Guidance Aug 29, 2018 Transition to 2018 Regulations Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the " Common Rule ") were issued by the Department of Health and Human Services (HHS) on January 18, 2017. The majority of changes are scheduled to go into effect on...
Policies Aug 28, 2018 Statement of Practice: IRBMED Communication Methods for Study Teams The IRBMED office prefers eResearch correspondence as a means of communication between IRBMED and study teams. Other communication options include phone, email, and in-person consultations. Click here for PDF version.
Policies Aug 28, 2018 Statement of Practice: Flexibility Initiatives The University of Michigan's federalwide assurance with the Department of Health and Human Services (HHS) allows the IRB flexibility in its application of federal regulations to studies not federally funded or FDA-regulated. Click here for PDF...
Templates Jan 13, 2014 Assent Template (Recommended for ages 10 to 14-years-old as well as 14 to 17-year-olds when the study involves drug or pregnancy testing and/or birth control.) Return to I nformed Consent Templates page.
Guidance Feb 7, 2013 Humanitarian Use Device Requirements for U-M Physicians & Investigators The Food and Drug Administration (FDA) defines a Humanitarian Use Device (HUD) as “a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in...
