Patient Safety and Ethics in Clinical Research Course
Register for this course
We are committed to delivering this course in multiple training formats to accommodate your needs. Our state-of-the-art learning facilities ensure a comfortable and engaging experience. With our flexible face-to-face training calendar, you can select any classroom course and have it delivered at a venue of your choice, offering you unparalleled convenience and exceptional value.
Course Overview
This course equips clinical researchers, ethics professionals, and research managers with a modern understanding of patient safety and ethical conduct in clinical trials. With increasing use of digital tools, decentralized trials, and complex risk models, the course blends traditional bioethics with emerging challenges such as data privacy, real world evidence, and AI in research to build capacity for ethically sound and safe clinical studies.
Course Duration
5 Days
Target Audience
- Clinical Investigators, CRAs, and Study Coordinators
- Ethics Committee / Institutional Review Board (IRB) Members
- Compliance & Quality Assurance Staff
- Safety Officers
- Clinical Operations and Regulatory Affairs Professionals
Personal Impact
- Develop enhanced capability in making ethical decisions in complex clinical research settings.
- Gain confidence in conducting, reviewing, and improving informed consent and patient protection practices.
- Strengthen the ability to identify and mitigate safety risks in trials, enhancing participant trust.
- Build an ethical leadership mindset, ready to navigate future clinical research challenges (digital, data, AI).
Organizational Impact
- Improve trial quality and integrity through stronger ethical and safety practices.
- Build trust and credibility with participants, regulators, and the public, reducing compliance risk.
- Foster a research culture committed to patient centered trial design and participant protections.
- Prepare the organization to responsibly leverage innovation (digital, AI) while upholding ethical standards.
Course Level: Intermediate
Course Objectives
By the end of this course, participants will be able to:
- Apply core ethical principles (respect for persons, beneficence, justice) in clinical research.
- Design and implement participant centered informed consent processes, including for vulnerable populations.
- Recognize, report, and manage risks to patient safety, including adverse events.
- Navigate evolving ethical frameworks, such as those relating to data protection, decentralized trials, and digital health.
- Use oversight structures (IRBs / ethics committees) effectively and ethically.
- Develop strategies for ethical decision making in innovation driven research (e.g., AI driven, real world data).
Course Outline
Module 1: Foundations of Ethics & Patient Safety
- Key bioethical principles: respect, beneficence, justice
- Historical lessons and their regulatory impact
- Evolving ethical challenges in modern research (global trials, data, inclusion)
- Safety vs. innovation: balancing risk and benefit
- Interactive Exercise: Reflect on real world research scenarios to identify ethical tensions and safety risks.
Module 2: Informed Consent & Human Subject Protection
- Core elements of informed consent; fostering participant autonomy
- Consent in vulnerable populations (children, incapacitated, marginalized groups)
- Ethical considerations in remote or decentralized trials
- Maintaining continuous consent in longitudinal studies
- Group Activity: Draft an informed consent form for a trial using a decentralized/digital model, flagging risky areas and drafting mitigation.
Module 3: Safety Monitoring, Adverse Events & Risk Management
- Types of adverse events, risk detection, and reporting systems
- Pharmacovigilance and safety monitoring plans
- Building clinical trial participant safety frameworks
- Ethics of risk: how much risk is acceptable, and how to communicate it
- Case Study: Analyze a trial incident, propose a risk monitoring system, and map how to ethically respond to safety signals.
Module 4: Regulatory & Ethical Oversight
- Ethical guidelines & declarations: Declaration of Helsinki, Belmont Report, etc.
- IRB / Ethics Committee roles, review, and continuing ethics oversight
- Risk benefit assessment and ethical review of study protocols
- Handling ethical violations, reporting, and remediation
- Exercise: Prepare a mock IRB submission and feedback, focusing on informed consent, risk management, and participant protection.
Module 5: Emerging Ethical Challenges in Clinical Research
- Data privacy, security, and patient confidentiality in modern trials
- Research using real world data: ethics of observational studies
- AI, machine learning, and algorithmic decision making in clinical research ethics
- Building ethical infrastructure for future trials: governance, participant engagement, monitoring
- Capstone Project: Design an ethics & safety framework for a future clinical study (e.g., AI enabled, decentralized or real world) that addresses consent, data, and risk.
Course Administration Details:
METHODOLOGY
The instructor-led trainings are delivered using a blended learning approach and comprise presentations, guided sessions of practical exercise, web-based tutorials, and group work. Our facilitators are seasoned industry experts with years of experience, working as professionals and trainers in these fields. All facilitation and course materials will be offered in English. The participants should be reasonably proficient in English.
ACCREDITATION
Upon successful completion of this training, participants will be issued a Skillstate Institute certificate.
TRAINING VENUE
The training will be held at a Skillstate Institute Training Centre. The course fee covers the course tuition, training materials, two break refreshments, and lunch. All participants will additionally cater to their travel expenses, visa application, insurance, and other personal expenses.
ACCOMMODATION AND AIRPORT PICKUP
Accommodation and airport pickup are arranged upon request. For reservations contact the Training Officer.
Email: info@skillstateinstitute.org
Phone: +254100920301
TAILOR-MADE
This training can also be customized to suit the needs of your institution upon request. You can have it delivered in our Training Centre or at a convenient location. For further inquiries, please contact us on:
Email: info@skillstateinstitute.org
Phone: +254100920301
PAYMENT
Payment should be transferred to our Skillstate Institute account through a bank on or before the start of the course. Send proof of payment to info@skillstateinstitute.org