COVID-19 Guidance for Researchers: Clinical Settings
This page contains information about research operations during the University of Calgary's COVID-19 response.
Last updated: June 15, 2020
- Monitoring visits: Effective March 27th, on-site monitoring visits are no longer permitted for pharma sponsored as well as investigator-initiated trials. Monitoring visits can either be deferred or remote monitoring can be arranged. Memo: Clinical Trials Remote Monitoring and Study Status Updates during the COVID-19 Pandemic
- When research staff are in AHS space, all AHS policies and procedures must be followed including infection prevention and control practices and workplace health and safety rules. Please see the latest guidance from AHS on research in AHS facilities.
- The FMC ICU clinical trials unit facility will be unavailable until further notice
- Limit personal contacts, laboratory visits or trips into clinics and hospitals. If conducting approved research activity in an AHS facility, please follow all AHS Infection Prevention and Control (IPC) guidelines and procedures. If there is any uncertainty, the AHS Health System Access team can connect you with the appropriate IPC representative for a consultation.
- For information on initiating or resuming a study in AHS, please visit the AHS Health System Access webpage at https://extranet.ahsnet.ca/teams/AHSRA/SitePages/Home.aspx
- The CFREB and CHREB advise investigators to consider if their research protocols could be modified or delayed, to limit personal contacts, laboratory visits or trips into clinics and hospitals. Specifically, in some research settings in-person participant interactions could be reduced and/or replaced with telephone or online communication.
- While TCPS 2 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 REB at the earliest opportunity (within 5 business days as a guide).
- The Heritage Medical Research (HMRC) will remain open but with a reduced capacity. Operation of the HMRC facility is following AHS guidance.
- Only patients and study monitors who pass the AHS screening test will be permitted to enter HMRC. Please check the HMRC website for further guidance.
- Research studies involving human participants are not permitted to operate in University of Calgary facilities unless they (a) occur in the HMRC, or (b) have received a Critical Research Designation
- Research studies that occur solely in AHS facilities (i.e. have no physical presence in a University of Calgary facility) do not require a Critical Research Designation or Essential Research Designation from the University. However, they must receive approval from AHS to resume or commence operations (see above and https://extranet.ahsnet.ca/teams/AHSRA/SitePages/Home.aspx).
- Consider which, if any, study visits could be canceled, delayed or held virtually as opposed to those which must proceed in-person (for example, administration of medication assessments that are clinically important). UCalgary now has an institutional license for Zoom.
- If you anticipate the need for ongoing study visits to administer study drug or facilitate study assessments, consider alternating attendance of your study staff at study visits. This will ensure that trained study staff remain available in case a study patient is found to have been infected with or exposed to COVID-19.
- If study staff are exposed to a patient, study monitor or employee who is later found to have been infected with or exposed to COVID-19, the study staff member must self-isolate for 14 days.
- Consider checking with Study Sponsors regarding their expectations, including how protocol violations should be handled and any special reporting requirements.
- Biosafety Committee authorization is required prior to performing research with the virus causing COVID-19 (including accepting patient samples). Contact firstname.lastname@example.org.
Clinical Research: Planning for a phased return
On May 25, 2020, the Office of the Vice-President (Research) and Alberta Health Services held a Town Hall to discuss considerations for a phased return to clinical research activities.
- Slide deck (pdf)
- Q & A (pdf)
- See guidance from the Research Ethics Board about consent
- Session recording: please request link by emailing email@example.com
Guidance for all researchers
Please stay up to date with rules and guidance from the Government of Alberta and AHS.
If you must conduct research, creative or scholarly activities on campus, in the field, or in the community, review the research exemption section and apply for the appropriate exemption.
If you are working on Main or Foothills Campus, you can contact Staff Wellness at firstname.lastname@example.org to schedule a time to pick up disinfectant wipes.
- Be aware of current guidelines from AHS on how to protect others and yourself.
- Be prepared for the possibility of core facilities and other fee-for-service resources becoming unavailable.
- Be prepared for delays in supply chain, including shortage of Personal Protective Equipment.
- Be prepared for delays in services provided by vendors.
- If you returned from travel abroad after March 12, be aware that a 14-day self-isolation period is required upon your return. Check Alberta’s current isolation requirements.
- Even in cases where you have a research exemption, please continue to work from home whenever possible and limit your presence in research facilities and in the workspaces on campus.
- Maintain a 2-meter separation between active work areas.
- Any in-person group activities including thesis defenses, mentorship committee meetings, seminars, journal clubs, laboratory meetings and hiring interviews should be canceled or held as virtual meetings by telephone, Skype, Zoom or similar. UCalgary now has an institutional license for Zoom.
- Although there are currently no plans to close the university, this could change in the future with very little or no notice. Further, individual COVID-19 cases could lead to closure of University buildings with no notice at all. Therefore, please take measures to ensure that your unit is prepared for the possibility of a closure at the end of each day.
- Visit the ‘Working and Learning from Home’ website for information about ensuring you are set up to be productive from home.
- Think carefully before initiating new experiments: consider the time required to complete them as well as the cost and inconvenience if they were interrupted before completion.
- Unit leaders should consider communicating with each other about opportunities to mitigate the impact of illness or self-isolation, such as by sharing staff between units.