Given the current COVID-19 outbreak, investigators should consider whether at any
point their research procedures involving human subjects should be revised to limit
personal contacts, for example by reducing the frequency of in-person visits or replacing
in-person interviews with telephone or virtual (e.g. Skype, Zoom) communication.
Whether and when this may be advisable will vary depending on your protocol and the
subjects with whom you are working.
We want to remind you that while the federal regulations that guide our oversight
of research require that we review revisions to protocol before they are implemented,
there is one important exception, “where necessary to eliminate apparent immediate
hazards to the human subjects.” 21 CFR 56.108(a)(4).
Should you determine that changes in your procedures are required, they can be implemented
- If it is necessary to eliminate apparent immediate harm to participants, you may implement
changes immediately, without prior notice to or approval from the IRB. The changes
need to be reported to the IRB as soon as possible and will require justification
for the delay if reporting takes more than 5 business days.
- If your changes are to reduce face-to-face contact (e.g. moving in-person interviews
to Skype) and no other risks are being introduced (e.g. you haven’t decided to now
video record rather than audio record), you can proceed with implementing your changes
after notifying the IRB via email. No prior approval will be required.
- If your changes are introducing other risks (e.g. video recording, recording additional
identifiers, change in site location, etc. that were not previously approved) you
will need to submit a modification request for approval. Please feel free to reach
out to the IRB for clarification or discussion.
Please send all email change requests to Nicole Morse (firstname.lastname@example.org). You
can also contact Nicole if you have any other questions.