Central IRB is a single board that reviews research studies for multiple sites.

A Central IRB can be any registered IRB that functions to review multiple sites but most commonly the term Central IRB references an independent IRB. Regardless of the group providing it, centralized IRB review is one review for a number of sites. Commonly, the sponsor determines which sites are to participate and suggests or requires those sites to use the Central IRB selected to perform the centralized review.

External IRB is outside the institutional framework. It could refer to being external to the immediate institution or to a larger system or framework of coordinating agreements. External IRBs are also called remote IRBs as they are generally geographically removed from the performance site.

Internal IRB exists within the institution engaged in the study.

This agreement may apply to research conducted under a PI from UT Southwestern or an affiliate and involves individuals who will be engaged in the research on behalf of an institution that does not hold a Federalwide Assurance. If the non-assured institution does not wish to establish a FWA with the Office of Human Research Protections (OHRP), an Individual Investigator Agreement may be established. This agreement will allow the UTSW FWA to cover the non-assured, collaborating institutional investigators.

Once an agreement is in place, the investigators will become “Affiliated Investigators” and will therefore be required to follow all UTSW institutional policies and procedures pertaining to research (COI disclosures, training, etc.).

IRB of Record is the lead IRB who will oversee the conduct of research-related activities at all research locations. The IRB of Record could also be known as the Lead IRB or a single IRB of Record.

Lead Study Team has the obligation to submit the IRB application to the IRB of Record and comply with any requests and clarifications from the IRB or Record.

The language required by UT Southwestern to be present in informed consents for studies reviewed by an external IRB.

Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA). MOUs are generally used when covering an entire research program; reliance agreements are generally used to cover a designated protocol or protocols.

A lead site is one that initiates or manages a research study involving multiple sites that conduct research procedures for the study. A lead investigator is one who oversees the operations of the study at the lead site and is ultimately responsible for coordination, management, reporting, and regulatory requirements between the multiple sites.

The Point of Contact (POC) is generally responsible for being the conduit of information, representing his or her organization, whether it is a lead or a relying institution. The Point of Contact could represent the lead study team coordinator or the IRB staff member identified as the point of contact. The Point of Contact is responsible for facilitation of communication between either the research study team(s) involved in the study or the communication between the IRB of Record and the Relying IRB.

A Reliance Agreement is a formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. Institutions may use different descriptive terms, e.g., reliance agreement, cooperative agreement or IRB authorization agreement (IAA).

Relying IRB is an internal IRB that is relying on the review by another IRB. This is rather a misnomer as it is the institution rather than the IRB that is relying on the external IRB or IRB of Record.

The relying study team is the study team who relies on review by an IRB outside of their institution. It is the responsibility of the Relying Study Team to designate a single Point of Contact who will serve as the communication portal with other Relying Site IRBs and the Lead Site IRB.