
Explore why informed consent is essential in clinical research, detailing voluntary participation, risks and benefits, post-trial rights, and protections grounded in the Nuremberg Code and Declaration of Helsinki.
Explore the informed consent process, covering competency, disclosure, understanding, and voluntary consent, with attention to vulnerable and illiterate subjects, information sheets, and the roles of sponsor, investigator, and monitor.
Learn how assent complements parental permission in pediatric trials, guiding an ongoing conversation with the research team, recognizing dissent, and using age-appropriate explanations and assent forms.
This conclusion highlights re-consent when new safety information or procedure changes arise, the PI’s delegation and monitoring of consent, and verifying the IRB/IEC approved signed forms before any study procedures.
Explore bonus resources from the NHS Health Research Authority and ICH GCP, learn the benefits of informed consent, and review the course agenda (chapters 1–5) and contact details for TrainingOnline4U.
This course will enable participants to have an understanding of the background and practical implications of the valid informed consent process. The knowledge and understanding gained, coupled with practical examples is intended to give participants the confidence to take a proactive role in the consent process back in the workplace.