pediatric assent – Clinical Trials 101

Remote Consent & Identity Verification in DCTs: A Compliance-First Blueprint (2025)

November 8, 2025November 14, 2025 digi

Remote Consent & Identity Verification in DCTs: A Compliance-First Blueprint (2025) Remote Consent and Identity Verification That Withstand Regulatory Scrutiny Purpose, Principles, and the Global Frame for Remote Consent Decentralized and hybrid clinical trials (DCTs) move critical interactions—screening, consent discussions, and confirmation of participant identity—outside the clinic. Remote consent is not simply “signing online.” It…

Decentralized & Hybrid Clinical Trials (DCTs), Remote Consent & Identity Verification

Safeguarding Vulnerable Participants: Operational Guidance for Pediatric, Cognitively Impaired, and Prisoner-Involved Trials

October 26, 2025 digi

Safeguarding Vulnerable Participants: Operational Guidance for Pediatric, Cognitively Impaired, and Prisoner-Involved Trials Ethical Operations for Children, Adults with Impaired Capacity, and Incarcerated Participants Defining Vulnerability and Translating It into Practical Protections “Vulnerable populations” is a regulatory shorthand for participants who—because of age, cognitive status, environment, or constrained liberty—may face elevated risks of misunderstanding, coercion, or…

Ethics, Equity & Informed Consent, Vulnerable Populations (Pediatrics, Cognitively Impaired, Prisoners)