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” Research: “Don’t study it without approval of a research ethics committee” Innovation: “… in the borderland…”

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

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.

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 self-regulation. 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 Barnard’s Flamboyant and sensational ..before immunosupression had evolved sufficiently

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 Adds “Columbus Clause” to standard consent form

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

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;194:792-801. 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):264-9. Agich GJ. Ethics and Innovation in Medicine. J Med Ethics. 2001;27:295-6.