March, 2015 - IRB Process: Determination of HSR, Waivers of Consent, Expedited vs. Full Board Review
This session is designed to help you understand some of the inter-workings of the MHC IRB:
(1) How the IRB determines if a research project is human subject research vs. non-human subject research
(2) When is informed consent required for participation in a study or when can it be waived.
(3) How the IRB determines if a new research projects qualifies for expedited or full board review
Historically, there has been confusion about what needs to be reported. OHRP and FDA have issued guidance that clarifies that investigators need only report “unanticipated problems involving risks to subjects or others” (or UPIRSOs). This session will review:
(1) Differences between SAE, AE and UPIRSO
(2) HRPP reporting policy (based on the OHRP and FDA guidance)
A breach of privacy or confidentiality violates an individual’s rights and poses a risk of dignitary harm to the research participant, ranging from social embarrassment and shame, to stigmatization, and even damage to social and economic status. This session will discuss concepts of privacy vs. confidentiality, HIPAA privacy rule as it relates to research and how to protect the research subject’s privacy and confidentiality.
Humanitarian Use Devices (HUD) and emergency use of investigational drugs prior to IRB approval are intended for a distinct population of subjects under specified circumstances. This session will help you to understand and know:
(1) How a medical device qualifies for HUD designation.
(2) What are the criteria for using a HUD?
(3) MHC IRB notification requirements for initial and continuing approval
(4) HRPP policy on emergency use of investigational drugs and devices