Protocol Review

IBC approval of Biological Research Registrations (also known as IBC protocols) is effective for five years. Principal Investigators must complete an Annual Update each year to continue work for up to five years after the initial approval. After five years, a new application must be submitted to the Committee in what is known as the de Novo review process.

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What is Reviewed?

The NIH Guidelines require that all research involving nucleic acids at NIH sponsored institutions be reviewed and approved by the IBC. The NIH has classified certain recombinant DNA (rDNA) work as “Exempt” from the requirements of the Guidelines. However, Brandeis requires that all work involving rDNA and synthetic nucleic acid molecules, including those considered “Exempt” by the NIH, be registered with and approved by the IBC.

The IBC is responsible for reviewing research involving the use of recombinant and synthetic nucleic acid molecules and biohazardous materials. Biohazardous material is considered to be an infectious agent or biological material presenting a risk to the health of humans, animals, or other forms of life.  Included in this are microorganisms, fungi, viruses, bloodborne pathogens, human and non-human primate cells and tissues, select agents, and biological toxins.
Protocol Review Process

The following provides an overview of the Brandeis IBC registration review process for both new/de Novo applications, as well as administrative and scientific modifications to existing registrations.

I. Pre-Review

All submissions to the IBC Office undergo a pre-review process before they are sent to the IBC for review. This is a review to ensure that, based on the type of submission (i.e. initial registration, de Novo, modification, annual update, etc.), the appropriate forms have been completed. Administrative and scientific sections will be checked for appropriateness and/or completeness.

 

II. Types of Review

a. Administrative Review

All administrative modifications (change in title and funding source, personnel changes, etc.) are reviewed by the IBC Office. The official determination is communicated to the PI by the IBC Office electronically. The IBC is notified of all administrative modifications during IBC meetings.

b. Full Committee Review

Once an initial registration/de Novo or a scientific modification application has been pre-reviewed by the IBC Office, it is added to the agenda for the next IBC meeting. Approval of these research projects may be granted only after review at a convened meeting of a quorum of the IBC and with the approval vote of a majority of the quorum present. No member may participate in the IBC review or approval of a research project in which the member has a conflicting interest except to provide information requested by the IBC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.

The comments (i.e. approval, revisions, etc.) from the meeting will be shared with the PI by the IBC Office electronically.

If revisions are required, the PI should submit the revised application to the IBC Office. This is sent for further review to the IBC Chair or back for another Full Committee meeting, depending on what has been decided during the initial Full Committee review meeting. The revision application is officially approved when either the Full Committee or the IBC Chair has reviewed and approved the application.

 

III. Review Outcomes

a. Approval

Once the Full Committee (or IBC Office in the case of administrative modifications) has approved the application, the IBC Office will send an electronic approval notice to the PI.

b. Conditional Approval

The application is approved contingent on minor revisions that need to be made. Once revised, the IBC Chair reviews the application. Once the IBC Chair approves of the revised application, the IBC Office will send an electronic approval notice to the PI.

c. Withholding Approval

The committee members can also vote to withhold approval. The PI receives written notification, including the reason for this decision, and must have an opportunity to respond in person or in writing

 

IV. Continuing Review

a. Annual Update

All annual updates are reviewed by the IBC. The primary purpose of this review is to inform the Committee of the current status of the project – if it needs to continue for an additional year or if it should be terminated. The purpose of this form is to inquire about the status of the registration (active or cancel/terminate).

If the Annual Update form is not completed by the submission deadline, the IBC may inactivate the registration.

b. Five-Year de Novo Registration

The IBC requires that all registrations be re-submitted as new registrations every 5 years. This review is referred to as a “de Novo” review because the registration receives the same level of review 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. The review of de Novo registration applications follows the same process as an initial registration application.