Presentations from the Clinical Research Ethics Conference | Vancouver | October 3, 2018
Includes topics relevent to the ethics review process
BC Health Research Connection Project | Amanda Chisholm
Discovery of research data | Eugene Barsky
Experimental Medical Device Studies - Canadian Regulations | Stephen Hoption Cann
Open Access, Data Management Plans, Secondary Use of Data | Holly Longstaff
Patient Engagement & Research Ethics Tensions & Opportunities | Julie Robillard
Research Ethics BC Update | Sarah Bennett
Secondary Use of Data at VCH | Janine Johnston
The Clinical Research Ethics Board offers two 30-minute lectures; one as an introduction to ethics, and one that goes into more depth about common errors seen in ethics submissions. These presentations are available by request.
Top 10 Things (to avoid and/or consider prior to submitting your application)
The deadline for CREB Full Board meetings is at noon on the given dates. This is a very strict deadline; any applications submitted after 12pm on deadline days will be forwarded to the next available CREB Meeting date. *PLEASE NOTE: Applications must be submitted by the Department Head by noon. Once the Principal Investigator hits “Submit” on a study, the application is routed through Department Approval; once the Department Head signs off, the study is forwarded to the CREB for review. Please keep this in mind if you have a study that is urgent in nature; you may need to contact your Department Head to let them know the study is waiting for them to sign off. Please also keep in mind that if your Department Head is involved in your study, you will need to alert the designated alternate to sign off on your application form. The alternate will have the study in their inbox; however, they do not always make a point to check if there is something to sign.
Refer to CREB deadlines and meeting dates for more information.
*Please note studies that qualify for Delegated/Expedited Review have an approximate turnaround time of 1-2 weeks. Submissions for Delegated/Expedited Review that are referred to the Full Board will increase turnaround time substantially; please contact the CREB office if you are unsure whether your study qualifies for Delegated/Expedited Review.
All studies which are not minimal risk should have some form of peer review attached to Box 9.8 of the RISe application form. This can be internal OR external, from an expert in the field who is at arms’ length from the study. Internal reviews could include colleagues in your Department who are not involved in your study in any way.
For graduate studies, the CREB accepts the committee review of the proposal as a form of peer review. Please click here for further information.
Investigators that receive funding for studies conducted by a U.S. government department and/or its agencies (e.g. Department of Health and Human Services (DHHS)/National Institute of Health/National Cancer Institute, Department of Defense, U.S. Army) OR are conducting studies regulated by the Food and Drug Administration are subject to the pertinent U.S. federal regulations. These are part of the Code of Federal Regulations (CFR) mandated by the United States government. The U.S. regulations that pertain to clinical research are:
Please ensure that your renewal requests are submitted 2 weeks prior to your study expiry. RISe will send automatic reminders; however, it is the responsibility of the Principal Investigator to ensure his or her study does not lapse. Please also consider the following:
Studies that must comply with U.S. regulations must be submitted for full board review unless they meet the following criteria for delegated/expedited review:
- The research is (i) permanently closed to the enrollment of new subjects; and (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow up of subjects; OR
- Where no subjects have been enrolled and no additional risks have been identified; OR
- Where the remaining research activities are limited to only the analysis of already collected data.
Please keep this in mind when submitting your renewals for review; PAAs that must go to the Full Board for approval must be submitted prior to the CREB deadline.
If your study requires institutional approval (i.e. hospital approval such as VGH, PHC, etc), you must contact these institutions separately. Renewal of your CREB application does not automatically renew your study at all appropriate institutions.
Please ensure all documents have the requested changes highlighted or tracked. Your response should also include a letter indicating the CREB’s provisos and how they have been answered. This can be attached via the “Submit Changes” box when submitting the response.
Please ensure all boxes of the RISe application form are filled out appropriately. If there is a question that does not apply to your particular study, please fill out the box as “N/A”.
All relevant study documents must be attached to page 9 of the RISe application form. Please ensure that the attached documents can be opened; if the document is password protected, please indicate the password on the RISe application form.
**PLEASE NOTE: Studies which do not have an appropriate protocol attached will be sent back to investigators.
When uploading documents on RISe, you are prompted to enter the proper version number and date on the application form. Please ensure this date matches the date on your document; the Certificate of Approval pulls the information from page 9 of RISe. The CREB is unable to issue corrected Certificates of Approval for documents with the wrong version date entered. If this occurs, you will be required to submit a PAA – Amendment to make this change.
As per UBC’s Policy #85 Original data for any given study must be retained in the unit of origin for at least five years after the work is published or otherwise presented (if the form of the data permits this, and if assurances have not been given that data would be destroyed to assure anonymity). Please indicate this will be the case in Box 8.6 of the RISe application form; this must also be stated in Box 1.5 of the PAA – Completion of Clinical Study coversheet when doing a study closure.
In an effort to develop common understanding of the ever changing ethics / privacy / security landscape the following are being provided as reference:
- Presentation slide deck
- UBC researcher data privacy and security checklist
- Link to consent form guidelines for projects involving data linkage
The above information was prepared by Kaitlyn Gutteridge, Lead, Privacy, Policy and Agreements for Population Data BC, in consultation with Paul Hancock, Access and Privacy Manager, Office of the University Counsel & Larry Carson, Associate Director, Information Security Management. They would be pleased to answer your questions.
Note that purely Quality Assurance (QA) projects do not require ethical review by the CREB. If you are uncertain whether your study requires ethical review, or can be designated as Quality Assurance, please complete the VCH/PHC QI & REB review checklist.