If a non-exempt study is being conducted at multiple sites, IRB approval is needed from all of the institutions “engaged” in research, one institution may act as the “IRB of record”. An IRB Reliance Agreement [also known as an IRB Authorization Agreement (IAA)] is used to document which institution will be the IRB of record. This cooperative IRB review arrangement helps avoid dual review. The agreement describes the role and authority of the IRB(s) involved in the study, the responsibilities of the investigator’s regarding human subjects protection education, training, policies, and reporting, the term/time period of the agreement and the number of protocols to be reviewed.
Investigators should contact the ORPC in a timely manner for advice and guidance whenever collaborative research is planned.
Please access the Kuali Protocols Portal to create an IRB Reliance Agreement. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating a protocol.
In order for the UMBC IRBs to cede or UMBC assume IRB oversight of a research study, please provide the following in the Reliance Agreement application:
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- UMBC IRB Information – Registration # 00000334; Federalwide Assurance (FWA) #: 00000069
- If not available, use the Office for Human Research Protections (OHRP) database for registered IRBs and approved FWAs
- Obtain copies of applicable institutional IRB approval letter, approved protocol and consent documents
- Choose if this agreement applies to all human subjects research covered by UMBC’s FWA, if this agreement is limited to a specific protocol(s), or if there is another arrangement
- List the names, roles and responsibilities and current IRB training dates (CITI) of the investigator(s) from both institutions
- Provide the contact information (name, phone and email) of thenstitution’s IRB Office
The ORPC will review the application and draft the reliance agreement. Following review by the PI, routing for official signatures, as defined by the ORCA Table of Authority for Authorized Signatures, will begin. The ORPC will forward the fully executed version to the investigator and upload to the Kuali protocol file.
Have a Kuali technical issue or problems with access? Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems
Investigators from institutions that do not have a Federalwide Assurance
Investigators, who are not faculty, staff, students, or employees of the University of Maryland, Baltimore County may be covered under the UMBC’s Federalwide Assurance (FWA) only in accordance with the submission of a formal, written agreement of commitment to relevant human subject protection policies and IRB oversight. (source: Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement)
The Individual Investigator Agreement (IIA) is a commitment statement that an unaffiliated investigator will comply with UMBC’s human subject protection policies and IRB oversight. This agreement is used when researchers at UMBC engage in research with a collaborating investigator who is not affiliated with UMBC or a collaborating investigator who is affiliated with another institution that may not have its own IRB to review a study. Once fully executed, the collaborating investigator agrees to abide by the ethical principles of beneficence, respect for persons, and justice for the protection of the human subjects while engaged in UMBC-directed research.
Collaborating investigators would contact the OPRC (compliance@umbc.edu) and provide the following information:
- The collaborating investigator’s signed version of the IIA
- A purpose statement that describes the research and why the collaborator requests UMBC IRB coverage
- Personnel involved in the research with a copy of a current human subjects use training certificate. Describe the criteria to select and their qualifications
- Describe how research staff will be trained to conduct of the research, e.g., by whom, covering what topics, etc.
- Procedures to obtain informed consent, administering surveys, collecting data, interacting with subjects, or analyzing identifiable data
- Procedures for monitoring compliance by assessing whether study procedures are being followed, what security procedures are followed for data while it is in the possession of the collaborating investigator, and how will safety of subjects be maintain (e.g., by ensuring that confidentiality, privacy, and contact procedures are being followed)
Upon review, the ORPC will contact the collaborating investigator for more information. If none required, the fully executed version is returned.