Releases and Updates to IRBMED Website

If you need historic information that pre-dates this webpage or more detailed information about historic guidance please contact the IRBMED office.

10-27-09 Standard Operating Procedures--Updated.

10-26-09 Reconsenting Study Subjects Guidance--posted.

10-22-09 Additional guidance provided regarding "Concurrent Reporting"--We added a statement to the Glossary and to the Study-Specific Reporting Plan Guidance to emphasize that investigators may delinate an exception plan and submit it to the IRB for approval.. These requests may be made for studies using the UM Standard AE Timetable as well as those choosing a Study Specific Timetable.

10-19-09 Revisions made to the Standard Informed Consent Template (click for details)--We changed the bullets in section 11 of the template from rectangles to solid circles because some auditors/study monitors interpreted the bullets to be checkboxes. Amending your consent document to reflect this change is left to the discretion of the principal investigator. Details are provided in the link above.

9-17-09 University of Michigan Registration with FDA and OHRP--information page posted. This page is linked from the "About IRBMED" page and the "Guidance" page. It provides information frequently requested by sponsors regarding the University's compliance with new registration rules.

9-14-09 Legacy Previously Approved Project Application--We revised questions 4.3 and 5.3 to match the corresponding question in the eResearch application. Instead of providing recruitment information with regard to race, ethnicity, and gender in a table, study teams must answer this question: Please describe the discrepancies between projected and actual enrollment progress. Also, explain how subject recruitment has been fair and equitable with regard to race, ethnicity, and gender.

09-14-09 Assent Template--We have added fields for the patient ID # and date of birth on the signature page. These fields are optional at the discretion of the principal investigator (PI) and/or IRB as determined for a particular study. We also fixed two typographical errors in the text. The PI may determine whether or not to update to the new template. You must submit an amendment if you switch to the new template.

09-07-09 "Is an IDE Required?" Guidance Document--We temporarily removed this from the website for updates. A link to an FDA guidance page is posted. Investigators can request further assistance on IDE issues by contacting the IRBMED offiice.

09-03-09 UM Standard Adverse Event Reporting--We reordered the display of information on the page to increase usability and added a link to the new Humanitarian Use Device AE reporting guidance.

09-03-09 Adverse Event Reporting Index--We added a link to the new Humanitarian Use Device AE reporting guidance.

09-02-09 FDA Part 11 Electronic Signature Certifications and Assessments for eResearch and CareWeb--We added these documents to the About IRBMED and the Guidance pages.

08-20-09 Humanitarian Use Device (HUD) Guidance--This new guidance reviews what type of application should be submitted for the different uses of an HUD and the reporting requirements.

08-13-09 Urgent Amendment Guidance—Updated to include details regarding the required reports.

07-16-09 Miscellaneous ORIO Reports Guidance—Modified the language regarding audits and inspections to include the following sentences from the UM Human Research Protection Program Operations Manual:  Any external investigation, inspection or other external review and its outcome must be reported to the IRB responsible for the research in question. Researchers should consult with their administrators, MICHR, the IRBs, as appropriate, OVPR, and/or the Office of the Vice President and General Counsel for assistance and representation.

07-16-09 ORIO Reporting Timetable—We revised the table to require 'Audits and Inspections' be reported as soon as possible after notification of the audit rather than within 7 days.

07-14-09 Patient Release Form for Case Studies posted on the Forms page.

06-01-09 Urgent Amendment Guidance posted.

05-14-09 Informed Consent Process Guidance—Updated.

4-30-09 Accessing Medical Records posted..

04-20-09 Frequesntly Asked Questions--We updated the IRBMED turn-around-time and number of submissions received each year on the About IRBMED page.

04-20-09 Instructions for American Reinvestment and Recovery Act (ARRA) Submissionsposted.

01-28-09 Exempt Research Guidance—Updated.

09-26-08 Assent Template announcement with waiver instructions posted.

09-13-08 Assent Template for Children Ages 10 to 14 posted.

09-13-08 Guidelines for Use by the IRBMED in Determining When Assent of Children Should be Waived or Required posted.

08-22-08 Clinical Research Billing Unit information page posted.

07-21-08 International Research Guidance—Updated.

06-25-08 Guidelines for Stacking Documents in eResearch posted.

04-11-08 UM Standard Adverse Event Reporting Timetable--Updated.

02-29-08 Advocate for Ward of the State Guidance—Updated.

02-11-08 Emergency Use of a Test Article Guidance—Updated.

02-01-08 Unanticipated Problems Guidance—We revised the examples provided.

01-28-08 Wards of the State Guidance—We linked additional supporting documents to this page.

01-17-08 Who Can Consent Guidance—Updated.

01-03-08 Clinical Trials Registration--Updated.

12-17-07 Clinical Trials Registration posted.

11-26-07 Wards of the State Guidanceposted.

09-28-07 Unanticipated Problems Guidance posted.

09-28-07 UM Standard Adverse Event Reporting Timetable--Updated.

07-31-07 General Guidelines—Updated.

07-18-07 IRBMED Guidance for IRB Reviewers and Medical School Investigators Regarding Genetic/DNA Research Studies--Updated.

04-09-07 IRBMED Standard Operating Procedures—Updated.

01-11-07 Exception from Informed Consent for Emergency Research--A new policy stipulating the requirements for conducting this type of research at UM replaced the previous policy which did not allow this type of research to be performed at this University of Michigan.

10-02-06 Approval Dates on Informed Consent Documents posted.

09-30-05 Exempt Research Guidance posted..

09-10-05 Informed Consent Process Guidance—Updated.

09-05-05 Non-English Speaking Subjects Guidance posted.

09-05-05 Tips on Preparing Understandable Informed Consent Documents posted.

07-18-05 General Guidelines--Updated.

07-01-05 Informed Consent Process Guidanceposted.