COVID-19

This guidance is for human subject research projects conducted under the oversight of the Creighton University Institutional Review Board. Creighton University IRB has received inquiries regarding procedures to be followed in the event of disruption of human subjects research due to COVID-19. Creighton University IRB has suggestions for researchers to minimize unnecessary study visits and potential exposure to COVID-19. Examples of proactive study modifications made to reduce risks to subjects and research personnel may include the following:

1. Consideration for whether protocols should be modified to maximize the potential for social distancing. For clinical research, this might include modifying studies to decrease the number of protocol-required in-person study visits, replacing protocol-mandated visits to healthcare facilities with home visits or visits conducted over the telephone or telemedicine where possible. This may mean postponement of in-person visits for non-therapeutic/data collection studies or postponement of other study activities conducted in-person such as focus-groups/interviews, etc.

2. Consideration of whether pausing new subject accrual is appropriate.

3. Consideration for sending study materials to participants via mail communication as appropriate and in accordance with CU policies and procedures.

The CU IRB expects these modifications to be made with consideration of the importance of subject safety evaluations/effects on scientific aims of research (to the degree possible). An Amendment/Modification in protocol should be submitted. Researchers are reminded that the IRB response to these requests may be slowed by reduced IRB staffing and volume of requests. CU IRB will review prospective changes (Amendment/Modification) to previously approved research and prioritize Amendment/Modification requests related to COVID-19 upon request from the researcher.

The CU IRB is required to follow policies and procedures for prospective review of Amendments/Modifications with the exception of changes necessary to eliminate immediate hazards to the subject which may be made without prior approval of the IRB (per 45 CFR 46.108(a)(3)(iii), 21 CFR 56.108(a)(4) and CU IRB policy 121 ?Modification of Approved Research?. However, the CU IRB requires these reports be submitted within 5 business days by submitting the Reportable New Information form. The submission must outline a description of changes made and provide sufficient information in order for the CU IRB to conduct a risk assessment of the changes.

Researchers are also reminded that protocol deviations (e.g. out-of-window visits that do not constitute a safety risk to the subject) should be submitted on the continuing review application. However, violations from study visit schedules that have or could have increased risks to participants should be promptly reported to CU IRB through a Reportable New Information submission within 5 business days.

If you have questions, or you need assistance, please contact me at (402) 280-2511 or the IRB office personnel at (402) 280-2126.

 

Thank you,

Joseph A. Knezetic

In the context of the COVID-19 pandemic, a temporary policy is being implemented to protect our participants, researchers, students, and larger community from risk of infection.  The risk of exposure and the risk/benefit ratio for face-to-face contact associated with research activities must be assessed for each project; therefore, Creighton University is imposing the following restrictions on human subject research conducted under the oversight of the Creighton University Institutional Review Board.  These restrictions are effective as of Friday, April 3, 2020 and will remain in effect until further notice.  Based on the current environment, there may be daily or weekly changes to these restrictions.  Please monitor the CU IRB website and email communications on a daily basis for any further notifications.

  • All currently active research which involves face-to-face contact that has no direct subject benefit must be halted.  Most exempt research falls into this category.  No further accrual, research interventions, or assessments may take place, unless done remotely.  Online/remotely conducted research can continue as planned.  If you wish to modify existing research to perform interventions or assessments remotely, you must submit a "Request for Modification" prior to implementing any modifications.
  • New subject accruals for research that involve face-to-face contact where there is only limited direct benefit must also be halted*.  Research interventions and assessments on already enrolled subjects may continue as long as those interventions can be performed with minimal risk to subjects and there are staff personnel available to complete those visits.
  • Studies with high prospect of direct benefit to subjects (therapeutic research) may continue (e.g. continued accrual, intervention, and assessment is based on the ability to implement precautions for the safety of the participants and investigative staff) as long as those studies are conducted with adequate precautions to minimize the risk of exposure to COVID-19 and there are research personnel available to complete those visits.  Research teams must assess their studies on a case by case basis and modify studies to reduce the risk to participants and study personnel.  This policy does not apply to IRB-approved study activities that do not involve direct subject contact (e.g. medical record reviews, Qualtrics surveys, remotely conducted interviews, etc.).

Researchers are reminded that the IRB response to Modification requests may be slowed by reduced IRB staffing and increased volume of requests.  CU IRB will review prospective changes (Modifications) to previously approved research and prioritize Modification requests related to COVID-19 upon request from the researcher.

The CU IRB is required to follow policies and procedures for prospective review of Modifications with the exception of changes necessary to eliminate immediate hazards to the subject which may be made without prior approval of the IRB (per 45 CFR 46.108(a)(3)(iii), 21 CFR 56.108(a)(4) and CU IRB policy 121 "Modification of Approved Research").  However, the CU IRB requires these reports be submitted within 5 business days by submitting the "Reportable New Information" form.  This submission must outline a description of changes made and provide sufficient information in order for the CU IRB to conduct a risk assessment of the changes.

Researchers are also reminded that protocol deviations (e.g. out-of-window visits that do not constitute a safety risk to the subject) should be submitted on the continuing review application.  However, violations from study visit schedules that have or could have increased risks to participants should be promptly reported to CU IRB through a "Reportable New Information" submission within 5 business days.

While it is difficult to predict the future of the COVID-19 pandemic, you must have a plan for cessation of in-person, no direct subject benefit / limited direct benefit research for several months.  Students should work with their faculty advisors regarding modifications to their human subjects research methods and IRB protocols.

If you have questions, or you need assistance, please contact the Director of Research Compliance at (402) 280-2511 or the IRB office personnel at (402) 280-2126 or irb@creighton.edu.

*If the PI feels there is a compelling justification to continue enrollment in a limited direct benefit study, the study team must submit a written justification to IRB@creighton.edu. Please see the attached "COVID-19 Frequently Asked Questions for Human Subjects Research at Creighton University" for guidance regarding this email communication.

 

Thomas F. Murray, PhD