What are the Human Subjects Research training (and other training) requirements?

Frequently Asked Question

Who is required to complete human subjects research training?

Anyone listed as a study team member in the IRB application who is engaged in human subjects research (including PIs and points of contact) must complete human subjects research training. This training must be completed before a submission can be approved by the IRB.

What type of training is required?

Anyone affiliated with UW-Madison, UW Health, or the Madison VA must take a human subjects research training course through CITI (Collaborative Institutional Training Initiative).To satisfy the training requirement, personnel who will be listed on applications submitted to the HS and MR IRBs may take either the biomedical or socio-behavioral course. NOTE: Personnel who will be listed on application for VA studies MUST take the VA human subjects training course. The VA course will be accepted in lieu of the biomedical or socio-behavioral course for non-VA studies.

We highly recommend completing Good Clinical Practice training, Responsible Conduct of Research training and the Basics of Clinical Research Course.

When is HIPAA training required?

In most cases, HIPAA training will also be required for studies involving subjects’ Protected Health Information (PHI) if the units are part of the UW-Madison Health Care Component (HCC) or affiliated covered entity (ACE).For more information regarding HIPAA at UW-Madison, please visit the website at http://hipaa.wisc.edu.

Is training required for personnel listed on exemption or not human subjects research applications?

Anyone engaged in human subjects research who is listed as a study team member in the IRB application must complete training, regardless of the type of application being submitted. In cases where an application is being submitted to have the IRB make a formal determination that the project is not research or does not involve human subjects, training would typically not be required as personnel in these case would not be engaged in human subjects research.

Do personnel or collaborators outside UW-Madison, UW Health, or the Madison VA need to take UW-Madison human subjects training?

Personnel or collaborators outside UW-Madison, UW Health, or the Madison VA may need to take UW-Madison human subjects research training if a) a UW-Madison IRB is serving as IRB of record for those personnel and b) the personnel have not completed comparable human subjects research training elsewhere. If UW-Madison is NOT serving as IRB of record for personnel not affiliated with UW-Madison, UW Health, or the Madison VA, they will not need to complete UW-Madison human subjects research training.

How do I access CITI?

For more information about the human subjects training requirement, see Instructions for Completing CITI Human Participants Research Training.

See Also:




Keywords:faq, training, citi, hipaa training, human subjects training portal renewal RCR GCP   Doc ID:22595
Owner:Faye L.Group:Health Sciences IRBs
Created:2012-02-09 10:10 CSTUpdated:2016-01-06 13:02 CST
Sites:Health Sciences IRBs
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