ETHICS in legal research with HUMAN SUBJECTS require:
Answer & Solution
Correct answer: C.
1. RESEARCH involving HUMAN SUBJECTS requires:
2. (i) INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL — protocol reviewed for ethical compliance;
3. (ii) INFORMED CONSENT — written, voluntary, informed about study purpose, procedures, risks, benefits, withdrawal right;
4. (iii) ANONYMITY and CONFIDENTIALITY — identifiable data protected;
5. (iv) RIGHT TO WITHDRAW at any time;
6. (v) PROTECTION FROM HARM — minimise risk;
7. (vi) VULNERABLE POPULATIONS need extra safeguards: children, prisoners, victims of crime, persons with mental illness, refugees.
8. INDIAN STANDARDS:
9. (i) INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR) Ethical Guidelines for Biomedical Research on Human Participants (2017);
10. (ii) Indian Council of Social Science Research (ICSSR) Ethics Norms;
11. (iii) UGC norms;
12. (iv) Digital Personal Data Protection Act 2023 for data handling.
13. Hence option B is correct.
_Source: Legal Research Methodology + Jurisprudence — Research Ethics with human subjects; ICMR Ethical Guidelines_
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