Informed Consent and Ethics Committees

Global Guidelines on Protection of Vulnerable Participants in Clinical Trials

June 30, 2025

Global trials must not only meet scientific standards but also uphold ethical obligations to vulnerable participants. By aligning with international guidelines—from ICH to CDSCO—and embedding robust monitoring and documentation, clinical teams can ensure both compliance and compassion. Ethical excellence enhances trial validity, fosters trust, and reinforces the integrity of pharmaceutical research.
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Ethical Considerations in Vulnerable Populations, Informed Consent and Ethics Committees

Case Studies of Ethical Violations in Vulnerable Group Trials

July 1, 2025

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Background: A large hospital in India conducted a vaccine trial on tribal children. It was later revealed that proper informed consent was not obtained from parents or guardians, and children were given investigational vaccines without full explanation or follow-up monitoring.
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Ethical Considerations in Vulnerable Populations, Informed Consent and Ethics Committees

Responding to Ethics Committee Queries Effectively in Clinical Trials

July 4, 2025

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Ethics Committee queries aim to:
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Ethics Committee Submissions, Informed Consent and Ethics Committees

Best Practices for Submitting Protocol Amendments to the Ethics Committee

July 4, 2025

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A protocol amendment is necessary when there is a modification to the originally approved clinical trial protocol. Amendments may include:
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Ethics Committee Submissions, Informed Consent and Ethics Committees