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This guidance is superseded by guidance dated June 15, 2020

April 9, 2020: Updated Guidance for Researchers Conducting Human Subject Research during Covid-19

In response to the COVID-19 outbreak, the Office of Research Compliance is providing guidance for research activities, effective April 9, 2020 and continuing until further notice.

Effective April 9, 2020, the Office of Research Compliance is determining what changes to human research need to be reported to the Institutional Review Board (IRB). This guidance applies to all ongoing research (including exempt research) that is conducted by Stony Brook University researchers. Because of public and institutional self-isolation efforts, as well as possible quarantine of exposed individuals, it may be necessary to alter your research plans in order to keep study team members and research participants safe. Please consider the following for each active study.

Alterations that do not require IRB review and approval
  • Additional clinical services, testing, and screening related to COVID-19 that need to be performed for research participants do not need IRB approval prior to initiation. Such procedures would be considered usual care outside of the research context. 
  • Placing your study on hold.  Discontinuing study participation during this time may not be safe or may jeopardize the results of the project. This decision should be made on a study by study basis, likely in consultation with departmental leadership to ensure that department and participant needs are met. This change does not need to be reported to the IRB.
  • Change to the consent location does not need to be reported to the IRB if the study protocol does not specifically address this (i.e., changing consent from face-to-face to remote consent but protocol does not specify face-to-face). If your study makes very specific notation to participant consent and your study will now conduct consent in a manner not in the protocol, you will need to amend your study.
  • Use of a local lab or facility for specimen collection or performance of scans does not need IRB approval if the protocol does not specify where the specimens are to be collected or the scans are to be performed. Study teams should consider any charges that might accrue to the participant due to the use of a local lab.
Alterations that DO require IRB review and approval
  • Any changes to the protocol or the research procedures requires an amendment with the IRB. 
  • Use of home visits and phone calls for participant data collection and monitoring, as long as no procedures would be performed that are unsafe in this setting. Home visits and phone calls need to be conducted by a member of the study team. The IRB application should be amended to include these methods if you choose to use them.
  • Questions added to the study about COVID-19 if the questions will now be part of data collection. These questions will need to be submitted as an amendment to the for review and approval prior to implementation of the question(s). 
  • Shipping of an oral or topical drug need approval prior to initiation. Document any changes you make to shipping the drug. If the drug is not oral or topical but requires intravenous administration, arrangements will need to made regarding how this will occur. Pharmacy will need to sign off on this amendment.

NOTE: The IRB acknowledges that the COVID-19 outbreak and isolation/quarantine requirements may result in deviations that are intended to eliminate apparent immediate hazard to a research subject. 

Therefore, deviations from the protocol deemed necessary to assure patient safety, such as conducting telephone or video contact visits for safety monitoring rather than on-site visits, can be immediately implemented with subsequent notification and review by the IRB. 

Additionally, the change to telephone or video contact visits would likely result in some protocol-required procedures not being conducted (e.g., vital signs, blood samples for safety, imaging studies, etc.). The PI must evaluate the potential impact on patient safety, and consider how to mitigate risks to patients, including the possibility of discontinuing the investigational product.

The potential impact on patient safety, and consider how to mitigate risks to patients, including the possibility of discontinuing the investigational product.