Bioethics Flashcards
define bioethics
study of ethical issues emerging from advances in biology and medicine
to ensure moral discernment as it relates to medical policy and practice
declaration Helsinki
outlined the ethical principles of medical research
it is doctors duty to protect life, privacy, and dignity of patient
basic tenants of declaration of Helsinki
- -research must be approved by irb
- -benefit > risk
- -voluntary
- -assent obtained for minors
the Belmont report was instated after the outing of the ?
tuskegee syphilis study
as ethical guidelines for the protection of human subjects
3 fundamental ethical principles identified for human research subjects by the Belmont report
respect for persons
beneficence
justice
bioethics mandates that clinical intervention research should be designed to ?
benefit the subject not society
research should be designed to contribute to general knowledge
IRB
institutional review board
and independent body made up of scientists and non-scientists
responsible for ensuring protection of subjects by approving research methods
research misconduct
falsification in performing research or in reporting the research
SAE
serious adverse event
any experience that suggests a significant side effect that develops during a clinical trial
must be reported
informed consent
consent to participate in a medical experiment
after being taught on the risks and benefits
w/o coercion
autonomy
capacity of an individual to make an informed, uncoerced decision
GCP
good clinical practice
standard by which clinical trials are designed, implement, reported to assure sound data and protection of subjects
beneficence
do no harm
maximize the benefits
minimize the risks
justice
benefits and risks are distributed equally
1987 IND revisions
allowed terminally ill patients w/ no alternatives
access to experimental drugs
