ethics--governance-and-law-in-research(編輯修改稿)
2025-08-20 10:32 本頁面
【文章內(nèi)容簡介】 s of participant ? Therapeutic vs. nontherapeutic research ? Riskbenefit or utility calculus ? Restricted new treatments versus widely available standard therapies ? Any controls must be best available standard。 – Placebos where no available standard ? Withdrawing individuals ? Continued access to effective interventions ? Compensation arrangements When is a placebo ok? A randomized doubleblind prospective study of pulsed electromagic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the controls. Spine. 1990 Jul。15(7):70812. Serious unexpected and suspected adverse reaction (SUSAR) Whilst in your trial, a patient, 25 years, developed scoliosis and claims that it was due to the electric stimulation that he’s received. What do you do? Informed consent ? Public involvement at every stage ? Respect for Autonomy – Human Rights Act 1998。 Clinical Trials Regulations 2022 etc ? Elements – Full and prehensible information – Competence as judged under Re C for 18+ years – Voluntariness measured by absence of pressure – Decision ? Diversity How much understanding? You are seeing a patient, 19 years, with spondylolysis and you are enrolling patients into the double blind study of pulsed electromagic fields. You’ve already tried a number of conventional treatments without success but the patient doesn’t seen to appreciate that he might get the control but nevertheless seems willing to sign the consent form. Vulnerable
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