IRB Guidance on Human Subjects Protections Considerations Related to COVID-19

TEMPLE UNIVERSITY IRB

Guidance on Human Subjects Protections Considerations Related to COVID-19

 

Updated: March 12, 2020 

The Temple University IRB is in receipt of questions concerning screening procedures and research methods that will be of the COVID-19 outbreak. Please see below for our immediate answers. 

Screening procedures to protect against COVID-19:

Temple University Health System, includes Temple University Hospital, Temple Faculty Physicians, Temple Physicians Inc. has instituted mandatory COVID19 screening at all entry points, asking patients about recent travel, potential exposures, and a variety of symptoms related to emerging illnesses. Additionally, multiple research labs have inquired about initiating similar COVID-19 screening procedures for research subjects. 

COVID19 screening procedures/questionnaires that are designed to protect against the spread of the virus, and the data collected will not be used/analyzed for purposes of the research, would not be considered as changes to IRB-approved procedures and methods. Therefore, a Modification to the study documents (e.g., protocol, consent, etc.) is not necessary. If the data obtained from these screening procedures/questionnaires are going to be used/analyzed for the purposes of the research, a Modification needs to be submitted to and approved by the IRB prior to using/analyzing that data.  

Changes to IRB-Approved Protocol Procedures:

Generally, any changes in IRB-approved research requires IRB review and approval prior to its implementation. However, both the Department for Health and Human Services (38 CFR §16.108(a)(3)(iii)) and Food and Drug Administration (21 CFR §56.108(a)(4)) have exceptions for changes that are needed to eliminate apparent immediate hazards to subjects. Due to the apparent immediate hazard proposed by COVID-19, interim measures to reduce immediate hazards to participants and staff can be implemented prior to approval by the IRB. If such changes are implemented the following requirements must be adhered to:

 

Requirement 1: The changes must be specific to preventing the immediate hazard posed by COVID-19, not a protocol-wide change that extends beyond this immediate threat. The term immediate threat in this case is the duration of the need for heightened precautions enacted against COVID-19 spread.

 

Requirement 2: Submit the actions taken as a Reportable New Information (RNI). If Requirement 1 is adhered to, no IRB documents (protocols, consents, etc.) need to be updated, but the RNI should include what actions were taken, the justification, how this change will not increase the risk to participants, and when this change in methodology will end—this can be event-based, rather than date-based.  Some examples of approaches that would reduce the risk to study participants include:   

  • Temporarily stopping IRB approved protocol procedures that involve direct subject contact that provide little or no benefit to subjects.  
  • Phone calls or (if applicable) HIPAA-compliant video conferencing instead of in-person visits.
  • Canceling nonessential in-person visits and/or allowing “out of window” visits.
  • PI and/or sponsor temporarily stopping recruitment, new enrollment, or placing the study on a temporary hold.

In all of these instances, or any other that would fall into this type of change to prevent immediate hazard, research teams should contact their funding and regulatory sponsors (Including FDA if you are an IND/IDE holder) to develop plans for participants and any applicable changes to research procedures.    

Research Staff Preparing to Work Remotely:

Privacy and confidentiality provisions remain of paramount importance at all times. Consistent with Temple University communications, clinical research staff should prepare for the possibility of working remotely.

    • Research teams should maintain secure contact information for research participants should they need to reach out to them. This information should be stored on Temple secure shared drives or Owlbox for remote access.
    • Ensure that access to PHI and other protected clinical research information is enabled with all required securities in place.

We will continue to update the IRB website with timely information. Please check here for updates as they come available.

If you have questions about this guidance, please email your IRB related inquiries to: IRB@temple.edu