Human Research Protection Program

What Requires IRB Review

• Guidelines for Determining if a Proposal Needs IRB Review 
  Understand whether an activity might be classified as "Exempt from IRB Review" or "Not Human Subject Research".

• Decision Charts
  Display decision trees regarding "Exempt from IRB Review" or "Not Human Subject Research.

• Research with Decedents
  Obtain information on submitting research with decedents for Privacy Board review.

Submitting New Studies

• Who can submit studies? 
  Refer to the MCW SOPs section 7.0 regarding who can act as the Principal Investigator for studies at MCW.
• Training Requirements
  Access information about the training that must be completed in order to conduct human subject research
• Funding (MCW network access required)
  Access information on funding sources, preparing a budget, submitting a sponsored project, and contracts.
• Understanding HIPAA
  Access MCW HIPAA policies, procedures, forms and contacts; regulations; and IRB forms relating to HIPAA
• Guidelines for Submitting New Studies 
  Access information about submitting new studies to the MCW/FH IRB, including full committee, expedited, and exempt. 

• Specialized Topics 
  Get information on guidelines for HUD Protocols and Consent Forms, IND Exemption Forms for Investigators, and NCI CIRB guidance for submitting to the MCW/FH IRB.

Electronic Submission System

• eBridge Information
  Access information on registering for eBridge and system and electronic signature compliance with FDA regulations

• eBridge Training - Human Research
  View training schedule and access hard copies of training materials, online training videos, PDF files of eBridge smart forms and workflows

• eBridge Frequently Asked Questions  

• eBridge Recent Announcements