Every submission arrives through
. Upon arrival it is logged into the database and acknowledged.
Step 1 Screening
It is screened to assure that all of the parts required for that level of review are present, all necessary forms are included and all of the fields are filled and signatures are in place.
- Study screeners will review the written study documents and attachments. They may return with questions to the investigator. Common problems include lack of a protocol or study description, referencing a grant and not attaching it, lack of recruitment materials or consent process, inclusion of a vulnerable population without the necessary forms.
- Investigator screeners will review materials about the people and places. These often generate more questions. Common problems include lack of signatures, CVs or training certificates and incomplete answers on forms.
When screening is complete, the package is released to an administrator who will be responsible for guiding the applicant through the process. The metric “Time to Approval” is based on this release time.
Step 2 Review
Studies submitted for determinations that the activity is not research or that there are no human subjects and those submitted for certification of exempt status will be sent to administrative review.
All non-exempt studies in the minimal risk category are reviewed using the expedited process. The administrator will work closely with the assigned reviewer. Reviews are done both electronically and in person in the office. Reviewers have authority to approve, ask questions leading to approval or refer to full board.
Step 3 Communication
The administrator’s responsibility is to communicate any issues to you quickly and clearly and to respond to your questions. Your responsibility is to respond completely and objectively. If the response does not make sense to you or irritates you, please call the administrator for clarification and advice. Almost always the response will need to be seen by the same assigned reviewer.
Step 4 Approval
Approvals are generally issued for one year. They are issued to one person for conduct at a specified place.
|Last Updated ( Wednesday, 16 September 2015 14:21 )