UNIVERSITY OF MICHIGAN MEDICAL SCHOOL

IRBMED Home Forms Informed Consent Templates Guidance Education About IRBMED Resources AE/ORIO IRBMED Members Research Participants

IRBMED
517 W. William, Argus I,
Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603

Updated IRBMED Informed Consent Document Template

This fall, the Medical School Institutional Review Boards (IRBMED) will implement an updated informed consent document template. This is being done to facilitate the University of Michigan 's compliance with the ‘National Coverage Decision for Routine Costs in Clinical Trials' (NCD) which concerns payments by the Center for Medicare & Medicaid Services (CMS). A task force comprised of investigators from different research areas, the IRBMED, regulatory, compliance, and billing administrators recommended the needed changes. Other minor pending changes were also added to this roll-out.

The new informed consent template will be required for new project applications received at the IRBMED as of 11/1/2007 (note, you are allowed to submit the new template sooner if you choose). Previously approved studies will be required to update to the new template at the next informed consent document amendment after 11/1 or the next scheduled continuation review (renewal), whichever comes first (note, for studies in eResearch this means completing an amendment application in addition to the continuing review application). Studies in which all interaction and intervention with subjects has been completed, other than data analysis and long-term follow-up that does not involve any billing to subjects or health plans, are not required to convert to the new template.

The decision as to whether or not previously consented subjects should be reconsented will, for most studies, be left to the discretion of the principal investigators (PIs). PIs should assess the impact of the update to each study's consent on an individual basis. The PI's decision to reconsent should be noted in 1.5 of the eResearch amendment cover sheet (Legacy studies, section 11.1 of the Previously Approved Project Application). The IRBMED may require reconsenting on a study-by-study basis.

The IRBMED will be offering an information session to the research community on October 16 and again on October 23, from 2-3:30 in the MCHC Auditorium (click the date to register). If you would like to request a session for your specific department/unit, please contact the IRBMED to arrange a date and time.

Links

• New standard template
• PDF with all instructions
• Marked up copy of the pre-9-15-07 template with all the changes (note, the version date on this information form is not the final 9-15-07 date)

Email irbmed@umich.edu with questions or contact a member of your IRBMED regulatory team.

 

Posted 9/14/2007