National Ethical Guidelines for Biomedical and Health Research Involving Human Participants
India · Guideline · Indian Council of Medical Research
Our summary
These guidelines establish ethical standards for conducting biomedical and health research with human participants in India, covering informed consent, vulnerable populations, clinical trials, and various research contexts including public health and genetic research. They provide principles for benefit-risk assessment, privacy protection, and distributive justice, along with procedures for ethical review committees. The guidelines apply to all researchers and institutions conducting human participant research and require compliance with specified requirements for research conduct and participant protection.
Written by the Index in our own words. It is not legal advice; the official text is the authority.
Inside this policy
Every section of this policy in order. Our notes summarise each one in plain language and do not quote the official text, which is the authority.
Drafted by the Index An automated summary of the official text, not yet reviewed by a person.Reviewed Checked by a person against the official text.
14 sections
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Section 1 Section 1
Section 2 Scope
This section outlines the main topics covered by the guidelines, including ethical principles for research with human participants, benefit-risk assessment, informed consent, privacy, justice, payment, harm compensation, conflicts of interest, vulnerable population selection, community engagement, and post-research access to benefits.
Section 3 Research conduct and planning
This section addresses responsible conduct of research, including values and policies for research, specific issues in planning and conducting research, responsible authorship and publication, research misconduct handling, clinical trial registration, collaborative research, and ethical review procedures.
Section 4 Section 4
Section 5 Reviewing and reporting research
This section covers the structure, composition, terms of reference and responsibilities of ethics committees, their review procedures and record-keeping, and detailed requirements for the informed consent process including essential information for participants, documentation, electronic consent, and special situations like deception or waiver of consent.
Section 6 Procedures after the consent process
This section establishes principles and additional safeguards for research involving vulnerable populations, including women, children, sexual minorities, tribal populations, individuals with mental illness or cognitive impairment, and those in dependent or hierarchical relationships.
Section 7 Clinical trials and interventions
This section addresses ethical guidelines for various types of clinical trials and research interventions including drug and vaccine development, bioequivalence studies, device trials, stem cell trials, surgical interventions, public health interventions, trials in HIV/AIDS, traditional medicine, diagnostic agents, and oncology research.
Section 8 Section 8
Section 9 Specialized research areas
This section covers ethics for research on contraceptives, pregnancy, radioactive materials, new technologies, synthetic biology, public health research, epidemiological studies, use of administrative data, and social and behavioural sciences research for health.
Section 10 Human genetics testing and research
This section addresses ethical and practical issues in genetic testing and research, including genetic counselling, privacy, informed consent, culturally sensitive considerations, sample storage, results communication, commercialization, quality standards, genetic diagnosis, gene therapy, research on embryos, and misuse prevention.
Section 11 Biological materials, biobanking and datasets
This section covers ethical governance of biobanks and biorepositories, including storage of biospecimens with identifiers, ethical considerations for donors and researchers, forensic use of biological materials, special issues with datasets, and contingency planning.
Section 12 Research during humanitarian emergencies and disasters
This section establishes guidelines for research conducted during or prepared for humanitarian crises, addressing informed consent modifications, risk minimization, equitable benefit distribution, privacy protection, ethics review procedures, post-research benefits, and continuation of ongoing studies during emergencies.
Annex 2 List of members of committees involved in revision of guidelines (2015-2017)
These guidelines apply to all biomedical, social and behavioural health research in India involving participants, biological material and data, building on prior Indian policy statements (1980, 2000, 2006) and international codes including the Nuremberg Code, Declaration of Helsinki and Belmont Report, adapted to India's social, cultural and healthcare context. The guidelines establish core ethical principles of respect for persons, beneficence, non-maleficence and justice, requiring research to enhance knowledge while treating participants with dignity, ensuring fair distribution of benefits and burdens without discrimination, protecting privacy and confidentiality (except with ethics committee approval for suicidal intent, homicidal tendency or HIV-positive status), and establishing benefit-risk assessments at all design and conduct stages with ethics committees ensuring compliance. Research institutions must develop governance policies assigning responsibilities to themselves, ethics committees and researchers to safeguard participants, including mechanisms for monitoring data handling, funding conflicts, misconduct reporting and researcher training, while promoting standards of truthfulness, precision, resource prudence, impartiality, independence, dependability, answerability and openness.
Annex 1 Standard Operating Procedures (SOPs)
This section lists 28 standard operating procedures for ethics committees covering constituting committees, reviewing different protocol types, managing informed consent, handling adverse events, reviewing vulnerable populations, and maintaining confidentiality and records.
Controls
What this policy requires, forbids, grants or penalises, one control at a time and in our own words. Each control links to the official text, which is the authority. This is not legal advice.
Drafted by the Index Drafted automatically from the official text, not yet reviewed by a person.Reviewed Checked by a person against the official text.
Themes covered 6 of 35
Choose a theme to see only its controls. About the themes
Risk and scope 1 of 4
- Risk classification, not covered
- Prohibited practices, not covered
- Impact assessment, not covered
Data and privacy 3 of 4
- Copyright and training data, not covered
Transparency and records 0 of 4
- Transparency and disclosure to users, not covered
- Labelling of synthetic content, not covered
- Technical documentation, not covered
- Record keeping and logging, not covered
Technical safeguards 0 of 4
- Human oversight, not covered
- Accuracy, robustness and cybersecurity, not covered
- Bias and non-discrimination, not covered
- Testing and evaluation, not covered
Assurance and lifecycle 1 of 4
- Registration and notification, not covered
- Incident and breach reporting, not covered
- Post-market monitoring and corrective action, not covered
Rights and protected groups 0 of 4
- Automated decision-making rights, not covered
- Children and vulnerable groups, not covered
- Biometric identification and surveillance, not covered
- Whistleblowing, complaints and redress, not covered
Roles and organisation 1 of 6
- Supply chain and provider-deployer duties, not covered
- General purpose and foundation models, not covered
- Training and AI literacy, not covered
- Public sector use and procurement, not covered
- Innovation support and sandboxes, not covered
Enforcement and sectors 0 of 5
- Enforcement, penalties and regulators, not covered
- Sector rules: health, not covered
- Sector rules: finance and insurance, not covered
- Sector rules: employment, not covered
- Sector rules: education, not covered
The full list of controls could not be loaded, so only the first 9 are shown.
Section 12 8 controls
- ObligationApplies to: ProviderDrafted by the Index
Organizations should prepare research protocols in advance for deployment during humanitarian emergencies and disasters.
- ObligationApplies to: ProviderDrafted by the Index
Researchers should obtain informed consent from participants in research conducted during humanitarian emergencies, with modifications to standard procedures as appropriate to crisis circumstances.
- ObligationApplies to: ProviderDrafted by the Index
Research during humanitarian emergencies should minimize risks to participants and distribute benefits and risks equitably across the affected population.
- ObligationApplies to: ProviderDrafted by the Index
Researchers should maintain privacy and confidentiality of participant data collected during research in humanitarian emergencies.
- ObligationApplies to: OthersDrafted by the Index
Ethics committees should review research conducted during humanitarian emergencies using expedited procedures suited to emergency circumstances.
- ObligationApplies to: ProviderDrafted by the Index
Researchers should provide benefits and support to participants after research completion, with special attention to emergency contexts.
- Applies to: ProviderDrafted by the Index
Ongoing research studies may continue during a humanitarian emergency with modifications to informed consent and risk management procedures.
- ObligationApplies to: ProviderDrafted by the Index
Research involving international participation during humanitarian emergencies should follow protocols appropriate to the multi-jurisdictional context.
Annex 1 1 control
- ObligationApplies to: OthersDrafted by the Index
Ethics committees should establish standard operating procedures covering committee constitution, review processes, adverse event handling, document management and special considerations for vulnerable populations.
Change history
No changes recorded since we began monitoring this policy.