Reliance Agreements
SMART IRB
SMART IRB
The SMART IRB is a Streamlined, Multisite, Accelerated Resource for Trials Reliance platform, designed to harmonize and streamline the IRB review process for multisite studies. However, SMART IRB is not an IRB or ethics review board. SMART IRB has developed an Online Reliance System that can be used to request, track, and document reliance agreements for participating institutions.
UIC is a participating institution under the SMART IRB Master Agreement.
For additional information regarding SMART IRB, visit the following website: https://smartirb.org/
IRB Authorization Agreements and Individual Investigator Agreements
An IRB Authorization Agreement (IAA) is one type of IRB reliance agreement typically used between just two institutions. An IAA is recommended when a non-UIC site, with or without its own IRB, relies on the UIC IRB as the IRB of record, or vice versa. At UIC, an IAA is limited to a single, specific protocol.
An Individual Investigator Agreement (IIA) may be requested when an individual, rather than an institution, will be engaged in the conduct of research that is overseen by another institution’s IRB. IIAs are also limited to a single, specific protocol conducted at UIC.
Reliance agreements are subject to acceptance by both the relying and reviewing institution. Requests for an IAA/IIA may or may not be granted at either institution’s discretion.
Establishing an IAA or IIA
When determining whether an IRB Authorization Agreement (IAA) or Individual Investigator Agreement (IIA) is appropriate for a specific research study, the UIC Office for the Protection of Research Subjects (OPRS) considers several factors. These include, but are not limited to, the risk level of the protocol, the level of engagement of each site/personnel (i.e., what role each institution/individual has in the conduct of research, including subject recruitment and enrollment, data collection, data analysis, and funding source), and the ability of the reviewing institution to provide adequate oversight of the conduct of the research. The UIC investigator must contact OPRS regarding the initiation of an IAA or IIA prior to engaging non-UIC sites/personnel in UIC research, or prior to participating in research activities conducted under a non-UIC IRB approval.
UIC does not require an IAA/IIA for collaboration on projects that are determined to meet the criteria for exemption, that do not meet the criteria of “Human Subjects Research,” or that do not engage UIC.
UIC is the lead site
When a site/individual wishes to rely on the UIC IRB for a specific UIC protocol, a formal IAA/IIA request is required. Investigators are encouraged to submit IAA/IIA requests via a Modification to previously approved research. Requests can be made at the time of Initial Review, but may delay final approval.
An IAA/IIA is not required if the research is not federally funded and is not subject to FDA regulations; however, UIC may comply with requests for an IAA/IIA as made by a non-UIC site, if appropriate. Additionally, UIC may require an IAA/IIA at its discretion.
General submission requirements are outlined below as they pertain to either non-federally-funded or federally-funded research. Additional institutional and/or external reviews may also apply (e.g., data use agreements, business associate agreements; Chicago Public Schools Research Review Board review) to collaborative research regardless of funding source.
Submission Requirements:
All submissions involving the inclusion/addition of non-UIC sites must include the following:
- A description of the role of the non-UIC site/personnel in the conduct of the research
- A list of all non-UIC personnel who will participate in the conduct of the research under the UIC IRB approval. Documentation of Investigator Training for such individuals must also be submitted.
In addition, there are 3 conditions that will determine the need for a Reliance Agreement and any additional documentation that is required:
- When research is supported by a non-federal sponsor or is not funded, and is not FDA-regulated, submissions should also include:
- A Letter of Support from the non-UIC site. The Letter of Support must be signed by an authorized executive from the non-UIC site and must outline the activities for which the non-UIC site has agreed to serve as host, provide resources, and/or participate.
- Institutional Review Board (IRB) Authorization Agreement (IAA) [or Individual Investigator Agreement (IIA), as applicable], signed by the Institutional Official at the relying site, IF requested by the non-UIC site. Templates for both the IAA and IIA can be found in the UIC Research IRB Library.
- When the research is supported by a federal sponsor, but the UIC IRB has determined that the non-UIC site/personnel is not actively engaged in the research, submissions should also include:
- A Letter of Support from the non-UIC site. The Letter of Support must be signed by an authorized executive from the non-UIC site and must outline the passive or supportive activities which the non-UIC site has agreed to host or accommodate. Passive or supportive activities may include, but are not limited to:
- Allowing recruitment materials to be posted, distributed, and/or announced;
- Providing space for research activities conducted by personnel;
- Allowing UIC personnel to observe subjects or otherwise collect data at the non-UIC site.
- A Letter of Support from the non-UIC site. The Letter of Support must be signed by an authorized executive from the non-UIC site and must outline the passive or supportive activities which the non-UIC site has agreed to host or accommodate. Passive or supportive activities may include, but are not limited to:
- When the research is supported by a federal sponsor and/or FDA-regulated, AND the non-UIC site/personnel is actively engaged in the research, the UIC Principal Investigator is responsible for ascertaining, facilitating the procurement of, and/or maintaining, as well as submitting evidence of, the following to the UIC IRB:
- An individual FWA for the engaged non-UIC site. Non-UIC sites that do not have an FWA may be directed to the OHRP website for filing instructions: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/index.html
- Institutional Review Board (IRB) Authorization Agreement (IAA) [or Individual Investigator Agreement (IIA), as applicable], signed by the Institutional Official at the relying site. Templates for both the IAA and IIA can be found in the UIC Research IRB Library.
The appropriateness of the IAA/IIA is evaluated during the submission review. If the IAA/IIA is acceptable, it will be routed for signature by the UIC Institutional Official upon approval of the submission and the signed copy will be uploaded to UIC Research and available to the investigator under “Approved Documents”.
If the IAA/IIA is not accepted, the investigator will be instructed to obtain an alternative IRB approval for the non-UIC site, as applicable.
Additional Considerations for Individual Investigator Agreements (IIA)
While an IRB Authorization Agreement (IAA) requires an institution to obtain its own FWA, an Individual Investigator Agreement (IIA) extends UIC’s FWA to cover the activities of the individual non-UIC investigator. As such, IIAs impose strict responsibilities on the non-UIC investigator. Please review the Individual Investigator Agreement form for a description of these responsibilities. Templates for both the IAA and IIA can be found in the UIC Research IRB Library.
UIC is ceding review to another IRB
When UIC will be engaged in research that is overseen by another institution, a request may be made by the UIC investigator for UIC to cede IRB review to that external (non-UIC) IRB. The UIC IRB may elect to cede review to another IRB on the basis of an IRB Authorization Agreement/Individual Investigator Agreement when other reliance mechanisms (e.g., NCI CIRB, WIRB, Single IRB review using SMART IRB) are not applicable.
All requests for reliance/external IRB review must be submitted via UIC Research for tracking and evaluation purposes. The UIC investigator must submit such requests per the Single IRB submission requirements.
The appropriateness of the IAA/IIA is evaluated during the submission review. If the IAA/IIA is acceptable, it will be routed for signature by the UIC Institutional Official and the signed copy will be uploaded to UIC Research and available to the investigator. OPRS will also issue a letter acknowledging the reliance.
If the IAA/IIA is not accepted, the investigator will be provided further instruction regarding the UIC protocol submission requirements needed to initiate the research at UIC.