Our IRB reviews amendments and adverse events as they are submitted, and
if any action is required, it is done at the time, for example, updating
informed consent due to an unanticipated adverse event.

At the time of annual review (although some protocols are reviewed either
quarterly or semiannually) investigators are required to fill out an
"Investigators Report on Review of Research Protocols Involving Human
Subjects".  This is a two page form, created by a subcommittee which asks
pertinent questions.  A sample of the questions are as follows:

Number of patients enrolled (locally or nationally, if known).    KH
Number of patients currently being followed.
Number of serious adverse events (mentioned in consent).
Number of unanticipated adverse events.
Any significant new findings?
Any change in risk/benefit ratio?
Any amendments, and if so, have they received previous IRB approval?

The forms are then submitted as part of the agenda each month for each
committee member to review.  During the meeting, the chair asks the
committee members to state concerns for or objections to continued approval.

Ronald Polizzi
Director, Grants/Faculty Finance
Cooper Hospital
Camden, New Jersey
Phone: 609-342-3130
EMail: xxxxxx@umdnj.edu