Entering Compliance Information in Proposal Development

The Compliance option in the Proposal Development document is used to indicate when circumstances exist that may require additional review. Those circumstances are:

• The inclusion of human subjects, whether sponsor or MSU initiated
• The inclusion of animals
• If international activities are taking place
• The need for additional space or renovations
• COI – Board of Trustee Review
• The inclusion of export-controlled information, if known at the time of proposal

WHO:

• College/Department Administrators
• Principal Investigators/Key Personnel

WHEN:

• Proposal includes one of the circumstances listed above

HOW:

1. Click on the Compliance option within the Proposal Development document.

2. Click on the Add compliance entry button at the top of the screen.

3. Select the Type from the drop-down menu, this is a required field and must be completed.
4. Select the Approval Status from the drop-down menu, this is also a required field.
   • For Human Subjects and Animal Use, unless there is already an approved study/protocol, Pending should be selected as the Approval Status, even if the Investigator has not yet applied for approval. This is to fulfill federal form requirements.
5. Enter the Compliance Identifier, if known. A Compliance Identifier is required if you have selected Human Subjects as your Type, with Approved as the Approval Status.
6. Enter the Application Date if you have already submitted an IRB or IACUC study/protocol for review.
7. Enter the Approval Date, if you have received an approval letter from the IRB or IACUC for a non-exempt study/protocol.
8. Enter the Expiration Date, if you have received an approval letter from the IRB or IACUC for a non-exempt study/protocol.
9. Select the Exemption # from the scroll down list when “Human Subjects” is selected for Type and the Approval Status is exempt. Please note the Exemption field is intended exclusively for system-to-system proposals and is related to OHRP regulations. You can select multiple exemption numbers from the list by holding down the control key when clicking on subsequent values.
10. Additional details may be provided in the Comments field.
11. Click the Add Entry button to add the item to the Compliance option.

12. Select the Save or Save and Continue button at the bottom of the page.
13. Once added, to view or edit the information, click the triangle icon next to the entry.  To delete the entry, click the trash icon.