The temporary hold on Category 3 on-site clinical research at UCSF will require some research teams to deviate from their IRB-approved protocols (e.g., postpone study visits, conduct procedures remotely, etc.). In such cases, the Human Research Protection Program offers the following guidance:
- If you can safely postpone study visits or delay enrollment, you may do so without obtaining prior IRB approval for this change.
- If there are safety implications to the proposed changes, such as elimination of safety labs or procedures, these should not be skipped or postponed. While the PI may determine whether the study should continue or be subject to the temporary hold, they may not decide to skip a safety visit without IRB review.
For more detailed IRB guidance, go to What to do when Temporary Holds on Research are in Place and FAQ Q1. Part of Q1 is pasted below for convenience:
Q1. If changes necessary for protecting research participants from COVID-19 are made in accordance with interim policies, what should we submit to the IRB, and when?
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Scenario A: Changes that do not increase risks to subjects
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Scenario B: Changes that may increase risks to subjects |
Scenario C: Changes that require IRB approval before implementation |
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Prior IRB approval required?
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No |
Yes*
*See the bottom of this column for exceptions |
Yes |
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When to submit |
At the time of your next necessary modification or continuing review.
Tip: Make notes to your study files to document the changes. |
Prior to implementing the change. |
Prior to implementing the change. |
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What iRIS form to use |
Modification form or Continuing Review form, as appropriate
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If the change is projected to be long or short term, impacting multiple participants, a Modification form should be submitted.
If the change will affect only 1-2 participants in a unique circumstance, see the “Exception” instructions at the bottom of this column. |
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Examples |
Changing visits that are not essential to the health and/or well-being of participants from in-person visits to remote/virtual visits. -- Incorporating screening questions to identify potential exposure to COVID-19. -- Adding links to reputable websites for information about COVID-19 (UCSF, CDC, etc.) to the study website. -- Postponing or cancelling non-essential study visits/procedures that do not impact participant safety. Add a note-to-file for the participant research chart that sufficiently documents the reason for the postponement or cancellation of the visit. -- Moving from in-person to remote consent and HIPAA authorization. Note: If your study has a requirement for signed consent, you must still collect signatures remotely. -- Pausing/suspending recruitment and enrollment.
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The IRB should be contacted for approval and guidance before critical safety labs or scans to monitor disease progression or to ensure safety are omitted as a result of COVID-19. --
Changing the timing or location of visits/procedures determined to be essential to the health and/or well-being of the participant, such as a significantly out-of-window safety lab, as determined by the PI.
*Exception: If you need to make special accommodations for 1-2 subjects to protect the safety of the subjects and/or the study team, please notify the IRB as soon as you are aware of the situation and we will determine whether a modification form should be submitted and approved prior to making the change. Notify us via the Ask Andy form. If we determine the change does not require a study modification, you will likely need to submit an Incident Report form after the change is made. A pdf file of your Ask Andy query and the IRB's response email should be attached to the incident report submission. Example of a scenario fitting this exception: A subject is under travel quarantine orders and cannot attend a safety-related study visit within the timeframe described in the protocol. The study team reschedules the visit at the soonest opportunity. |
Changes to inclusion/exclusion criteria, even if being changed in response to COVID-19. -- Changing from signed consent to verbal or implied consent (e.g., no longer obtaining wet or electronic signatures) -- All changes not related to the UCSF interim policy (i.e. not related to immediately protecting participants from COVID-19 exposure)
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