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Ethics and informed consent in clinical trial integrity: An international, multi-stakeholder consensus statement by
Mohamed Fawzy1, Khalid Saeed Khan2,3, Patrick Chien4
1IbnSina (Sohag), Banon (Assiut), Amshaj (Sohag), and Qena (Qena) IVF Centres, Sohag, Egypt.
Summary
This study developed an international consensus statement on ethics committee approval and informed consent for randomized clinical trials (RCTs). The framework enhances ethical practices and participant protection in global clinical research.
Area of Science:
- Clinical Trials and Research Ethics
- International Research Standards
Background:
- Recent studies highlight ethical practice and informed consent challenges in randomized clinical trials (RCTs).
- A need exists for a unified, international approach to ensure ethical conduct in RCTs.
Purpose of the Study:
- To develop an international, multi-stakeholder consensus statement on human research ethics committee (HREC) approval for RCTs.
- To establish consensus on informed participant consent procedures within RCTs.
Main Methods:
- A systematic scoping review was conducted.
- A modified two-round Delphi survey involving 36 international stakeholders (trialists, ethics committee members, patient representatives, editors, etc.) was employed.
- A final consensus meeting synthesized findings, utilizing the Average Percentage of Majority Opinions (APMO) threshold for consensus.
Main Results:
- The consensus process consolidated 77 statements across nine domains, including general aspects, journal policies, institutional policies, ethics committee regulations and evaluation, informed consent monitoring, trial compliance, and post-publication ethics.
- Key domains focused on robust ethics committee assessments, stakeholder training, patient engagement, and trial monitoring.
Conclusions:
- The international consensus statement provides a comprehensive integrity framework for RCT ethics and informed consent.
- Implementation of this framework is crucial for addressing unique challenges and enhancing ethical standards in global clinical trials.
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