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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Human Participants & Ethics Approval Course & Certification
Intermediate
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4.8
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97% Recommended
3 hours
172 active users
2 points
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About
The Human Participants & Ethics Approval Course is designed to provide a comprehensive understanding of ethical principles and approval processes required for research involving human participants, ensuring protection of rights, dignity, and wellbeing while maintaining regulatory compliance.
This course covers key areas including informed consent, research ethics principles (respect for persons, beneficence, and justice), ethics committee/IRB/REC approval processes, risk assessment, confidentiality, data protection, vulnerable populations, and responsible research conduct. It also highlights governance requirements, protocol amendments, adverse event reporting, and ethical decision-making in human-subjects research. Upon completion, learners receive a certification demonstrating competency in human research ethics and approval processes.
Who Should Enrol?
- Clinical Researchers and Investigators
- Clinical Trial Assistants (CTAs)
- Clinical Research Associates (CRAs)
- Regulatory Affairs Professionals
- Healthcare Professionals involved in research
- Pharmaceutical and CRO staff
- Ethics Committee members and coordinators
- Life science, nursing, pharmacy, and medical graduates
What you will learn
Understand the fundamentals of human research ethics, including informed consent, autonomy, and participant rights.
Learn key ethical frameworks such as respect for persons, beneficence, and justice, and how they apply to research involving humans.
Gain knowledge of ethics committee/IRB/REC review processes, approvals, amendments, and regulatory requirements for human-subjects research.
Develop understanding of data protection, confidentiality, risk assessment, vulnerable populations, and safe research conduct.
Course Syllabus
- Why research ethics exists
- Historical foundations: Nuremberg, Helsinki, Belmont
- The Belmont principles
- Core ethical requirements
- Who oversees research ethics
- What informed consent is
- Required elements of consent
- Doing consent well
- Special consent situations
- Common consent pitfalls
- Weighing risk and benefit
- Types of risk
- Risk minimisation
- Privacy and confidentiality
- Keeping benefits honest
- Who is vulnerable
- Vulnerable groups and safeguards
- Capacity, assent and surrogates
- Power and coercion
- Equitable recruitment
- The purpose of ethics approval
- The ethics committee
- The submission package
- Levels of review
- Possible committee decisions
- Ethics as an ongoing process
- Continuing review
- Amendments
- Safety and adverse-event reporting
- Compliance and deviations
- Principles across contexts
- Secondary data and records
- Biobanking and genetics
- Global and cross-border research
- Digital and social-media research
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom, usable towards the distance-learning element of relevant schemes.
Certificate of Completion
Receive a Whitehall Training certificate on passing the final assessment, evidencing your competence for audits, appraisals and CVs.
Practical + Scenario-Based
Learn through real-world case studies, decision frameworks and checklists you can apply immediately in your own research environment.
Self-Paced Online Learning
Study anytime, anywhere, at your own pace, with bite-sized modules and built-in knowledge checks.
Expert-Reviewed Content
Material aligned to recognised international standards and codes, written and reviewed to a professional, practitioner-grade level.
Assessment + Knowledge Checks
Reinforce learning with per-module knowledge checks and a final scenario-based assessment.
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