Research ethics

Middlesex has a responsibility to ensure that research conducted by its employees, researchers and students, or by others in its name is carried out in conformity with the law, and in accordance with the best current practices and principles, and follows the University’s Code of Practice for Research: Principles and Procedures.

The University is committed to maintaining high standards of ethics in research and has established a Research Ethics Review Framework (doc link) supported by the Middlesex Online Research Ethics (MORE) system. The aim is to support researchers at all levels to undertake research according to relevant ethical, legal and professional obligations and standards, in whatever context.

It is important to remember that research data collection/analysis must not be undertaken prior to approval from your Research Ethics Committee.

The MORE system is for all student and staff researchers requiring research ethics review and approval. The system can be accessed at https://MOREform.mdx.ac.uk All users must use their MDX email to log-on and access the system. Guidance document for applicants, supervisors and reviewers can be found on the MyLearning Research Ethics MORE area (login required).

Amendment forms and extension forms for live research projects are part of the MORE online system.

Templates for consent forms, participant information sheets, permission letters for organisations and risk assessment forms etc are also available on the MOREform system under the Help/Templates menu and on the MyLearning Research Ethics MORE area (login required).

Staff supervising student research projects will need to log on to the MOREform system to support their students’ their applications.

Students will need to request their supervisor to assess and sign their research ethics application form on the MORE system before it can be submitted. Staff will not be recognised on the MORE system unless they have logged on, so please check with your supervisor.

Reviewers of research ethics applications will need to access the MORE Review site - guidance is available on the MyLearning Research Ethics MORE area (login required).

Further guidance documents, a list of FAQs, and video tutorials are available on the MyLearning Research Ethics MORE area (login required).

If you have any problems or feedback, please use the MOREsupport@mdx.ac.uk email address.

Please consider the following policy statements when planning and conducting your research.

• Middlesex University definition of research
• Middlesex University research ethics review framework
• Middlesex University statement on the use of animals in research, practice and teaching
• Middlesex University Data Protection Checklist (GDPR) 2018
• Research Participant Privacy Notice Information
• Code of practice for research: principles and procedures
• Security Sensitive categories

WORKING WITH BLOOD AND HUMAN TISSUES – THE HUMAN TISSUE ACT (2004)

1. Middlesex University research licence 
   The University has been granted a single licence by the HTA (Licence No 12533) for the purposes of research. The storage and use of human organs and tissue from the living, and the removal, storage and use of tissue and organs from the deceased, for specified health-related purposes including medical research will potentially be covered by the licence, subject to a satisfactory demonstration of compliance with HTA requirements. Please note that under this licence human tissue and fluids of human origin retained after seven days must be stored in specific Hatchcroft Laboratories only. A copy of the licence can be downloaded below: HTA Licence
2. Background The Human Tissue Act 2004 (HT Act 2004) is a framework for regulating the storage and use of human organs and tissue for specified health-related purposes including medical research. The HT Act 2004 replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989. The Human Tissue Act 2004 (HT Act 2004) is applicable in full to England, Wales and Northern Ireland; there is a separate legislation for Scotland. The Act was fully implemented on 1st September 2006.The Human Tissue Authority (HTA) is the governing body set up to regulate activities that come under the HT Act. The HTA provides advice and guidance about two laws: the HT Act and the EU Tissue and Cells Directive (Quality and Safety for Human Application) 2007. The HTA aim is to have a regulatory system for the removal, use and disposal of human tissue. The human tissue is referred to in the act as relevant material (RM) and the regulated activities are referred to as scheduled purposes. The HTA issues licences to organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions. Nine Codes of Practice provide guidance and lay down expected standards for each of the sectors regulated. Further information on the HTA Codes of Practice can be found at www.hta.gov.uk.

3. Governance In order to ensure proper governance of the acquisition, storage, use and disposal of human samples for research, the following roles and responsibilities are identified: The Designated Individual (DI), - Dr Lucy Ghali - is legally responsible for ensuring compliance with the conditions of the licence. A Designated Person (DP) is appointed to support the DI to ensure that procedures and systems are in compliance with the HT Act and with the terms of Middlesex University's HTA Licence which covers specific Hatchcroft Laboratories ONLY. Middlesex University Governance structure

4. Quality Manual and Standard Operating Procedures 

   In order to ensure proper governance of the acquisition, storage, use and disposal of human samples for research, Middlesex University has developed a Quality Manual and Standard Operating Procedures (SOPs) to ensure compliance with the HT Act and the standards and guidance set by the HTA. The Quality Manual MUST be read by all staff and students working on research projects involving human tissue and the declaration contained in within must be signed to confirm the Quality Manual and SOPs have been read and understood. The HTA Quality Manual and HTA Standard Operating Procedures (SOPs) documents are provided on the MyLearning Research Ethics MORE area (login required).