Ethics - Medical research

From CambridgeNotes

History of research regulation

  • The appalling experiments by some Nazi doctors led to the first guidelines – Nuremberg Code (1946)
  • This was later incorporated into the Declaration of Helsinki by the world medical association; it states that experiments involving humans have their protocols reviewed by an independent ethics committee (lay people and professionals)

Summary of guidelines on research

  • Central principles: risk of harm to patient; consequences of research; patient autonomy
    • Participants should be at minimal risk (balance against potential benefits to individual and to society – difficult in non-therapeutic research!)
    • Participants should be fully informed; no coercion to take part in research; payments only to offset reasonable costs (not incentive!)
    • Participants that are not competent to give consent may still be eligible if: risk of harm is very low; aims cannot be achieved by other means; research of considerable value; relevant person (e.g. relative) gives consent
    • If individual consent is difficult (e.g. using case notes) then research must be of sufficient value to justify breach in autonomy
  • Research defines best practice while audits improve services against this standard (no need for ethics committee in the latter)