Health Research Ethics Authority Research Ethics Office guidance regarding COVID-19
The Health Research Ethics Authority (HREA) Research Ethics Office (REO) has been closely monitoring the developments related to COVID-19.
In light of recent restrictions, the REO of the Health Research Ethics Board (HREB) wishes to advise researchers that, effective immediately, their research protocols must be modified or delayed to avoid face-to-face personal interactions with research participants. Specifically, research protocols for continuing research will need to be amended to replace face-to-face interactions with remote communication.
Any change to research protocols should be carefully considered to maximize participant safety. Considerations include the nature of your protocol, the type of participants engaged in the research and any additional risk that may arise by switching from in-person to remote communication. Revised informed consent forms and/or consent addenda may be required (e.g. to update participants with regard to privacy considerations arising from the use of different communication channels, etc.)
The REO would like to direct researchers carrying out planned temporary changes to approved study procedures, because of COVID-19, to submit either an HREB Amendment Form (HAF) or an HREB Protocol Deviation Form (HPDF). HAFs will be required when changes to the research protocol can be anticipated. While TCPS2 typically requires review and approval of modifications prior to implementation, an exception can be made where the change is necessary to eliminate an immediate risk to participant(s) (Article 6.15). Such changes may be implemented but must be reported to the HREB at the earliest opportunity. HPDFs will be required when a change is immediately necessary to maximize participant safety. Please ensure your HPDF describes both the deviation from the approved research protocol and a description of the arrangement for returning to normal processes. For both the HAF and the HPDF please be sure to provide any supporting documentation from the project’s Sponsor, if applicable.
If you require any assistance in the use of this form, please contact the ethics officers at firstname.lastname@example.org for clinical trials and genetics studies, and email@example.com for non-clinical trials.
Thank you so much for your attention and patience during this challenging time.
A series of Frequently Asked Questions (FAQ) for researchers are now available on the university’s COVID-19 resource page.