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Changes for human subjects research coming to Illinois State University

Update on New Federal Regulations 

The Office for Human Research Protections (OHRP) has announced a further delay in the implementation of new federal regulations pertaining to human subjects research. The new implementation date is January 21, 2019. In the announcement, however, permission was given for institutions to implement three “burden-reducing” provisions effective July 19, 2018. ISU has chosen to implement these provisions as follows:

1)  The revised definition of “research” will be implemented for all non-federally funded research effective July 19, 2018. This new definition excludes certain categories of research, including journalism and oral history, as long as these activities focus directly on the specific individuals about whom the information is collected. Scholarly activities using data collected through these methods that go beyond the specific focus could still be subject to human subjects regulations. Please note that ethnographic studies were not excluded by the new regulations and are still subject to review.

2)  The elimination of the requirement for annual continuing review for all non-federally funded Expedited Review level research effective July 19, 2018. This means that Expedited Review studies with expiration dates as of or after July 19, 2018, will not require annual renewal. We are working out the details of how to accomplish this in Cayuse IRB and will be contacting PIs once the process is finalized. In the meantime, if you receive a renewal or expiration notification for a non-federally funded Expedited Review study, please contact us to determine next steps. As always, PIs are still required to report any adverse events or noncompliance and receive prior approval for any modifications to the study.

3)  Removing the requirement that the Institutional Review Board (IRB) assure congruence between grant proposals and IRB protocols at the time of submission or proposal unless required by the agency. This is merely an administrative function for funded projects and will be addressed on a case by case basis with individual PIs.

  • Note that the first two provisions do not apply to studies that are funded by any of the following federal agencies:

Agency for International Development

Agriculture Department

Commerce Department

Consumer Product Safety Commission

Defense Department

Education Department

Energy Department

Environmental Protection Agency

Health and Human Services Department

Homeland Security Department

Housing and Urban Development Department

Labor Department

National Aeronautics and Space Administration

National Science Foundation

Social Security Administration

Transportation Department

Veterans Affairs Department

Federally funded projects were excluded from the first two provisions because any study that implements the burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 requirements for the balance of the study’s duration, which would constitute a much greater burden. If you have a federally funded study that you would like to transition to the new regulations, please contact the Research Ethics and Compliance (REC) office at  IRB@ilstu.edu to discuss options. If you have a study that is pending federal funding, please contact the REC office as well since there may be additional considerations.

New IRB Chair

We are pleased to announce that Jessie Krienert has been named as the IRB chair. Krienert is a professor in the Department of Criminal Justice Sciences and a prolific researcher. We also want to thank Alycia Hund for her outstanding service as IRB chair for the last three years. Serving as IRB chair was particularly challenging as we transitioned from paper submissions to IRBNet and then to Cayuse IRB. 

New Process for Expedited Review 

The IRB has modified the process for Expedited Review. Previously every study was reviewed by one member of the Executive Committee as well as the IRB chair. The new process only requires the IRB chair to review Expedited Review studies, which should result in fewer delays on these studies while boosting consistency and turnaround time. The chair, as always, still may consult with IRB members or others during the review, and has the authority to forward the study to the full IRB. 

Research Incentives 

Progress is being made toward finalizing the process, required consent language, and receipt documentation. We anticipate this will be finalized early in the fall semester.

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