Research with humans, their data or tissue

Human participants in research

Research involving human participants is undertaken in many different disciplines and conducted in a wide range of settings.

The University
  • ensures all research complies with sector principles and professional standards (Concordat to Support Research Integrity), legislation and regulatory frameworks (UK Policy Framework for Health and Social Care) where appropriate
  • has an established set of fundamental principles to ensure the protection of human participants that are outlined in the Research Ethics Policy,
  • undertakes the ethical review of pure and applied research (except that which falls under the remit of Department of Health approved ethics committees). See Ethical review and committees
  • ensures the development, implementation and monitoring of research ethics policies and review committees as directed by the University Research Ethics Committee (UREC).

University of Plymouth Research Ethics Policy 2013 (includes our Code of Good Practice in Research)

Key legislation for researchers:

Human tissue

The use of human tissue in research is covered by Human Tissue Act (2004)  legislation for the storage and use of human tissue from the living, and the removal, storage and use of tissue from the deceased. The regulating body, the Human Tissue Authority, issues specific licences to research organizations, provides guidance and carries out inspections.

University of Plymouth holds a corporate licence to store human tissue classed as ‘relevant material’ under the Act, for research purposes only (not for human application). All studies involving human tissue must be University sponsored and have received NHS National Research Ethics Service (NRES) approval and the relevant Faculty Research Ethics Committee (FREC) notified. On expiry of ethical approval, any remaining samples are booked in and stored under licence.

More information on human tissue is available for internal staff (select the 'windows authentication' and log in).
Further information:
WMA Declaration of Helsinki
Medical Research Council data and tissues toolkit
EU Clinical Trials Directive
Medicines and Healthcare products Regulatory Authority
NHS Code of Practice on Confidentiality