RESEARCH ETHICS REVIEW FOR RESEARCH COVERED BY LEGISLATION RESEARCH ETHICS REVIEW FOR RESEARCH COVERED BY LEGISLATION

Types of research covered by legislation:

  • the Mental Capacity Act 2005

  • the Human Tissue Act 2004

  • the Medicines for Human Use (Clinical Trials) Regulations 2004

  • the Medical Devices Regulations 2002

You may find this document published by the National Research Ethics Service (NRES) useful in determining whether your research is covered by legislation and/or Department of Health policy.

Research in all of these categories requires ethics review by a National Research Ethics Service committee whether or not the participants are patients or service users within the services for which the UK Health Departments are responsible.

Since this will involve an application via the Integrated Research Application Service (IRAS) you should refer to "Research Governance and Ethics Guidance for Researchers and Supervisors - Health and Social Care" which contains information about making IRAS applications.

Any researcher planning to work with human body tissues, cells, fluids and blood products must contact Dr Mark Williams (BIO) the University Human Tissue Safety Officer.