GCP for Ethics Committee Members

Course content

12 units and 63 lessons. Times are planned study time, including the end-of-unit test.

1. Unit 0

   Orientation & pre-test

   30 min

   1. 0.1How the course works; choose your EC role5 min
   2. Pre-test (30 questions, ungraded)25 min

2. Unit 1

   Foundations: three frameworks, one purpose

   3 h 30 min

   1. 1.1Why ethical review exists; the Indian context40 min
   2. 1.2ICMR general principles45 min
   3. 1.3ICH E6(R3) principles of GCP45 min
   4. 1.4NDCT Rules: scope, key definitions; how NDCT, ICMR and E6(R3) fit together40 min
   5. 1.5Scenarios: which framework applies?20 min
   6. Unit test: 10 questions, pass mark 70%20 min

3. Unit 2

   The EC: mandate, constitution, registration

   4 h 30 min

   1. 2.1Mandate and terms of reference40 min
   2. 2.2Composition: minimum seven members, required member types, ≥50% unaffiliated, chair and member secretary50 min
   3. 2.3Registration: clinical-trial ECs with CDSCO (validity, renewal, suspension); biomedical and health research ECs (Chapter IV); accreditation50 min
   4. 2.4Training, competence, independence and conflict of interest45 min
   5. 2.5Role lens: what each member type brings (chair, member secretary, clinician, lay, legal, social scientist)45 min
   6. 2.6Case: is this EC properly constituted?20 min
   7. Unit test: 10 questions, pass mark 70%20 min

4. Unit 3

   EC operations

   4 h 30 min

   1. 3.1SOPs, administration and management35 min
   2. 3.2What a submission must contain40 min
   3. 3.3Types of review: exemption, expedited, full committee45 min
   4. 3.4The full committee meeting: quorum, deliberation, decisions50 min
   5. 3.5Communicating decisions; format of approval30 min
   6. 3.6Records and archiving30 min
   7. 3.7Case: a meeting without quorum20 min
   8. Unit test: 10 questions, pass mark 70%20 min

5. Unit 4

   Reviewing the protocol

   5 h 30 min

   1. 4.1Benefit-risk assessment50 min
   2. 4.2Reading a protocol as an EC member50 min
   3. 4.3The Investigator's Brochure: what the EC should check35 min
   4. 4.4Ethics of study design: controls, placebo, randomisation45 min
   5. 4.5Investigator and site suitability; the investigator's undertaking35 min
   6. 4.6Recruitment, advertisements and payment to participants30 min
   7. 4.7Workshop: review a protocol synopsis55 min
   8. Unit test: 15 questions, pass mark 70%30 min

6. Unit 5

   Reviewing informed consent

   5 h 30 min

   1. 5.1Requisites and essential information55 min
   2. 5.2Reviewing consent documents: readability, language, translations45 min
   3. 5.3Consent process and documentation; LAR and impartial witness45 min
   4. 5.4Audio-video recording (vulnerable subjects in New Chemical Entity / New Molecular Entity trials; audio only for anti-HIV and anti-leprosy trials) and e-consent35 min
   5. 5.5Waiver of consent, re-consent, studies using deception35 min
   6. 5.6Specific issues in clinical trials; special situations30 min
   7. 5.7Workshop: critique a sample consent form55 min
   8. Unit test: 15 questions, pass mark 70%30 min

7. Unit 6

   Vulnerable populations

   4 h 30 min

   1. 6.1Principles and additional safeguards; duties of stakeholders45 min
   2. 6.2Children and assent40 min
   3. 6.3Women in special situations; pregnancy35 min
   4. 6.4Mental illness and cognitive impairment; dependency and hierarchy; terminal illness40 min
   5. 6.5Sexual minorities and sex workers; tribal populations35 min
   6. 6.6Cases: judging vulnerability50 min
   7. Unit test: 12 questions, pass mark 70%25 min

8. Unit 7

   Participant safety, SAEs and compensation

   4 h 30 min

   1. 7.1Safety concepts an EC member needs (AE, SAE)40 min
   2. 7.2SAE reporting to the EC: who, what, when (investigator within 24 hours; 14-day follow-up)40 min
   3. 7.3EC review of SAEs and its opinion on relatedness45 min
   4. 7.4Compensation and medical management; the Seventh Schedule formula55 min
   5. 7.5Ancillary care; insurance and compensation arrangements25 min
   6. 7.6Workshop: an SAE from report to compensation decision40 min
   7. Unit test: 12 questions, pass mark 70%25 min

9. Unit 8

   Continuing review, deviations and termination

   3 h 30 min

   1. 8.1Continuing review and amendments40 min
   2. 8.2Protocol deviations and non-compliance35 min
   3. 8.3Site monitoring by the EC35 min
   4. 8.4Suspension, premature termination, completion35 min
   5. 8.5Case: responding to repeated deviations at a site40 min
   6. Unit test: 12 questions, pass mark 70%25 min

10. Unit 9

    Special research types

    4 h 30 min

    1. 9.1NDCT categories: new drug trials, academic clinical trials, BA/BE studies, post-trial access50 min
    2. 9.2Multicentric research: review models30 min
    3. 9.3Specific trial types: devices, biologicals, stem cells, oncology, traditional medicine, HIV, surgery, investigator-initiated50 min
    4. 9.4Public health and social/behavioural research40 min
    5. 9.5Genetics, biobanking and datasets45 min
    6. 9.6Research during humanitarian emergencies and disasters30 min
    7. Unit test: 12 questions, pass mark 70%25 min

11. Unit 10

    Privacy, transparency and modern trial designs

    2 h 30 min

    1. 10.1Privacy and confidentiality30 min
    2. 10.2CTRI registration, community engagement, post-research access, research misconduct40 min
    3. 10.3Decentralised elements, pragmatic designs and real-world data: what the EC should look for45 min
    4. 10.4Data governance basics for EC members20 min
    5. Unit test: 8 questions, pass mark 70%15 min

12. Unit 11

    Capstone: mock EC meeting

    3 h

    1. 11.1Individual review of a full submission package (protocol, consent form, IB summary, investigator undertaking) in your chosen role1 h 15 min
    2. 11.2Simulated full committee meeting: raise issues, check quorum, deliberate, decide1 h
    3. 11.3Draft the decision letter; compare with the model answer45 min

13. Final

    Final exam

    1 h 30 min