Guidance
Jan 16, 2019

Transition to 2018 Regulations

On January 21, 2019 most provisions of the Revised Common Rule become fully effective ("Effective Date” and "general compliance date"; single IRB-of-Record provisions will go into effect in January 2020). As of that date, the eResearch system...
Guidance
Jun 5, 2017

Telephonic Consent

In most cases, a potential research subject (or subject's representative) must be given an explanation of the protocol , including its risks , benefits , and alternatives. The subject's voluntary and un-coerced choice to participate must usually be...
Guidance
Apr 12, 2013

Assent of Children in Research

The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here . Below are frequently asked questions about assent. More information is available here .
Guidance
Apr 18, 2012

Who May Consent for Participation in Research Studies (Michigan)

Participant = Minor Participant = Incapacitated / Incompetent Adult Outpatient Psychotherapy Minor age 14 or over if seeking limited confidential outpatient psychotherapy services under M.C.L. §330.1707 Parent(s)* with legal custody or guardian† See...
Guidance
Apr 17, 2012

Prisoners in Research

Federal Guidance [Office of Human Research Protections ( OHRP )] OHRP FAQs University of Michigan Subject becomes a prisoner / Study not previously approved to recruit prisoners seeks to enroll new subject who is a prisoner Created 4/17/2012
Guidance
Oct 26, 2009

Reconsenting Study Subjects

Informed consent is an ongoing process requiring you to provide subjects with continual information and clarification, which will enable them to decide whether to continue participating in research studies. Encourage all subjects to ask questions...