What's New on Legacy Applications

New Project Application

Prev. Approved Project App.

Emergency Use Report

ENGAGE-only Application

Request Form: Waiver of Consent

Request Form: Waiver of Documentation of Consent

This form is no longer valid. Use eResearch.

6/13/05

3/28/05

10/2/07

4/12/07

12/4/06

5/11/06

3/25/06

1/17/06

12/23/05

6/13/05

2/2/05

This form is no longer valid. Use eResearch

6/13/05

2/2/05

This form is no longer valid.

1/4/06

4/21/05

6/8/05

6/8/05

2/2/05

Previously Approved Project Application October 2, 2007

The instructions and section 6 were updated in connection with the new guidance for reporting of external adverse events. Click here to see a marked up copy of the application changes.

Previously Approved Project Application April 12, 2007

The instructions were modified to make it clearer that an electronic copy on CD or disk must be submitted with an application.

• The box at the beginning of the instructions, where directions to provide the IRB with an electronic copy are given, was changed from white to yellow.
• The instruction to submit an electronic copy on CD or disk was added, in red, to section one of the application.

Click here to see a sample.

Previously Approved Project Application December 4, 2006

The definition of 'unexpected' provided in Section 6 was changed to be consistent with the new web-posted guidance for adverse events.

CURRENT:

Unexpected: An event that has not been addressed or described in one or more of the following:

•  Informed consent document(s) for this study

•  IRB application for this study

•  Grant application or study agreement

•  Protocol or procedures for this study

•  Investigators' brochure or equivalent (for FDA regulated drugs or devices)

•  DSMB/DSC Reports

•  Published literature

PRIOR TO 12-4-06

Unexpected: Not included in consent document under “Risks”.

.

Previously Approved Project Application May 6, 2006

The 'completeness checklist' at the end of the application was deleted.

Previously Approved Project Application March 25, 2006

Inconsistencies in the instructions related to subject interactions/involvement (versus recruitment) and when a copy of the previously informed consent document should be submitted were resolved.

Previously Approved Project Application January 4, 2006

The AE/ORIO links in the application were repaired. No other changes were made.

Engage Only Application January 4, 2006

In response to an IRB-Council decision to integrate the recent OHRP and FDA Guidance regarding procedures for posting clinical trials information the application will be discontinued. Under the authority of the Office for the Vice President of Research, Engage web postings of IRB-approved protocols will no longer require separate IRB review and approval.

Previously Approved Project Application December 23, 2005

Section three, question 3.1 was changed to require a copy of the informed consent document(s) be submitted with an application as long as subject interactions are continuing, even if recruitment for the study has closed. For a marked up copy of the application section, click here.

 

eResearch—process changes made June 13, 2005:

• The paper-based New Project application is no longer posted, instead users are linked to the eResearch home page.
• Completed New Project applications will be accepted in the IRBMED office until 7/17/05.
• Exemption, HUD, and emergency use applicants should also use eResearch.
• Additional eResearch impacts on previously approved projects are noted on the Applications page.

HIPAA Waiver Forms—Changes made June 8, 2005:

A note was added indicating that these forms are not required if using eResearch

Engage-Only Project Application—Changes made April 21, 2005:

      The instructions were changed to indicate that we will accept the Engage-Only Project Application for studies in Legacy (the paper-based system) until a study is converted to eResearch. Studies initiated in eResearch should submit an amendment in eResearch to add an Engage posting in section 8.

New Project Application—Changes made March 28, 2005:

      Questions relating to the use of FDA controlled agents were revised in sections 7, 14 and 15. Click here to review the specific changes.

All Applications—Changes made February 2, 2005:

Ø      IRBMED Address changed throughout to:

Argus I Building

517 W. William

Ann Arbor, MI 48103-4943