Consultations
The University of Michigan IRBMED offers consults on various human subjects’ research protection topics. These educational consults are designed for small groups (typically less than 10 people). We can attend research team or divisional meetings and present on the following topics:
Compliance
This is an informal overview of the process that is followed should a subject file a complaint about your project, including information about what is Serious or Continuing Non-Compliance. You’ll also be provided with tips and examples regarding how to avoid non-compliance issues. To request this session, please email Georgia Marvin at: gmarv@med.umich.edu.
General Education
The education group is available to provide information regarding the IRBMED structure and processes, information on policies and regulations, and adverse events (AEs) and ORIOs. Help with using eResearch—IRBMED’s electronic application system—is also available. The education group is available to provide tailored informational sessions for study teams or departments. To request such a session, please email Joseph Austin at: sjaustin@med.umich.edu.
HIPAA/Privacy Board
This is a brief overview of HIPAA regulations as they relate to research, with a focus on how and when to request a Waiver of HIPAA Authorization. This session also includes information regarding exempt and not-regulated application types and the functions of Privacy Board. To request this session, please email Lark Speyer at: larkspur@med.umich.edu.
Informed Consent
IRBMED’s technical writer can offer basic suggestions to help you write informed consent documents that are clear to subjects and compliant with federal and IRBMED requirements. For more information, please contact Brian Seabolt, at bpsea@umich.edu.
Created 1/31/12
Updated 1/3/13
