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Policy and Procedures for Review of Registrations

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 Three-Year, One-Year (BSL-3 & HGT), and Annual Update Requirements

Three-Year Renewals

  1. One hundred twenty (120) days before registration expiration correspondence is sent to the Principal Investigator (PI) stating that the approved protocol is subject to 3-year renewal and, if the PI desires to continue to perform the research uninterrupted, a new registration must be submitted. The letter indicates the deadline for the 3-year renewal submission.

  2. A reminder is sent ninety (90) days before registration expiration to the Principal Investigator (PI) restating the information in #1.

  3. A second reminder is sent sixty (60) days before registration expiration.

  4. A third and last reminder is sent thirty (30) days before the registration expiration. It is the responsibility of the PI to confirm with the IBC staff if he/she will not continue the registered research after the expiration date. Upon the date of expiration, registered agents can no longer be used.

  5. If no correspondence has been received from the PI, the Vice Provost for Research at Tufts and the Vice President of Research Administration at Tufts Medical Center are informed of the expired registration.

Annual Updates

  1. Ninety (90) days prior to the anniversary date of approval, correspondence is sent to the PI explaining how to complete the Annual Update form. The correspondence indicates the registration will be terminated if the Annual Update is not received by the anniversary date and subsequently approved by the IBC.

  2. A reminder is sent sixty (60) days prior to the anniversary date to the PI restating the information in #1.

  3. A second reminder is sent thirty (30) days prior to the anniversary date to the PI restating the information in #1. It the responsibility of the PI to confirm to the IBC staff if he/she will not continue the registered research after the anniversary date.

  4. If the Annual Update is not received and approved by the anniversary date, correspondence is sent to the PI indicating that the registration is terminated and what that entails (see Expiration Policy above). This information is also sent to the Vice Provost for Research at Tufts and the Vice President of Research Administration at Tufts Medical Center.

 

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