External Collaborations

If you are a 快活app 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:

  • Exempt projects
    • Each investigator obtains IRB approval through their own institution's IRB, OR
  • Expedited/Full Board projects
  • List all investigators on one IRB application through one institution's IRB to serve as the IRB of Record and establish听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 快活app IRB.

听

  • 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.
    • The proposed project involves ceding with a foreign IRB or ethics committee. Any requests involving a foreign PI to cede to or rely on 快活app for IRB approval is not allowed. 快活app investigators may not obtain or cede IRB approval through any foreign institution with an IRB or ethics committee.
  • 快活app as IRB of Record

    The 快活app 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 快活app 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 快活app 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 快活app investigator must complete and submit Appendix Q (and the additional documentation listed within) as a new project in IRBNet 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 快活app investigator and the external institution, and the 快活app 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 externalirb@du.edu if you have any questions during this process while we communicate with the external institution.

  • Adding an Unaffiliated Independent Individual

    If a 快活app 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 快活app 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 快活app 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.

    All Data Use Agreements requests must be submitted using the Office of Intellectual Property and Technology Transfer (OIPTT) .

    If you have any questions please contact the OIPTT at DataContract@du.edu

  • NIH Single IRB (sIRB) Review

    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.

    听

  • Collaborative Agreements

    IRB Authorization Agreement (IAA)

    IRB Authorization Agreement (IAA)

    An IRB Authorization Agreement (IAA), also referred to as a reliance agreement, is required if an institution outside of 快活app is "engaged" in human subjects research and files a FederalWide Assurance with the Office for Human Research Protections designating 快活app as the IRB of Record. This is a written agreement between 快活app and the other institution to document the extent to which 快活app's IRB will act in this capacity.

    The IAA can be written so that 快活app's IRB will review:

    鈥 all studies conducted at that institution;
    鈥 a particular study named in the IAA; or
    鈥 a subset of studies designated (e.g., "all studies conducted by 快活app faculty, staff, or students"). The IAA is signed by the Institutional Official for each institution.

    Note that 快活app investigators should not complete the IAA or facilitate its execution; the 快活app IRB is responsible for those processes. Permission should be obtained before 快活app'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 externalirb@du.edu.

    Individual Investigator Agreement (IIA)

    Individual Investigator Agreement (IIA)

    There are instances when an individual, who is not acting as an employee or agent of 快活app is 鈥渆ngaged鈥 in human subjects research in collaboration with a 快活app 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听as well as the 快活app Principal Investigator.听All ceding inquiries should be directed to externalirb@du.edu.