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Collaborative Research

While there are many types of collaborative research, this page is designed to provide information for ISU researchers who are collaborating with co-investigators/research team members who are affiliated with other institutions or are independent investigators. 

When an institution's employees or agents (faculty, staff, students, contractors, and volunteers) are "engaged" in the collaboration," federal guidance deems that the collaborating institutions must either enter into a joint review, rely upon the review of another institution via an IRB Authorization Agreement (IAA) or make some other similar arrangement.  For most federally funded projects, collaborating institutions must typically rely upon approval by a single IRB.   

Engaged in the research generally means that the employees or agents obtain for the purposes of the research:

  1. data about the subjects of the research through intervention or interaction with them;
  2. identifiable private information about the subjects of the research; or
  3. the informed consent of human subjects for the research.

Collaborative Research Scenarios

To determine whether another institution holds an FWA, you may either consult with your collaborating colleagues, access OHRP's database or Collaborative Research.

  • Scenario 1: ISU IRB is serving as the Lead IRB with an institution that has a Federalwide Assurance
  • Scenario 2: ISU is Relying on IRB Approval for Nonexempt Research from an Institution holding a Federalwide Assurance with OHRP
  • Scenario 3: ISU is Engaged in Research Designated as Exempt by an IRB that has a Federalwide Assurance with OHRP
  • Scenario 4: Collaborating with Institutions that Do Not Have an Federalwide Assurance (FWA) from OHRP
  1. Determine whether personnel at collaborating institutions are considered engaged in the research under the definition above.  If they are, proceed to the second point.  If they are not, they do not need to be listed on the ISU IRB protocol; nothing further is required. Contact the Human Subjects Research Specialist  if you have any questions on this.
  2. Personnel from other institutions need to determine their institutions requirements regarding collaborative research.  If the other institution requires an IAA, continue to point three. 
  3. Complete the ISU IRB Collaboration Form
  4. Email the completed IRB Reliance Determination Form to IRB@IllinoisState.edu with the subject line: IAA.
  5. The Office of Research Ethics and Compliance (REC) will consult with the other institution’s IRB office to determine if they are willing to enter into an agreement with ISU and to determine who will prepare and route the IAA. 
  6. When the IAA is fully executed agreement, REC will email the researcher at ISU to notify them the collaboration may commence. 
  7. Important Note:  If the study was designated as Exempt by the ISU IRB, then you may just add the non-ISU unaffiliated investigator to your research team information.  There will be no need for an IAA or other agreement unless your collaborator’s institution requires a formal IAA for exempt research.
  1. Determine whether you are engaged in the research. If yes, move to number 2. If no, nothing further is required.  If you are unsure, contact the Human Subjects Research Specialist .
  2. Complete the ISU IRB Collaboration Form
  3. Email the completed IRB Reliance Determination Form, a copy of the approved protocol (including questionnaires, consent, recruitment material etc.), and the approval letter to IRB@IllinoisState.edu with the subject line: IAA.  Note:  All ISU personnel engaged in the research must be included on the other institution’s protocol.  Some institutions will not do so until the IAA has been executed.
  4. The Office of Research Ethics and Compliance (REC) will review the provided documents. At this time, they may make additional requests for more information.
  5. REC will consult with the other institution’s IRB office to determine if they are willing to enter into an agreement with ISU and to make a decision if this agreement is appropriate.
  6. If REC is satisfied with the other institution’s review and the other institution is willing to enter into an IAA, REC will prepare the IAA ceding authority to the other IRB for review, obtain the signature of ISU’s Institutional Official, and forward the IAA to the other institution for signature.
  7. When the fully executed agreement is returned, REC will email the researcher at ISU to notify them they can start their research.
  1. Determine whether you are engaged in the research.  If yes, move to number 2.   If you are unsure, contact the Human Subjects Research Specialist . 
  2. Complete the ISU IRB Collaboration Form
  3. Email the completed IRB Reliance Determination Form, a copy of the protocol (including questionnaires, consent, recruitment material etc.) or related documents that were submitted to the IRB for determination, and the exempt determination letter to IRB@IllinoisState.edu with the subject line: IAA.
  4. The Office of Research Ethics and Compliance will review the provided documents. At this time, they may make additional requests for more information.
  5. The Office of Research Ethics and Compliance will notify you that they are satisfied with the review or provide additional direction.

ISU can only cede authority to institutions that hold an FWA. If ISU personnel are considered engaged in the research, an IRB protocol must be submitted to ISU's IRB (or potentially another institution for multi-site studies).  

Agreements such as the Individual Investigator Agreement (IIA) may be advised to cover the research components being covered at the other institution.  Please contact REC for more information.

2022-06-23T13:13:12.420046-07:00 2022