Biological Services - Training Records for Research Legislation

Proposal Sponsor:

Biological Services

Overview

New system to manage training records for Biological Services:

The process will be initiated by new student or staff who wish to work on protected animals in research. It will also be needed for visitors such as researchers from another institution, though numbers are expected to be small.

Biological Services staff will be able to administer the system:

Create, update and delete a TRAR and where appropriate include the unique Home Office Personal Licence number which will be assigned when a PIL is granted via the Home Office portal (note that an end date for validity of TRAR must be included in the TRAR to support revocation; ideally a cost centre should also be included).
- TRAR also to include a field to save the cost centre to allow a yearly audit of all licence holders to be checked against the Home Office invoice[1] to ensure that individuals are still working here and the charge is relevant. Note: this should not interface with Finance to determine whether the cost centre is valid if this is too complex (estimate assumes no Finance interface).
Revoke a TRAR (by changing the end date of validity to the past, or a field for status) including the wording “NO LONGER AUTHORISED TO CONDUCT ANY PROCEDURE”. Note around 100 licences are revoked annually.
Reinstate a TRAR (by changing the end date of validity to be current, or a field for status). Note many researchers and students are on fixed term agreements so come in and out of the system.
View a history of changes to the TRAR
View all TRARs for at least the last 5 years
- It is a requirement that all TRARs for current personal licence holders are available – these could be valid for 50 years if someone works at the University for a long period, as the renewal of the PIL doesn’t change the training record status.
- If personal licences are revoked then should see the training record for the 5 years only (longer is acceptable).
- If personal licence stay revoked for 5 years then can be removed from system.
Create, update and delete (only if they are not used) techniques. Sending a technique to an archive system might be useful. This would ensure that the technique is still available on any old Training Records, but would be unavailable to any new Trainees.
Create, update and delete (only if they are not used) competency levels for techniques (note competency level also denotes species)
Generate reports for:

o Valid TRAR holders (i.e. excluding those revoked) competent to train by technique

o Techniques for which there are no TRAR holders competent to train

o Certificate for TRAR holder to prove technique competency level

Perform any of the actions for the other user types for any TRAR holder, e.g. update training competency for a technique for a specific person (in case the trainer doesn’t do it or leaves without doing it)
Print the official certified training record for an individual TRAR holder so that they may take it outside of the University

Individual TRAR holders will be able to:

Create a training request in a particular technique and a particular species from someone competent to train in that technique
View a report of their TRAR on their competency level for each technique
Click on a link in an email (generated by the system every 6 months) asking for confirmation that the TRAR holder is still working within the University by clicking on a link to validate their status.

o At least one email must be sent in February as this is when the annual audit of PILs currently takes place to capture any PILs to revoke. The Home Office financial year runs from April/March, therefore the current system means that we must have all revocations notified to the Home Office by 31st March to ensure that the University is not charged an additional £226 in the new financial year – currently the Home Office charge per year, not part of a year.

o Biological Services would need a list of those TRAR holders who have not confirmed they are still members of the University in order to verify their status.

TRAR holders who are also competent to train in a particular technique will be able to:

See their own requests from individuals to be trained in that particular technique
Record the date the training was given and the competency level achieved on the individual’s Training Record
Generate a report showing how many people they have trained [can be anonymous by number] and in what techniques over particular time periods

All reports should be able to be printed, but personal data must be omitted.

Out of scope:

Sharing the data with the student record system for the Higher Education Achievement Record (some students may not want this sensitive data in their HEAR).
Storing Project Licence (PPL) data on this system would add a layer of complexity as the master PPL record is within an Access database, this would not be of any significant benefit.

Configuring and maintaining workflow (triggering of email with a link is in scope as defined above)

[1] Currently the Home Office charges £226 per person per licence per year. The cost of licences to the University is very large [£187,000+] It is also important to identify anyone not on the Home Office invoice conducting any regulated work, as this would mean a legal infringement for the individual and the University.

Other contributors:

Jamie Thin

Why is it needed/What are the benefits?:

Why execute this project?

The ANIMALS (SCIENTIFIC PROCEDURES) ACT 1986 states that no one may carry out a regulated procedure on a protected animal unless the procedure is authorised by the Secretary of State. The Home Office Personal Licence is the legal document that currently gives this authorisation to an individual.

A new EU Directive came into force on 01 January 2013, which means significant changes to the Home Office Personal Licence (PIL), system. The onus has moved to the University to prove that all staff and students have been trained in the relevant techniques and are competent to conduct procedures; i.e. proving that each Training Record Holder is competent. It is unclear exactly how the Home Office will legislate, but we will have to comply with the legislation, with guidance expected. Processes and systems therefore need to be put in place to enable us to meet our legal obligations and avoid infringing the law. Note that a Training Record holder may or may not also be a Personal Licence holder.

Currently manual paper systems are in place. In future there would be benefits if there was system support for this new business process.

Update August 2013: (from Biological Services)

The UoE are now working under the new EU regulations and, for the time being, have introduced a paper-based system for training records, which is adequate but somewhat cumbersome. Meanwhile, Biomedical Research Resources have finalised the purchase of a management database, which includes a training record component.

We are not absolutely clear on the functionality of the training components of this database , but it may be adequate for our purposes. If we are not happy with it, an alternative is the LANTRA training record database, which has been purchased by a number of Universities for this purpose.

At this stage, therefore, we would like to continue to defer the project from 13-14 to 14-15, as if either of the above "off the shelf" systems are suitable, we will opt for one of them. Biological Services will be in a position to make a decision by end of Jan 2014, whether this proposal is required in 2014-2015.

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What will the project deliver?

This project will support the Biological Services’ aim of complying with the legislation by:

Supporting development of new business processes for the administration of the new PIL requirements.
Developing a new system to store and maintain Training Record (TRAR) data to support individuals working with animals in research
Supporting development of training for use of the new system
Identifying ongoing support needs for the system administration.

How will success be measured?

The University will promote health and welfare of the animals under its care by ensuring appropriate training is being undertaken and given to individuals and be able to show that all staff and students have been trained in the relevant techniques they perform.
Only authorised staff will be able to access the system; details of individual TRAR holders will be unavailable to unauthorised staff; only Biological Services staff and Named Animal Care and Welfare Officers (NACWOs) in the animal units will be able to view details of all the TRAR holders.
Home Office Inspectors can be given the data they need for audit: a report of the techniques for any TRAR they wish to view.
Individual TRAR holders will be able to view their competency levels and request training.
Biological Services staff will be able to administer the data within the system, and use it to provide a certificate for individual TRAR holders
NACWOs will be able to use the system to support meeting their statutory requirements for care and welfare for the animals.

What benefits can be expected?

Compliance with the legislation (avoidance of infringement): ideally to be seen as a leader for compliance within the UK since the University is the second largest user of animals in research within the UK.
All TRAR holders will be able to obtain a complete record of their techniques and competency level, which can be taken outside of the University if they take up new appointments.
Reduced likelihood of losing training information, since paperwork may not currently be moved from ‘clean’ areas due to disease risk.

When will benefits be realised?

As soon as the system is available for the users to support the new business process

Planning Status:

Suggestion

Planned Start:

14/15

Multi-Year:

Project Owner:

SASG

Procurement > £50K:

Funding Source:

Core Grant

IS Admin Tab

Estimation Reference:

330 days ( Nov 2012 ) as part of the previous planning round for 13-14

Estimation Type:

Software Development

Estimated IS Apps Days:

Large

Estimated Business Partner Days:

Medium