Policies

Statement of Practice: Approval Dates on Consent Documents & Recruitment Materials - ARCHIVED

IRBMED
Feb 27, 2014 12:00 pm

This document is obsolete as of August 22, 2018. It has been replaced by Statement of Practice: IRBMED Finalization of Study DocumentsClick here for PDF version of the current document.

When watermarking consent documents and recruitment materials, the watermark “Approval Date” is assigned in accordance with the date that the application was either “Approved” or “Approved with Contingencies.” This determination may be made by the Board or by an Expedited Reviewer.

  • STATEMENT OF PRACTICE

    When watermarking consent documents and recruitment materials, the watermark “Approval Date” is assigned in accordance with the date that the application was either “Approved” or “Approved with Contingencies.” This determination may be made by the Board or by an Expedited Reviewer.

    A. New Applications

    For new applications that are approved with contingencies, study activities may not begin until all outstanding contingencies have been met and verified with the IRBMED. At that time, consent documents and recruitment materials will be watermarked (when possible) with the “Approved with Contingencies” date.

    B. Scheduled Continuing Review or Amendment applications

    For Scheduled Continuing Review or Amendment applications approved with contingencies, study team members should continuing utilizing the most recently approved consent documents and recruitment materials until all contingencies are cleared and new/updated documents and materials are issued under “Approved Documents.” At that time, consent documents and recruitment materials will be watermarked (when possible) with the “Approved with Contingencies” date.

Questions?

Contact us at [email protected] or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: [email protected]
Last Updated: August 22, 2018 5:00 PM