Agreement Characteristics

The resulting Master IBC Reliance Agreement (“IBC Agreement”) [14] provides a flexible and replicable framework for IBC reliance that can be adapted by other academic medical centers and research institutions that, given the current NIH Guidelines [10], share geographic location. The requirement that IBC membership includes two members “of the surrounding community” [10] has been interpreted narrowly to imply that the community members must be residents of that community; the IBC Agreement, therefore, is currently limited in its reach to local institutions.

The Master IBC Agreement allows for sIBC review across 16 institutions in Boston and Cambridge, MA. The initial signatories are listed in Table ​Table1.1. The IBC Agreement specifies a process whereby the Principal Investigator (PI) or IBC administrator can propose that an institutional IBC review on behalf of other institutions or, alternatively, cede review to the IBC of another institution for a specified project. In order to request ceded review, investigators must complete and submit a Cede Review Form prior to submitting their IBC application. Each participating IBC makes the decision on a protocol-by-protocol basis whether to rely on the review of another IBC (to cede the review) or to conduct its own review. The IBC Agreement does not require or prescribe reliance for all protocols; each institution determines the appropriateness of reliance on a protocol-by-protocol basis. The process for ceding review is outlined in Fig. ​Fig.11.

Harvard catalyst reliance model Institutional Biosafety Committee (IBC) cede review process. The process for IBC reliance involves not only the IBC but also institutional and IBC leadership and the involved investigators. PI, Principal Investigator; sIBC, single IBC.

The bulk of the IBC Agreement is devoted to defining roles and responsibilities of the Reviewing IBC and the Relying Institution. Section IV of the NIH Guidelines (2019) is devoted to the roles and responsibilities of the institution, the IBC, the Biological Safety Officer (BSO), and the PI. The IBC, in particular, has numerous responsibilities, including assessing the containment levels, facilities, and procedures involved in the proposed research. The IBC is also required to review and screen the expertise of personnel listed on each project to ensure appropriate education and training. The sIBC Agreement delineates the responsibilities that are shared or partitioned between the Reviewing IBC and the Relying Institution. The reviewing IBC has responsibility for the elements of the IBC protocol review including review of the application, access to minutes, approval notification and updates, and communication regarding suspension, termination, accidents, spills, and exposures. The Relying Institution has responsibility for elements related to their own staff and facilities, including training, facility inspections, and an occupational medicine program. There are a number of responsibilities that are shared between the collaborating institutions, including compliance requirements (e.g., reporting of incidents to NIH). Table ​Table22 provides a further list of requirements for the reviewing and relying IBCs.

Responsibilities of participating institutions and IBCs outlined in IBC agreement

Maintain current IBC registration with NIH OSP, as appropriate

Notify other Participating Institutions if registration with the NIH OSP is terminated

Maintain current IBC registration with NIH OSP, as appropriate

Notify other Participating Institutions if registration with the NIH OSP is terminated

Maintain local municipality registration for recombinant or biological materials as applicable

Maintain local municipality registration for recombinant or biological materials as applicable

Perform review consistent with applicable laws, regulations, and guidance

Determine whether health surveillance and immunizations are necessary

Report to Reviewing IBC special considerations that may impact the review process

Right to review and comment, but not approve application

Make IBC minutes available to Relying Institution

Allow attendance of (nonvoting) representatives of Relying Institution to IBC meeting

Acknowledges that Reviewing IBC holds jurisdiction over review and IBC oversight of ceded Research

If requested by Reviewing IBC, send a Relying IBC representative to the meeting to ensure adequate consideration of location conditions.

Executing additional requirements imposed by Reviewing IBC (e.g., additional training, health screenings)

Notify Investigators and Relying Institution of review decisions

Notify Investigators of renewal deadlines

Notify Relying Institution of Suspension or Termination

Submitting Annual Report to NIH and applicable local municipality

Notifying Biological Safety Officer (BSO), Occupational Health and other institutional personnel of information received from Reviewing IBC

Upon receiving information regarding an accident, spill or exposure, and in consultation with PI and BSO, determine if notification to Relying Institution is required.

Determine with Relying Institution if external reporting is necessary.

Determine with Reviewing IBC if external reporting is necessary.

Investigate allegations of noncompliance

Afford Relying Institution an opportunity to attend any meetings associated with the investigation of noncompliance

Notify Relying Institution of decision and steps necessary for remediation of noncompliance

Notify reviewing IBC of any identification of noncompliance

Perform routine inspection of their own facilities

As needed, perform routine, not-for-cause audits with reasonable notification of Relying Institution facilities.

Perform routine inspections of their own facilities.

As needed, perform routine, not-for-cause audits with reasonable notification of Reviewing Institution facilities.

Provide training to their respective Investigators, Research Personnel, and IBC members

Provide training to their respective Investigators, Research Personnel, and IBC members

Provide an Occupational Health and Safety Program

Agree to work with counterpart at other Participating Institutions where necessary

Provide an Occupational Health and Safety Program

Agree to work with counterpart at other Participating Institutions where necessary

Develop policies and procedures to address injuries, accidents, illnesses, or emergency situations

Share these policies with Participating Institutions

Develop policies and procedures to address injuries, accidents, illnesses, or emergency situations

Share these policies with Participating Institutions

Report injuries, accidents, and serious adverse events to the Reviewing IBC

Notify Relying Institution of determination that external reporting is needed.

Give Relying Institution an opportunity to review and comment on report

Consider filing a joint report with the Relying Institution

Notify Reviewing IBC of determination that external reporting is needed.

Give Reviewing IBC an opportunity to review and comment on report

Consider filing a joint report with the Reviewing IBC

Distribute relevant annual reports and/or meeting materials to Relying Institution (e.g., meeting minutes)

Distribute relevant annual reports to Reviewing IBC (e.g., safety reports)

Agree to work collaboratively to settle any differences. If a disagreement cannot be resolved, Participating Institutions may request that the respective Institutional Officials communicate to resolve the matter.

Agree to work collaboratively to settle any differences. If a disagreement cannot be resolved, Participating Institutions may request that the respective Institutional Officials communicate to resolve the matter.

IBC, Institutional Biosafety Committee; NIH, National Institutes of Health; OSP, Office of Science Policy; BSO, Biological Safety Officer; PI, Principal Investigator

To avoid confusion and to help standardize processes, model forms and other resources for ceding review have been developed [14]. In addition, the signatory institutions agreed to periodic review and re-evaluation of the sIBC agreement in order to allow for interval quality and operational improvement. The process is simplified by the development of and utilization of shared forms and server access.