ARTICLE H.13. PLAN FOR SINGLE INSTITUTIONAL REVIEW BOARD (sIRB)
For this multi-site study, the (contractor/each contractor) agrees to adhere to the NIH sIRB policy, and the (IRB Name) IRB shall serve as the single IRB of record. All participating sites have agreed to rely on the (IRB Name) IRB, and a written authorization/reliance agreement shall be developed. Any additional sites added after contract award shall also agree to rely on this study's single IRB of record. Communication plans for interactions between the sIRB and participating sites shall be described in the authorization/reliance agreement. All participating sites shall, prior to initiating the study, sign the authorization/reliance agreement that shall clarify the roles and responsibilities of the sIRB and participating sites. The (Contractor Name/Name of the Coordinating Center or Contract Research Organization (CRO)/Names of Contractor's Lead Person and Alternate Person) shall maintain records of the authorization/reliance agreements, including the communication plans. The approved sIRB plan will be incorporated as a term and condition of the award. Any updates/changes to the plan shall be provided to the Contracting Officer's Representative with a copy submitted to the Contracting Officer within 30 calendar days.
Exceptions to the Single IRB Plan
The Contractor may request an exception to the sIRB plan under the following instances:
Sites for which federal, state, or tribal laws, regulations or policies require local IRB review (policy-based exceptions)
Review by a single IRB of record will not be possible for (sites)because of federal/state/tribal law, regulation, or policy (provide specific citation(s))
Review by a single IRB of record will not be possible for (this contractor)because of (provide compelling justification and rationale why local IRB is uniquely qualified to be the reviewing IRB for the specific site(s)).
Time Limited Exceptions: New multi-site non-exempt human subjects' ancillary studies, that would otherwise be expected to comply with the sIRB policy, but are associated with the ongoing multi-site parent studies, will not be required to use the sIRB of record until the parent study is expected to comply with the sIRB policy.
Review by a single IRB of record will not be possible for (sites)because of ongoing multi-site parent study (provide parent contract number).
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****(USE BELOW IN SOLICITATIONS AND CONTRACTS FOR APPLICABLE CLINICAL TRIALS.
ADDITIONAL INFORMATION ABOUT THIS ITEM:
For information about how to determine "applicable clinical trials" see Step 1 of the following link: http://grants.nih.gov/ClinicalTrials_fdaaa/index.htm#whatsteps
For information about how the "Sponsor" role is determined, see the flowchart at: http://grants.nih.gov/ClinicalTrials_fdaaa/docs/registration_flow_chart.pdf
ADDITIONAL INFORMATION TO COMPLETE THIS ITEM:
CLINICAL TRIALS CONDUCTED UNDER INVESTIGATIONAL NEW DRUG/INVESTIGATIONAL DEVICE EXEMPTION (IND/IDE) REQUIREMENTS:
INCLUDE this Article in all contracts as follows:
When the Contractor is the IND/IDE holder (Sponsor) select the words: "Contractor is the Sponsor, therefore the" from the drop down box.
When the Government is the IND/IDE holder (Sponsor) AND the Government will delegate the role of "Responsible Party" to the Principal Investigator, select the words: "Government is the Sponsor and delegates the Contractor's Principal Investigator as" from the drop down box.
When the Government is the IND/IDE holder (Sponsor) AND will not delegate a PI as "Responsible Party," select the words: "Government is the Sponsor, therefore" from the drop down box.
If neither the Government nor the Contractor is the IND/IDE holder, consult with the Project Officer to determine how to address this situation. Note: If none of the choices in the drop down box apply in this situation, you can delete the drop down box and insert the appropriate Sponsor information.
SINGLE CENTER TRIALS (not conducted under IND/IDE requirements):
INCLUDE this Article in all contracts as follows:
When the Government will not delegate the PI as "Responsible Party," select the words, "Government is the Sponsor, therefore" from the drop-down box.
When Government will delegate the PI as the "Responsible Party," select the words: "Government is the Sponsor and delegates the Contractor's Principal Investigator as" from the drop down box.
If neither the Government nor the Contractor has initiated the trial (neither is the "Sponsor"), consult with the Project Officer to determine how to address this situation. Note: If none of the choices in the drop down box apply in this situation, you can delete the drop down box and insert the appropriate Sponsor information.
MULTICENTER TRIALS (not conducted under IND/IDE requirements):
INCLUDE this Article in the contract as follows:
When the Government will not delegate a PI as "Responsible Party," select the words, "Government is the Sponsor, therefore" from the drop-down box AND include this Article in all of the multi-center trial contracts.
When Government will delegate a PI as "Responsible Party," select the words: "The Government is the Sponsor and delegates the Contractor's Principal Investigator as" from the drop down box AND include this Article in only the contract that has been delegated "Responsible Party" (generally the designated lead clinical site) Note: Contractors involved in the Multi-Center trial, but not designated "Responsible Party, will require the clause in the next item (Below) .
Note:The Contracting Officer should consult with the Project Officer/Contracting Officer's Representative (COR) to assist in making this determination )****
