Research Ethics Flashcards
What were the guiding ethical principles of traditional Hippocratic ethics?
What does this mean for research?
“benefit” and “do no harm”
• Any experiment must be placed exclusively within a
therapeutic or preventive context.
• Any trial should entail direct potential benefits to the
patient/participant.
• Patients should not be treated as mere means for learning.
• Introduction of a new treatment must be made cautiously (‘Catch 22’).
• The integrity of the researcher is beyond doubt, thus there is no need to inform patients or obtain their consent for the research.
In the second half of the 19th century, new interests in medical sciences led to experiments on humans in non-therapeutic circumstances. Consent was not obtained.
What are the ethical justifications?
• Search for truth.
• Benefit to mankind.
• “No harm” (most experiments performed on
“anyway” dying patients).
What is the Nuremberg code?
VOLUNTARY CONSENT IS VITAL PERSON NEEDS FREE POWER OF CHOICE EXPERIMENT NEEDS TO YIELD FRUITFUL RESULTS FOR THE GOOD OF SOCIETY PRIOR EXPERIMENTS WITH ANIMALS AVOID UNNECESSARY PHYSICAL/MENTAL HARM A PRIORI ASSURANCE THAT NO DEATH OR INJURY RESULT RESEARCHERS MUST BE QUALIFIED SUBJECT HAS RIGHT TO OPT OUT DUTY TO STOP TRIAL IF HARMFUL
When was the Helsinki Declaration issued?
1964
What are the key principles of the Helsinki Declaration?
Research must conform to generally accepted scientific
principles, and be based on adequate
laboratory and animal experimentation.
Design of trial should be formulated in a protocol
+ submitted to an independent committee.
Experiment should be conducted by scientifically
qualified persons, under supervision
of a clinically competent medical person.
Responsibility must always rest with a medically qualified person and never on the subjects.
The importance of the research objective must be in proportion to the inherent risk to the subject.
Must assess potential risks and benefits to subject and others.
Concern for the interests of the subject must always prevail over the interests of science and society.
Respect the subject’s autonomy and
privacy. Minimise harm.
Doctors should abstain unless satisfied that hazards
involved are believed to be predictable.
Doctors should cease investigation if hazards are found to outweigh potential benefits.
In publication of the results the physician
is obliged to preserve accuracy.
If not in accordance with principles, should not be accepted for publication.
The potential subject must be informed of aims, methods, potential benefits and hazards, discomfort, liberty to abstain from participation, freedom to
withdraw at any time. Consent must be obtained preferably in writing and be free from coercion or duress.
In case of dependent relationship consent must be obtained by an independent physician.
In case of legal incompetence informed consent must be obtained from legal guardian.
What are the principles of HD in care?
Every patient should be assured of the best proven diagnostic and therapeutic methods.
Placebo may be used where no proven diagnostic or
therapeutic method exist, unless there are compelling
scientific reasons justifying using it even if proven
therapy is available (e.g. scientific reason, minor
condition).
The refusal of the patient to participate in a
study must never interfere with the d-p
relationship.
If the physician considers it essential not to
obtain informed consent, the reasons should be
stated in the protocol. (Incompetent patients,
OO v. OI consent, study of compliance).
Medical research aiming at acquisition of
knowledge can be combined with care only to
the extent that the diagnostic and therapeutic
values to the patient can be justified.
How does the requirement for consent differ in HD compared to the NC?
Weaker in the HD
- HD authorises consent from guardians and relatives
of incompetents
- HD permits the investigator/physician to omit
informed consent under special circumstances.
