Policy on Regulatory Requirements for Continuing Review of IBC Registrations
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 form must be submitted each year for each approved registration. For BSL-1 and BSL-2 registrations, a new registration document must be completed every three years. For BSL-3 and Human Gene Transfer registrations, a new registration document must be submitted yearly for the Boston/Medford IBC. 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.
IBC Administrative Policy and Procedures for Notification of Annual Renewals and Three-Year De Novo Review Requirements
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 form which will be provided to the PI by the IBC Office. This form includes questions such as inquiring the status of the registration (active or cancel/terminate) and reporting any adverse events which may have occurred during the past year.
If the Annual Renewal form is not completed by the submission deadline, the IBC may inactivate the registration.
Three-Year De Novo Review
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 is sent by the IBC Office well in advance of the expiration date to the PI stating that the approved protocol is subject to the de novo review. Notifications will continue to be sent by the IBC Office until either a new de novo protocol is submitted or the PI confirms the registration’s termination (see Terminations/Expirations of Registrations below).
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. The IBC Office 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.
Terminations/Expirations of Registrations
If the PI is allowing the registration to expire or is terminating the project before its expiration date, the IBC Office 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.