1. 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

2. Should the surgeon decide when it’s okay to try something new?
If not, who should?
“Meditation before surgery” by Joseph Wilder, MD

3. 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.

4. Helsinki Innovation Paradox
Practice: “If it might help, give it a try” Research: “Don’t study it without approval of a research ethics committee”
Innovation: “… in the borderland…”

5. Innovation
A new evolving intervention …
Safety and reliability
Effects and side effects
Complications
not yet known
McKneally & Daar WJS 2003

6. Distinguishing Innovation from Research
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.

7. 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?

8. Clinical equipoise:
Uncertainty in the informed medical community about which is the best test or treatment.
Benjamin Freedman

9. 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

10. 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.

11. 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

12. 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 self-regulation.
Professions and their members are accountable to those served and to society
Gruen et al. J. Am. Coll. Surg. (2003)

13. 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.

14. Bright Side of Innovation
Anesthesia
Appendectomy
Organ Transplantation
Open-Heart Surgery

15. Dark Side of Innovation
Internal Mammary Ligation
Radical Mastectomy
1968 Heart Transplant Epidemic
Living Donor Liver Transplant
Barnard’s Flamboyant and sensational ..before immunosupression had evolved sufficiently

16. 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

17. 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

18. Professional Oversight
… is your friend (colleagues, peer review, IRB, safety cmtes)
✔ GUARDRAILS
✗ STUMBLING BLOCKS

19. 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

20. “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.”

21. Toronto Innovation Approach
1. Surgeon initiates “Enabling Innovation Letter” to SIC
Expected benefits, risks and costs
Cosigned by two informed colleagues
Adds “Columbus Clause” to standard consent form

22. SIC shows letter and form to Chair of REB*
If needed, SIC consults Innovation Task Force (nursing, anesthesia, engineering, law, ethics)
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

23. 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.

24. Reitsma AM, Moreno JD. Ethical regulations for innovative surgery: the last frontier? J Am Coll Surg ;194: McKneally MF. Editorial: A Bypass for the IRB. JTCVS 2001;121(5): McKneally MF, Daar AS. Introducing New Technologies. World J Surg 2003;27: McKneally MF, Martin DM. An Entrustment Model of Consent for Surgical Treatment. JTCVS. 2000;120(2): Agich GJ. Ethics and Innovation in Medicine. J Med Ethics. 2001;27:295-6.