Module 5 Presentations

19/07/2024

Consent and Information

Information sheets – checklist • Participation is voluntary and refusal will not affect medical care • The right to withdraw at any time without giving a reason • Subject may be withdrawn by the investigators during the trial • The fact that personal information will be collected and scrutinised, stating for what purpose and by whom and where, but will otherwise be kept confidential. Adherence to data protection legislation (identification of data controller) including possibility of transfer outside EEA • Person to contact for further information and in the event of trial related injury

• Requirement for permission to contact subject’s GP • Specific information where genetic testing planned

The Organisation for Professionals in Regulatory Affairs

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• Voluntariness – No “undue influence, including that of a financial nature” exerted on subjects to participate (Art 28 CTR) – Non –financial incentives – Vulnerable populations (eg medical students, prisoners, chronically ill) – When are payments an inducement? – Ethics committee scrutiny Consent and Information

The Organisation for Professionals in Regulatory Affairs

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