If you are a DU investigator and are collaborating on a research project with an external investigator or individual, decisions need to be made to determine how each investigator or individual will obtain appropriate IRB approval.
The following options are available:
- Each investigator obtains IRB approval through their own institution's IRB, OR
- List all investigators on one IRB application through one institution's IRB to serve as the IRB of Record and establish a reliance agreement between the participating institutions, OR
- If a reliance agreement cannot be established because the external individual is NOT affiliated with an organization who has a Federalwide Assurance (FWA), the individual(s) must meet certain requirements and be approved by the DU IRB.
Use this document to determine the approval process for your collaborative project.
Ceding Will Not Occur If:
- The proposed project is categorized as an exempt project. If an investigator at any site is conducting activities that are granted an exempt status, no ceding can occur with the other collaborating sites. If any site involved in the collaborative project conducts activities that are categorized as non-exempt through expedited or full board review, the exempt portion of the project cannot be ceded to the other institution.
- The proposed project involves ceding with a foreign IRB or ethics committee. Any requests involving a foreign PI to cede to or rely on DU for IRB approval is not allowed. DU investigators may not obtain or cede IRB approval through any foreign institution with an IRB or ethics committee.
DU as IRB of Record
The DU investigator must complete and submit Appendix P (and the additional documentation listed within) to IRBNet for review and processing as part of their initial IRBNet application, or as an amendment if the project has received final approval from the DU IRB. If ceding is approved, the IRB staff will contact the external institution and obtain the necessary signatures. The fully executed agreement will be posted in IRBNet along with the formal IRB approval letter.
Ceding to an External IRB
The DU investigator must first confirm that the external IRB is willing to serve as the IRB of Record for the collaborative project. If ceding is allowed by the external IRB, the DU investigator must complete and submit Appendix Q (and the additional documentation listed within) to firstname.lastname@example.org for evaluation and approval. If approved, the IRB staff will contact the external institution and obtain the necessary signatures. When the fully executed agreement is obtained, a copy of the fully executed agreement will be sent to the DU investigator and the external institution, and the DU IRB will retain a copy for our records.
Though we cannot guarantee a specific timeline for the full execution of this request, we will nonetheless be diligently working to finalize the agreement. Contact email@example.com if you have any questions during this process while we communicate with the external institution.
Adding an Unaffiliated Independent Individual
If a DU investigator wants to add an individual who is not affiliated with an organization that has been issued a Federalwide Assurance (FWA) or has an IRB, this individual must be approved by the IRB. The DU investigator must submit Appendix R (and the additional documentation listed within) in addition to a signed Individual Investigator Agreement (IIA) as part of an initial IRBNet application, or as an amendment if the project has received final approval from the DU IRB. The unaffiliated individual must also complete the mandatory human subject protection training through the CITI Program before final approval be granted.
Receiving or Sending Data or Materials
Data Use Agreement
A Data Agreement is a written contract governing the transfer of data, including human subject data, between entities for the purposes of research. These can be set up between academic institutions, non-projects, government agencies, and/or corporate entities. The Data Agreement will govern data ownership, permitted uses of the data, publication of results, development of inventions, disposal of the data, and liability.
When data will be transferred to DU from an outside entity, the Data Agreement Request Form for RECEIVING data is required.
When data will be transferred from DU to an outside entity, the Data Agreement Request From for SENDING data is required.
All Data Use Agreements requests must be submitted with the appropriate Data Agreement Request Form and sent to:
NIH Single IRB (sIRB) Review Using SMART IRB
If a multisite research project is funded through the NIH, each institution must implement a Single IRB (sIRB) review per NIH policy, effective date: January 25, 2018. SMART IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for the institution to implement the NIH Single IRB (sIRB) Review policy, effective date: January 25, 2018.
DU is submitting an application to participate in the SMART IRB consortium but is not currently eligible.
sIRB Learning Center: Videos and Resources for investigators and study teams
IRB Authorization Agreement (IAA)
An IRB Authorization Agreement (IAA), also referred to as a reliance agreement, is required if an institution outside of DU is "engaged" in human subjects research and files a FederalWide Assurance with the Office for Human Research Protections designating DU as the IRB of Record. This is a written agreement between DU and the other institution to document the extent to which DU's IRB will act in this capacity.
The IAA can be written so that DU's IRB will review:
• all studies conducted at that institution;
• a particular study named in the IAA; or
• a subset of studies designated (e.g., "all studies conducted by University of Denver faculty, staff, or students"). The IAA is signed by the Institutional Official for each institution.
Note that DU investigators should not complete the IAA or facilitate its execution; the DU IRB is responsible for those processes. Permission should be obtained before DU's IRB is designated on an FWA for an outside institution because there are occasions when this would not be appropriate. All inquiries related to an IAA should be directed to firstname.lastname@example.org.
Individual Investigator Agreement (IIA)
There are instances when an individual, who is not acting as an employee or agent of DU is “engaged” in human subjects research in collaboration with a DU researcher. In most cases, that individual will not have access to an IRB to provide approval and/or oversight for the research activities being performed. For these situations, an Individual Investigator Agreement (IIA) may be appropriate. An IIA is a formal agreement describing the expectations and responsibilities for the unaffiliated individual and is signed by the unaffiliated/individual investigator as well as the DU Principal Investigator. All ceding inquiries should be directed to email@example.com.