When is it okay
to try something
new on
Grandmother?
Surgical Ethics:
Innovation and Research
Martin McKneally
University of Toronto
Department of Surgery
Joint Centre for Bioethics
Principles of Surgery
Sept 6, 2011
When is it okay to try
something new?
on someone’s
mother?
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 Case
Dr. 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 techniques
required follow-up tests
• Conflicting interests
the investigator
the sponsor
the institution
• Confidentiality may be breached
through data collection & storage
World Medical Association
Declaration 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 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”
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.
Innovation
A new evolving intervention
Safety and reliability
Effects and side effects
Complications
not yet known
McKneally & Daar WJS 2003
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
Shouldn’t there be some oversight?
Surgical Peers and Trainees
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.”
I told them I
wouldn’t sail
off the edge!
The Columbus Clause
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
On the day after the death of Louis Washkansky,
the first heart transplant recipient …
“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”
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
Views of Residents
Chief Residents 7:
- How would you rate ethics teaching compared
to clinical teaching
N = 22
70
As important
60
50
40
Less important
30
20
10
More important
Much less important
0
Levin, Kassarjian, et al.
martin.mckneally@utoronto.ca
Acknowledgements
Paintings by Robert Pope and Joe Wilder
Slides by Deborah McKneally, The Ravine
Research and Education Centre
POS Ethics
What 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