Releases and Updates to IRBMED Website - Archive For Notices prior to 2011

 

11/22/2010: Standard Operating Procedures - Updated. Summary of Changes Document.

10/22/2010: The guidance regarding Clinical Trials Registration (ClinicalTrials.gov information) was updated.

10/14/2010: The Informed Consent Template has been revised to address a problem with the approval stamping and fix misplaced bullets in the Genetic Information Nondiscrimination Act (GINA) language in the embedded Comments in Section 5.1. The Informed Consent Template Instructions were also updated to reflect the same changes.

10/6/2010: An updated version of the Legacy appplication for migration to eResearch / previously approved Legacy studies was posted.

10/4/2010: Revised Informed Consent Template updated with new headers, new Research-Related Injury for Industry-Sponsored, Federally-Funded and Investigator-Initiated Internally Funded Projects language has been added to the Comments in Section 8.1, and new Genetic Information Nondiscrimination Act (GINA) language has been added to the Comments in Section 5.1. Study teams submitting a New Project Application will be required to use the new informed consent template. Study teams with a Currently Approved Application do not need to take any immediate action.  Study teams submitting an Amendment to a Currently Approved Application will be required to update the informed consent document using the new template .

6/23/2010: Revised the Privacy Board Website

4/6-7/2010: Revised Informed Consent Template Announcement.

3/23/2010: Updated the name change and web link for the Clinical Research Calendar Review & Analysis Office (CRAO), formerly the Clinical Research Billing Unit (CRBU)

3/18/2010: Updated the link to the Final Oct 2009 "Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects"

2/24/2010: Standard Operating Procedures - Updated.

1/21/2010: Updated the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Unanticipated Problems Involving Risks to Subjects or Others (UaPs). Changed "UM Adverse Event Timetable to "UM Adverse Event Reporting Timetable." Changed "standard UM timetable" to "UM Standard Timetable" under "The Study-Specific AE Reporting Option" and "The 'Study-Specific' AE Reporting Option box.

1/21/2010: Reworded "Reports and Letters from Oversight Agencies" to "Reports and Letters from Oversight Bodies and Agencies. Updated the section to read: Reports to or from internal oversight bodies...should be submitted to the IRBMED for review according to the UM Standard Timetable for Adverse Event (AE) or Other Reportable Information or Occurence (ORIO) OR as required in the Study Specific AE Reporting Timetable which may allow for non-concurrent reporting.

1/21/2010: Changed the title of the "Study Specific Timetable" to "Study Specific AE Reporting Timetable."

1/21/2010: Updated the UM Standard Adverse Event Reporting page. Reworded "Study Specific Timetable" with Study Specific Adverse Event (AE) Reporting Timetabl in the second paragraph.. Reworded the first Event Type to oversight body or agency. Reworded the first timeline to "Concurrently (in relation to reporting) Reporting should occur in parallel or no later than five (5) calendar days to all oversight bodies or agencies."

1/20/2010: Reformatted the Study Specific Adverse Event Reporting Timetable and reworded the first timeline (deleted the word 'sooner') so it was in accord with the the second row of the table.

12/7/2009 Added links on the IRBMED Guidance page to FDA guidance: Emergency Research with Exception from Informed Consent

11/23/2009 Added links on the IRBMED Guidance page to FDA guidance: Use of Investigational Products When Subjects Enter a Second Institution

10/27/2009 Standard Operating Procedures--Updated.

10/26/2009 Reconsenting Study Subjects Guidance--posted.

10/22/2009 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.

10/19/2009 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.

9/17/2009 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.

9/14/2009 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.

9/14/2009 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.

9/7/2009 "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.

9/3/2009 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.

9/3/2009 Adverse Event Reporting Index--We added a link to the new Humanitarian Use Device AE reporting guidance.

9/2/2009 FDA Part 11 Electronic Signature Certifications and Assessments for eResearch and CareWeb--Archived documents for Careweb: Letter and Checklist.

8/20/2009 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.

8/13/2009 Urgent Amendment Guidance—Updated to include details regarding the required reports.

7/16/2009 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.

7/16/2009 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.

7/14/2009 Patient Release Form for Case Studies posted on the Forms page.

6/1/2009 Urgent Amendment Guidance posted.

5/14/2009 Informed Consent Process Guidance—Updated.

4/30/2009 Accessing Medical Records posted..

4/20/2009 Frequesntly Asked Questions--We updated the IRBMED turn-around-time and number of submissions received each year on the About IRBMED page.

4/20/2009 Instructions for American Reinvestment and Recovery Act (ARRA) Submissions posted.

1/28/2009 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 Guidance posted.