Transcript DIA 2010 Annual Meeting

Informed Consent:
Promise, Pledge,
Contract, or Platitude?
Presented by:
Michael A. Swit, Esq.
Vice President,
The Weinberg Group Inc.
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Historical Background
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The Nuremberg Code (1947)
• First modern ethical code requiring
– Voluntary consent
– Benefits outweigh risks
– Ability of the subject to terminate
participation
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Declaration of Helsinki (1964)
• Recommendations Guiding Medical Doctors in
Biomedical Research Involving Human Subjects
• Adopted by the 18th World Medical Assembly,
Helsinki, Finland, 1964; revised in Tokyo, 1975;
Venice, 1983; Hong Kong, 1989; South Africa,
1996;Edinburgh 2000; Note of clarification on
paragraph 29; Washington 2002
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Helsinki Declaration …
• “Concern for the interests of the subject must
always prevail over the interests of science
and society”
http://www.wma.net/e/policy/b3.htm
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Beecher Article (1966)
• “Ethics and clinical research” — Henry
K. Beecher, New England Journal of
Medicine 274 (1966):1354-60
– 22 published medical studies presenting risk
to subjects without their knowledge or
approval
– Published in some of the most prestigious
journals and conducted at some of the most
acclaimed institutions by some
of the
most highly regarded researchers
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Where the Burden Lies
• “The duty and responsibility for ascertaining the
quality of the consent rests upon each individual
who initiates, directs or engages in the
experiment.”
– Principle 1, The Nuremberg Code
• “When obtaining informed consent for a
research project, the doctor should be
particularly cautious if the subject is in a
dependent relationship to him or her, or under
duress.”
– The Declaration of Helsinki
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Where the Burden Lies …
• “In that case, the informed consent
should be obtained by a doctor who
is not engaged in the investigation
and who is completely independent
of this relationship.”
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Beecher’s Paradox
• The voluntary consent of the human
subject is absolutely essential.
– Nuremberg
• True informed consent is probably an
unattainable goal.
– Beecher
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The Belmont Report
• 1974 – The National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral Research
• 1979 – Commission Report – “Belmont”
– Validates IRB role as a key aspect of subject
protection
• 1981 – Federal Regulations Revised
– “Common Rule” – basically across whole fed.
govt.
– FDA – some exceptions, minor in nature
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Where the Regulations Lie
• HHS – if supported by federal funding – 45 CFR
116.
• FDA – 21 CFR Part 50
• Differences
– FDA, but not HHS, provides for an exception from the
informed consent requirements in emergency
situations. The provision is based on the Medical
Device Amendments of 1976, but may be used in
investigations involving drugs, devices, and other
FDA regulated products in situations described in ß
50.23.
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Differences – FDA vs. HHS
• HHS provides for waiving or altering elements of
informed consent under certain conditions. FDA
has no such provision because the types of
studies which would qualify for such waivers are
either not regulated by FDA or are covered by
the emergency treatment provisions (§ 50.23)
• FDA explicitly requires that subjects be informed
that FDA may inspect the records of the study
because FDA may occasionally examine a
subject's medical records when they pertain to
the study. While HHS has the right to inspect
records of studies it funds, it does not impose
that same informed consent requirement.
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Differences – FDA v. HHS …
• FDA explicitly requires that consent forms be
dated as well as signed by the subject or the
subject's legally authorized representative.
The HHS regulations do not explicitly require
consent forms to be dated.
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The Law of Informed Consent –
Contract, Fiduciary Duty, Promise,
Pledge or Platitude?
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Treatment vs. Research – Key
Distinction
• Law of Informed Consent – must remember that what
governs medical treatment is not always same as what
governs research
• Treatment
– Doctor – arguably -- is a fiduciary – owes duty to protect
patient
– Traditional view – unconsented treatment = battery
– Causation –
•
•
•
•
Not disclosed
Injured
Reasonable Patient would want to know
Reasonable Patient would have refused the treatment –
HARD PART
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How Research Differs from
Treatment
• Goals – treatment vs. developing generalizable
knowledge
• How Overseen:
– Treatment – doctor supplies expertise
– Research – highly regulated by sources other
than the doctor – protocol and government
regulation
• e.g., if sponsor concludes treatment is
ineffective, must stop research
• Law – state (treatment) vs. federal (research) –
some exceptions
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Battery
• Problem – any failure could be alleged to
be a battery, which is an intentional tort
(technically); due to this, courts do not favor
it as a remedy
• Will occur:
– Complete lack of consent
– Procedure given differed from that consented
– “Ghost Surgery” – undisclosed replacement
surgeon
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Is the I.C. a Contract Legally
Enforceable by the Subject?
• Basic contract law
– Parties in privity – i.e., two make a deal
– Legal subject
– Offer
– Acceptance
– Consideration
• Problem – lack of privity – sponsor may
provide the form, but it is obtained by P.I.
from the subject – no privity
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But, People (Alan Milstein) Still Argue
Contracts
• Suthers & Abney Cases
– GNDF trials – discontinued by Amgen as showing
no benefit – thus, required under IND rules
– Plaintiffs – you owe us the drug under normal
contracts theory and the doctrine of “promissory
estoppel” – also a contracts theory
• Clear promise
• Detrimental reliance by promisee
• Damages by promisee
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Suthers and Abney Decisions
• No contract
– Amgen not a party to I.C., nor was the P.I. an
agent of Amgen that could bind Amgen via
the I.C.; rather they were “independent
contractors”
• Look at control over the P.I.’s work
– Here the protocol drafted by the P.I.
• No promissory estoppel
– Unable to show Amgen promised continued
access
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Fiduciary?
• Suthers & Abney – also asserted that the
Amgen was a fiduciary; not found by court
– Amgen did not set up the clinical initially; no
unique duty owed to subjects or proof that
Amgen’s role was done for the benefit on the
patients
• Note: court suggested that the parties to
be bound by contract via the I.C. were the
P.I. and the universities where P.I. worked
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Problems with Fiduciary Theory
• Goal of research – generalizable knowledge
• Subject is not the prime beneficiary of
research – rather it is the public at large
• P.I. and sponsor both have less control over
the way research is done
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Questions?
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President
The Weinberg Group Inc.
336 North Coast Hwy. 101
Suite C
Encinitas, CA 92024
Phone 760.633.3343
Fax 760.454.2979
Cell 760.815.4762
[email protected]
www.weinberggroup.com
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About your speaker…
Michael A. Swit, Esq., is a Vice President at THE WEINBERG GROUP, where he develops and ensures the
execution of a broad array of regulatory and other services to drug and biologics clients seeking to market products in
the United States. His expertise includes FDA development strategies, compliance and enforcement initiatives, recalls
and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and
clinical research efforts.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His multi-faceted experience
includes serving for three and a half years as corporate vice president, general counsel and secretary of Par
Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial
perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of
FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the
FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the
FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug
Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced
FDA regulatory law with the D.C. office of Burditt & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial
activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and
editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the
Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored
by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his
law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars.
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