Compliance Returns

There are a number of Governmental regulations that apply to research and other work carried out at the University. Some of these require personal or institutional licenses or registration, and others require information to be submitted to the Government.

In order to ensure compliance with these regulations, the University requests information from the schools and research institutions twice a year, once in the summer and again in the winter.

Summer 2024

We have received the annual request from David Barker (University Director of Compliance and Risk) to return information regarding Controlled Drugs, DEFRA/Plant Health/SAPO licence, Explosives and desensitised explosives, Schedule 5 pathogens and toxins, Firearms and Zoo licences.

If your activities include any of the above, please complete and return the relevant form (details below) to FBMHhealthandsafety@manchester.ac.uk by Friday, 16 August 2024.

Nil returns may be declared by email without submitting forms.

The Compliance and Risk team will collate and submit the Faculty response to the University’s Regulatory Compliance Officer.

In addition to the normal Summer Regulatory Compliance Return we have been asked to distribute 4 surveys covering Medical Devices, Human Tissues, Information Governance and the Nagoya Protocol. If you have any work involving these topices please complete the relevant survey.

1: Regulatory Return

If you possess or supply any of the following items;

Controlled Drugs
DEFRA licences (Plant Health licences and/or SAPO licences)
Explosives and desensitised explosives
Schedule 5 pathogens and toxins and their nucleic acids
Firearms licences
Zoo licences

Please download the “Summer Regulatory Return form 2024” complete and return it to the FBMH Compliance and Risk team via email to FBMHhealthandsafety@manchester.ac.uk before Friday, 16^th August 2024.

To submit a “Nil” return, an email to FBMHhealthandsafety@manchester.ac.uk will suffice (i.e. A form does not need to be completed to submit a “Nil” return.)

Please direct any questions to your School Compliance and Risk Manager via email to FBMHhealthandsafety@manchester.ac.uk.

2: Medical Devices Survey

If you are involved with the design/manufacture/use of a medical device, please complete and submit the online Medical Device Survey before Friday, 30^th August 2024

Please direct any questions to the Clinical Trials team via email: medicaldevices@manchester.ac.uk

3: Human Tissues Survey

If you use or store a human biological sample, please download the form “Annual HTA survey 2024”, complete and return it to diane.escott@manchester.ac.uk before Friday, 30^th August 2024.

Please direct any questions to Diane Escott via email: diane.escott@manchester.ac.uk.

4: Information Governance Survey

If you are in receipt of (or are storing) data provided by organisations such as;

NHS England
NHS Digital
Public Health England
Office for National Statistics (ONS)
National Pupils Database
or other organisations with security arrangements that can be met by the University’s Data Safe Haven

Please complete the online Information Governance Survey before Friday, 30^th August 2024.

Please direct any questions via email to Data_RG@manchester.ac.uk

5: Nagoya Protocol Survey

Please complete the online Nagoya Protocol Survey before Friday, 30^th August 2024

Full guidance and relevant links can be accessed on the University's Nagoya Protocol webpage.

Please direct any questions to April Lockyer via email: april.lockyer@manchester.ac.uk

Additional information about the regulatory compliance returns is available on the University’s Compliance and Risk website: https://www.staffnet.manchester.ac.uk/compliance-and-risk/compliance/.

If anything about this request is not clear, please contact the Compliance and Risk team or your Compliance and Risk Manager:

Compliance and Risk team: FBMHhealthandsafety@manchester.ac.uk
Faculty – Fiona Marriage: Fiona.Marriage@manchester.ac.uk
SBS – Lisa Grady: Lisa.Grady@manchester.ac.uk
SMS – Suzanne Raw: suzanne.raw-2@manchester.ac.uk
SHS – Brent Collins: Brent.C.Collins@manchester.ac.uk

A reminder from the University’s Regulatory Compliance Officer

Remember: Do not send any sensitive material in the body of the email when sending your returns. Use encrypted attachments to send sensitive data and communicate the password by MS Teams or telephone (phone call or text message).
There is a university guide on handling sensitive data and on how to encrypt files using Microsoft Office.