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 AssociationDeclaration 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.

Practice: “If it might help, give it a try”

Research: “Don’t study it without approval of a research ethics committee”

Helsinki Innovation Paradox

Innovation: “… in the borderland…”

A new evolving intervention … Safety and reliability Effects and side effectsComplications

not yet known

McKneally & Daar WJS 2003

Innovation

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

Medicine, Law, Theology, Teaching

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 & ChildressPrinciples of Biomedical Ethics 1994, p.7

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

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;194:792-801.

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.