several instances of research controversies
and atrocities in many di...
Governance of Human Subject
Research in Canada
in Canada, no comprehensive legislation to
regulate all research involving ...
Newfoundland Legislation
some statutes in NF containing provisions
applicable to research:
- Advance Health Care Directive...
Codes, Guidelines and Policies
these “extra-legal instruments” play important role
in regulation of research in Canada
pro...
Tri-Council Policy Statement on the Ethical
Conduct of Research Involving Human
Subjects (1998)
MRC, NSERC, SSHRC
context ...
CMA Code of Ethics
duty of physicians to obtain from research
ethics committee review and approval of
research involving h...
Some Major Ethical/Legal Issues
in Medical Research
1. conflicts of interest
2. consent - informed, voluntary
3. confident...
Conflicts of Interest
investigator’s interests
- fame, publishable results, medical breakthroughs to benefit
society
finan...
Conflicts of Interest and REB’s
one role of REB’s is conflict of interest
oversight:
- financial conflicts
- impact of con...
Consent - General Principles
capacity
- must be given by person legally capable of making decision
voluntary
- no coercion...
Consent to Research
in the Courts
two categories of research dealt with
differently by the courts:
1. consent to research ...
Research with no Intended
Benefit for Participants
Halushka v. U. of Saskatchewan (Sask. C.A. 1965)
- healthy university s...
Research with no Intended
Benefit for Participants
Weiss v. Solomon (Que. Sup. Ct. 1989)
- trial of ophthalmic drops in re...
Research with Intended Benefit
for Participants
no Canadian cases involving research pursuant to
protocol reviewed for eth...
Confidentiality
general obligation of confidentiality owed
by physicians to patients extends to
researchers
embodied in re...
Confidentiality
tension between need to share data and
privacy of subjects
beware of over-promising confidentiality:
- acc...
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Gastroenterology - Research Ethics I

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Transcript of "Gastroenterology - Research Ethics I"

  1. 1. Research Involving Human Subjects: Ethics, Law and Regulation December 2002
  2. 2. 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? – Be careful of applying present-day standards to historical figures – The prime value of this case lies in what it tells us about how to do things today, not whether Beaumont was a good or bad man
  3. 3. Beaumont (1785-1853) Had a 2 year apprenticeship with a country doctor Enlisted as a surgeon’s mate in 1812. Briefly left the army after the War of 1812, but rejoined as a surgeon in 1820 1822 – Encounters St. Martin 1833 – Experiments and Observations on the Gastric Juices and the Physiology of Digestion – “produced a picture of the living stomach that has required only a little updating in the century and a half since he made his observations.”
  4. 4. St. Martin (1803?-1880) June 6, 1822 – St. Martin, a French-Canadian working for the American Fur Company, was accidentally shot in Northern Michigan The result was a fistula exposing part of St. Martin’s lung and stomach St. Martin survived, but the fistula never closed fully After 8-10 months of attempts to close it, Beaumont concluded that the only means of doing so was to suture the sides together, “an operation to which the patient would not submit.”
  5. 5. The Experiments First experiment in May, 1823? – Administering a cathartic by pouring it in Literally hundreds between 1825 and 1833, most involving inserting or removing material through the ‘valve’ in St. Martin’s stomach
  6. 6. The Relationship 1825 – Beaumont carried out experiments from May- August then St. Martin “returned to Canada … without obtaining my consent.” (18) – In correspondence, Beaumont described this as a “faithless absconding”. 1829 – St. Martin enters Beaumont’s “service” in August – St. Martin “performed all the duties of a common servant” when experiments were not being carried out. (19) – This continues until March, 1831, when Beaumont allows St. Martin to return home.
  7. 7. The Relationship 1832 – In October, St. Martin returns. – The two sign a contract binding St. Martin to “obey, suffer & comply with all reasonable & proper orders or experiments.” – In exchange, St. Martin was to receive $150 plus room and board. – In 1832, St. Martin was persuaded to join the U.S. Army for a period of 5 years. He was eventually assigned to Beaumont as an assistant
  8. 8. The Relationship 1833 – A new contract is signed, for 2 years at $200 a year Shortly afterward, Beaumont advances St. Martin some of the $200 in order for St. Martin to return his family to Canada. St. Martin never returned, although Beaumont made increasingly lucrative offers ($500/year in 1850, shortly before Beaumont’s death)
  9. 9. Beaumont as Medical Ethics Pioneer? Beecher (1970) credits Beaumont with producing the “oldest American code” concerning human experimentation: – “5. The voluntary consent of the subject is necessary… – “6. The experiment is to be discontinued when it causes distress to the subject… – 7. The project must be abandoned when the subject becomes dissatisfied.” There is, however, some dispute about whether this code actually existed. (Numbers, 1979)
  10. 10. Some Issues When did Beaumont take St. Martin into his home? – Beaumont tells us it was before he began using St. Martin as a research subject. Others (Numbers, 1979) say it was after. Returning to Canada “without my permission”? Some experiments clearly caused St. Martin discomfort Payment for participation in research
  11. 11. Outline 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
  12. 12. What is Research? sometimes difficult to distinguish research from therapy: – often carried out simultaneously – investigators often physicians – terminology - “therapeutic research”, “clinical research”, “experimental interventions” – research vs. “innovative care”
  13. 13. Research and/or Therapy? Why is the distinction important? – determines whether particular set of regulations or research ethics guidelines must be followed – determines whether prior approval by a Research Ethics Board (REB) is required – affects the legal standard for disclosure of information – may affect ability of substitute decision-maker to give consent
  14. 14. What is Human Subject Research? “the generation of data about persons, through intervention or otherwise, that goes beyond that necessary for the person’s immediate well-being” 1987 MRC Guidelines an activity that involves “a systematic investigation to establish facts, principles or generalizable knowledge” 1998 Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans
  15. 15. Rationale For Research Ethics Review part of crucial system of checks and balances safeguard rights and well-being of research subjects address actual, perceived, potential conflicts of interest reinforce and rehabilitate public trust in medical research
  16. 16. Rationale For Research Ethics Review inherent tension between primary aims of research and treatment when patients participate in clinical research, physician-investigator may experience this tension notion of “clinical equipoise”: - RCT’s ethically acceptable where expert community in state of honest professional disagreement as to relative merits of two alternatives
  17. 17. Research Codes and Guidelines primary purpose - to protect the physical well-being, dignity and integrity of individuals who serve as participants interests of investigators in pursuing their professions interests of society in increasing knowledge re public and individual health
  18. 18. Historical Context will be covered in future session several instances of research controversies and atrocities in many different countries a number of international instruments have been developed to try to address ethical standards and regulation of human subject research
  19. 19. Governance of Human Subject Research in Canada in Canada, no comprehensive legislation to regulate all research involving humans - 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
  20. 20. Newfoundland Legislation some statutes in NF containing provisions applicable to research: - Advance Health Care Directives Act - Access to Information and Protection of Privacy Act - Hospitals Act - Human Tissue Act
  21. 21. Codes, Guidelines and Policies these “extra-legal instruments” play important role in regulation of research in Canada promulgated by governmental bodies, funding agencies, professional organizations and local institutions ethics codes, guidelines and policy statements usually lack means of direct legal enforcement however may be relied on by courts to indicate applicable standards of conduct
  22. 22. Tri-Council Policy Statement on the Ethical Conduct of Research Involving Human Subjects (1998) MRC, NSERC, SSHRC context - the need for research, guiding ethical principles, “subject-centered perspective” research requiring ethics review, REB’s consent, confidentiality, conflict of interest inclusion in research - women, incompetent individuals, aboriginal people clinical trials human genetic research, research on embryos/fetuses and human tissues
  23. 23. CMA Code of Ethics duty of physicians to obtain from research ethics committee review and approval of research involving humans duty of physicians to obtain informed consent from potential research subjects duty to report unethical research behaviour
  24. 24. Some Major Ethical/Legal Issues in Medical Research 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
  25. 25. Conflicts of Interest investigator’s interests - fame, publishable results, medical breakthroughs to benefit society financial conflicts of interest - pharmaceutical companies - partnerships between academic institutions and corporations - commercial value of research results
  26. 26. Conflicts of Interest and REB’s one role of REB’s is conflict of interest oversight: - financial conflicts - impact of conflicts on informed consent conflicts of interest involving the REB: - membership, operation within institution - collegiality, concerns about promotion, bringing valuable research funding into institution, etc.
  27. 27. Consent - General Principles capacity - must be given by person legally capable of making decision voluntary - no coercion/undue influence specific - to procedure(s), physician(s) involved informed - disclosure/discussion required
  28. 28. Consent to Research in the Courts two categories of research dealt with differently by the courts: 1. consent to research with no intended benefit for participants 2. consent to research with intended benefit with participants
  29. 29. Research with no Intended Benefit for 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
  30. 30. Research with no Intended Benefit for Participants 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
  31. 31. Research with Intended Benefit for Participants no Canadian cases involving research pursuant to protocol reviewed for ethical/scientific merit cases involving individual MDs testing therapeutic innovations of their own design in course of Dr.- pt. relationship courts have applied standard of disclosure generally applied to Dr.-pt. relationship - “What would reasonable pt. want to know? fact that procedure “unique” or “experimental” something most people would want to know
  32. 32. Confidentiality general obligation of confidentiality owed by physicians to patients extends to researchers embodied in research codes, guidelines REB’s typically require policies re storage and destruction of data and samples, anonymization of data should also be addressed in consent forms
  33. 33. Confidentiality tension between need to share data and privacy of subjects beware of over-promising confidentiality: - 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?
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