Make Changes to Approved Research alpha assessment
Source: gov.uk (2025-01-27)

Service Standard assessment report Make Changes to Approved Research 28/11/2024

Service Standard assessment report

Make Changes to Approved Research

Service description

Health and care research is regulated by a combination of UK-wide and devolved review bodies. Different types of research require different approvals. ‘Make changes to approved research’ allows researchers and research sponsors to describe and submit any changes they want to make to their research after the research has received regulatory approvals. Some changes to research just need to be notified while others require approval from review bodies. The service will route the change to the appropriate pathway and the back-stage part of the service will manage the receipt and approval part of the process by the relevant review bodies.

Service users
- researchers – research teams who run and manage research projects and need to make changes to their research
- sponsors – and their representatives who oversee research and agree changes to research
- delivery teams – the organisations and teams that deliver research and need to implement the changes
- reviewers – approval specialists, committee members and other review bodies who need to review and approve changes to research
- staff – operational and support staff who need to process approvals, manage committees, and manage support requests.
High level user needs this service aims to meet
- as a researcher I need to make changes to my research and notify my sponsor and delivery teams so that my research can continue to run safely and efficiently.
- as a sponsor I need to understand what has changed and what impact this may have on the research so that I can support researcher teams and sign off changes before they are submitted.
- as a member of the delivery team, I need to be notified of changes and have up to date documentation so that I know which aspects of research delivery I need to change.
- as a reviewer I need to understand which aspects of the research have changed so that I can provide regulatory review, ethical opinion and issue the approval.
- as a member of staff, I need to manage reviewers, review meetings and report on service performance so that approvals are issued in good time and research can continue to run smoothly.
Things the service team has done well:
- made a good start on performance measures for the service
- made changes during Alpha to ways of working in response to lessons learned and had a good understanding of capability and capacity they would need to deliver private beta
- the design and test iterative cycle for the prototype was a team sport to get the most value out of each sprint
- used a hypothesis driven approach where they gathered and prioritised their assumptions and tested those. They presented these findings regularly with leadership, product team, developers, and business analysts
- the team has conducted user research with a wide spread of both front stage and backstage users and have pulled together a good understanding of their various user groups and their needs
1. Understand users and their needs

Decision

The service was rated green for point 1 of the Standard (https://www.gov.uk/service-manual/service-standard/point-1-understand-user-needs).

Optional advice to help the service team continually improve the service:
- it is important that the team make an effort to carry out face to face user research with their various user groups to gain contextual and ethnographic insight which will help them design a service that meets user needs
- currently in the private beta user research plan there is no mention of observing users using the live service. The team should plan running private beta tests of the end-to-end service with real users, including support options
- some of the persona specific user needs are not solution agnostic. make sure you are focusing on the user’s problems and not the potential solution
2. Solve a whole problem for users

Decision

The service was rated green for point 2 of the Standard (https://www.gov.uk/service-manual/service-standard/point-2-solve-a-whole-problem).

Optional advice to help the service team continually improve the service
- consider the impact on the users of not importing the existing data into the new service
Optional Advice about Data Migration Approach from Lead Assessor
- the team have decided not to carry out data migration from existing legacy systems due to technical feasibility and complexity, but this would be reliant on the user of the Make a Change service to upload documents required for the review and approval service.
- it is important to understand the impact on the user experience of doing this and the level to which it will create an additional pain point while resolving others with the new service versus the cost and effort of building software on legacy services to control what changes are made to documentation
3. Provide a joined-up experience across all channels

Decision

The service was rated green for point 3 of the Standard (https://www.gov.uk/service-manual/service-standard/point-3-join-up-across-channels).

Optional advice to help the service team continually improve the service
- the team might benefit from mapping the wider ecosystem and the entry points into the system
- more refinement, which the team acknowledges, on the entry point and start page
4. Make the service simple to use

Decision

The service was rated green for point 4 of the Standard (https://www.gov.uk/service-manual/service-standard/point-4-make-the-service-simple-to-use).

Optional advice to help the service team continually improve the service
- the team might benefit from mapping the wider ecosystem and the entry points into the system
- more refinement, which the team acknowledges, on the entry point and start page
- the team is using GOV.UK design system but is developing some additional patterns to reflect the needs of review committees. They might benefit from speaking to departments who have their own design systems that focus on the needs of internal users (Ministry of Justice might have helpful insights)
- make sure a user centric approach is taken to dual running on the end-to-end journey if incremental implementation to ensure it does not make it more complex for the user
5. Make sure everyone can use the service

Decision

The service was rated amber for point 5 of the Standard (https://www.gov.uk/service-manual/service-standard/point-5-make-sure-everyone-can-use-the-service).

During the assessment, we didn’t see evidence of:
- a documented understanding of the assisted digital journey and how this service will support those users
- we appreciate based on user types it is challenging but the team need to continue explore assisted digital during beta by looking at universal barriers to digital take up and where users may need digital support to use the service
- more user research with a broad range of accessibility needs
6. Have a multidisciplinary team

Decision

The service was rated green for point 6 of the Standard (https://www.gov.uk/service-manual/service-standard/point-6-have-a-multidisciplinary-team).

7. Use agile ways of working

Decision

The service was rated green for point 7 of the Standard (https://www.gov.uk/service-manual/service-standard/point-7-use-agile-ways-of-working).

8. Iterate and improve frequently

Decision

The service was rated green for point 8 of the Standard (https://www.gov.uk/service-manual/service-standard/point-8-iterate-and-improve-frequently).

9. Create a secure service which protects users’ privacy

Decision

The service was rated green for point 9 of the Standard (https://www.gov.uk/service-manual/service-standard/point-9-create-a-secure-service).

Optional advice to help the service team continually improve the service
- while the panel welcomes that the team has already identified fraud vectors. the team must develop a full threat model which goes beyond fraud and cover all threats, countermeasures, and mitigation
- it can be useful to add “anti-personas” (hypothetical users with an interest to disrupt the system) alongside existing personas, in order to include security concerns in the user-centred design process
- the team needs to keep the organisation’s senior information risk owner informed of all decisions regarding data protection. generally speaking, keeping a technology decision log that can be shared with interested parties is recommended
10. Define what success looks like and publish performance data

Decision

The service was rated green for point 10 of the Standard (https://www.gov.uk/service-manual/service-standard/point-10-define-success-publish-performance-data).

Optional advice to help the service team continually improve the service
- there are 4 mandatory GDS KPI for a service one of which is completion rate. This will be a good indicator for total number of transactions completed but with a longer more complex journey with multiple users and a save & return function be mindful that drop off rates per screen may not be a good measure for what users are finding difficult with the digital service. Think about other options for collecting better user insight to continuously improve your service
- it is also important to have baseline measures on “as is” to set targets to measure the success of the service.
- if you are dual running and giving a user the option to use the old and the new service for Make Changes to Research it is really important to have processes in place to understand at the right level the barriers to a user opting to use the new service
11. Choose the right tools and technology

Decision

The service was rated green for point 11 of the Standard (https://www.gov.uk/service-manual/service-standard/point-11-choose-the-right-tools-and-technology).

Optional advice to help the service team continually improve the service
- even though the choice of going with Microsoft for the technology stack makes sense in the context of the HRA’s existing estate, it restricts the pool of developers that will be working on the maintenance of the service, even beyond PA’s involvement. The service team should bear it in mind for future iterations
- the use of GOV.UK Notify, currently under evaluation, is strongly advised
- the use of OneLogin should be re-considered, considering recent developments with identify provider support. The service team should contact the OneLogin project for details
- The technical architecture as presented is classic but sound
12. Make new source code open

Decision

The service was rated amber for point 12 of the Standard (https://www.gov.uk/service-manual/service-standard/point-12-make-new-source-code-open).

During the assessment, we didn’t see evidence of:
- the source code of that prototype being open. It is useful, even for prototypes and other throw-away code, to code in the open for a few reasons, in particular for the panel to be confident that the service team is able to build a good Beta service. During the assessment, a “technical prototype” was presented.
- the service team have reassured the panel that the Beta service is going to be coded in the open (which does not mean the code should be dumped on a public website at some point never to be updated again, but instead should be started and iterated in a public repository)
13. Use and contribute to open standards, common components and patterns

Decision

The service was rated green for point 13 of the Standard (https://www.gov.uk/service-manual/service-standard/point-13-use-common-standards-components-patterns).

Optional advice to help the service team continually improve the service
- the service team should continue exploring this point during the beta phase. Whatever current choices in technology have been made, they can change, and new opportunities may arise to choose open standards or common components. Examples include GOV.UK Notify and OneLogin as previously mentioned
- the team has expressed its intention to contribute to the GOV.UK Design System. Although the Design System does not officially provide a .Net package, the team is encouraged to contribute to existing one such as the Cabinet Office’s implementation (https://github.com/cabinetoffice/govuk-design-system-dotnet)
14. Operate a reliable service

Decision

The service was rated green for point 14 of the Standard (https://www.gov.uk/service-manual/service-standard/point-14-operate-a-reliable-service).

Optional advice to help the service team continually improve the service
- the team should design a backup strategy as early as possible. Data being hosted on a cloud service does not mean it is safe, even if the databases are replicated. Disaster scenarios should be envisaged, and recovery strategies established. Refer to the service manual
- although using the full range of MS monitoring services as the team plan to, is welcome, external monitoring services (e.g. Sentry, Pingdom) will be useful in case a MS data centre goes offline, for example
Next Steps

This service can now move into a private beta (https://www.gov.uk/service-manual/agile-delivery/how-the-beta-phase-works) phase, subject to addressing the amber points ahead of private beta (in the readiness for beta assessment) and CDDO spend approval. The service team should liaise with the assurance team to confirm their plans to move into private beta ahead of time, so we can check against the amber points.

To get the service ready to launch on (http://gov.uk/)GOV.UK (http://gov.uk/) the team needs to:
- get a GOV.UK service domain name (https://www.gov.uk/service-manual/technology/get-a-domain-name)
- work with the GOV.UK content team (https://www.gov.uk/service-manual/service-assessments/get-your-service-on-govuk) on any changes required to GOV.UK (http://gov.uk/) content