Notice to Investigators: NIH Single IRB Mandate, effective January 25, 2018
The NIH Policy on the Use of a Single Institutional Review Board for Multi-site Research, effective January 25, 2018 will require all NIH funded multi-site studies, in which each site is conducting the same non-exempt human subjects research, to use a single IRB to obtain IRB review and approval for all participating sites.
The NIH policy applies to all studies that are:
- Funded through grants, cooperative agreements, contracts, or the NIH Intramural Research Program, and
- Involve non-exempt human subjects research, and
- Involve multiple sites, all of which are conducting the same protocol.
The policy does not apply to studies that are:
- Funded to foreign awardees and/or conducted at foreign sites, or
- Funded through career development, research training or fellowship awards, or
- Where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy, or
- Collaborative projects in which multiple sites are involved but different sites may complete different parts of the study.
If your proposal falls under this policy, please contact the Human Subjects staff at firstname.lastname@example.org and your Sponsored Projects team to coordinate your submission.
COLLABORATIVE NON-EXEMPT HUMAN SUBJECTS RESEARCH WITH EXTERNAL INSTITUTIONS
Investigators “engaged” in collaborative human subjects research with an external institution or external individual may or may not need a reliance agreement to conduct the human subjects research activities. Individuals may seek IRB approval through their home institution to cover research activities that are occurring at their institution and likewise, UCSB investigators may obtain IRB approval from the UCSB IRB to cover their own research activities.
Below are examples of instances that may not require a reliance agreement:
- If one site is only analyzing coded, de-identified data, and no one at that site can ever access the key linking codes to identifiers, then that site may not be considered "engaged" in human subjects research and therefore a reliance agreement would not be required.
In instances where a reliance request may be needed, investigators may request UCSB to be the IRB of record or may request to rely on another IRB’s review of the research. UCSB must evaluate each reliance request on a case-by-case basis when determining if UCSB will be the Reviewing or Relying IRB. Typically, UCSB will only enter into reliance agreements with institutions operating under a current FederalWide Assurance (FWA). If your collaborator is not operating under an institution that has a current FWA, contact the Human Subjects staff to discuss the collaboration. The sections below are intended to assist investigators when a reliance is needed.
If you are requesting UCSB to be the Reviewing IRB:
The Human Subjects staff should be contacted to discuss the collaboration before a reliance agreement is initiated. The location of research activities, as well who is serving as the lead investigators and the human subjects interactions and interventions to occur will play a role in determining whether UCSB will be the Reviewing IRB. The Human Subjects staff will discuss roles and responsibilities with you to determine whether the UCSB IRB can serve as the Reviewing IRB (or IRB of record) for the particular study.
If it has been determined that UCSB will serve as the Reviewing IRB, you will need to submit a protocol application in ORahs. If your project qualifies for exemption, please contact the Human Subjects staff to discuss whether a reliance agreement is needed for your project.
The protocol application should include, at a minimum, a description of the following:
- On the One Tab of the protocol, identify the investigators and the institutions they are affiliated with under the Collaborations section. Indicate whether they are obtaining IRB approval through their home institution or requesting to rely on UCSB’s IRB review of the research.
- On the Locations Tab, identify the research activities that are occurring at off-site locations with the external investigators. Provide a brief description of each location of activity.
- On the Procedures Tab, describe any human subjects research activities the external investigators will be conducting.
Depending on the collaborator’s role in the research, more information may be needed in the protocol application. For example, if you will be sharing identifiable private information with your collaborator, a description of the confidentiality/privacy risks and data sharing and storage may need to be included in your application.
It is important to coordinate the proposed research activity with your collaborator and their institution since each external institution will have local policies and procedures regarding their requirements for ceding review to the UCSB IRB. External investigators should discuss these requirements with their local IRB in advance of submitting a protocol through UCSB.
Once the protocol application has been reviewed and approved by the UCSB IRB, an IRB Authorization Agreement (IAA, i.e., a reliance agreement) will be negotiated.
Human subjects research may not commence until UCSB has approved the protocol and the reliance agreement has been executed.
If you are requesting UCSB to be the Relying IRB:
Contact the Human Subjects staff at email@example.com to discuss whether ceding review to another IRB is appropriate for the study.
If ceding review is appropriate for the study and the collaborating institution has agreed to serve as the IRB of record, then the following documents must be submitted to the Human Subjects staff before UCSB can agree to be the Relying IRB for the human subjects research activities:
- UCSB HSC Non UC Reliance Application
- UCSB HSC COI Checklist
After these forms have been completed, submit them to firstname.lastname@example.org for review. The Human Subjects staff will contact the Reviewing IRB to begin executing a reliance agreement. You will also be required to submit:
- The approval notice from the Reviewing IRB
- Approved consent forms
- Approved protocol
- Approved materials (such as the recruitment materials, surveys, questionnaires, instruments, etc.)
It is important to note that the Reviewing IRB may require additional documentation from you, such as completion of their training requirements, local recruitment materials, and documentation of ancillary reviews, etc. It is your responsibility to comply with any additional determinations and requirements of the IRB of record. It is recommended to coordinate external investigators to ensure you are in compliance with the Reviewing IRB’s requirements.
After the reliance agreement has been negotiated and executed, the Human Subjects staff will create a “Notice of Cede Review” for your record, which acknowledges the reliance agreement and outlines your investigator responsibilities, briefly summarized below.
Responsibilities of the UCSB Investigator:
- Forward relevant information (e.g., ancillary approvals) to the Reviewing PI before the study is submitted to the Reviewing IRB for initial review, amendments, or continuing review.
- Comply with the protocol as approved by the Reviewing IRB.
- Report any unanticipated problems, adverse events, protocol non-compliance or incidents to the UCSB IRB.
- Follow the Reviewing IRB standards for reporting any post-approval events, protocol violations, or incidents, in addition to following the UCSB IRB requirements for reporting.
Human subjects research may not commence until the Reviewing IRB has approved the protocol and the reliance agreement has been executed.
COLLABORATIVE NON-EXEMPT HUMAN SUBJECTS RESEARCH WITH OTHER UC INSTITUTIONS
If you are requesting a UC Reliance Agreement:
UCSB uses the online UC IRB Reliance Registry for all sites covered by the Memorandum of Understanding (MOU) between the UC campuses.
If you are a first-time user and have not used the Reliance Registry before, please see the:
Creating a New Reliance Request
- If you are the Reviewing PI, click the Create Request tab and disclose if your study involves the Veteran Administration. Complete the information regarding your role in the study and the other required fields marked by an asterisk. Make sure to save your entries if you need to log out at any time.
- If you are a Student Investigator for the Reviewing or Relying Campus, you must identify yourself as a Research Coordinator and your faculty sponsor as the PI. You will have access to the online reliance request but only Reviewing PIs may formally submit it via the Registry.
- Identify your Relying PIs. The Registry will notify Relying PIs via email to register and confirm their involvement in the study. Email addresses must be entered accurately as there is no bounce-back function in the system.
- Once all Reviewing and Relying PIs have signed up for the study via the Registry, the Reviewing PI will be able to sign a reliance request form, convert it to a PDF and submit it with their protocol application to their campus IRB for review.
- Upon approval of the study, the Reviewing IRB will add the approval/expiration date, approved protocol, approval letter and any applicable consent forms to the study’s Registry record and an automated email notice will be sent to all PIs and the Relying IRB.
- The Relying IRB will review the documents and accept or deny the reliance via the Registry. If accepted, all PIs and the Reviewing IRB will be notified of this decision via automated email.
Submitting Renewals and Amendments
Reviewing PIs should submit Continuing Review applications of their studies to their campus IRB, per usual. Upon approval, the Reviewing IRB will update the study’s expiration date in the Registry. No Relying PI can continue work on the study if the Reviewing Campus does not submit a renewal on time.
Amendments must be submitted to the Reviewing IRB who will update any changes to the study in the Registry. The Relying PI is also responsible for informing the Reviewing PI of any necessary amendments.
Reporting Adverse/Unanticipated Events
Reports of adverse and/or unanticipated events must be submitted to the Reviewing IRB staff who will update any changes to the study in the Registry. The Relying PI is also responsible for informing the Reviewing PI of any adverse/unanticipated events.