The documents on this page are intended to provide you with general guidance in the conduct of research and/or the IRB submission process:
What's on this page
Click here to find up to date information regarding the proposed Common Rule changes
Guidance on QI/QI vs. Research
Investigator Handbook (Pre-2018 Common Rule before 1/21/19)
MHC Investigator Responsibility Policy
GCP Guidelines
IRB Guidance on Case Reports / Case Series
IND Worksheet
Example for Waiver of Informed Consent 1 (2018 Common Rule)
Example Waiver of Informed Consent
Example for Waiver of Documentation of Informed Consent 1 (2018 Common Rule)
Example Waiver of Documentation of Informed Consent
Translation Requirements - Guidance (2018 Common Rule)
Translation Requirements Guidance
Lay Language Glossary for Medical Terminology
Subject Advertisement Guidelines
IRB Fees
IRB Fees Effective October 14, 2019
IRB Meeting Dates
IRB Roster