Clinical & Research Ethics
Clinical Ethics

  • CECs are multidisciplinary groups
  • Are advisory bodies (only)
  • Provide support for decision making on ethical issues
  • Offer ethical input into NHS trust policies (e.g. issues that arise from provision of healthcare within the individual trusts, or discussing individual cases referred by professionals within the trust) as well as other healthcare institutions.
  • Although the exact function of each CEC varies between different trusts, according to the individual needs and resources of each trust or healthcare institution.
  • Currently there are 85 such committees in the UK.
  • Topics discussed by CECs include Confidentiality, Consent, Capacity, Refusal of Treatment, Advanced Directives, End of Life Decisions, Genetic Testing and Resource Allocation.
Research Ethics

  • The National Research Ethics Service (NRES) is the main body in the UK which regulates research involving any patients or users (including staff) of the National Health Service (NHS).
  • Taken over activities and roles of Central Organisation of Research Ethics Committees (April 2007).
  • Dual Mission of NRES 6:
    • "to protect the rights, safety, dignity and well-being of research participants."
    • "to facilitate and promote ethical research that is of potential benefit to participants, science and society."
  • Research involving patients and users with in the NHS needs approval from the NRES.
  • However, all research within the NHS also needs individual governance approval from the research and development offices at the NHS sites where the individual research will be carried out.
Making an NRES Application
  • Guidelines for applications for research approval can be found at the NRES website application page (http://www.nres.npsa.nhs.uk/applications/).
  • Applications need to be made using the Integrated Research Applications System- IRAS (https://www.myresearchproject.org.uk/).
  • Applications then need to be booked in for review with an appropriate REC, either to via the central allocation system, or directly via the local allocation service. Once a booking is made, the application and supporting documents need to be submitted to the allocated REC within 4 days.
  • Once a valid application is received, the REC has 60 days to return an opinion on whether the research complies with the current ethical regulations.
References