10/21/2011: Addendum A change
Please see Dr. Iafrate’s official announcement regarding our recent change to Addendum A at:
IRB-01 recently added a new column on Addendum A to have investigators indicate what study activities they are engaging in. As part of this change, IRB-01 is also expecting investigators to list anyone who is engaging in the research by conducting any of the following activities:
- Interacts or intervenes directly with subjects
- Performs any study related activities but does not interact directly with study subjects
- Obtains informed consent
- Access or obtains, for research purposes, any PHI from paper or electronic medical records (e.g. EPIC)
- Enteres research related orders into EPIC for subsequent study physician or provider’s electronic signature approval
- Evaluates any adverse events, unanticipated events, and protocol deviations.
Researchers will be required to use this newest Addendum A on all future submissions on December 1st, 2011:
- New studies.
- Your next Continuing Review. New signatures are only required if you are adding previously unlisted investigators.
- Any revision that affects Addendum A. New signatures are only required if you are adding previously unlisted investigators.
Please read Dr. Iafrate’s announcement for further details: /docs/addaannounce.pdf