Updated July 8, 2020
(Originally posted June 22, 2020)
Based on the advice that we have received from Public Health in this dynamic environment, and weighing the proportional risk to initiating in-person human studies, the following Frequently Asked Questions have been developed.
Yes. However, serious consideration needs to be given to the current public health emergency related to COVID-19. Please see the standard operating procedure (SOP) for details involving human participant research. Where feasible, modifications should be made to eliminate in-person interactions (e.g., conduct interviews, focus groups remotely, on-line surveys, etc.).
Amendments to ongoing research studies should clearly outline all strategies being implemented to eliminate face-to-face interactions, where possible (i.e., virtually or through other means)
At the present time, in-person research that includes vulnerable populations should continue to be conducted without in-person contact, where possible.
- Researchers working with distinct communities/groups (e.g., Indigenous peoples, Amish, faith-based, etc.) should consult with the community in question. It is best practice to consult with the communities to determine whether they wish for you to continue with the research collaboration at this time and to ensure that you are following their health and safety practices.
If you are unable to conduct your research remotely and it must be conducted in-person or within a specific community, please see To All Researchers Undertaking Human Participant Research Guidelines and SOP. Additional considerations include:
Where possible, studies that involve in-person contact should find alternatives to the exchange of papers and pens. Alternatives could include iPads or other electronic devices that can be readily disinfected.
All members of the research team must be asymptomatic of COVID-19 symptoms and this must be validated against the screening protocol every 24 hr.
All participants need to be screened no more than 24 hr prior to the study using the Public Health Ontario screening questions for health care providers which can be found here. Participants need to be symptom free to participate in “in-person” research.
- Complete and submit the appropriate ethics application form in TRAQ (FAQ re: registering in TRAQ posted on the GREB/HSREB websites). Ensure you have reviewed the GREB/HSREB LOI/CF Checklist (posted on the GREB/HSREB websites) as applicable.
- Once the application has been submitted through the TRAQ website, forward the notification of submission from TRAQ via email to email@example.com
- For hospital-based research at KHSC/PCC and/or for contract/agreement review, you will also be required to submit a TRAQ DSS FORM application. This should be submitted at the same time as the ethics application to streamline the review process.
Any changes should be implemented to eliminate immediate hazards to participants prior to review by the appropriate REB. If any changes are implemented, submit for REB review as soon as possible.
- For GREB, submit this information using the GREB Amendment Event Form in TRAQ.
- For HSREB, submit any planned and/or previously implemented changes using the HSREB Amendment Event Form. Additionally, for changes implemented prior to HSREB review, submit a HSREB Protocol Deviation Event Form.
- All event forms can be found through the ‘events’ link beside the file number when you log into TRAQ.
- For CTO/OCREB submit through CTO Stream.
As per the new FDA Guidance titled, ‘FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic’ we are following the same guidelines:
“COVID-19 screening procedures that may be mandated by the health care system in which a clinical trial is being conducted do not need to be reported as an amendment to the protocol even if done during clinical study visits unless the sponsor is incorporating the data collected as part of a new research objective.”
If you plan to store any research files at home they must be de-identified as outlined in the ethics application. Keep in mind the following:
- Take all reasonable precautions to protect privacy. Protecting privacy should be a priority (e.g., secure storage in a separate room that can be locked, locking files in the trunk of a car during transport rather than the backseat where they are visible).
- Files should only be kept off-site for as long as necessary.
- Document in a log all study-related documents that are leaving KHSC/PCC, which includes what research files were taken off-site, participant ID# of files taken, date of removal of research files, date of return of research files, and who took the files (study staff ID).
- Submit an Amendment Event Form to the appropriate REB outlining the new storage procedures and location.