Table 3 Processes of Ethics Review (n = 12)
From: Identifying structures, processes, resources and needs of research ethics committees in Egypt
Review Process | Response |
|---|---|
Investigators are required to submit protocol using an REC submission form | 58% (7/12) |
A primary review system is used to review protocols | 75% (9/12) |
Attempt to match subject matter of protocol to primary reviewer's expertise | 75% (9/12) |
A system is in place whereby the chair or an authorized person is able to approve protocols by an expedited review process | 42% (5/12) |
Number of days that REC members have to review materials prior to meeting | <3 days (0/11) 3-7 days (4/11) 8-14 days (5/11) >14 days (2/11) |
REC notifies investigators in writing of its decision | 92% (11/12) |
Time interval between meeting and written notification to investigators | Average: 5.2 days Median: 5 Range: 2-10 days |
Contents of Approval Letter | Â |
For studies approved for 1 year, approval letter states expiration date | 50% (6/12) |
Requirement to use the REC-approved informed consent form | 67% (8/12) |
Copy of REC-approved consent form is attached to the approval letter | 67% (8/12) |
Attached REC-approved consent form is stamped with expiration date | 25% (3/12) |