when is it okay to try something new on grandmother?

When is it okay to try something new on Grandmother?

Surgical Ethics: Innovation and Research

Martin McKneallyUniversity of Toronto

Department of Surgery Joint Centre for Bioethics

Principles of SurgerySept 6, 2011

on someone’s mother?

When is it okay to try something new?

on someone’s child?

PURPOSE

Clarify our thinking about innovation and research

Share experience with an approach to innovation developed in Boston and Toronto

Research Ethics CaseDr. Edge is studying the Zeus robotic system for

minimally invasive cardiac surgery. It minimizes the need for residents to hold the heart, position the telescope, apply suction, or irrigate the field.

He will report his experience at the upcoming AATS meeting. He needs 6 more patients to round out his series to 100 cases. The safety committee has asked for increased surveillance because of concerns about side effects: 4 aortic dissections, 2 strokes, 2 ischemic limbs, 1 amputation.

Grandmother wants a minimally invasive CABG. She does not quite fit eligibility criteria – at 72 she is 2 years over the protocol age limit. She wants to wait a few weeks before the surgery.

You are a Resident on the Research Ethics Board. What advice would you give Dr Edge?

Questions

1. Should Grandmother be entered into the study if she is willing to have the surgery now?

2. Can we use a patient’s consent to treatment to enter her into a study?

Why not use a patient’s consent to treatment to enter her into a study?

• “Tyranny of the protocol”mandated techniquesrequired follow-up tests

• Conflicting intereststhe investigatorthe sponsorthe institution

• Confidentiality may be breached through data collection & storage

World Medical AssociationDeclaration of Helsinki

• The well-being of the subject should take precedence over the interests of science.

• Each experimental procedure should be formulated in a protocol.

• Consent should be fully informed about the experiment.

• Subjects have a right to withdraw.

http://www.wma.net/e/policy/b3.htm

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…”

Questions

3. Is it morally acceptable for physicians to use patients from their practice as subjects in research?

4. 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

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.

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.

A new evolving intervention Safety and reliability Effects and side effectsComplications

not yet known

McKneally & Daar WJS 2003

Innovation

Innovation Case

Dr. Keshavjee has a donor lung that proves to be too large for the thorax of the recipient. He considers performing a volume reduction operation on the recipient’s contralateral residual lung to make room for the transplant.

This has never been done before. You are the resident. Is this innovation ethically justified?

If it works, should this be adopted as standard treatment?

The Bright Side of Innovation

Anesthesia

Appendectomy

Transplantation

Heart surgery

The Dark Side of Innovation

Internal Mammary Ligation

Radical Mastectomy

1968 Heart Transplant Epidemic

Living Donor Liver Transplant

The Expensive Side $1.2 M

Should the surgeon decide when it’s

okay to try something new?

“Meditation before surgery”

by Joseph Wilder, MD

Surgical Peers and Trainees

Shouldn’t there be some oversight?

OR Community Oversight

Surgical Oversight Paradigm• OR community oversight

• Operating schedule published*

• M & M conferences

• Audit and quality improvement reports

• Professional and public reporting

• SIC responsible to public

• Credentialing and privileging processes

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

Heung Kim’s STEP

How We Do It at UHN & HSC

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*

“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.”

The Columbus Clause

I told them I wouldn’t sail off the edge!

How We Do It at UHN & HSC

3. If needed, SIC consults Innovation Task Force (nursing, anesthesia, engineering, ethics)

4. SIC shows letter and form to Chair of REB who accepts, or advises full 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

Toronto Examples: UHN - HSC

• Phototherapy of esophageal cancer

• Retinal vein decompression

• Laparoscopic prostatectomy

• Minimal access pediatric surgery– Pectus repair– Hirschprung’s disease

Some Patients are Heroes

Some Rely Only on Trust

“Professor Barnard, I want to go through with it now more than ever - not only for my sake but for you and your team…” Philip Blaiberg

From: Jay Katz, “The Silent World of Doctor and Patient”

On the day after the death of Louis Washkansky, the first heart transplant recipient …

The Case revisited

Grandmother should not be pressured to accept an earlier surgery date to meet the conflicting scientific goal of 100 patients in time for the AATS meeting.

She and other patients can be offered the innovative treatment off protocol – on a preapproved compassionate basis,

or as part of a less restrictive, exploratory plan to evaluate the innovation.

Guardrails -

Not Hurdles

Chief Residents 7: How would you rate ethics teaching compared to clinical teaching

N = 22

0

10

20

30

40

50

60

70 As important

More important

Less important

Much less important

-

Levin, Kassarjian, et al.

Views of Residents

martin.mckneally@utoronto.ca

Acknowledgements

Paintings by Robert Pope and Joe Wilder

Slides by Deborah McKneally, The Ravine Research and Education Centre

POS EthicsWhat should I do about an unethical surgeon?

Professional - Manager/Collaborator

When am I competent as a surgeon? Competence - Expert

Don’t tell my husband he has cancer.

Truth telling - Communicator

When is it okay to try something new?

Innovation - Scholar/Advocate

What if the parent refuses a needed operation on religious grounds?

Religious issues - Communicator/Professional

No beds in the ICU

Resource allocation - Advocate/Manager

Finder’s fee for residents?

Conflict of interest - Professional