Ethical guidelines for human research – ICMR and related guidance MCQs With Answer

Introduction

Ethical Guidelines for Human Research – ICMR and related guidance MCQs With Answer is a focused quiz collection designed for M.Pharm students to strengthen understanding of India’s regulatory-ethical framework for biomedical and health research. These questions cover core principles from the ICMR National Ethical Guidelines, institutional ethics committee responsibilities, informed consent, vulnerable populations, compensation and safety monitoring, biospecimen governance, and trial registration. Each MCQ emphasizes practical application in clinical and pharmacoepidemiologic research, helping students prepare for academic exams and research oversight roles. Use these items to test knowledge, identify gaps, and reinforce ethically sound research planning and reporting in the Indian context.

Q1. Which primary purpose best describes the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants?

• To provide legally binding statutes for clinical trial approval
• To offer an ethical framework and practical guidance for conducting research involving human participants in India
• To prescribe specific laboratory procedures for all biomedical research
• To replace institutional rules for hospital administration

Correct Answer: To offer an ethical framework and practical guidance for conducting research involving human participants in India

Q2. In which year did ICMR publish the consolidated National Ethical Guidelines for Biomedical and Health Research Involving Human Participants that are widely cited?

• 2002
• 2008
• 2017
• 2020

Correct Answer: 2017

Q3. Which set lists the core ethical principles emphasized by ICMR for human participant research?

• Profitability, feasibility, publicity
• Respect for persons, beneficence, non‑maleficence, justice
• Confidentiality, publicity, intellectual property
• Efficiency, speed, reproducibility

Correct Answer: Respect for persons, beneficence, non‑maleficence, justice

Q4. Which of the following is an essential element that must be included in an informed consent document according to ICMR guidance?

• Researcher’s private bank account details
• Purpose of the study, procedures, foreseeable risks and benefits, voluntary nature and contact information
• An unconditional waiver of the participant’s legal rights
• Only a brief title of the study without details

Correct Answer: Purpose of the study, procedures, foreseeable risks and benefits, voluntary nature and contact information

Q5. Which classification of ethics committee (EC) review is appropriate for minimal‑risk research that involves anonymized questionnaires?

• Full committee review only
• Mandatory multicentre review
• Expedited review or exemption, depending on institutional policy
• Automatic approval without any review

Correct Answer: Expedited review or exemption, depending on institutional policy

Q6. What is the ICMR/Indian requirement regarding registration of clinical trials prior to participant enrollment?

• Registration is optional and only for international trials
• All clinical trials must be registered prospectively in the Clinical Trials Registry – India (CTRI) before enrolling the first participant
• Trials must be registered only after study completion
• Only drug trials require registration; device trials do not

Correct Answer: All clinical trials must be registered prospectively in the Clinical Trials Registry – India (CTRI) before enrolling the first participant

Q7. Which group is specifically identified by ICMR as potentially vulnerable and requiring additional protections in research?

• Highly educated university professors
• Employees or students who may feel coerced due to hierarchical relationships
• Frequent international travellers
• Professional clinical trial monitors

Correct Answer: Employees or students who may feel coerced due to hierarchical relationships

Q8. For research involving minors, what does ICMR recommend regarding consent and assent?

• Only the child’s assent is required regardless of age
• No parental involvement is necessary for any minor
• Obtain parental/guardian consent and, where appropriate, the child’s assent based on age and comprehension
• Only parental consent is needed and assent should never be sought

Correct Answer: Obtain parental/guardian consent and, where appropriate, the child’s assent based on age and comprehension

Q9. Under ICMR ethical guidance, when is the use of placebo considered acceptable in a clinical trial?

• When an effective proven therapy exists and researchers prefer placebo for convenience
• When no proven effective intervention exists or where use of placebo is methodologically necessary and not harmful
• Placebos are never acceptable under any circumstances
• Only when participants specifically request a placebo

Correct Answer: When no proven effective intervention exists or where use of placebo is methodologically necessary and not harmful

Q10. What does ICMR advise regarding Data Safety Monitoring Boards (DSMBs) in clinical trials?

• DSMBs are mandatory for all questionnaire‑based surveys
• DSMBs are recommended for high‑risk, large, or multicentre interventional trials to monitor safety and efficacy
• DSMBs must only be internal to the sponsor and not independent
• DSMBs should replace institutional ethics committees

Correct Answer: DSMBs are recommended for high‑risk, large, or multicentre interventional trials to monitor safety and efficacy

Q11. According to ICMR guidance, who is primarily responsible for ensuring compensation for research‑related injury to participants?

• The participant’s family
• The institutional ethics committee alone
• The study sponsor, with arrangements described in the protocol and consent
• The journal that publishes the study

Correct Answer: The study sponsor, with arrangements described in the protocol and consent

Q12. Which statement aligns with ICMR recommendations about use of biological specimens and future research (biobanking)?

• Identifiable specimens can be used for any future research without any consent
• Explicit, appropriately documented consent (or ethically governed broad/tiered consent with safeguards) is required for future use of identifiable biospecimens
• Biobanks are not governed by ethical oversight
• Researchers may freely sell specimens to commercial parties without disclosing to participants

Correct Answer: Explicit, appropriately documented consent (or ethically governed broad/tiered consent with safeguards) is required for future use of identifiable biospecimens

Q13. What is the recommended composition characteristic of an Institutional Ethics Committee (IEC) according to ICMR?

• Only clinicians from the host department
• Multidisciplinary membership including scientific, non‑scientific, lay and independent members for balanced review
• All members must be full‑time employees of the sponsor
• No lay or community representation is necessary

Correct Answer: Multidisciplinary membership including scientific, non‑scientific, lay and independent members for balanced review

Q14. Which practice is consistent with ICMR guidance to protect participant confidentiality in research data management?

• Publishing full identifiers in open access repositories
• De‑identification, secure storage, access controls and limiting identifiers to essential personnel
• Leaving physical records unlocked for convenience
• Sharing raw participant lists with all collaborating sites without controls

Correct Answer: De‑identification, secure storage, access controls and limiting identifiers to essential personnel

Q15. How does ICMR view payments to research participants?

• Payments should be so large that they ensure rapid recruitment
• Payments should reimburse expenses and compensate for time without becoming undue inducement
• Any payment automatically invalidates consent
• Participants should be paid only after study completion and never for follow‑up visits

Correct Answer: Payments should reimburse expenses and compensate for time without becoming undue inducement

Q16. What is the typical expectation for continuing review of approved research by an IEC under ICMR guidelines?

• No continuing review is ever required once initial approval is given
• Continuing review is usually conducted at least annually or as determined by risk and protocol
• Continuing review must be daily for all studies
• Continuing review is only required if there is a participant complaint

Correct Answer: Continuing review is usually conducted at least annually or as determined by risk and protocol

Q17. Regarding inclusion of pregnant and lactating women in research, what is the ICMR position?

• They should be categorically excluded from all research
• They may be included when research is likely to benefit them or when data are needed and risks are minimized and justified
• They can be enrolled without any special considerations
• They can only participate in observational studies, never interventional ones

Correct Answer: They may be included when research is likely to benefit them or when data are needed and risks are minimized and justified

Q18. Under what conditions does ICMR permit the use of deception in research involving human participants?

• Deception is never permitted under any circumstances
• Deception may be used only if scientifically justified, no alternative exists, harm is minimized, and participants are debriefed
• Deception can be used freely as long as the investigator believes it is necessary
• Deception is permitted only in drug trials

Correct Answer: Deception may be used only if scientifically justified, no alternative exists, harm is minimized, and participants are debriefed

Q19. What does ICMR guidance state about dissemination of research results?

• Results should be kept confidential and not shared outside the sponsor
• Researchers have a responsibility to publish results and where applicable share findings with participants and communities, irrespective of outcome
• Only positive results should be published
• Results must be destroyed after study completion

Correct Answer: Researchers have a responsibility to publish results and where applicable share findings with participants and communities, irrespective of outcome

Q20. How should conflicts of interest (COI) be handled according to ICMR ethical guidance?

• COI should be concealed to protect reputations
• COI must be disclosed to the IEC, documented, and managed or eliminated to protect participant welfare and scientific integrity
• Only financial COI matters; non‑financial COI can be ignored
• COI disclosure is optional and left to individual preference

Correct Answer: COI must be disclosed to the IEC, documented, and managed or eliminated to protect participant welfare and scientific integrity

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