IRB Basics
This committee reviews research involving people and protects participant rights and welfare
What is the IRB?
This should be your first call when you have a research idea
Who is the reserach coordinator?
This is the preferred tool for storing and entering research data
What is REDCap?
You cannot enroll patients until the study has this status
What is "Open to Accrual"?
This type of IRB review is typically for minimal-risk studies with limited oversight
What is exempt review
A SlicerDicer search shows 250 possible patients. Why might the final analyzable sample be much smaller?
What are: Inclusion/exclusion criteria, missing data, duplicate encounters, coding limitations, and manual review may reduce the final sample?
Your IRB is submitted but not approved yet. You want to build your REDCap project and organize your data collection forms while you wait. Can you start?
What is yes — you can build REDCap while IRB review is pending, but you cannot collect real study data yet?
Name one type of study that may require IRB review
What is a chart review, prospective study, survey/questionnaire, or clinical trial?
A study involves collecting identifiable patient information but does not plan to obtain consent. What type of document may be needed?
What is a waiver of consent and/or HIPAA Authorization
You have a study question but has not identified the outcome variable, predictor variables, or covariates. Who should they involve early?
Who is the biostatistician?
A resident is listed on the study team but has not signed off on their delegated tasks in eReg or on paper. Can they start performing study activities?
What is no — they must sign off on delegated tasks before beginning study activities?
This type of IRB review is usually used for higher-risk or interventional studies
What is full board review
Your protocol is ready, but the study involves chart access, no consent, and a special patient population. You submit only the protocol and Departmental & Scientific Review. Name one likely reason the submission may be delayed.
What is missing required supporting documents, such as consent/HIPAA waivers, vulnerable population information, or RIDGe review?
You are submitting a retrospective chart review. They have a protocol and Departmental & Scientific Review, but they forgot to start the additional review required for accessing patient charts. What is missing?
What is a RIDGe review?
You consent a patient for a study, the consent is signed and dated, and then the form sits in the workroom for two weeks before being passed off to the CRC. What went wrong?
What is the consent must be uploaded into eDH and the patient registered to the study within 5 business days?