TAMUK IAA - TAMUK as reviewing IRB

Local Context Worksheet

Continuing Review Local Context Worksheet

(to be use when renewing a protocol upon expiration of approval)

 

What is Collaborative Research?

Collaborative research involves researchers from more than one institution, either at a single site or when researchers from multiple institutions conduct different parts of a protocol.

Changes to the Common Rule and the NIH Policy on the Use of a Single IRB (sIRB) for Multi-Site Research now require the use of a single IRB for cooperative or multi-site research. This policy aims to reduce redundant IRB reviews, thereby improving and streamlining the IRB review process for multi-site studies, ensuring research can proceed as efficiently and quickly as possible.

Federal regulations (45 CFR 46.114) permit reliance agreements between institutions engaged in cooperative research projects to avoid duplication of effort.

When utilizing a reliance agreement:

• The Single (sIRB) is responsible for conducting the ethical review of multi-site studies for participating sites.
• The Principal Investigator (PI) is responsible for ensuring that authorization agreements are in place, maintaining copies of those agreements, and establishing communication channels between the sIRB and participating sites.

When conducting collaborative or multi-site research involving human subjects, the investigator is responsible for contacting their institution’s Institutional Review Board (IRB) office to determine which IRB will oversee their research. One IRB will be designated as the IRB of record, while others will act as relying IRBs.

The Reviewing IRB (IRB of record) is the IRB that reviews the research on behalf of one or more institutions. It ensures that the research complies with relevant regulations, ethical standards, and institutional policies. The Relying IRB accepts the review and oversight of the research project from the Reviewing IRB.

Both the Reviewing and Relying IRBs have the authority to investigate protocol deviations, noncompliance, or unanticipated problems. However, the Reviewing IRB will rely on information from the Relying IRB.

 

What is a reliance agreement?

A reliance agreement is a formal, written document that allows one institution engaged in research to delegate IRB review to an independent IRB or an IRB from another institution. Institutions engaged in human subjects research, where one institution will rely on another’s IRB, must agree to the terms of the Reliance Agreement before research can proceed.

 

How do I request a reliance agreement?

The first step is to contact your IRB Coordinator at TAMUK. Your IRB Coordinator will help determine if a reliance agreement is necessary. Failing to contact your IRB Coordinator early in the planning stages may cause delays.

 

How do I fill out the TAMUK reliance agreement and local context questionnaire?

If TAMUK is the Reviewing IRB, you will need to complete the TAMUK IRB Authorization Agreement (IAA). Since TAMUK is the Reviewing IRB, you will fill out the Institution A sections of the IAA form, while the relying IRB will fill out the Institution B sections. Additionally, the Local Context Questionnaire must be completed and submitted to TAMUK for review and approval.

*Please submit the IAA completed by the other institution and the local context questionnaire as a new submission in Cayuse for final review.

TAMUK will not sign the IAA form until the relying IRB has signed it first. Once the IAA form and Local Context Questionnaire are completed and signed, the investigator may begin their research project.

The Principal Investigator (PI) is responsible for completing the Local Context Questionnaire and submitting it to the TAMUK IRB along with the completed IAA form.

 

What if another institution will be the sIRB for a protocol?

If your research will be approved through another institution, please follow their directions for completing a reliance agreement and submit it to TAMUK IRB at TAMUK.IRB@TAMUK.EDU for review.

 

What if my study is exempt?

TAMUK does not participate in collaborative research agreements for exempt research.