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Information for Researchers

Please note that as things change rapidly, Q&As and guidelines will be updated. Review this website often to ensure you have the most up to date information or consult your leader if you have concerns or identify discrepancies. More information about research activities and COVID-19 can be found on the UBC Research website and the SFU Research website.

UBC and PHC mask wearing mandate - September 17, 2020

Dear Colleagues,

Last week, UBC sent out a memo regarding mandatory mask wearing requirements. I have confirmed with UBC Safety and Risk Services and the Faculty of Medicine office that as a Health Authority Research Institute, we are exempt from this requirement.

However, it has prompted us to review the PHC requirements for mask wearing at work.

This requirement is as follows:

  • Non-surgical masks or multi-layered cloth masks are recommended to be worn in the hospital.
  • If working with patients, or if you are in patient areas, it is mandatory to wear a mask and follow PPE procedures.
  • If you cannot physically distance 2 metres from others within Research Areas, it is mandatory to wear a mask.
  • If your laboratory or research protocol requires PPE that includes a mask, it is mandatory to wear a mask.
  • If you are in an office by yourself, it is optional to wear a mask. 
  • Non-surgical face masks are widely available at Research Centres or by contacting the Research Institute: VPResearchSupport@providencehealth.bc.ca
  • Most importantly: Please remember to stay at home if you have any signs of illness. Use the daily self-assessment tool at https://bc.thrive.health/covid19/en, wash your hands frequently and work remotely when you are not required to be on site. Wipe down high-touch surfaces in your area before and after use with ethanol spray bottles or Lysol wipes.

Thank you and stay safe. Like always, if you need any more information please feel free to contact me.

 

Dr Darryl Knight
President, Providence Health Care Research Institute (PHCRI),
Vice President, Research & Academic Affairs, Providence Health Care (PHC)
Associate Dean - Research, Faculty of Medicine, University of British Columbia (UBC)
 
Memo - STAGE 2 - PHCRI Resumption of Human Subject Research - August 24, 2020
Click here to download an important memo regarding the Stage 2 resumption of human subject research.

Related documents:
PHCRI Unit Level Research Access Summary for Human Subject Research
PHCRI - VCHRI Animal Research Resumption Access Request
COVID-19 Safety Plan Guidelines
COVID-19 Safety Plan Checklist (Clinical)
COVID-19 Safety Plan Checklist (Non-Clinical)
Canada Research Continuity Emergency Fund - July 2, 2020

Colleagues:

I am sure you are aware that the Canada Research Continuity Emergency Fund was announced earlier this week (https://www.sshrc-crsh.gc.ca/funding-financement/crcef-fucrc/index-eng.aspx). This memo and attachment will outline our plans.

This fund is the operationalization of the $450M announced in mid-May to: 1)  provide wage subsidies (75%) to help retain research personnel paid from non-governmental sources and 2) support extraordinary incremental costs for research infrastructure and ramp-in costs during the COVID-19 pandemic.

UBC’s allocation is $17.7M for stage 1 – and this includes for UBC-O and the health research institutes. The deadlines are extraordinarily tight for stage 1 and importantly, if additional funding is required for wage subsidy support, an application to access additional funding (beyond the 17.7M) in stage 2 must be submitted by July 29th.

UBC has been instructed to use CAUBO data from 2016-2018 (for research income from non-governmental sources) to calculate funding allocations to UBC and your institutes.  UBC has generated a rough estimate of what each HA-based institute is eligible for - and PHCRI will receive a minimum of $620k.

The attached memo outlines the process to date - based on a meeting on Monday evening.  As always, if you have any queries or comments, please let me know.

Jo-Lynn Mervyn will be the PHCRI contact person for this initiative.

Dr. Darryl Knight
VP Research & Academic Affairs, PHC
President, PHCRI
Associate Dean Research, Faculty of Medicine, UBC

PHCRI Resumption of Human Subject Research - June 10, 2020
Click here to read the full memo from Dr. Darryl Knight

The process for resuming human subject research is complex and requires significant coordination with operations teams at PHC, in addition to departments responsible for research oversight at UBC. A thoughtful and measured approach is needed in determining the scope of Stage 1 research resumption for human subject research at PHC. In accordance with PHCRI’s previous communication of June 3, 2020, there will be a phased-in approach to resumption of on-site human subject research activity at PHC. This phasing is needed to responsibly restore clinical services and other patient and public spaces across PHC’s facilities and is aligned with the VCH/PHC COVID-19 Recovery Planning Framework. This will enable VCH/PHC’s ability to maintain acute care capacity for COVID-19 cases, while simultaneously minimizing impact to non-COVID cases.

The attached fillable checklists for both clinical and non-clinical spaces must also be included with your submissions as required by PHC Occupational Health and Safety. Submissions without a completed safety plan and applicable checklist(s) cannot be submitted to UBC until this information is available and approved by PHCRI. For reference, please also find below a sample safety plan template, courtesy of the CGSHE. 

Related forms:
PHCRI Unit Level Research Access Summary for Human Subject Research
COVID 19 Safety Plan Guidelines
COVID 19 Safety Plan Checklist (non-clinical)
COVID 19 Safety Plan Checklist (clinical)
SAMPLE ONLY - CGSHE COVID 19 Safety Plan
PHCRI Resumption of Research Activities - June 2, 2020
Click here to read the full memo from Dr. Darryl Knight

In response to the ongoing COVID-19 situation, Providence Health Care Research Institute (PHCRI) will commence a gradual, phased resumption of research at Providence Health Care (PHC) by following the guidelines set out by the BC Public Health Officer and the principles, prioritization and contextual information set out by UBC. The approach, however, will also be aligned with PHCRI and PHC requirements.

Related forms:
PHCRI-VCHRI animal research resumption access request
PHCRI-VCHRI Access Priority Template May 29 2020 
PHCRI-VCHRI Unit Level Research Access Summary May 29
 
HealthCareCAN update on $450 million federal funding package - May 29, 2020

HealthCareCAN would like to provide an update on the $450 million funding package that the federal government announced on May 15th.  Since that time, HealthCareCAN has had a number of meetings with SSHRC (lead organization on this funding package), ISED and CIHR regarding the allocation of these funds. From these meetings we note:

  • Both the Canada Research Coordinating Committee and the Treasury Board will need to sign off on the funding package in the end.
  • Components of the funding include salaries / wage supports and restart costs. A list of eligible expenses has not yet been determined. 
  • Funding in wave 1 will occur by block funding, i.e., a special allocation going through the universities with no costs/hold back incurred to health research institutes.  The remaining monies, i.e. wave 2 will occur in September and will require an application / demonstration of ongoing financial need.
  • The current suggested approach from SSHRC is that there will not be negotiation required between the health research institute and the university, i.e. amounts will be predetermined.  We strongly expressed HealthCareCAN member concerns here regarding funding flow through universities that have occurred in the past. SSHRC, ISED, and CIHR are all very aware of these concerns.
  • HealthCareCAN strongly expressed concerns from emerging research institutes that do not have a university affiliation. All government departments are very much aware.  HealthCareCAN has shared a list of our members and research institutes and departments across the country with CIHR and SSHRC.  We are told that no institution will be “frozen out.”
  • Timeline: funding is expected to flow by the end June for Wave 1, retroactive to mid-March.  We discussed concerns from our members to increase the percentage of wave one from a 50%/50% split.  At the ISED call yesterday, my thanks to David, Ellen and Brad for joining and reiterating the urgency of this funding.
  • The allocation formula has not yet been determined – SSHRC has looked at all available data sources including research infosource.

We will be calling upon the VPR Rapid Response team to assist us in providing guidance and options to SSHRC and the government, especially related to the allocation formula. With my thanks, members of the Rapid Response team from across the country include David Hill, Ellen Chesney, Rob McMaster, Brad Wouters, Mike Salter, Duncan Stewart, Jim Woodgett, Allison Sekuler, Bruce Mazer, and Jean Shoveller.

This next process is as important as the initial advocacy focus that secured the funding announced. We have requested another meeting with SSHRC over the next days as soon as possible. 

HealthCareCAN will continue to keep you informed as further information becomes available.  Please do not hesitate to contact me further anytime.  We will also be looking to have a VPR meeting shortly to have further discussion on this and updates from CIHR with our full VPR group. 

Prime Minister announces support for research staff in Canada - May 15, 2020
Read the full news release here.

From life-saving cancer treatments to clean technologies that protect our environment, thousands of research staff in Canada are driving discoveries and innovations that support our well-being and our economy. When we need them the most, many members of Canada’s academic research community have been forced to temporarily suspend their work due to COVID-19. To ensure they can keep their jobs, safeguard their research, and continue their important work after this crisis, the Government of Canada is stepping up to support them.

The Prime Minister, Justin Trudeau, today announced $450 million in funding to help Canada’s academic research community during the COVID-19 pandemic. The investment will:

Provide wage supports to universities and health research institutes, so they can retain research staff who are funded from industry or philanthropic sources and are unable to access some of the government’s existing COVID-19 support measures. This would apply even if their work has been temporarily suspended. The government will provide up to 75 per cent per individual, with a maximum of $847 per week.

Support universities and health research institutes to maintain essential research-related activities during the crisis, and to ramp back up to full research operations once physical distancing measures are lifted. This will cover up to 75 per cent of total eligible costs, and will support activities such as the safe storage of dangerous substances, and restarting data sets that were interrupted during the pandemic.

This investment is part of the Government of Canada’s COVID-19 Economic Response Plan, which has helped protect Canadian jobs, and committed billions in support to Canadians and businesses facing hardship as a result of the pandemic. It will help sustain Canada’s research excellence and protect our research talent, in support of the COVID-19 response and the post-pandemic economic recovery.

Plans for the phased resumption of on-campus research - May 12, 2020
Read the original message from UBC President and Vice-Chancellor Santa J. Ono

In March, UBC introduced curtailment of on-campus research on both our Vancouver and Okanagan campuses. Since that time many of you have made great efforts to support this transition, conducting your research and scholarly activity remotely.

We recognize that the on-campus curtailment has had significant impacts for many of you, your graduate students and your research teams. Thank you once again for your commitment to the university.

In collaboration with our Faculties, we are now planning for the phased resumption of on-campus research from the beginning of June, adopting a gradual approach over the summer months. Conducting on-campus research and scholarship will be limited to those who require on-campus resources and cannot conduct this work remotely. As a reminder, and in keeping with public health guidelines, the majority of our faculty and staff will need to continue working remotely, wherever possible.

As part of our planning, UBC is working with the Ministry of Advanced Education, Skills and Training and post-secondary institutions within BC to ensure we are aligned with health and safety guidelines and WorkSafeBC. The phased resumption of on-campus research is also being informed by feedback we received during consultation with Faculties and units, including town halls that engaged more than 950 faculty members.

We have asked the Faculties to develop plans to embark on this phased approach. The plans will be led by Deans and Associate Deans of Research, with coordination and guidance provided by the Office of the VP, Research & Innovation. Given the complexity of coordinating safe access to different spaces within buildings, and managing the associated demand for multiple on-campus services, there is still significant planning to be done.

It is important to stress that health and safety remains our priority. As such, UBC will continue to work closely with the provincial government to ensure our plans are consistent with public health requirements. We also recognize that this will be an iterative process, and we may need to be prepared to reinstate curtailment measures, should the situation regarding COVID-19 change.

For more information, please visit https://research.ubc.ca/COVID-19/phased-resumption.

Santa J. Ono
President and Vice-Chancellor

Gail Murphy
Vice-President, Research & Innovation
PHC Research Guidance During Curtailment - May 7, 2020
View the PHC Research Guidance During Curtailment document for a summary of current PHC REB submission guidelines during the curtailment period. 
UBC Bulletin: Extension of Remote Work Arrangements and on-campus research curtailment - April 28, 2020

The following message was sent to UBC faculty and staff in Vancouver and the Okanagan. Read the original here.

As you know, the health and wellbeing of our university community remains our priority, and we are continuing to follow guidance from the Provincial Health Officer, Dr. Bonnie Henry, to limit the spread of COVID-19.

In keeping with the direction from Dr. Henry that the requirement for physical distancing remains in place, we are extending Remote Work Arrangements and on-campus research curtailment as outlined below.

Remote Work Arrangements

UBC’s Remote Work Arrangements will continue to apply to faculty, staff, graduate students, postdoctoral fellows, and student employees until further notice. Thank you to everyone who has made the transition to remote working in the last few weeks, and to those who have continued to provide required on-campus services during this time. You can find FAQs to support Remote Work Arrangements at http://www.hr.ubc.ca/covid-19/.

On-Campus Research Curtailment

We appreciate that many researchers have been able to transition to conduct their research and scholarship remotely. However, we are aware that this curtailment has significantly impacted many faculty members, graduate students, research trainees, postdoctoral fellows and research staff. To address this, we are working with Faculties on both campuses to consider how we will gradually ease curtailment restrictions in ways that are consistent with public health requirements. This advance planning effort will allow us to safely and judiciously increase on-campus research activities when public health conditions allow. We will advise you as to where we are in the planning process within the next two weeks. Please visit https://research.ubc.ca/covid-19 for more information about the ongoing curtailment and the status of exempted activities.

As a reminder, FAQs related to COVID-19 and UBC’s response can also be found at https://covid19.ubc.ca/.

We will provide further updates regarding Remote Work Arrangements and on-campus research curtailment as the situation evolves. In the meantime, thank you for your ongoing efforts and commitment to the university.

Marcia Buchholz
Vice-President, Human Resources

Gail Murphy
Vice-President, Research & Innovation

Andrew Szeri
Provost and Vice-President, Academic, UBC Vancouver

Ananya Mukherjee Reed
Provost and Vice-President, Academic, UBC Okanagan

Memo: Provincial Research Register - April 17, 2020

Dear All,

The negative impact of the SARS-Cov-2 pandemic will be felt by us all for sometime. However, it has also had a profound galvanizing effect on BC clinicians, academics and researchers. There are many provincial funding opportunities for teams and as a result many projects initiated or about to start. 

To this end, the BC Academic Health Science Network has compiled a register of current SARS-Cov-2 research and funding opportunities around the province.  

It can be found here (https://bcahsn.ca/covid-19-response/).

This is an excellent resource and serves to highlight the wonderful work that BC researchers are involved in to tackle the Covid-19 pandemic.  Importantly, this is a living document.  Currently, any updates on research not included on the document or research requiring updating are provided to the AHSN and then uploaded. Starting very soon (aiming for next week), the document will be editable by individuals in real time,  so please check back regularly  on this update.

I would encourage anyone undertaking or interested in Covid-19 research activity to have a look at the website and if necessary, contact the AHSN for more details.

Also, as a reminder, if anyone needs to talk to me about the situation we are in with this pandemic, please reach out to me.

Best wishes, stay safe and remember to laugh at least 3 times today if you can.

Dr. Darryl Knight
President, PHCRI
VP, Research & Academic Affairs, PHC
Associate Dean, Research, Faculty of Medicine, UBC

PHCRI Updated Memo Re: PHCRI Research Activity - April 6, 2020
 

To: All PHCRI Investigators

As you know, on March 19, UBC announced a curtailing of on-campus research activities at UBC Vancouver and Vancouver Okanagan. This curtailment was initially in effect until April 15. In accordance with guidance from the Provincial Health Officer, UBC will be extending this curtailment of research activities until April 30, 2020.  PHCRI will adopt the same extension deadline.  

For Clinical Trials and REB approved clinical research please note a PHCRI exemption form may be required. An updated memo pertaining to clinical trials and REB approved clinical research is also attached.

We will continue to monitor the situation and send updates as needed. Thank you for your cooperation.

Dr. Darryl Knight
President, PHCRI
VP, Research & Academic Affairs, PHC
Associate Dean, Research, Faculty of Medicine, UBC

Download the updated memo

Download the exemption form (no longer accepted)

Update:Advisory on clinical trials and clinical research operations at Vancouver Coastal Health (VCH) and Providence Health Care (PHC) - April 2, 2020
Click here to download the memo

During this time we must follow VCH and PHC directives relating to the COVID-19 pandemic, and be aware that these directives will change to accommodate the rapidly evolving situation. Efforts to reduce, minimize or eliminate risks related to research participants and the public are critical at this point, and we must minimize any burden that clinical trials and clinical research activity can create for our health care system.

Key principles:
Clinical trials and clinical research operations at VCH and PHC sites
With consideration for continuity of care and participant and staff safety, VCH and PHC are suspending the initiation of new clinical trials and clinical research studies and halting recruitment for new and ongoing clinical trials and clinical research studies until Thursday April 30, 2020.

Enrollment into clinical trials and clinical research studies that are part of essential clinical care, projects related to the COVID-19 pandemic, or those that have significant cost or time-related implications will be assessed on a case by case basis. Please contact the appropriate operational site contact(s) noted below to discuss further.

We recognize that some ongoing clinical trials and clinical research studies require important safety monitoring and on-site visits that are critical to the participant’s clinical care, and therefore encourage investigators to use good judgment and consider the level at which this is appropriate for each ongoing protocol and patient participant. If such ongoing clinical trial and clinical research activities are deemed essential, investigators must receive an exemption from VCHRI or PHCRI (as applicable) to be classed as critical research.

The following are to be instituted in regards to ongoing clinical trials and clinical research studies:
  1. At the direction of VCH and PHC, all visitors to VCH and PHC sites are being restricted to immediate family members only. Study sponsor on-site monitoring visits should be re-scheduled or conducted remotely where possible.
  2. Study sponsor scheduled monitoring visits may be permitted outside of the VCH and PHC clinical settings. Monitors with a history of U.S. or international travel within 14 days are not permitted into the facility. Remote monitoring and virtual appointments must be conducted where possible (e.g. meeting with the PI or other staff).
  3. Clinical trials and clinical research staff should contact clinical trials and clinical research participants beforehand to actively screen for symptoms of or exposure to COVID-19 infection prior to their appointments in the clinic or facility.
  4. Good communication with study sponsors, when applicable, should be maintained to inform them of any protocol deviations or interruption of accrual activities. Attempts should be made to contact and screen monitors attending a facility outside of the VCH or PHC clinical setting prior to the visit.
  5. Please be mindful of any FDA or Health Canada directives that may be affecting the conduct of specific clinical trials when applicable.
     
​Research ethics considerations
In relation to practical aspects where protocol deviations may be necessary due to COVID-19, while the Tri-Council Policy Statement (TCPS2) typically requires review and approval of modifications prior to implementation, “changes that are necessary to eliminate an immediate risk(s) to the participants may be implemented as needed, but must be reported to the REB at the earliest opportunity.” (Article 6.15). In relation to FDA regulated trials, 21 CFR 56.108(a)(4) similarly allows for modification without prior approval “where necessary to eliminate apparent immediate hazards to the human subjects”, and again, these changes must be reported to the REB at the earliest opportunity.

We ask that any Post Approval Activities (PAAs) or e-mails sent to the REB that relate to issues or queries relating to COVID-19 are named accordingly so that they can be more easily tracked. For example, the PAA nickname should include “COVID-19”, or e-mail subject line should include “COVID-19”. In all cases, accurate and detailed documentation of the circumstances surrounding any alterations or amendments is extremely important.

If you are submitting a new research project directly related to COVID-19, please contact the REB to discuss and inform your regional medical director.

We recognize the impact this will have on our research staff and their work. However, our decision is consistent with many of our peer organizations, as well as with the current escalation of school and other business closures. We will continue to assess the situation on a real time basis and prepare for scenarios that allow restoration of research activity as soon as possible.

For OPERATIONAL questions and concerns relating to clinical trials and clinical research activities, please contact:

For VCH:
Dr. W. Robert McMaster
Vice President Research, VCH and Executive Director, VCHRI
E: robert.mcmaster@vch.ca

Stephania Manusha
Director, Clinical Trials Administration, VCHRI
E: stephania.manusha@vch.ca

For PHC:
Dr. Darryl Knight
President, PHCRI
E: dknight2@providencehealth.bc.ca

Julie Hadden
Manager, Ethical Review, PHCRI
E: julie.hadden@ubc.ca

For REB related questions or concerns, please contact:

For VCH:
Laurel Evans
Director, Research Ethics
E: laurel.evans@ors.ubc.ca

For PHC:
Julie Hadden
Manager, Ethical Review, PHCRI
E: julie.hadden@ubc.ca

 
PHCRI Memo: Research Day and Research & Mission Award - March 31, 2020
Click here to download the memo

Dear PHC Researchers, Staff, Trainees and Students:

Due to the ongoing COVID-19 pandemic, we have made the decision to cancel 2020 Research Day and postpone the announcement of the 2020 Research & Mission Award. Although registration for Research Day had not yet opened, it was scheduled for June 5.

As you have likely heard, PHC has similarly cancelled its Long Service & Mission Awards Gala, which was scheduled for May 29, and has postponed the announcement of its suite of 2020 Mission Awards.

We would like to thank those who submitted nominations for this year’s Research & Mission Award. Rest assured we will keep these nominations on file and we look forward to announcing a winner as soon as we are able.

Celebrating our people and their many achievements is very important to us. We hope to reschedule Research Day, or a similar version of this annual event, when it is safe to do so. Please stay tuned for updates.

If you have any questions or concerns about the above, please contact research@providencehealth.bc.ca.
 

FDA Issues Updated Guidance on Clinical Trial Conduct During the COVID-19 Pandemic - March 27, 2020

On March 18, 2020, FDA issued “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.  

On March 27, 2020, FDA amended the guidance to include an appendix to further explain those general considerations by providing answers to questions about conducting clinical trials that the Agency has received during the COVID-19 pandemic. For the updated guidance, please see:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic
Message from PHCRI President Dr. Darryl Knight - March 23, 2020

PHCRI Memo - March 23, 2020 (click to download PDF)

Dear colleagues,

What a couple weeks that have hit us. Unfortunately, by all accounts there will be several weeks more. I want to take this opportunity to thank you for your support of our decision to suspend non-essential research activities across PHC. You have likely seen that UBC, SFU, and all our research hospitals have now taken a similar and coordinated approach. Due to your efforts, this difficult process has gone as smoothly and quickly as could be expected. I know this curtailing of research will have significant impact to your research programs and graduate student progress and will affect the careers of your staff. It is the right decision and we will continue to work hard on ways to mitigate and support you through this in the coming weeks. I also want to say a huge thank you to a very dedicated team of staff behind the scenes: PHCRI managers, their office staff, and all the teams in PHC and PHCRI that have been working flat over the last week to assist during this rapid transition.

What can and should you do now?
1. Help PHC and our patients: We have received great support from our Research Centres in our request for redeployment of clinically trained staff to assist in clinical activities across PHC to ensure it continues to deliver the best healthcare to those that need it most. A similar request has more recently been distributed for non-clinically trained staff and a database is being generated by Centre Directors and PHC/RI managers. This too is crucially important and the need for our staff to contribute will no doubt increase. Just to remind everyone that all PHC employees are eligible for redeployment and I encourage all of you, if you are well and able, to put your names forward. Note, however, that trainees – students and postdocs – are currently not eligible for redeployment, but will be asked to volunteer should they feel inclined.

The BC Life Sciences and UBC community has rallied support for increased access to essential laboratory, safety and PPE equipment. Similarly, there are plans to engage with offshore enterprises to increase our urgent and essential supplies. However, if anyone has unique ideas to support shortages in PPE, please let myself and/or Brian Simmers (bsimmers@providencehealth.bc.ca) know.

2. Engage and support your staff: In these uncertain times, it’s critical that we, as principal investigators and leaders, ensure that our research teams feel safe and supported. I have heard many stories of PIs staying in touch through regular teleconferencing or on-line chat forums, maintaining weekly journal clubs/lab meetings, as well as 1:1 meetings. I encourage everyone to develop a similar plan for this regular communication using these remote tools. From a current personal experience, this is particularly important if trainees remain quarantined overseas.

3. Continue to mentor your trainees: The support and mentorship of our trainees remains one of our key responsibilities as leaders. The trainee group is feeling additional anxiety due to delayed timelines and what the uncertain funding landscape means for their projects, theses and careers (see pt 2 above). Several things can be done from home: Provide new learning opportunities. We all get multiple requests for manuscripts, so now is the time to write, or encourage trainees to write those reviews; or analyze data and write up results. Please do everything you can to support their research and
development.

What is PHCRI doing?
1. Communications: In an ever rapidly changing environment, we will strive to provide appropriate communication to you in a timely manner. We will aim to provide regular updates on validated scientific evidence that supports best practice. We would like to continue to promote your stories.

2. Research activity: Over the past several weeks, there has been a tremendous upsurge in the amount of research activity around COVID-19. In addition to new CIHR grants recently announced, “real-world” analysis of transmission data and epidemiology, clinical trials examining potential treatments and new high throughput screening are already underway at PHC and several additional trials are being planned. We are engaging with our Foundation to create new resources to support COVID-19 research. If any investigators are able to “re-tool” their research activity to focus on COVID-19, there are mechanisms to provide rapid access to support. We are retooling our clinical research services team and REB to enable rapid study activation. So if you have developing studies, please let me know. Finally, in these rapidly changing times, please remember to be kind to yourselves and those around you and if you need any assistance, as always please contact me.

With best wishes,

Dr. Darryl Knight
President, Providence Health Care
Vice-President, Research & Academic Affairs, Providence Health Care
Associate Dean, Research, Faculty of Medicine, University of British Columbia

PHCRI Memo on Research Activity - March 20, 2020
Click here to download memo

To: All PHCRI Investigators

In response to the ongoing COVID-19 situation, PHCRI will follow exactly the same procedures as outlined by UBC for research (subject to the directives implemented by the health authority research institutes for clinical trials and REB approved clinical research). Therefore, as of March 24, 2020, all research activities should be curtailed; faculty, staff, undergraduate and graduate students, post-doctoral fellows and visiting professors should work remotely and avoid entering PHC facilities.

This curtailment will be until April 15, 2020 and due to the changing nature of this pandemic, may be extended. This curtailment is to ensure the health and safety of all research personnel and the community. We ask that all Principal Investigators discuss this curtailment with their research personnel and implement plans accordingly.

Exemptions from this curtailment, such as research involving COVID-19, long-term or ongoing research involving animal models, may be requested to continue. However, physical distancing and laboratory safety must be maintained. Please complete the PHCRI Exemption form, obtain signature from your Centre Director or Department Head and submit to VPResearchSupport@providencehealth.bc.ca for expedited review and approval by PHCRI.

For clinical trials and REB-approved clinical research please refer to the memo below.

We fully understand the impact that this curtailment will have on your research programs and research personnel. We are grateful for your attention and cooperation to this crucial matter.

As always, if you have any questions or concerns, please do not hesitate to contact me.


Dr. Darryl Knight
President, Providence Health Care
Vice-President, Research & Academic Affairs, Providence Health Care
Associate Dean, Research, Faculty of Medicine, University of British Columbia

Advisory on clinical trials and clinical research operations at Vancouver Coastal Health (VCH) and Providence Health Care (PHC) - March 18, 2020
Click here to download the memo

Date: March 18, 2020
To: VCH and PHC Research Community
From: Dr. W. Robert McMaster, Executive Director, Vancouver Coastal Health Research Institute and Dr. Darryl Knight, President, Providence Health Care Research Institute
Subject: 

During this time we must follow VCH and PHC directives relating to the COVID-19 pandemic, and be aware that these directives will change to accommodate the rapidly evolving situation. Efforts to reduce, minimize or eliminate risks related to research participants and the public are critical at this point, and we must minimize any burden that clinical trials and clinical research activity can create for our health care system.

Key principles:

  1. Safety of our research participants, their families and staff.
  2. Limit excessive use of resources within VCH and PHC, given the increased risks involved with decreased number of staff and increasing demands on our health care system.
  3. Minimize the potential spread of COVID-19.
  4. Limit adverse impact on the integrity of ongoing trials.
  5. Guidance is subject to change as the situation evolves. We will review and advise on any changes on a regular basis.

Clinical trials and clinical research operations at VCH/PHC sites
With consideration for continuity of care and participant and staff safety, VCH and PHC are suspending the initiation of new clinical trials/clinical research projects and halting recruitment for new and ongoing clinical trials/clinical research studies until Monday April 6, 2020.

Enrollment into clinical trials and clinical research studies that are part of essential clinical care, projects related to the COVID-19 pandemic, or those that have significant cost or time-related implications will be assessed on a case by case basis. Please contact the appropriate operational site contact(s) noted below to discuss further.

We recognize that some ongoing clinical trials and clinical research studies require important safety monitoring and/or on-site visits that are critical to the participant’s clinical care, and therefore encourage investigators to use good judgment and consider the level at which this is appropriate for each ongoing protocol and patient participant.

The following are to be instituted in regards to ongoing clinical trials and clinical research studies:

  1. At the direction of VCH and PHC, all visitors to VCH and PHC sites are being restricted to immediate family members only. Study sponsor on-site monitoring visits should be re-scheduled or conducted remotely where possible.
  2. Study sponsor scheduled monitoring visits may be permitted outside of the VCH and PHC clinical settings. Monitors with a history of U.S. or international travel within 14 days are not permitted into the facility. Remote monitoring and virtual appointments must be conducted where possible (e.g. meeting with the PI or other staff).
  3. Clinical trials and clinical research staff should contact clinical trials and clinical research participants beforehand to actively screen for symptoms of or exposure to COVID-19 infection prior to their appointments in the clinic or facility.
  4. Good communication with study sponsors, when applicable, should be maintained to inform them of any protocol deviations or interruption of accrual activities. Attempts should be made to contact and screen monitors attending a facility outside of the VCH or PHC clinical setting prior to the visit.
  5. Please be mindful of any FDA or Health Canada directives that may be affecting the conduct of specific clinical trials when applicable.

Research ethics considerations
In relation to practical aspects where protocol deviations may be necessary due to COVID-19, while the Tri-Council Policy Statement (TCPS2) typically requires review and approval of modifications prior to implementation, “changes that are necessary to eliminate an immediate risk(s) to the participants may be implemented as needed, but must be reported to the REB at the earliest opportunity.” (Article 6.15). In relation to FDA regulated trials, 21 CFR 56.108(a)(4) similarly allows for modification without prior approval “where necessary to eliminate apparent immediate hazards to the human subjects”, and again, these changes must be reported to the REB at the earliest opportunity.

We ask that any Post Approval Activities (PAAs) or e-mails sent to the REB that relate to issues or queries relating to COVID-19 are named accordingly so that they can be more easily tracked. For example, the PAA nickname should include “COVID-19”, or e-mail subject line should include “COVID-19”. In all cases, accurate and detailed documentation of the circumstances surrounding any alterations or amendments is extremely important.

If you are submitting a new research project directly related to COVID-19, please contact the REB to discuss and inform your regional medical director.
We recognize the impact this will have on our research staff and their work. However, our decision is consistent with many of our peer organizations, as well as with the current escalation of school and other business closures. We will continue to assess the situation on a real time basis and prepare for scenarios that allow restoration of research activity as soon as possible.

For OPERATIONAL questions and concerns relating to clinical trials and clinical research activities, please contact:

For VCH:
Dr. W. Robert McMaster
Vice President Research, VCH and Executive Director, VCHRI
E: robert.mcmaster@vch.ca

Stephania Manusha
Director, Clinical Trials Administration, VCHRI
E: stephania.manusha@vch.ca

For PHC:
Dr. Darryl Knight
President, PHCRI
E: dknight2@providencehealth.bc.ca

Julie Hadden
Manager, Ethical Review, PHCRI
E: julie.hadden@ubc.ca

For REB related questions or concerns, please contact:

For VCH:
Laurel Evans
Director, Research Ethics
E: laurel.evans@ors.ubc.ca

For PHC:
Julie Hadden
Manager, Ethical Review, PHCRI
E: julie.hadden@ubc.ca

For more information and situation updates related to COVID-19, visit:
VCHRI
PHC
UBC Faculty of Medicine
U.S. Food and Drug Administration

Updates for Clinical Trials BC regarding COVID-19 
 

The continued spread of COVID-19 (or Coronavirus) in British Columbia, across Canada and beyond has understandably raised concerns among members of the clinical research community. Clinical Trials BC has created a special page on its website to keep members informed of the latest developments for clinical researchers. This page will be checked and updated regularly. 

Content includes:

  • Institutional and Academic Notices and Advisories
  • Recommended Documentation Practices
  • Regulatory Consulting Services
  • Trial Linking Services
  • News from key health research agencies, and more resources. 
This page last updated Sep 17, 2020 3:08pm PDT