COVID-19 Guidance

COVID-19 is changing the way we are able to perform some research activities. Most notably are virtual visits and other actions that would be categorized as protocol deviations. Below are questions and answers to COVID-19 concerns. Note: this is specific to research overseen by the Piedmont Healthcare IRB. Links to NCI and WIRB guidance are provided at the end of this document.

Frequently Asked Questions

  • Will there be a ramp down to research involving human subjects?
    It is not intended that all non-critical research activities should stop; indeed, those that can be carried out remotely will continue during this time. Examples: studies with no face-to-face participant interactions such as chart review studies or on-line surveys will continue as approved. Note: some such changes may result in COVID-19 specific deviations.
  • Will research with participant interaction continue?
    Yes. As much as possible, adjustments, as appropriate, can be made to certain research to now allow for virtual visits and/or telephone contact visits in place of in office visits. Sponsored projects should have sponsor input on how they would like to proceed with the research going forward. Examples: phone visits, pausing certain activities, allowable deviations or permanent modifications.

    Amendments will be handled per the usual submission, review and determination processes.Note: Per policy #6413 ‘…changes to an approved research proposal must first be reviewed and approved by the IRB prior to initiation except is necessary to eliminate immediate hazard to a subject…’. Any actions undertaken to reduce the potential exposure to COVID-19 qualify as exceptions. In such circumstances a revised consent form document is not required and you may notify the participant by other means and succinctly update the research record.

    COVID-19 specific sponsor allowed deviations will be handled per the following:
    • Maintain COVID-19 Deviation Log Per Sample and submit with the renewal request.
    • Submit sponsor notification of such deviation allowance for PHCIRB acknowledgement.
  • Does adding COVID-19 screening before study visits require an amendment?
    Not unless the data will be used for research purposes.
  • What if during the course of a visit a participant reveals they have or may have COVID-19?
    In addition to the research visit requirements, the participant should be referred to 1-866-460-1119 for screening appointment consideration. Not all callers will be approved for an appointment. Only patients with moderate symptoms who meet other CDC guideline criteria will be offered an appointment.

Other COVID-19 IRB Guidance

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