Abbreviations
IRB
What is Institutional Review Board?
Consent is a ______, not just a form.
What is a process?
Respect for persons, beneficence, and justice
What are the three principles of the Belmont Report?
Back button
How do I move to a previous screen?
IRB Board Specialist
Who do I let know if I can/cannot attend a meeting?
FDA
What is Food and Drug Administration?
All consent forms >4 pages should start with a _____.
What is Concise or Key Information Summary?
Per the Federal regulations children, pregnant women and prisoners are considered to be this type of study population.
What is a vulnerable population?
Review Board Internal Documents
Where do I upload a document the team sent me for this review?
IRB Writer
Who keeps the minutes for the IRB meeting?
IND
This is who may sign the consent when a participant lacks capacity.
What is a LAR?
Persons who have not attained the legal age for consent.
Who are minors?
Protocol Items
Where do I find the Application, Informed Consent(s) and Other Study Documents?
Who is the IRB Executive Director?
PHI
What is Protected Health Information?
This is when reconsenting is required.
What are changes that can affect the subject's participation in the study?
Established by the International Conference on Harmonization (ICH), it is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies.
What is Good Clinical Practice (GCP)?
9 AM
When does my checklist in iRIS need to be completed by on the day of the meeting?
Chairs
Who do I reach out to if I have questions about my review?
DSMB
What is Data Safety Monitoring Board?
A subject’s affirmative agreement to participate in research
What is assent?
“a living individual about whom an investigator conducting research obtains data through interaction or intervention with the individual or through identifiable private information.”
What is a human subject?
Section 1500
Where do I typically find the research summary?
IO
Who is Dean Klotman?