Human Subject FAQs
If there is a future outbreak of COVID-19, what should I do about my research?
Researchers must maintain plans and be prepared to return to remote activities on short notice if this becomes necessary.
Is the Institutional Review Board at Stony Brook University operating as usual?
The Stony Brook IRB continues to meet as scheduled via videoconference. All email addresses will continue to be monitored with the same frequency as typically provided. The main office number is being monitored regularly and any messages left on the main line will be returned.
What is the effect on the review of new studies?
The Human Research Protection Program will continue to receive and review new studies. For studies that are approvable, but involve in-person interactions with study subjects and do not have the potential for direct benefit, the IRB will approve the study but with a stipulation that the study cannot begin enrollment until official guidance (e.g., government) states that social distancing is no longer necessary.
Which human subject studies should be placed on hold during the outbreak of the COVID-19?
For studies in which there is no direct benefit to subjects or where there is subjects travel for research purposes (and no direct benefit), studies must be paused, effective immediately or as soon as can be implemented. Procedures such as telephone contact or monitoring or remote data collection, if part of such studies, may continue.
Studies in which there is direct benefit to subjects may continue. If possible, these studies should be performed remotely. This would include the collection of safety data (based on the ability to detect potential adverse events). It is suggested that laboratory tests or imaging needed for safety monitoring occur at local laboratories or clinics.
Do I need to contact the industry sponsor if my research activities are placed on hold?
Yes. If it is determined that your study will be placed on hold. However, trials with investigational treatments, including drugs and devices, that provide the potential for direct benefit should continue.
What do I need to do to place my study on hold?
Submit an amendment indicating which study components should be placed on hold and which will remain open. Provide a short statement of the risks and benefits in light of the COVID-19 epidemic. The IRB will review each response and make a determination.
Can I continue to collect data and follow-up information from subjects by telephone when in-person data collection has been placed on hold?
Yes. Once the amendment is approved for the change in data collection (through an IRB amendment) you can continue to collect information from subjects. NOTE: You do not need to modify your protocol in order to hold visits remotely or to change the schedules if the study is exempt or if the IRB protocol does not specifically describe whether the visit would be in person or remote, or give specifics about visit schedules .
Can I continue to collect data from home visits?
If there is no benefit to the subjects, you should not collect data from a home visit. If there is another way for the subject to participate in the study, pursue those avenues (i.e., phone visits, email).
Do I need IRB approval to let my study subjects know that the study has been placed on hold?
No. An amendment is not needed for this activity.
How do subjects need to be notified of visit cancellations and changes?
When a study visit needs to be cancelled or changed to a phone call or on-line encounter, the subject should be told the reason and that they will be contacted again when the in-person visit can be rescheduled. These messages to subjects do not require IRB approval.
Will the IRB provide language that we can use in contacting our subjects?
“Due to the potential or perceived risks of COVID-19, Stony Brook University has to place this study on hold. This study will continue to contact you and regular data collection activities may resume when the risk of COVID-19 has passed.”
Do I need to register modifications with ClinicalTrials.gov?
Some studies registered at the federal site ClinicalTrials.gov are modifying their research procedures to include testing for SARS-CoV-2 and/or assessment of COVID-19 symptoms. The ClinicalTrials.gov information for the study should be updated to include these new procedures, if they are done for research purposes. If they are being added as public health surveillance activities in coordination with public health authorities, the registration information does not need to be modified.
The federal requirement about modifications is that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study’s ClinicalTrials.gov registration with 30 days after IRB approval of the modification.
I am conducting an FDA-regulated study. I hold the IND or IDE. Do I need to notify the FDA if I place my study on hold?
Yes. The FDA will need to be notified.
When do I need to report protocol deviations to the Institutional Review Board (IRB)?
Protocol deviations do not need to be reported to the IRB unless they impose an increase risk of harm to participants or adversely affect the integrity of the data. As a reminder, a protocol deviation is something that applies to one individual.
· Example: A subject is not able to travel for an in-person visit because of self-quarantine. This is a minor deviation and does not need to be reported to the IRB unless it impacts the risk to the participant.
· Example: A subject has self-reported or documented symptoms compatible with COVID-19 infection 24 hours prior to dosing or at the time of dosing. The Principal Investigator will determine whether or not the subject will not receive the study drug. This situation is considered a protocol deviation as it could impact subject risk. This deviation needs to be reported to the IRB.
· Example: A subjects’ insurance does not cover monthly laboratory testing, subjects with normal laboratory values skip the laboratory testing at the discretion of the Principal Investigator, in order to limit contact. This is a protocol deviation as it could impact subject safety and data integrity and is reportable to the IRB.
· Example: In order to minimize contact between study staff and subjects at the time of home visits, body measurements and vitals are not be documented. This will not be considered a deviation as it does not impact subject safety or data integrity and does not need to be reported to the IRB.
· Example: Final diagnostic testing (e.g., MRI, biopsies, etc.) is postponed based on COVID-19 precautions. This is a protocol deviation as it impacts subject safety and is reportable to the IRB.