501.Requirements for External Investigator to Use the University IRB
Updated July 1, 2019
Circumstances arise in which an individual who is not a University/Affiliate investigator may wish to use the University IRB for review and oversight of her/his non-exempt human subject research or to rely on Research Integrity (RI) for oversight of exempt human subject research.
- An Independent Investigator is one whose home institution does not have an IRB.
NOTE: If the Independent Investigator's home institution is engaged in multiple human research projects or if the research is supported by the US DHHS, the institution must obtain a Federalwide Assurance (FWA).
- An External Investigator is one whose home institution has an IRB.
Students/trainees cannot be an Independent Investigator for any research involving human participants that will be overseen by the University.
External Investigators include researchers engaged in or collaborating on research projects when the University/Affiliate investigator is the lead researcher or is responsible for the overall conduct of the research. When a University/Affiliate Investigator is the lead researcher, the University prefers the External Investigator's institution cede review to the University IRB.
Non-exempt Research: Independent Investigator (no IRB)
An Independent Investigator wishing to use the University IRB for review and approval of non-exempt research must
- Coordinate with RI to execute an Independent Investigator Agreement (see IRB policy for IRB and investigator agreements (requires the Independent Investigator's curriculum vitae).
- Register in IRBNet (for information, see the RI IRBNet webpage).
- Follow the instructions in the IRB policy submission requirements for Full Committee or submission requirements for Expedited Review to create and submit a new project in IRBNet.
The Independent Investigator Agreement specifies the duties/responsibilities of the Independent Investigator related to the protection of human participants; compliance in the conduct of the research; disclosure of conflicts of interests; requirements for prior notification and IRB approval for changes to the research; requirements for post-approval notifications (e.g., safety reports, safety-related interim findings, and unanticipated problems involving risks to participants or others); and maintaining research records.
Non-exempt Research: External Investigator (with IRB)
There are two situations in which an External Investigator affiliated with an institution with an IRB may use the University IRB as the IRB of Record for non-exempt research:
- A University/Affiliate investigator is the lead researcher on a multi-center project, is responsible for the overall conduct of the research, and provides study-wide services, such as data coordination, for the sites engaged in the research. The External Investigator is engaged in the research at one of the participating sites.
- An External Investigator is collaborating with a University/Affiliate Investigator in a non-exempt human research project for which a University/Affiliate investigator is the lead researcher and will interact with participants at a University site or the investigators will share personally identifiable information about participants.
Other situations may arise in which an External Investigator wishes to use the University IRB as the IRB of Record for non-exempt research, for example, a research project requires the expertise of the University IRB. These situations are evaluated on a case-by-case basis by the RI.
NOTE: When University/Affiliate faculty, students, or staff are involved as collaborators in human subject research for which an External Investigator is the lead researcher, the University IRB may cede review to the external IRB. Review IRB policy for using an external IRB or Contact RI for information.
The University/Affiliate investigator must
- Identify all external (or collaborating) researchers in the Part I Application (Cover Sheet) in IRBNet.
- Coordinate with RI to execute an IRB Authorization Agreement between the University and the External Investigator's IRB, designating the University IRB as the IRB of Record (see IRB policy for IRB and investigator agreements).
- Ensure the External Investigator completed her/his home institution's or the University's requirements for human research protection training.
- Follow the instructions in the IRB policy submission requirements for Full Committee or submission requirements for Expedited Review to create and submit a new project. (Or, follow the instructions in IRB policy for submitting an amendments to an approved project if an External Investigator is being added to an approved project.)
- Share appropriate Access in IRBNet with each external investigator (e.g., grant Full, Write, or Read access to allow her/him to work with study-documents and IRB notifications as consistent with her/his role on the project).
The IAA templates specify the requirements for the University and its IRB and the External Investigator and her/his home institution in the conduct of the research, including requirements for disclosure/management of researcher conflicts of interests; reporting and review of participant complaints, changes to the research, safety monitoring, unanticipated problems involving risks to participants or others, and safety-related interim findings; post-approval monitoring; and maintaining research records.
Exempt Research: Independent Investigator (no IRB)
An Independent Investigator wishing to obtain an exempt determination from the University's RI, must
- Comply with the University's requirements for training in human research protection.
- Obtain and complete the HHS form Protection of Human Subjects: Assurance Identification/Certification/Declaration of Exemption, available from the HHS IRBs and Assurances Forms page, requesting Exemption Status under item 6 and skipping item 7; obtain the signature of the institutional official for the external site (contact the RI with questions about completing the form).
- Register in IRBNet (for information, see the RI IRBNet webpage).
- Follow the instructions in IRB policy for submission requirements for exempt research to create and submit a new exempt project.
- Prior to submission, Add the completed and signed Declaration of Exemption form to the project in IRBNet.
- Prior to submission, Add a copy of the Independent Investigator's curriculum vitae to the project in IRBNet.
Exempt Research: External Investigator (with IRB)
An External Investigator who is engaged in exempt research for which a University/Affiliate Investigator is the lead researcher may provide
- the University/Affiliate investigator with documentation of exempt determination from her/his home IRB (or other designated authority); or
- her/his home IRB with documentation of exempt determination by the RI.