Announcement
Clarification on handling the Human and Animal Subjects Section of the Electronic Approval Form
July 10, 2007
Starting July 1, 2007, any electronic approval forms prepared by SPHHP Research Administrative Services (RAS) will be sent to the PI with a “yellow light” in the “Special Approvals” section, as follows:

This is because RAS will no longer enter on the approval form any information regarding the use of human or animal subjects. After July 1, the PI (when s/he receives the electronic approval form) will need to click on the “Special Approvals” link and indicate on this page (shown below) whether or not human or animal subjects will be involved in that particular research project and, if so, whether key project personnel have received the appropriate training, whether IRB or IACUC approvals are pending or already received, etc. This change in procedure is being made because it’s important that the determination as to whether or not research subjects are involved (and therefore whether or not IRB or IACUC approval is indicated) is made by the PI and not by a staffperson in the RAS office.
Please note that in order for the PI to approve the form and send it to the Co-PIs and Department Chairs, s/he must complete this section. The default value for both of these sections is “Yes”; therefore, if no research subjects are involved, the PI must check “No” in both the Human subjects and Laboratory Animals section. If “Yes” is checked in either case, then the PI must complete the remainder of the section. In the case of Human subjects, the PI must indicate (a) have key personnel completed training, (b) Is IRB approval pending or received, and (c) the date of IRB approval or date that the protocol was submitted to (d) the appropriate IRB committee. See below regarding dating this section of the approval form
For Human Subjects:
- Check the first “Yes” box indicating that human subjects are involved
- Check the “Yes” box indicating that key personnel have completed training.
- Check the second box indicating that “Protocol is pending Approval” and was submitted to
- Check the applicable IRB committee
- Enter the current date or any date in the recent past
For Animal Subjects:
- Check the first “Yes” box indicating that animal subjects are involved
- Check the second box indicating that “IACUC approval requested on”
- Enter the current date or any date in the recent past.

If you have any questions regarding this procedure, please do not hesitate to contact me.
Regards,
Lesley
[ Top of Page ]
