Transcript Human Subjects & Research

Human Subjects & Research
Understanding the protection of
human subjects, HSRC, and the
nature of the process.
Definition of Research
“Research” means
– a systemic investigation
– designed to develop or contribute
to generalizable knowledge
Research includes research
development, testing, evaluation -i.e., pilot studies
Definition of Human Subject
• a living individual about whom an
investigator conducting research obtains
(1) data through intervention or interaction
with the individual, OR
(2) identifiable private information, i.e.
codes, social security numbers, name,
etc.
• Subjects have a reasonable expectation
of privacy
Why?
• 1947: Nazi
• Tuskegee, Alabama,
physicians are tried
untreated syphilis
at Nuremberg,
studies in
German, resulting in
uninformed, poor,
the Nuremberg Code
black males are
denied treatment
even after a
treatment is found,
thru 1972!
More ...
• 1940s experiments
injecting plutonium
into human research
subjects; secret
radiation
experiments; poor
and mentally
retarded children
deceived about their
treatments.
• 1950s: GIs are
ordered near
ground zero in
nuclear tests
without their
knowledge of
possible effects.
Ethical issues in human
subject research
From the Belmont Report
• Autonomy
• Beneficence
• Justice
Of critical importance -• Adequate preparation is taken to
protect the privacy and confidentiality
of subjects.
• Informed consent.
• Adequate provisions are made for the
ongoing monitoring of the subjects’
welfare.
Autonomy
• Each person should be given the
respect, time and opportunity to make
his/her own decision.
• No pressure or coercion.
• How will vulnerable populations make
an informed decision?
• CHOICE
Beneficience
• Essentially the well-being of all study
participants.
• Protect participants from harm.
• “maximize possible benefits and
minimize possible harms” … Belmont Report
• Weighing benefits to society versus the
possible risks.
Justice
• Who bears the risk, who is equal and
who is not, who should receive the
benefits?
• Participant selection may not be
EXCLUSIVE unless scientifically justified.
Circumstances requiring review
• conducted by
faculty, staff, or
students;
• involves College
students, staff, or
faculty as subjects;
• performed on the
campus;
• performed with or
using College
facilities or
equipment
• satisfies a
requirement
imposed by the
College for a degree
or completion of a
course of study;
What does this mean at
Fredonia?
• All research at SUNY Fredonia that
involves humans, human tissue, or
records gathered on human
subjects requires IRB (HSRC)
review. This is true regardless of
funding source or area of research.
HSRC responsibilities
• Identification of risks
• Determination that risks are minimized
• Determination that “risks to subjects
are reasonable in relation to anticipated
benefits.”
• Determination that subjects are
adequately informed about “any
reasonably foreseeable risks or
discomforts.”
HSRC review criteria
• Risks to the subjects
are minimized.
• Risks to the subjects
are reasonable in
relation to
anticipated benefits.
• Selection of subjects
is equitable.
• Informed consent is
sought from each
participant or legally
authorized
representative
(LAR), and is
properly
documented.
Identifying risks
• Social and
psychological risks
are REAL risks.
• HSRC should not
and do not rely on
researchers to
identify risks.
• There are two
sources of harm:
– breach of
confidentiality
– participation in the
research
Breach of confidentiality
• Confidentiality and anonymity are not
the same
• Names are not the only identifiers
• Subject participation in the research
may need to be kept confidential as
well as their data
Psychological & social harm
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Emotional distress
Psychological trauma
Invasion of privacy
Embarrassment
Loss of social status
Loss of employment
How do you minimize risk?
• Precautions
• Safeguards
• Alternatives
Informed
Consent
Informed consent
• The process should empower subjects
to make their own determination about
risk.
• Risks should be explained in terms that
the subjects can relate to.
• Consent process should not do more
harm than the research.
8 Required Elements
1. Statement that study is research and
information on purposes, duration,
procedures and/or experimental procedures
2. Reasonably foreseeable risks or discomfirts
3. Benefits which my reasonably be expected
4. Alternative procedures
5. How confidentiality will be maintained
8 Required Elements (cont’d.)
6. For more than minimal risk, compensation
for injuries
7. Contact names - at least one not associated
with the research is recommended
8. Statement that participation is voluntary and
the subject can withdraw at any time without
penalty or loss of benefits to which the
subject is otherwise entitled
In General
• There is no such thing as “passive
consent”
– consent is required
– Written consent MAY be formally waived
• There is no such thing as a “secondary
subject”
– if an investigator obtains “identifiable private
information” about a living individual, the
individual is a human subject, regardless of the
source
Researcher responsibility
• to educate the participants about risks
and benefits
• to obtain their consent before involving
them in your research
• to keep them informed
This is the "informed consent process."
Impact
“What’s at stake is the integrity of
research, and public confidence in that
research”
DHHS Secretary, Donna Shalala, May 2000
Consequences of
Non-Compliance
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Restrictions on Assurance
Suspension of Assurance/Research
Negative publicity
Warning letters
Loss of public confidence in research
Personal financial loss
Disciplinary action