Game 20 · Public health and research practice
Can this study go ahead?
Informed consent, ethics committee review and good clinical practice.
Read with: Research ethics30 DNB questions
Play
You sit on the institutional ethics committee
Each round puts a made-up proposal in front of you. Tick the problems in a protocol and decide, check a consent form for its essential elements, choose the type of review, or work out the compensation owed after a trial injury. You have three lives.
Loading the first round…
Every rule in the game comes from the Research Ethics chapter: ICMR 2017, NDCT Rules 2019, the Declaration of Helsinki (2024) and ICH E6(R3). The protocols, Drug K and Condition M are made up.
Informed consent
Consent is a process, not a signature
ICMR describes consent as giving relevant information, making sure the person is competent, making sure the information is understood, and making sure the decision is voluntary. The document has two parts, the participant information sheet and the informed consent form. The 10 essential elements (ICMR 2017, Box 5.1) are:
- A statement that the study is research
- Purpose and methods, in simple language
- Expected duration, frequency of contact, number of participants, types of data collection
- Benefits that might reasonably be expected
- Foreseeable risks, discomfort or inconvenience
- How far confidentiality can be maintained, and the consequences of a breach
- Payment or reimbursement for participation and incidental expenses
- Free treatment and/or compensation for research-related injury
- Freedom to participate or withdraw at any time without penalty or loss of benefits
- Identity of the research team and contact details, including the EC Chairperson or Member Secretary for complaints
| Feature | Consent | Assent |
|---|---|---|
| Given by | A competent adult, or the LAR for someone who cannot consent | A child (or an adult who cannot consent) who can still understand and agree |
| Age bands (ICMR 2017, Box 6.6) | 18 years and above | Under 7: not documented. 7 to 12: verbal, recorded. 12 to 18: written |
| If the person objects | No enrolment | The objection is respected |
A waiver of consent is possible only when the research is less than minimal risk and the waiver will not harm the participants' rights and welfare. The EC decides, not the researcher (ICMR 2017, 5.7 and Box 5.2).
Types of review
The risk decides the type of review
| Risk (ICMR 2017, Table 2.1) | Example | Review (Table 4.2) |
|---|---|---|
| Less than minimal | Anonymised data, meta-analysis | Exemption (no linked identifiers) |
| Minimal | History, examination, urine sample, questionnaire | Expedited: Chairperson, Member Secretary and 1–2 members |
| Minor increase over minimal | A small blood sample | Full committee |
| More than minimal | Drug, device, biopsy, endoscopy | Full committee |
Research on a vulnerable group goes to full committee review even when the risk is minimal. Box 6.2 lists, among others, children, pregnant women, people with mental illness, the terminally ill, and people in a hierarchy such as students, employees and prisoners. Every proposal is submitted. “A researcher cannot decide that her/his proposal falls in the exempted, expedited or full review category” (4.8.3).
The committee
Composition, placebo, registration and compensation
- ICMR 2017: 7 to 15 members, preferably half from outside, quorum of at least 5 with medical and non-medical members and at least one non-affiliated member.
- NDCT Rules 2019, rule 7 (trial ECs): at least 7 members, at least half not affiliated, at least one lay person, one woman and one legal expert. Chairperson from outside, Member Secretary from inside.
- Placebo: only if no proven intervention exists, or for compelling methodological reasons without risk of serious or irreversible harm (Declaration of Helsinki 2024, para 33).
- Registration: with CTRI, before the first participant is recruited (ICMR 2017, 7.1.10; Declaration of Helsinki 2024, para 35).
- Serious adverse events: reported to the EC within 24 hours (NDCT rule 42(1)).
Compensation for death = (B × F × R) ÷ 99.37
- B
- base amount, ₹8 lakh
- F
- age factor from Annexure 1 of the Seventh Schedule (207.98 at 30 years, 99.37 at 65 or more)
- R
- risk factor at enrolment: 0.5 terminally ill, 1.0 high risk, 2.0 moderate, 3.0 mild, 4.0 healthy volunteer
For permanent disability, 100% disability earns 90% of the death amount, in proportion to the percentage of disability. This is in addition to free medical management. The full chapter is Research ethics.
Writing the answer
How to write this in a 10-mark DNB answer
- Name your sources first: ICMR National Ethical Guidelines 2017, NDCT Rules 2019, Declaration of Helsinki (October 2024), ICH E6(R3) (January 2025).
- For informed consent: define it as a process, list the four parts (information, competence, understanding, voluntariness), then the 10 essential elements of Box 5.1.
- Add the special cases: LAR consent, impartial witness for illiterate participants, assent by age band, waiver only by the EC, re-consent.
- For the ethics committee: draw the membership table (who, inside or outside), give the quorum, the types of review with the risk table, and its functions (initial and continuing review, SAEs, compensation, records).
- Close with one worked example from your branch, such as a paediatric trial needing parental consent and written assent.
The one thing to remember
No participant is enrolled until the ethics committee has approved the protocol and the participant has given informed consent.
Past papers
DNB questions this game helps you answer
Questions from NBE theory papers for DNB, DrNB and Diploma courses, most often asked first. The tag after each question is the specialty and the year it was set.
- ×6Informed consent.
- ×3What is informed consent?
- ×1Informed consent and assent in pediatric practice. [5]
- ×1According to ICMR guidelines for biomedical and health research in human participants, discuss the following: b) Informed consent.
- ×1Enumerate the basic responsibilities of the Institutional Ethics Committee (IEC). Discuss the review procedures, monitoring and record keeping by the IEC.
- ×1What ethical challenges do Indian ICU clinicians face when conducting clinical research involving critically ill patients, especially in ensuring voluntary participation and informed consent in a diverse, multilingual population?
- ×1What is informed consent and why is it important?
- ×1What issues are involved in informed consent? What is informed refusal?
- ×1Informed consent in paediatric practice.
- ×1What is informed consent? What are the various components of informed consent? Discuss its relevance in the patients with psychotic disorders as compared to medical disorders.
- ×1Role of Ethics Committee in Institutional Research.
- ×1What are the components of informed consent?
- ×1Describe the informed consent document in research.
- ×1Discuss the roles and composition of Institutional Ethics Committee as per ICMR guideline and NDCT Rule, 2019.
- ×1Written and informed consent.
- ×1Describe the composition, roles and responsibilities of Institutional Ethics Committee.
- ×1Informed Consent
- ×1Informed Consent.
- ×1What are the types of consent used in Biomedical research? Enumerate the components of an informed consent form for a vaccine trial?
- ×1Informed consent and assent.
- ×1What do you understand by informed consent?
- ×1Enumerate the essential and additional elements of informed consent documents according to recent Indian Guidelines. Ethics Committee may grant waiver of consent? In which conditions
- ×1Good clinical practices.
- ×1Informed consent
- ×1Write short notes on: a) What are the components of ethical decision making and principles of medical ethics? b) What is informed consent? c) What are levels of evidence in research?
- ×1Good Clinical Practice (GCP) guidelines.
- ×1Role of Ethics Committee as per amendment of Schedule Y.
- ×1What is ‘Informed Consent’?
- ×1Discuss the ethical principles to be followed while conducting clinical trials. According to the recent guidelines, what are the roles and responsibilities of “Institutional Ethics Committee” (IEC) with regard to payment of compensation in the event of an adverse drug reactions occurring during clinical trial?
- ×1Discuss the roles and responsibility of an Institutional Animal Ethics Committee (IAEC). What is the role of the Ministry of Forest and Environment in the functioning of an IAEC?
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