The Ethical Guidelines for Biomedical Research involving Human Participants were first released by the Indian Council of Medical Research (ICMR) in 2006. Since 2016, the Indian Drugs and Cosmetics Act (first published in 1945) and Rules (first published in 1947) have received several updates related to clinical trials regulations. In October 2017, after ten years of careful deliberations with stakeholders and under the leadership of the Director General Dr Soumya Swaminathan, ICMR released their revised guidelines. These guidelines came one year after the release of the International Ethical Guidelines for Health-related Research involving Humans by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO).
The new ICMR guidelines have 12 sections and cover ethical issues in all aspects of research. Whilst responsible conduct of research, informed consent and vulnerability have been a part of many standard ethical guidelines in the past, detailed direction has been lacking on areas such as public health research, socio-behavioral research, human genetic testing research, biological materials, bio-banking, research using datasets, research during disasters or emergencies and collaborative research. Information on some of these areas was included in the 2016 revised CIOMS guidelines, however the release of the new ICMR guidelines is the first time that standard guidance has been provided on many of these areas in India. Some of the salient features are presented below.
The guidelines not only incorporate ethical considerations for clinical trials of drugs, but also ethical considerations for clinical studies on vaccines, phytopharmaceuticals, biologics, biosimilars, stem cells, interventions in HIV/AIDS, surgical interventions, public health interventions, trials on diagnostic agents and on traditional systems of medicine. Different types of research and the specific issues related to those types of research are discussed separately in the guidelines since, for example, the type of consent required for clinical drug trials is a separate issue to the consent required in public health research. Additionally, the composition and responsibilities of members of ethics committees have been discussed in much detail, helping to define the duties for each member of the committee, including the responsibilities of a public facing representative. The guidelines help to avoid confusion related to the expected qualification level of ethics committee members by clearly stating whether they should have medical, non-medical or technical expertise. They mandate that ethics committee members have or receive training with detailed documenting evidence and signature of a conflict of interest statement. They also list the necessary components of an informed consent document, which includes additional safeguards for vulnerable populations and the defines when approval from an ethics committee is required. Those research areas with minimal risk include research on anonymous or non-identified data/samples, data available in the public domain and meta-analysis. Surprisingly, even for those research areas, the investigator is required to seek exemption from review by the ethics committee. For example, a meta-analysis conducted from studies available in the public domain would require exemption from the ethics committee.
Other notable changes in the new guidelines include information on animal experimentation, ethics related to authorship for publication of results, ethics of peer reviewing research, and research misconduct in publication and research grants. The previous set of guidelines already required that clinical studies involving human participants were registered with the Clinical Trial Registry of India (CTRI) and the new guidelines now mention observational studies, preclinical studies of experimental therapeutics and preventives and alternative medicine studies. Studies from the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) now need to be registered prospectively with CTRI. Ethical considerations in collaborative research, both nationally and internationally, are discussed and it is noted that it is the responsibility of the ethics committee to ensure that the country’s regulatory guidelines have been followed.
Though not legal binding, the guidelines are important for all stakeholders involved in biomedical or other types of health research. It is yet to be seen how the ethical environment in India will change after the introduction of these detailed guidelines in all sectors of public health research. It is notable that the guidance document uses the word ‘human participants’ instead of ‘subjects’ and it is expected that these guidelines would encourage the investigators, ethics committee members and all other stakeholders involved in clinical or socio-behavioral or any other type of health research in India to be more ethically driven with the upmost respect for participants involved in research and at the same time more quality-driven, by maintaining required standards for research.
ICMR Ethical Guidelines 2017- Major Sections
Sections 1-6: General Ethical Aspects
1. Statement of General Principles
2. General Ethical Issues
3. Responsible Conduct of Research
4. Ethical Review Procedures
5. Informed Consent Process
6. Vulnerability Sections
7-12: Ethical Aspects Specific to type of research
7. Clinical trial of Drugs & other Interventions
8. Public Health Research
9. Social & Behavioral Science Research
10. Human Genetics testing & research
11. Biologic materials, bio-banking & datasets
12. Research using humanitarian emergencies & disasters
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