Principles of Ethics in
Human Research
Lisa Schwartz, PhD
Arnold L Johnson Chair in Health Care Ethics
McMaster University
Graduate Studies
A Troubled History
"the basic approach to the ethical conduct of research and
approval of investigational drugs was born in scandal and
reared in protectionism“ (Levine 1988)
► Nuremberg
& Japan
► Tuskegee
► Milgram
► HeLa
experiments
cell line
History
► The
Tuskegee Syphilis Study remains one of the
most outrageous examples of disregard of basic
ethical principles of conduct (not to mention
violation of standards for ethical research). In
1976, historian James Jones (1981) interviewed
John Heller, director of the Venereal Diseases unit
of the PHS from 1943 to 1948. Among Heller's
remarks were the following: "The men's status did
not warrant ethical debate. They were subjects,
not patients; clinical material, not sick people"
(Bad Blood; p. 179).
►
Tuskegee University http://www.tuskegee.edu/Global/Story.asp?s=1207598
The response
►
Nuremberg code
http://www.med.nus.edu.sg/phar/sgcpp/nuremburg.htm
Declaration of Helsinki www.wma.net
CIOMS Statement http://www.cioms.ch/
Tri-Council Policy Statement (Canada)
National Committee on Ethics in Human Research
(Canada) http://ncehr-cnerh.org/
► Belmont Report (US)
► Office of Human Research Protection (US)
►
►
►
►
http://ohrp.osophs.dhhs.gov/index.html
►
►
►
MRC guidelines (http://www.mrc.ac.uk/ethics UK)
British Sociological Society (UK)
Nuffield Reports (UK)
►
Research Ethics Boards
http://www.nuffieldbioethics.org/home/index.asp
Problems
► They
need to be interpreted
► Variability
of application
2
underpinning themes
in human research ethics
I
Tension: one vs many
II
Trust
Underpinning Themes
-1The good of the many
(the general good)
The good of the few
(individual interests)
Research is beneficial
► Can
bring benefits, goods, better lives, safer
lives…
► No
argument there.
► Research
is a good thing.
M.H. Pappworth in 1967
► “No
physician is justified in placing science
or the public welfare first and his obligation
to the individual, who is his patient or
subject, second. No doctor, however great
his capacity or original his ideas, has the
right to choose martyrs for science or for
the general good.”
► Pappworth
M.H. Human Guinea Pigs; Boston: Beacon
Press, 1967; pg. 27
Research entails risks
► No
research is risk free
► Some risks can be anticipated
► Some risks can be mitigated
► Some risks can be avoided
► But
because it is research we cannot
anticipate all risks
Some Guiding Principles
►Respect
for participants (living & not)
►Beneficent
►Utility
►Justice
intentions
Tri-Council Policy Statement: Ethical Conduct
for Research Involving Humans (TCPS)
Core
Principles
Respect
for
Persons
Justice
Concern
for
Welfare
Respect for Participants
► Respect
for autonomy and human dignity
► Informed
Consent
► Honesty
► Confidentiality
► Fair
fairly applied
recruitment procedures
► Follow
up
► Collaborative
research
Ends, means,
subjects and objects
There is a danger of reducing research
subjects to research objects
Edward Weston Nude
1936
© Center for Creative Photography, Arizona Board of Regents Scan courtesy of Masters of Photography
Edward Weston Shells
1927
© Center for Creative Photography, Arizona Board of Regents Scan courtesy of Masters of Photography
Ends, means,
subjects and objects
► Be
aware of the humanity in each person
► Treat
persons as ends in themselves and
never solely as means to ends - Kant
Vulnerable
►Special
populations
 Children, adolescents, Indigenous
persons, pregnant women, marginalized,
low income, homeless…
►All
research participants
 Because of the unknown
Informed Consent for Research
Information…
► Who is conducting and funding the study
► What the study is about
► What is entailed
► What are the alternatives
► What are the risks
► What are the benefits
► What if they want to withdraw
…Permission
Must be…
► Clear
and meet the patient’s needs
► Honest as far as possible
► Obtained in advance
► Signed or recorded (unless waived by REB)
► Voluntary, uncoerced, not unduly influenced
► Allow time to ask questions and consider
► Continual or repeated
Beneficence
► Given
that we will ask persons to take risks
for the benefit of others we must do what
we can do mitigate these risks and avoid
them wherever possible
► Duty to do good
► Duty to do good research
► Duty to anticipate and avoid harm
► TCPS: Balance Benefits and Harms
Utility
► Make
best use of scarce resources
► Research
participants are a valuable
resource
► Ensure
value of the research question
► Ensure
quality of method
US Hearings on Human Experimentation,
1973
► “Those
who have borne the brunt of
research – whether it is drugs or even
experimental surgery – have been the more
disadvantaged people within our society;
have been the institutionalised, the poor,
and minority members.”
► Sen.
T Kennedy, prt 3, 7.3.1973, p. 841
Justice & Inclusiveness
► Given
that risks cannot be avoided altogether
► But are justified because of the benefits research
confers
► Justice asks us to share the burdens and benefits
of research fairly
► Fair distribution of risks
 Do not over burden participants
► Fair
distribution of benefits
 Give everyone access to the benefits of being studied
and of study outcomes
2 Underpinning Themes
-1Tension between
the good of the many
(the general good)
vs
The good of the few
(individual interests)
Underpinning Themes
-2Trust
&
Trustworthiness
Trust
►Ticket
►Key
Without trust…
►
The suspicion and fear generated by the Tuskegee Syphilis
Study are evident today. Community workers report
mistrust of public health institutions within the African
American community. Alpha Thomas of the Dallas Urban
League testified before the National Commission on AIDS:
"So many African American people I work with do not trust
hospitals or any of the other community health care service
providers because of that Tuskegee Experiment" (National
Commission on AIDS, 1990).
►
http://www.tuskegee.edu/Global/Story.asp?s=1207598
Academic Freedom & Responsibilities
► Depends
► honest
on trustworthiness and integrity
and thoughtful inquiry,
► rigorous analysis,
► accountability for the use of professional
standards
► the whole process should always be open to
critical assessment and debate
(TCPS)
Research Ethics Boards
► The
REB is your friend
► Element
of peer review
► Protects
participants
► Protects
researchers
References
►
►
►
►
►
►
►
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Beauchamp T L, Childress J F, 1994 The principles of biomedical ethics, 4th
edn. Oxford University Press
Centre for Disease Control and Prevention
http://www.cdc.gov/nchstp/od/tuskegee/time.htm#top
Health Care Consent Act Ontario, 1996
Hornblum, Allen M 1998 Acres of Skin. Routledge, NY
MRC guidelines for good clinical practice in clinical trials 1998.
http://www.mrc.ac.uk/ethics
Pappworth M H 1990 "Human Guinea Pigs"- a history. British Medical Journal
301:1456-1460
Pappworth M H 1967 Human Guinea Pigs. Beacon Press, Boston
Tri-Council Policy Statement
http://www.nserc.ca/programs/ethics/english/index.htm
Uris L, 1992 QB VII Harper Collins London