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Performing clinical health research: In light of COVID-19 

ACRC and Alberta Innovates continue to support Alberta’s clinical health research community during the COVID-19 pandemic.  Please reach out to us at acrc@albertainnovates.ca if you need assistance related to your research project.

The universities, institutions and research ethics boards (REBs) in Alberta have issued guidance and advisory documents on the conduct of research and clinical trials within their facilities at this time. These documents are subject to change and updates. Researchers and research teams are therefore strongly advised to read, follow, and keep to date with their institutional specific directives. 
To pause, or not to pause: considerations for essential vs. non-essential ressearch
ICH GCP 4.3.1: A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions
Whether a participant visit is deemed medically necessary is up to the Principle Investigator. In the wake of COVID-19 it is not always clear what research could continue and what research could be put on pause. Some considerations for whether a study could be either put on pause, or continued in a different manner are:

Will stopping the intervention endanger the health of the participant? An assessment needs to be made as to what risk to benefit ratio is; for example, phase 3 studies where there is a direct benefit to the patient should not be stopped. A non-direct benefit study may be put on pause. For example, observational studies, pragmatic trials, or phase 1 studies.

How are sponsors helping with the COVID-19 crisis? Many sponsors are providing administrative staff  and process guidance to help deal with staffing shortages at hospitals and clinics. If the PI is the sponsor, this task will fall on the PI, it is the PIs responsibility to make the decision to continue, pause, or alter the study.

Will travel restrictions or isolation restrictions pose unnecessary risk? Currently, public transit restrictions may be restricted and either not allow participants to come in for a visit or participants are in self-quarantine. Decisions need to be made whether travelling to a hospital or clinic visit would pose undue risk to the participant. The principal of nonmaleficence, meaning non-harming or inflicting the least harm possible to reach a beneficial outcome, must be followed.

Is the study diverting crucial staff from the COVID-19 crisis? Considerations may need to be made that if the study is non-essential and takes a nurse, physician or medical staff away from addressing the COVID-19 crisis directly, the study may be put on pause, or diverted to administrative staff to continue alternative measures, Many of health system staff are directly dealing with the crisis and are not available to deal with a study or trial and we have a moral obligation to not divert resources from this effort.

Can some work be done remotely? Not all activities need to stop, writing, planning remote data collection, online survey can continue. Alternative methods of collecting samples and data can be employed. Considerations need to be made when adopting new study activities. Does the new process carry validity (Ie. if you were previously collecting data in a different way, does the new process offer the same amount scientific rigor). All new processes need to be documented and the REB should review new processes or procedures.

Can the research still reach its end point of some study visits or activities are eliminated? A review can be undertaken to determine whether this could be done. Temporary protocol changes may be employed during COVID-19 which keep the research viable, but eliminate risk.

How do we support our current participants if a study is put on pause? If a study or trial is put on pause, communication with current participants do not necessarily need to be paused. It is important to keep an open communication pathway for participants to keep them informed on any study changes and how their participation will be affected. Also, it is important that a re-engagement plan be made about how patients will be brought back into the study after the pause ceases. Keep in mind that all patient-facing communication must be reviewed by the REB.

What does the REB need to know? Keep the REB informed of substantial changes to protocol, protocol deviations that have negative impacts or risks to participants. Temporary protocol measures may be taken during this time and regular protocol reinstated at the end of the crisis, but these changes may need to be reviewed by the REB. Anything that you would normally provide the REB still needs to be done. When it doubt, contact your REB for more information.

What do research staff need to document? In short, everything. At the end of this disruption it will be important for all those involved to be able to look back and see exactly how each study was handled. Document each change, deviation etc. diligently. 

During the COVID-19 pandemic researchers will face a multitude of decisions regarding their research. REB, institutional and regulatory guidelines must be maintained during this tumultuous time. There is technology available to help researchers to work remotely. eSource applications that utilize audio and video recording of interactions with patients, eConsent platforms, and Telemedicine options are all available for use, but privacy and security concerns need to be addressed prior to implementation. Decisions are to be made by PIs on a case by case basis. Flexibility and nimbleness are key in this era of rapid change.
More Information on Essential vs. Non-essential Research
Health Canada: COVID-19 updates
Management of clinical trials during the COVID-19 pandemic: Notice to sponsors
Health Canada is aware of the impact of the COVID-19 pandemic on the conduct of clinical trials, and recognizes that there may be an increase in protocol deviations. Therefore, they have issued a notice to sponsors on how to deal with these deviations. Learn more

Expedited review of health product applications to address COVID-19  
The Minister of Health has approved an Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. This order will enable an expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19, at no cost. Read more 

Related updates:
Privacy during COVID-19

The Office of the Information and Privacy Commissioner of Alberta (OIPC) has noted that privacy laws do not impede the work of public health officials during a public health emergency. What constitutes “reasonable safeguards” during a public health emergency may be different from normal circumstances.

"During these unprecedented times, if a health custodian is considering new administrative practices or information systems with implications for individuals’ privacy to combat the pandemic, the OIPC is asking that health custodians, at the very least, notify the Commissioner about the new administrative practice or information system. Notification of a new administrative practice or information system can be submitted to the OIPC via email.”

See more information from OIPC on:

Measuring the impact of COVID-19 on Alberta's physicians - CPSA and UofA work together

The current pandemic puts at risk the health of Alberta’s physicians, both through exposure to the virus and through the demands of practicing the best possible medicine under extraordinary conditions. University of Alberta researchers are working with the College of Physicians and Surgeons and Physicians of Alberta (CPSA) to build a cohort of physicians to determine the effects of working through the COVID-19 pandemic. Learn more 

Visit Be The Cure for more of the COVID-19 research happening in Alberta.
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