CITI Program: Human Subjects Research Training Course

CITI Program: Human Subjects Research Training Course

Introduction

The CITI Program: Human Subjects Research Training Course is a globally recognized compliance and ethics training designed to strengthen researchers’ understanding of ethical research conduct, regulatory frameworks, and participant protection. CITI Program: Human Subjects Research Training Course emphasizes Belmont Report principles, informed consent, risk-benefit analysis, data privacy, and institutional oversight, ensuring that research involving human participants meets the highest standards of integrity, accountability, and regulatory compliance. Through evidence-based instruction, real-world case studies, and scenario-driven learning, participants gain the knowledge required to conduct responsible, transparent, and ethically sound research across diverse disciplines.

In an era of data-driven research, AI-assisted studies, global clinical trials, and digital data collection, the ethical treatment of human subjects has become increasingly complex. This training equips learners with critical competencies in IRB processes, research misconduct prevention, participant rights, vulnerable population protection, and international research standards. By integrating practical case analyses, regulatory updates, and compliance best practices, the course prepares researchers to navigate evolving ethical challenges while maintaining public trust and scientific credibility.

Course Duration

5 days

Course Objectives

1. Understand ethical principles of human subjects research
2. Apply Belmont Report and bioethics frameworks
3. Ensure informed consent compliance and transparency
4. Identify and mitigate research risks and harms
5. Protect privacy, confidentiality, and data security
6. Navigate IRB/IACUC review and approval processes
7. Address research misconduct and non-compliance risks
8. Conduct research involving vulnerable populations ethically
9. Comply with federal, international, and institutional regulations
10. Implement responsible data management practices
11. Apply ethical decision-making in real-world scenarios
12. Understand emerging trends in digital and AI-based research
13. Promote research integrity, accountability, and public trust

Target Audience

1. Academic researchers and faculty members
2. Graduate and doctoral research students
3. Clinical investigators and trial coordinators
4. Institutional Review Board (IRB) members
5. Healthcare and biomedical researchers
6. Social and behavioral science researchers
7. Data scientists conducting human-centered research
8. Research administrators and compliance officers

Course Modules

Module 1: Foundations of Human Subjects Research

• Definition and scope of human subjects research
• Historical research ethics violations
• Belmont Report principles
• Role of ethics in scientific credibility
• Case Study: Tuskegee Syphilis Study analysis

Module 2: Informed Consent Process

• Elements of valid informed consent
• Documentation and consent forms
• Cultural and linguistic considerations
• Ongoing consent and withdrawal rights
• Case Study: Incomplete consent in clinical trials

Module 3: Risk–Benefit Assessment

• Identifying physical, psychological, and social risks
• Risk minimization strategies
• Balancing scientific value and participant safety
• Monitoring adverse events
• Case Study: High-risk behavioral research scenario

Module 4: Privacy and Confidentiality

• Data protection and anonymization techniques
• HIPAA and GDPR considerations
• Secure data storage practices
• Managing sensitive information
• Case Study: Data breach in health research

Module 5: Vulnerable Populations

• Defining vulnerability in research
• Additional safeguards and protections
• Research involving children and prisoners
• Consent capacity challenges
• Case Study: Research involving cognitively impaired adults

Module 6: Institutional Review Boards (IRB)

• IRB roles and responsibilities
• Review categories and exemptions
• Continuing review and amendments
• Non-compliance reporting
• Case Study: IRB suspension of a study

Module 7: Research Misconduct

• Fabrication, falsification, and plagiarism
• Conflict of interest management
• Whistleblower protections
• Institutional investigation processes
• Case Study: Data manipulation in published research

Module 8: Emerging Ethical Challenges

• Digital research and online data collection
• AI and algorithmic bias in human studies
• Global and cross-border research ethics
• Future regulatory trends
• Case Study: Ethics of social media data research

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

• Interactive lectures and presentations.
• Group discussions and brainstorming sessions.
• Hands-on exercises using real-world datasets.
• Role-playing and scenario-based simulations.
• Analysis of case studies to bridge theory and practice.
• Peer-to-peer learning and networking.
• Expert-led Q&A sessions.
• Continuous feedback and personalized guidance.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.