Regulatory Oversight Overview

IRBs for physicists Kellie Bodeker, CCRC, B.Sc. Department of Radiation Oncology

Today, we’re going to review ,[object Object],[object Object],[object Object],[object Object],[object Object]

HIPAA ,[object Object],[object Object],[object Object],[object Object],~ http://www.hhs.gov

HIPAA exceptions ,[object Object],[object Object],[object Object],[object Object],~ http://www.hhs.gov/ocr/privacysummary.rtf

Research defined by HIPAA ,[object Object],[object Object],[object Object],[object Object],[object Object],~ http://www.hhs.gov/ocr/privacysummary.rtf

This means…to publish or research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],You can still use these for quality control or teaching

So you need an “IRB” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Research-speak ,[object Object],[object Object],[object Object],[object Object],[object Object]

Standard of care ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Prospective Studies ,[object Object],[object Object],[object Object],[object Object],[object Object]

Retrospective ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Quality Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Delegate ,[object Object],[object Object],[object Object],Jane Hershberger

What do you need: prospective ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

What do you need: retrospective ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

So, how do I get an IRB? ,[object Object],[object Object],[object Object],[object Object],[object Object],https://login.uiowa.edu/uip/login.page?service=https://hawkirb.research.uiowa.edu/hawkirb/

Assign both Kellie (bodekerk) & Jane (hershbergerj)

Writing an IRB application ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

At the start ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Your research team ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Then…decide your project type ,[object Object],[object Object]

Waiver of consent (retrospective)

[object Object],[object Object]

Privacy & confidentiality ,[object Object],[object Object]

You have to name names for each and every IRB application

Statistics ,[object Object],[object Object],[object Object],This is a feasibility study, to determine trends and/or if it is even applicable/possible. If a trend is seen, a larger study will be requested with statistical justification provided by the Biostatistics Core of the HCCC.

And when we’re done? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Regulatory Oversight Overview

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