Cooperative/Multi-institute Research (IAA)
It is not uncommon for an external institute to have different standards or different policies and procedures for executing agreements or IAAs than we do. The Kent State IRB, ORC and University Counsel occasionally collaborate to negotiate agreements with your collaborator's IRB. This means that we may not always be able to follow uniform processes and delays may be experienced. In some cases, when allowable by the regulations, we may advise you or your collaborator to obtain their own approval. However, most NIH-funded studies must go through a single IRB (sIRB).
- The NIH sIRB policy does not apply to exempt research, so most IRBs, including Kent State's, prefer to not 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.
Are there any special rules about sharing genomic data?
- Yes. See these NIH resources 1) https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing-faqs/ 2) https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/
How should data collected under the approval of the KSU IRB be stored?
- Identifiable "offsite" data needs to be stored per the KSU-approved IRB application and IS security policy (https://www.kent.edu/is/security-requirements-faculty-and-staff).
How can I expedite the review of an IAA?
- As early as possible let all institutes involved in the IAA know of your plans to request single IRB review.
What is an interinstitutional authorization agreement?
- 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. In general Kent State University does not enter into IAAs for exempt/level I projects. If your project is exempt, please contact the Office of Research Compliance for guidance.
What is local context review?
- This is a process where we review the external IRB's review to ensure that it is consistent with local requirements. This includes consistency with local and state laws as well as Kent State policies and ancillary reviews such as IBC or Radiation Safety review.
- If any actionable items are identified during local context review, we will notify the PIs accordingly.
- Review this DHHS guidance document: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2013-january-10-letter-attachment-a/index.html
What does it mean to be engaged in research activities?
- Visit OHRP's website: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/determining-when-institutions-are-engaged-in-research/index.html
- View the OHRP You Tube video: https://www.youtube.com/watch?v=7gmRz0dNUmI&feature=youtu.be
How do I know which institute should be the IRB of record?
- External Review:
- 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, an international research project where the interaction with subjects is performed at an external site and the site has an FWA.)
- This is a multi-site study with multiple IRB reviews/approvals.
- This is a multi-site study and all sites are deferring to only one approving IRB.
- KSU Review:
- The majority of the study procedures will be performed at Kent State, or by Kent State faculty/staff.
- This is a multi-site study and all sites are deferring to one approving IRB.
- This is a multi-site study with multiple IRB reviews/approvals.
How long do IAAs last?
- IAAs last for the life of the project unless there is a change to the agreement (including an institute ceasing engagement in research).
I have an IAA, what do I need to do now?
- KSU Review: You should correspond with the Office of Research Compliance and the IRB as you normally would, such as submitting renewals, amendments, closures and etc…
- KSU Review - The KSU PI is responsible for the external collaborators. It is important to communicate clearly and openly with external collaborators.
- External Review: You correspond with the other institution in accordance with their procedures. You must contact the KSU Office of Research Compliance and IRB if there is a change in study risk level, if a subject complaint or unanticipated problem occurs, the project is suspended or terminated by the IRB of record, change in funding, change in KSU role, or the study is closed. You should also file copies of approved amendments and continuing reviews with the Office of Research Compliance.
Does KSU have any standing agreements?
- We have standing agreements with Akron Children’s Hospital, Akron General Hospital, Summa Health System, Ursuline College, University of Akron, NEOMED, YSU, Cleveland State University and Cleveland Clinic.
What is the regulation on cooperative research?
- 45CFR46.114 states
- 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
- 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 Review 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.
- The following research is not subject to this provision:
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
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.
- 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.