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Policies, Procedures & Guidelines


The Medical College of Wisconsin’s Corporate Compliance office and Human Research Protection Program maintain institutional policies and standard operating procedures pertaining to aspects of human subject research.

 

MCW/FH IRB SOPs, Policies & Guidelines

Choosing this link will direct you to the HRPP web site which lists IRB policies & procedures. Use the back arrow to return to this site.

MCW Corporate & other policies related to human subjects research

Information on MCW Corporate Policies related to human subjects research as well as the MRI Safety SOP.

Good Clinical Practice: FDA-regulated clinical trials of drugs, devices & biologics

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects.

Using medical records and HIPAA Privacy Rule

Under the Privacy Rule, a researcher using or disclosing identifiable health information must (in addition to IRB and informed consent requirements) fulfill one of six allowable “HIPAA research pathways.”

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Page Updated 05/02/2014