Confidentiality and the Management of Health Care
Information: Research ethics
Research ethics:
● Ethics is concerned with the conduct of a
human being.
● All scientific activities, including those by
social scientists, are conducted with the
participation of human beings or have an
impact on human beings and on the wider
society and environment.
● For making an ethical judgment, the
researcher relies upon various standards of
ethics, which could be universal or specific to
the cultures or localities.
● A researcher should have a deep concern
for human welfare and sensitivity for the
rights of the research subjects.
The dark ages of ethics
● The period during the origin of ethical
research is known as the dark ages of
ethics.
● Slaves, prisoners, criminals, children, and
poor people were forcibly used as samples
or experimentation subjects for the research
activities. They were treated like animals and
there was no consideration for their rights,
consent, wishes, or values.
● This dark period of ethical concern is
considered to be a big unhealed wound in
the initial period of development of ethical
research.
Nazi experiments
exposed during the Nuremberg Trials (1946)
● German doctors committed crimes against
humanity for “performing medical
experiments upon concentration camp
inmates and other human subjects without
their consent”.
The experiments
On limits of human endurance in high altitudes
● Subjects were placed in low-pressure
chambers
On the most effective means of resuscitating
pilots who have been severely chilled/ frozen after
falling into the sea
● Subjects were forced to remain in ice water
for 3 hours
For diseases troubling German occupation forces
● Malaria
○ Healthy subjects infected using
mosquitos
● Infected Wounds
○ Sulfanilamide clinical trial
○ Subjects deliberately wounded,
infected with bacteria, circulation
interrupted, aggravated by forcing
wood shavings and ground glass.
● Feasibility of organ transplantation
○ Bone, muscle, and nerves were
removed from one group and
transplanted into the other group.
On methods of sterilizing men and women
On the most efficient means of mass execution of
“useless” people
e.g. poisons
The Nuremberg Code of 1947
● The Nuremberg Code was created by
opening on the testimony of physician
witnesses and was said to represent current
thoughts on the topic of human
experimentation.
● Although intended to refer to this particular
trial and never formally adopted by any state
or international agency, the Nuremberg Code
has been tremendously influential—
becoming the basis of later documents that
are highly relevant to research today.
Declaration of Helsinki
● Set of ethical principles developed for the
medical community in 1964
● Cornerstone document of human research
ethics
★ Protect life, health, dignity, integrity, right to
self-determination, privacy and confidentiality
of personal information of research
participants ... (9)
★ Responsibility for the protection of the
research subjects must always rest with the
physician or other health care professionals
(9)
★ Comply with ethical, legal and regulatory
norms (10)
 ★ Appropriate compensation and treatment to
those who are harmed (15)
★ Justify potential preventive, diagnostic or
therapeutic value when combining medical
research with medical care (14)
★ Ensure favorable benefit-risk ratio; if
unfavorable, physicians must assess to
continue, modify or stop the study (18)
★ Vulnerable Groups and Individuals – An
increased likelihood of being wronged or
incurring additional harm (19)
★ Research protocols should conform to
generally accepted scientific standards;
justify the methodology used (22)
★ Research Ethics Committees must consider,
comment, guide and approve research
before the study begins; monitor, review
SAR, amendments and final report (23)
★ Protect the privacy of research subjects and
the confidentiality of their personal
information (23)
Universal Declaration of Human Rights - 1966
● (UN General Assembly) International
Covenant on Civil and Political Rights
● Art. 7: No one shall be subjected to torture or
to cruel, inhuman, or degrading treatment or
punishment. In particular, no one shall be
subjected without his (her) free consent to
medical or scientific experimentation.
Other studies
Tuskegee Clinical Trial (1932-1972)
● NIH-sponsored, Alabama, USA
● Objective:
○ To determine the clinical course of
untreated syphilis.
● Subjects:
○ 600 men with syphilis
● Participants:
○ Africa-Americans
○ Told they were treated for “bad
blood”
○ Not given Penicillin when this was
proven to be the treatment for
Syphilis in 1947
Milgram Study on Obedience to Authority
(1961)
Objective
To measure the willingness of subjects to obey
an authority figure
Subjects
40 mostly young male students from Yale
Method
The experimenter instructed the “teacher” (subject) to
give electric shocks (increasing intensity) to the
“learner” (actor) every time the “learner” gave a wrong
answer.
Result
only 14 subjects stopped while 26 finished the
experiment (max 450v shock)
Willowbrook Hepatitis Experiment - 1960’s
Objective
To determine the mode of infection the hepatitis virus
and the course of the disease and to test the
effectiveness of gamma globulin.
Subjects
>700 mentally retarded children
Methodology
● deliberate infection with hepatitis virus
● early subjects fed extracts of stools from
infected individuals; later subjects received
purified virus preparations
Defense
The majority of the children will acquire the infection
at Willowbrook so it is better for them to be infected
under carefully controlled research conditions.
The Tearoom Trade Study (1965-68)
● A study of homosexual encounters in public
toilets.
● Author played role of “watch queen” to look
out for intruders and did not reveal his
research.
● Data on locations, the frequency of acts, the
age of the men, the roles they played, and
whether money changed hands.
● He later revealed to some men what he did
and interviewed them on their daily life.
 ● He tracked some men using the car license
plates and interviewed them at home under
the guise of conducting a public health
survey.
The Belmont Report (1974)
The National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
issued "The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of
Research."
● sets forth three principles underlying the
ethical conduct of research: Respect for
Persons, Beneficence, and Justice.
● explains how these principles apply to
research practices. In response to the report,
both the U.S. Department of Health and
Human Services and the U.S. Food and
Drug Administration revised their regulations
on research studies that involve people.
International Ethical Guidelines for Biomedical
Research Involving Human Subjects
1982, 1993, 2002
(Council for International Organizations of
Medical Sciences - founded under the auspices of
WHO and UNESCO in 1949)
21 guidelines with commentaries
● Ethical justification and scientific validity of
research
● Ethical review, informed consent, the
vulnerability of individuals, groups,
communities, and populations
● Women, children, and pregnant as research
subjects
● Equity regarding burdens and benefits
● Choice of control in clinical trials
● Confidentiality, compensation
● Strengthening of national or local capacity
for ethical review and obligations of sponsors
to provide healthcare services
Guidelines for Good Clinical Practice (1996)
International Conference on Harmonization of
Technical Requirements for Registration of
Pharmaceuticals for Human Use.
Objective
● To provide a unified standard for the EU,
Japan, and the United States to facilitate the
mutual acceptance of clinical data by the
regulatory authorities in these jurisdictions
“A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides assurance”
● that the data and reported results are
credible and accurate, and
● that the rights, integrity and confidentiality of
trial subjects are protected.”
WHO Operational Guidelines for Ethics
Committees that Review Biomedical Research
(Geneva 2000)
Intended to facilitate and support ethical review in all
countries around the world.
Objective
● To contribute to the development of quality
and consistency in the ethical review of
biomedical research.
● To be used by national and local bodies in
developing, evaluating and progressively
refining SOPs for ethical review of
biomedical research.
Standards and Operational Guidance for
Ethics Review of Health-Related Research
with Human Participants (WHO 2011)
● Standards for the Research Ethics Review
System
● Standards and Guidance for Entities that
Establish Research Ethics Committees
(composition, resources, independence,
training, transparency, accountability, and
quality)
● Standards and Guidance for Members of the
Research Ethics Committee (the ethical
basis for decision-making in research ethics
committees)
● Standards and Guidance for the Secretariat,
Staff, and Administration of the Research
Ethics Committee Standards and Guidance
for Researchers