01/05/2012: Change in IRB Policy : Addendum A and Continuing Review

01/05/2012: Change in IRB Policy : Addendum A and Continuing Review

Last October IRB-01 announced a change in Addendum A requiring investigators to list the roles/functions of all study staff. This announcement (/docs/addaannounce.pdf) included the implementation plan for submitting the new version of Addendum A and became required on 12/01/2011.

During our first month of processing submissions with the new Addendum A we experienced some issues with Continuing Reviews. In order to provide a more efficient but still compliant process, the IRB voted to accept the following policy change when submitting an updated Addendum A along with your Continuing Review for 2012:

  1. You must submit a copy of the current Addendum A with your continuing review.
  2. This Addendum A must list all investigators, UFID#s and other staff currently engaged in the study.
  3. This Addendum A must list the roles and functions of everyone.
  4. You do not have to obtain the signatures of anyone listed on Addendum A that are included with Continuing Reviews that are submitted during the 2012 calendar year.

    1. If you are adding a new investigator or staff it is in your best interest to obtain their signature so you have documentation that they acknowledge their role on the study.
  5. IRB records will be updated to reflect only those people listed. Any subsequent changes will require an official revision AND the signatures of anyone added.
  6. If you choose to update to the current Addendum A with an upcoming Revision please indicate this in your Project Revision form. You should then include any updated Addendum As with future Continuing Reviews.

Signatures must always be obtained when submitting: (a) Addendum A for new studies (everyone listed must sign), and (b) revisions – anytime you need to change current staff roles or when new staff is added (only those affected need to sign).

Please let us know if you have any questions: (352) 273-9600 or ufirb-l@lists.ufl.edu.