I would like to learn more about IRB reliance
What is IRB reliance?
IRB reliance (or “single IRB review”) is a legal arrangement that allows one IRB to review a study that is occurring at multiple sites or to review a single-site study that involves personnel from multiple institutions. Opportunities for single IRB review are established by entering into formal IRB reliance agreements.
Under what circumstances can single IRB review be arranged?
- When the KUMC IRB is being asked to serve as the Reviewing IRB for a multi-center study
- When KUMC personnel plan to participate in research covered by another IRB
- When KUMC investigators plan to conduct research at non-KUMC locations and personnel from the non-KUMC location will be part of the study team, or
- When non-KUMC personnel come to KUMC to participate in our research
Is KUMC willing to serve as the single IRB for a multi-site study?
Yes, in many cases KUMC is able to serve as the single IRB. The IRB will evaluate the investigator’s plan to oversee the study and assist the investigator in making arrangements for review of the non-KUMC sites.
How do I get approval to work with an outside IRB?
When requesting oversight by an outside IRB, investigators must always start with a permission from their home institution. The KUMC Human Research Protection Program (HRPP) provides an abbreviated application form; requests are reviewed administratively by HRPP staff.
What is an IRB reliance agreement?
A reliance agreement is signed by two or more institutions that normally would be required to conduct their own IRB review. The reliance agreement allows for one IRB to conduct the review that fulfills federal requirements about human subjects protection. The other institutions ‘rely’ on the Reviewing IRB, thus streamlining the approval process. Even when relying on another IRB, all institutions must comply with applicable state laws and institutional policies.
Why are reliance agreements necessary?
Every institution is responsible for research conducted by its own personnel, regardless of where the research occurs. When KUMC personnel conduct human subjects research, the institution has two options:
· Review the research through the KUMC IRB, or
· Arrange reliance on another qualified IRB
KUMC personnel may not conduct human subjects research until approval has been obtained through one of the above options and all institutional requirements have been met.
Which IRBs can I use?
Our current IRB reliance arrangements include:
- SMART IRB (a network of multiple academic institutions, hospitals and institutes across the United States)
- National Cancer Institute Adult IRBs
- National Marrow Donation Program
- Advarra IRB
- WCG IRB
- Frontiers Regional Partners (Children's Mercy Hospital, St. Luke's, UMKC, KCUMB)
- Great Plains Cooperative (12 medical centers, funded by PCORNET)
- StrokeNet network
- KU Lawrence campus
- KU School of Medicine-Wichita collaborations
- Individual research consortium
Do the reliance requirements differ if the research is a student project?
Student projects require the same reliance arrangements if the project is being conducted as part of the student’s degree requirements. On the other hand, students may pursue research opportunities for personal and professional enrichment. Research being undertaken for the student’s enrichment may not require an approval or reliance by KUMC.
Besides IRB review, what else do I need?
Even when an external IRB reviews and oversees a project, there are other institutional requirements that must be addressed. These include requirements for investigator training, conflict of interest review, HIPAA, data security, radiation safety, management of grants and contracts, and compliance with state laws. These additional requirements are categorized as “local context” issues that are evaluated at the time the study is proposed.
Once an external IRB has approved the study, what updates does KUMC require?
Investigators using an external IRB remain responsible to update the HRPP when key events occur. The HRPP must be aware of:
- Changes to the principal investigator or other study personnel
- Any changes to the local context information on the consent documents
- Any KUMC specific recruitment materials
- Updates on conflict of interest disclosures
- Changes that impact any of the KUMC ancillary reviews (such as changes to the amount of radiation used in the study)
- Contractual changes related to payment for study-related injury
- Changes impacting HIPAA privacy or data security
- Changes impacting costs to participants
- Addition of payments to participants, if payments were not included in the original submission or the removal of payment to participants if payments were included in the original submission but will no longer be issued
- Adverse events that occur to a subject at our site:
- Serious protocol deviations at our site
- Continuing Review Approvals or Study Closures by the External IRB
- Adverse events and protocol deviations should be reported for any that occur at the KUMC site. However, these should be reported as RNIs and not as external updates to the study. Additional information can be found on the RNI reporting page.
When should I request single IRB review?
Please request a single review as early as possible, in the planning stages of your project.
· For new studies, the PI should pursue this step before the grant submission (if applicable) or before submitting the protocol to any IRB for review.
· When a new site or external collaborator is added to a study that is already approved at KUMC, please contact the IRB office as soon as the site or collaborator is identified. The KUMC IRB office can work with the other organization to see if they will rely on our review.
How do I get started with a request for single IRB review?
All research proposals are submitted through our electronic IRB system. Instructions are included in the various reliance scenarios discussed on this website.
Where can I learn more about single IRB review?
The KUMC HRPP has a dedicated IRB reliance specialist. For questions, you may contact IRBreliance@kumc.edu.