Sunnybrook Health Sciences Centre (Sunnybrook), is an academic hospital located in Toronto, Ontario, Canada. It is the largest trauma centre in Canada.
At any given time, Sunnybrook has approximately 1,900 active studies with approximately 500 new study submissions in a typical year. Sunnybrook’s REB (Research Ethics Board) provides ethical oversight for the majority of these studies and their associated amendments, continuing annual reviews and reportable events throughout the year.
Some multi-centre studies in the Province of Ontario, however, may be submitted and reviewed through the Clinical Trials Ontario Streamlined Research Ethics Review model – which also uses Ethics Review Manager.
The types of studies carried out at Sunnybrook include:
- Retrospective and/or prospective chart reviews
- Clinical trials (Phase 1, 2, 3, 4) involving one
or more of
- Investigational drug(s)
- Investigational biologic(s)
- Investigational natural health product(s)
- Investigational medical device(s)
- Approved product(s) for new indication, dosage or formulation
- Health-related interventions (e.g. surgical procedures)
- Qualitative studies
- Human tissue and biological specimens
- Case studies
- Epidemiological / Database
- Quality Assurance / Quality Improvement
The studies may be single or multi-centred, investigator-initiated or industry-sponsored
How were things done before Ethics Review Manager?
Historically, Sunnybrook managed its ethics review processes using a paper-based model, which resulted in large volumes of paper files stored both on-site and in archive facilities.
Full board submissions take around one month (from receipt of application to sending to REB for review) and required thirty copies of the application forms and submission documents. Low risk/expedited/delegated submissions were a little faster, at 2-3 weeks as they are only reviewed by one or two committee members.
“It’s much easier to do delegated reviews in the system – it’s more systematic and you don’t need to flip through pages to find sections, they’re all links online.”REB Member
What did Sunnybrook want from a new system?
Sunnybrook desired a modernized, electronic ethics review and management process. They needed a way to coordinate application forms and signatures electronically as well as to record audit trails and reduce paper and storage costs.
The priorities were to have a system that was –
- User friendly
- Configurable (not completely dependent on vendor to make changes)
Why was Ethics Review Manager chosen?
Sunnybrook selected Ethics Review Manager as it was felt it could achieve its priorities with this system.
From the user perspective, Ethics Review Manager made a lot of sense as this is the system that is also used to run CTO stream – the system used by Clinical Trials Ontario to coordinate research ethics reviews across Ontario.
How was implementation tackled?
Infonetica held monthly teleconferences with Sunnybrook during implementation to ensure the process went smoothly. These provided a perfect platform for Sunnybrook to raise any issues and concerns so that they could be quickly identified and easily resolved. The teleconferences were also useful for building up a good knowledge base of the system to help with roll out.
“Infonetica offered a very generic system in which each process step and every part of the application forms can be tailored to fine detail.”
The set-up phase lasted approximately seven months, during which Sunnybrook replicated its workflow within Ethics Review Manager.
What about roll out and user feedback?
Sunnybrook decide on a phased roll-out approach, starting as a pilot with only a small number of actual studies and gathering feedback from the applicants. This allowed time to make any necessary changes before opening the system to a wider user base.
The preparation and training sessions delivered early on for users ensured a smooth transition.
During the soft launch, many in-person training sessions with groups of applicants were held. At this point, tip sheets were provided to the different user groups. Advising users early on to register their accounts was also advantageous and worked well.
Infonetica was able to provide information on commonly asked questions as well as how to troubleshoot issues. In addition, Infonetica’s Service and Support Desk was very helpful as it allowed Sunnybrook to quickly address questions/issues users face.
Applicants use the systems handy “completeness checker” feature so they cannot submit applications that are missing any mandatory information. Sunnybrook also makes good use of the in-built, customizable help text feature, which allows administrators to add and edit question-specific information and guidance – “which is great.”
Sunnybrook named its version of Ethics Review Manager, Sunnybrook’s REB Information System “SunRISE” which became the required system of record for all ethics submissions and review in March 2020. Some users were anxious about the transition from paper to online review but once they tried their first submission, they found the system easy to use.
“I loved it!”
“…very easy and it was way better than making 25 copies.”Research Coordinators
Principal Investigators have also been positive about the new system, highlighting its intuitive interface. The REB Chair and Vice Chair have echoed these comments and are excited about the new system.