EC48 · 48 hours

GCP for Ethics Committee Members

For ethics committee members and member secretaries.

Assessment

• An ungraded pre-test (30 questions) at the start.
• A test at the end of each unit; pass mark 70%.
• A scored capstone exercise.
• A final exam: 75 questions in 90 minutes; pass mark 80%.
• A certificate with a public verification ID, valid for 3 years.

Course outline

1. Unit 0: Orientation & pre-test (1 lesson)

   • 0.1 How the course works; choose your EC role · 5 min
2. Unit 1: Foundations: three frameworks, one purpose (5 lessons)

   • 1.1 Why ethical review exists; the Indian context · 40 min
   • 1.2 ICMR general principles · 45 min
   • 1.3 ICH E6(R3) principles of GCP · 45 min
   • 1.4 NDCT Rules: scope, key definitions; how NDCT, ICMR and E6(R3) fit together · 40 min
   • 1.5 Scenarios: which framework applies? · 20 min
3. Unit 2: The EC: mandate, constitution, registration (6 lessons)

   • 2.1 Mandate and terms of reference · 40 min
   • 2.2 Composition: minimum seven members, required member types, ≥50% unaffiliated, chair and member secretary · 50 min
   • 2.3 Registration: clinical-trial ECs with CDSCO (validity, renewal, suspension); biomedical and health research ECs (Chapter IV); accreditation · 50 min
   • 2.4 Training, competence, independence and conflict of interest · 45 min
   • 2.5 Role lens: what each member type brings (chair, member secretary, clinician, lay, legal, social scientist) · 45 min
   • 2.6 Case: is this EC properly constituted? · 20 min
4. Unit 3: EC operations (7 lessons)

   • 3.1 SOPs, administration and management · 35 min
   • 3.2 What a submission must contain · 40 min
   • 3.3 Types of review: exemption, expedited, full committee · 45 min
   • 3.4 The full committee meeting: quorum, deliberation, decisions · 50 min
   • 3.5 Communicating decisions; format of approval · 30 min
   • 3.6 Records and archiving · 30 min
   • 3.7 Case: a meeting without quorum · 20 min
5. Unit 4: Reviewing the protocol (7 lessons)

   • 4.1 Benefit-risk assessment · 50 min
   • 4.2 Reading a protocol as an EC member · 50 min
   • 4.3 The Investigator's Brochure: what the EC should check · 35 min
   • 4.4 Ethics of study design: controls, placebo, randomisation · 45 min
   • 4.5 Investigator and site suitability; the investigator's undertaking · 35 min
   • 4.6 Recruitment, advertisements and payment to participants · 30 min
   • 4.7 Workshop: review a protocol synopsis · 55 min
6. Unit 5: Reviewing informed consent (7 lessons)

   • 5.1 Requisites and essential information · 55 min
   • 5.2 Reviewing consent documents: readability, language, translations · 45 min
   • 5.3 Consent process and documentation; LAR and impartial witness · 45 min
   • 5.4 Audio-video recording (vulnerable subjects in New Chemical Entity / New Molecular Entity trials; audio only for anti-HIV and anti-leprosy trials) and e-consent · 35 min
   • 5.5 Waiver of consent, re-consent, studies using deception · 35 min
   • 5.6 Specific issues in clinical trials; special situations · 30 min
   • 5.7 Workshop: critique a sample consent form · 55 min
7. Unit 6: Vulnerable populations (6 lessons)

   • 6.1 Principles and additional safeguards; duties of stakeholders · 45 min
   • 6.2 Children and assent · 40 min
   • 6.3 Women in special situations; pregnancy · 35 min
   • 6.4 Mental illness and cognitive impairment; dependency and hierarchy; terminal illness · 40 min
   • 6.5 Sexual minorities and sex workers; tribal populations · 35 min
   • 6.6 Cases: judging vulnerability · 50 min
8. Unit 7: Participant safety, SAEs and compensation (6 lessons)

   • 7.1 Safety concepts an EC member needs (AE, SAE) · 40 min
   • 7.2 SAE reporting to the EC: who, what, when (investigator within 24 hours; 14-day follow-up) · 40 min
   • 7.3 EC review of SAEs and its opinion on relatedness · 45 min
   • 7.4 Compensation and medical management; the Seventh Schedule formula · 55 min
   • 7.5 Ancillary care; insurance and compensation arrangements · 25 min
   • 7.6 Workshop: an SAE from report to compensation decision · 40 min
9. Unit 8: Continuing review, deviations and termination (5 lessons)

   • 8.1 Continuing review and amendments · 40 min
   • 8.2 Protocol deviations and non-compliance · 35 min
   • 8.3 Site monitoring by the EC · 35 min
   • 8.4 Suspension, premature termination, completion · 35 min
   • 8.5 Case: responding to repeated deviations at a site · 40 min
10. Unit 9: Special research types (6 lessons)

    • 9.1 NDCT categories: new drug trials, academic clinical trials, BA/BE studies, post-trial access · 50 min
    • 9.2 Multicentric research: review models · 30 min
    • 9.3 Specific trial types: devices, biologicals, stem cells, oncology, traditional medicine, HIV, surgery, investigator-initiated · 50 min
    • 9.4 Public health and social/behavioural research · 40 min
    • 9.5 Genetics, biobanking and datasets · 45 min
    • 9.6 Research during humanitarian emergencies and disasters · 30 min
11. Unit 10: Privacy, transparency and modern trial designs (4 lessons)

    • 10.1 Privacy and confidentiality · 30 min
    • 10.2 CTRI registration, community engagement, post-research access, research misconduct · 40 min
    • 10.3 Decentralised elements, pragmatic designs and real-world data: what the EC should look for · 45 min
    • 10.4 Data governance basics for EC members · 20 min
12. Unit 11: Capstone: mock EC meeting (3 lessons)

    • 11.1 Individual review of a full submission package (protocol, consent form, IB summary, investigator undertaking) in your chosen role · 75 min
    • 11.2 Simulated full committee meeting: raise issues, check quorum, deliberate, decide · 60 min
    • 11.3 Draft the decision letter; compare with the model answer · 45 min