Recombinant DNA research must be done in accordance with the current edition of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules. Infectious Agent research must be done following the NIH/CDC publication Biosafety in Microbiological and Biomedical Laboratories. In addition, any substantive changes in procedures or type of recombinant and synthetic nucleic acid molecules/infectious agents should be reported to the IBC through an amendment to the active registration. This also includes changes in key personnel, laboratories, or other modifications to the active registration. An Annual Renewal and Modification Form must be submitted each year for each approved registration. A new registration document must be completed every three years. The allowance of a grace period would be out of compliance with National Institutes of Health and institutional policy.
The investigator should also be aware that doing work on an expired registration is a violation of NIH grants policy as well as the pertinent NIH regulations governing the specified research and would constitute a significant issue of non-compliance. Significant issues of non-compliance are reportable to the NIH and to the relevant funding section.
|New or Resubmission (Required every 3 years)
The IBC requires that all registrations are re-submitted as new registrations every 3 years. This review is referred to as a “de novo” review because the registration receives the same scrutiny by the Committee as if it were a brand-new submission. A notification will be sent by ORI in advance of the expiration date to the PI stating that the approved protocol is subject to the de novo review.
If the PI intends on renewing the protocol, the new protocol should be submitted early enough to avoid delays that could lead to a lapse in approval. ORI suggests, at a minimum, submitting to the meeting that occurs in the month prior to the original registration expiration (e.g., registrations expiring in June should be submitted for review at the May IBC meeting) to ensure proper time for review and approval.
|Annual Renewal and Modification Form||
The IBC requires that all registrations be renewed during the first and second year of the registration’s lifespan in order to remain active. Principal Investigators are required to complete an Annual Renewal and Modification Form.
**If the Annual Renewal and Modification Form is not completed by the submission deadline, the IBC may inactivate the registration.
|Notice of Termination||
If the PI is allowing the registration to expire or is terminating the project before its expiration date, ORI must obtain written confirmation from the PI that no work will continue prior to the expiration date and the disposal, transfer, or storage of biohazardous agents needs to be recorded.
This form must be completed when reporting adverse events or unanticipated problems to the IBC.
|Evaluation||IBC Risk Assessment & Evaluation Form|
Complete the two-step submission process by selecting and completing the appropriate form for your research.
- Submit the completed and signed form to: Office of Research Integrity, MSC 5738 (Electronic Signatures are accepted)
- Submit the completed form electronically (as a Word document) to: firstname.lastname@example.org
Prior to any committee action, all registrations must be submitted electronically and a dated and signed form must be received.