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.

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

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 Apr 6, 2020 4:41pm PDT