Transcript Ethical Issues

How is innovation different
from research?
Paul W.M. Fedak, MD PhD FRCSC
Associate Professor, University of Calgary
Section of Cardiac Surgery, Department of Cardiac Science,
Libin Cardiovascular Institute of Alberta
Should the surgeon
decide when it’s
okay to try
something new?
If not, who should?
“Meditation before surgery” by Joseph Wilder, MD
World Medical Association
Declaration of Helsinki
Where proven methods do not exist or have
been ineffective, the physician, with informed
consent from the patient, must be free to use
unproven or new measures, if (they) offer
hope of saving life, re-establishing health or
alleviating suffering.
Helsinki Innovation Paradox
Practice: “If it might help, give it a try”
Innovation: “… in the borderland…”
Research: “Don’t study it without approval
of a research ethics committee”
Innovation
A new evolving intervention …
Safety and reliability
Effects and side effects
Complications
not yet known
McKneally & Daar WJS 2003
Distinguishing Innovation from Research
Innovation
• modify accepted procedures in incremental steps
• change accepted practice based on observation /
reasoning
Research
• systematic investigation to yield generalizable data
• test a hypothesis
“Family resemblance” based on experimental nature.
An experiment is not necessarily research.
Surgical Research Issues
• Is it morally acceptable for physicians to use
patients from their practice as subjects in
research?
• Is it morally acceptable to enter your patients
in a randomized trial when you strongly
believe that one treatment is superior to the
other?
Clinical equipoise:
Uncertainty in the informed medical
community about which is the best
test or treatment.
Benjamin Freedman
Scientific Experiment:
A procedure tentatively adopted
without certainty that it will
achieve its purpose.
Experimental: tentative,
provisional… based on (often
incomplete) experiment
Canadian Oxford Dictionary 1998
Quality Improvement
• Surgeons have a moral obligation
to improve the quality and
outcomes of their interventions.
• Studying the quality and
outcomes of treatment is not
identical with formal research.
Learned & Helping Professions
Professions maintain self-regulating organizations
that control entry by certifying that candidates have
necessary knowledge and skills that patients
[clients, parishioners, students, etc.] lack, and that
morally must be used to benefit society.
Beauchamps & Childress
Principles of Biomedical Ethics 1994, p.7
Medicine, Law, Theology, Teaching
Professionalism in Surgery
• Members are governed by codes of ethics and
profess a commitment to competence, integrity and
morality, altruism and to the promotion of the public
good within their domain.
• These commitments form the basis of a social
contract between a profession and society which, in
turn, grants the profession a monopoly over the use
of its knowledge base, the right to considerable
autonomy in practice and the privilege of selfregulation.
• Professions and their members are accountable to
those served and to society
Gruen et al. J. Am. Coll. Surg. (2003) 197 605-608.
Premises
• Surgeons have an obligation to set
standards and improve the quality of
clinical practice.
• Research Ethics Boards (REB) are not
responsible for protecting subjects of
clinical practice.
Bright Side of Innovation
• Anesthesia
• Appendectomy
• Organ Transplantation
• Open-Heart Surgery
Dark Side of Innovation
• Internal Mammary Ligation
• Radical Mastectomy
• 1968 Heart Transplant Epidemic
• Living Donor Liver Transplant
Surgical Innovation
• An “innovative” new procedure is really a
“non-validated” procedure
• Innovation can also be simply a change in
current surgical practices
• As a surgeon, you have a MORAL
OBLIGATION to continually improve the
quality of your procedures and the outcomes
of your patients
The Process of Innovation
• We have a similar duty and obligation to
VALIDATE our “innovative” procedures
• Validation is not research but involves:
– professional committee oversight
– adequate follow-up of outcomes (risks / benefits)
– reporting of outcomes to the overseers
Professional Oversight
… is your friend (colleagues, peer review, IRB, safety cmtes)
✔
GUARDRAILS
✗ STUMBLING BLOCKS
When Should Innovation
Require Additional Oversight ?
– Procedure carries significant increase in
risk above alternative approaches
– Procedure is so novel that risks and
benefits are unknown
– Procedure affects the allocation of
resources
Kornetsky & McKneally
“Columbus Clause”
“I understand that this
treatment is new to this
hospital. I will be one of
the first [#] patients to
receive it here. I have
been offered the standard
treatment. My doctors and
nurses are working to find
the best way to perform the
new treatment and learn
which patients will benefit
most from it.”
Toronto Innovation Approach
1. Surgeon initiates “Enabling Innovation Letter”
to SIC
• Expected benefits, risks and costs
• Cosigned by two informed colleagues
2. Adds “Columbus Clause” to standard consent
form
3. If needed, SIC consults Innovation Task Force
(nursing, anesthesia, engineering, law, ethics)
4. SIC shows letter and form to Chair of REB*
–
who accepts, or advises review
5. Innovator reports outcome in first [#] patients to SIC
–
–
Help from hospital data managers
Cost estimates from OR manager
6. SIC reviews projects annually with REB chair*
7. Formal research initiated when appropriate
Ethics Bottom Line
• Innovation is not research.
• Surgeons should innovate to improve practice.
• Innovation should have appropriate
professional oversight.
• Professional oversight serves as a guardrail to
protect both patients and surgeons.
• The Toronto policy provides a reasonable
framework for others to follow.
Reitsma AM, Moreno JD. Ethical regulations for innovative
surgery: the last frontier? J Am Coll Surg. 2002;194:792801.
McKneally MF. Editorial: A Bypass for the IRB. JTCVS
2001;121(5):837-839.
McKneally MF, Daar AS. Introducing New Technologies.
World J Surg 2003;27:930-935.
McKneally MF, Martin DM. An Entrustment Model of
Consent for Surgical Treatment. JTCVS. 2000;120(2):2649.
Agich GJ. Ethics and Innovation in Medicine. J Med
Ethics. 2001;27:295-6.