Ethics Flashcards
IACUC
Institutional Animal Care and Use Committee
standards for animal research, have very different rules/restrictions vs human research
Adverse Events
untoward or unfavorable occurrence in a human subject. Can be anticipated, related to study participation, considered moderate to severe
must be reported to IRB within 30 days
Unanticipated Problems
any incident or experience that is unexpected, related to participation in study, suggests that research increases risk of harm to subjects
must be reported to IRB within 3 days
Informed assent
for minors under age 18 need parental permission
lack of capacity or unconsciousness, need surrogate to make the decision
Informed consent includes
- study purpose and brief intro/background
- explanation of all study procedures
- all risks and benefits of participation
- must state that participants are free to withdraw at any time
- participation is voluntary
- details compensation for participation
- how confidentiality will be protected
- contact info for study staff
Minimal Risk
probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams/tests
Full Board Review
more than minimal amount of risk to potential subjects
do not fit the exempt or expedited categories
ex: invasive studies, vulnerable populations, rigorous ex, drug testing
Expedited Review
minimal amount of risk to potential subjects
data collected through non-invasive procedures
ex: non-invasive methods, analyses of voice recordings, studies involving collection of hair/saliva/plaque
Exempt Review
lowest amount of risk to potential subjects
often involves anonymous or publicly available data
ex: retrospective chart reviews, research on educational practices, outcomes of standard clinical practice
Types of IRB Reviews
exempt, expedited, full review
Study Approval Factors
- scientific merit
- perceived competence of investigators
- participant characteristics and vulnerability
- safety of the procedures
- risk/benefit ratio
- informed consent process
- data security and confidentiality
Who sits on the IRB?
faculty, clinicians, community members
Role of IRB
meet and review all research proposals
make decisions regarding study
follow up on studies
implement policies, procedures, and documentation for review and follow-up
Justice
ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly and equally
Beneficence
philosophy of do no harm while maximizing benefits for the research project and minimizing risks to the research subjects
