Ethics RM Case Study: King’s College
King’s College, London handles around 1,900 ethics approval applications across all disciplines every year. For a long time, the process has relied heavily on paper copies of applications that required ink signatures from reviewers. All correspondence was distributed manually, by post or by individual emails. Online review was difficult at best. Separate spreadsheets were used to monitor reviewer availability and track the distribution of applications to reviewers.
There was no single store of information. Data was spread between an Access database, email records and many hard copy files.
Marice Lunny, King’s College Research Integrity and Ethics Manager, felt it was time to change. “The system wasn’t actually broken but it was very unwieldy and took a lot of resource to operate.”
Defining The Solution
Fortunately, after rigorously reviewing procedures tasks and workflows with key stakeholders, Marice and her team had clearly defined what they needed from the new system. “We knew things we needed the system to do and what we’d like it to do.” However, they were wary of replacing the old system with another home-grown one. “We had experience of when the internal expertise leaves,” said Marice, and they were keen not to repeat it.
They decided that the new system should be able to –
- Streamline the application, review and administration process
- Create a fully integrated online application
- Document management capabilities
- Support tailoring of the application to support the College’s low- and high-risk processes from one starting point
- Accommodate its three review processes (1 through meetings and 2 virtual)
- Allow ongoing support and development
- Permit in-house changes to be made
- Make the review process as self-sufficient as possible.
After considering all the options, and after receiving a demonstration of Ethics Review Manager, King’s College decided to work with Infonetica to produce an automated yet flexible system that didn’t compromise on the rigor of their review process.
Key to the new system was a smart application form based on the information captured in the old, hard copy forms. Question dependencies were set within Ethics RM’s form builder to create a filter system that determines the nature of the application (risk level, type of data collection etc). Depending on the result of the filter, various other sections are made available or hidden, if they are no longer relevant to the application. To make the process even clearer, specific guidance notes were added to each question.
Creating the three workflows for the three key types of application was the next vital step. This needed to accommodate the lowest risk applications from undergraduates and postgraduates (usually having one virtual reviewer) right up to the highest risk ones that require full face-to-face committee approval.
To achieve this, four different levels of reviewer role and two types of administrator were set up within EthicsRM. Each user can carry out specific actions and see specific information that relates directly to their particular role.
If this all sounds daunting, Marice points that she is by no means an IT specialist. Infonetica worked closely with her and her colleague, Dan Butcher, every step of the way. “With Infonetica’s support, Dan and I could do it,” she stresses. “If I can do it, anybody can.”
The system has just gone live and as Marice says, “we already received feedback from users and it’s been very positive.”
Watch the short video to see Marice and Dan discuss their new system...
To sum up, King’s College’s new REMAS (Research Ethics Management Application System) has many important benefits over the old system for the three main types of user –
- Are able to log-into system using their KCL log-in
- Can create and store applications in their own account
- Create their own application specific to their project, and not presented with questions they do not need to answer
- Are no longer required to submit hard copy form
- Receive an automatic confirmation that their application has been received
- Receive fewer returns of incomplete forms, as the System prompts where required questions have been omitted
- Can rely on electronic sign off by applicant and supervisor instead of an ink signature
- Are emailed automatically as soon as signatures have been provided.
- Can easily find all correspondence and applications without having to go through numerous emails and databases
- Easily review of all applications online but can also print of hard copies where they prefer
- Are able to make on individual sections of the application or that apply to the form as a whole
- Can easily submit their comments prior to a review meeting
- Are able to navigate through the application form section by section from the project home page
- Can refer back to a record of all applications reviewed.
- Now have one central system for both processing and storing applications
- Need to return fewer incomplete form as they cannot be submitted if mandatory questions and basic study documents have been omitted
- Are no longer required to triage applications for some low risk applications as the reviewer can send the outcome directly to applicant
- Need to keep fewer hard copy records
- Can complete the Research Ethics Checklist online
- Have more time free for post-approval monitoring.