Cooperative/Multi-institute Research (Section 8)

Multi-site research often allows and, in some cases requires, review by only one institution’s IRB with other institutions relying on that review. The single IRB (sIRB) process requires documentation of the reliance arrangement. Kent State researchers collaborating on studies with other institutions or individuals engaged in research may need to work with the Office of Research Compliance to appropriately document IRB reliance arrangements.

There are multiple approaches to reliance and there is variation in how institutions implement reliance arrangements. The Office of Research Compliance advises contacting the office to discuss the appropriate approach if you are not sure how to manage IRB oversight of a multi-site project. In some cases, when permitted by the regulations, we may advise you or your collaborator to obtain their own IRB review. In some cases, as in NIH funded studies, single IRB review may be required.

8.1 Reliance Agreement Types

  • Master IRB Collaboration Agreement or SMART IRB Agreement                                                        The Kent State IRB has entered into multiple master agreements with institutions including Akron Children’s Hospital, Akron General Hospital, Summa Health System, Ursuline College, University of Akron, NEOMED, YSU, Cleveland State University and Cleveland Clinic. KSU may also use the SMART IRB Agreement which is a standing authorization agreement many other institutions have also signed. We also maintain an agreement with Advarra, a commercial provider of IRB and other services. Use of Advarra is ideal for commercial and industry sponsored studies, and some studies occurring in clinical settings. If you have questions about partnering with Advarra, please contact researchcompliance@kent.edu.                                                                           
  • IRB Authorization Agreement (IAA)                                                                                              An IAA is a formal written agreement between two or more institutions that have IRBs, which permits IRB review to be limited to one institute – the reviewing institution is referred to as the IRB of record or Reviewing IRB. To execute and IAA, the Kent State IRB, ORC and University Counsel collaborate to negotiate study specific agreements with your collaborator’s IRB. It is not uncommon for external institutions to have different standards or policies and procedures than KSU for oversight of research and executing agreements. As a result, IAAs may delay the review process.  To expedite review of IAAs, as early as possible let all institutes involved in the IAA know of your plans to request single IRB review.
  • Individual Investigator Agreement (IIA)                                                                                        In the event your collaborator’s institution does not operate an IRB, the Kent State IRB may extend oversight to individuals engaged in research under the Individual Investigator Agreement (IIA). Additional information for individual investigators may be provided in the application via Appendix B - Ancillary Personnel. 

8.2 What are the steps for reliance arrangements?

  • Work with your collaborators to determine (1) engagement; (2) reviewing IRB; (3) agreement type. Review this FAQ and contact the Office of Research Compliance if you have questions about these determinations.
  • Access the Kuali/electronic application to prepare the submission. Application type will depend on the reliance arrangement; however, a submission is required regardless of reviewing IRB.
  • Develop a communication plan with your collaborators to ensure submission processes at all engaged institutions are followed during the initial review process and for the full life of the study, including amendments, continuing reviews and events.
  • When KSU is to be the IRB of record, the following forms may be required:

8.3  What does it mean to be engaged in research activities?

8.4 How do I know which institution should be the IRB of record?

External Review

If any of the following are true about the study, use of an external IRB may be appropriate:

  • Kent State faculty/staff will be performing the majority of the study procedures at an external institution/site and the institution/site holds a current FWA and IRB registration.
  • The involvement of the KSU investigator(s) is limited. (For example, data analysis of information collected at another institution.)
  • Another institution’s reviewing IRB is more properly constituted to review a certain scope of work, or may have knowledge of the local research context. (For example, a biomedical research project where the interaction involves a clinical investigation with patients as subjects)
  • The IRB of Record has been determined by a sponsor.

KSU Review

If any of the following are true about the study, KSU as the IRB of record may be appropriate:

  • Most of the study procedures will be performed at Kent State, or by Kent State faculty/staff.
  • KSU faculty/staff are serving as the coordinating center.
  • The KSU IRB is more appropriately constituted to review the scope of work.

8.5 What is local context review?

  • Local Context Review refers to the process of considering institutional, local and state specific laws, policies and procedures with regard to a specific research study. IRBs frequently use local context review procedures to document and communicate site specific information.
  • When KSU is the IRB of Record, local context information is required when adding an external, relying site. Local context information is submitted via the electronic application via Appendix O - Relying Site Local Context. 
  • When KSU is relying on another IRB, the office of Research Compliance completes a local context review to ensure state laws and institutional policies and procedures, including ancillary reviews, are addressed in the research protocol. Review for local context is completed via the electronic application.
  • For more information, review this DHHS guidance document: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2013-january-10-letter-attachment-a/index.html

8.6 Special Considerations for Reliance Arrangements

Exempt research

  • The NIH sIRB policy does not currently apply to exempt research, so most IRBs, including Kent State's, opt not to enter into IAAs for exempt research. If you are working on a project that was exempted (level I approval) by another IRB, we will either require you to submit a KSU level I application or review the application that was approved by the external institute. The external collaborator may be asked to enter into a data use agreement (per University Counsel), consult with their IRB or another action may be required.     

International research

  • Authorization agreements are generally not applicable when working with sites outside of the United States. If you are planning a multi-site study with international sites engaged in the research, contact the Office of Research Compliance.

Collection and storage of shared data

Genomic Data

8.7 What is the regulation on cooperative research?  

45 CFR 46.114 states:

  1. Cooperative research projects are those projects covered by this (45CFR46) policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.
  2.  
    1. Any institution located in the U.S. that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the U.S. The Reviewing IRB will be identified by the federal department or agency supporting or conducting the research or proposed by the lead institution subjects to the acceptance of the federal department or agency supporting the research. 
    2. The following research is not subject to this provision:
      1. Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native Tribe); OR
      2. Research for which any federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
  3. For research not subject to paragraph b of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort. 

8.14 International Research

  • If you plan to conduct a project outside of the US, plan for extra time for review. There is no guarantee of IRB approval by a given deadline.
  • Any human subjects research that is conducted internationally must be reviewed and approved by the IRB. The protections offered to subjects must be at least equivalent to those stated in 45CFR46.
  • A study is considered to be international if information is collected from participants that are outside of the US even if the investigators do not leave the US. For example, US based investigators conducting an online study in which the subjects live outside of the US is considered an international study.
  • Research with international populations that occurs within US borders is not considered international research. 
  • The study must also adhere to local laws, customs, and traditions that apply to human subjects research.
  • International studies must consider management of non-English speaking populations. This includes a consent form and process that is understandable to subjects that do not speak English.  
  • Investigators need to consider data laws such as UK-GDPR and GDPR.
  • The IRB may consult with subject matter experts and may require investigators to do the same.
  • Helpful information from OHRP is available at: https://www.hhs.gov/ohrp/international/index.html
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