National Ethical Guidelines for Health and Health-Related Research (original) (raw)
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Indian Journal of Medical Ethics, 2018
The Indian Council of Medical Research (ICMR) has been at the forefront in setting up the ethical guidance for the conduct of biomedical and health research in India. The latest version of National Guidelines for Biomedical and Health Research Involving Human Participants, 2017 was planned in order to provide a more detailed guidance to the existing topics in view of emerging ethical concerns and to add a number of newer areas in which guidance was lacking. The scope of the guidelines has been expanded to include socio-behavioural research related to health and research involving biological material and datasets. The guidelines have 12 sections which cover a wide range of topics and areas of research. The first six sections are more generic, applying to all types of biomedical and health research, while the next six sections are more subject specific. The guidelines have been revised in consultation with a large number of experts and stakeholders and went through an exhaustive process stretching over a period of two years in its drafting, review, consultation and finalisation. This commentary seeks to explain the process and key components of the Guidelines.
The year 2000 was significant for the health research in India. Two ethical guidelines were finalised and published in that year. In September 2000 the Central Ethics Committee on Human Research (CECHR), under the Chairpersonship of Honourable Justice Shri M. N. Venkatachaliah, appointed by the Indian Council of Medical Research (ICMR), New Delhi published the "Ethical Guidelines for Biomedical Research on Human Subjects". This was an elaborate follow up by the ICMR of its document titled "Policy Statement on Ethical Considerations Involved in Research on Human Subjects" brought out two decades earlier, by the Committee Chaired by Honourable Justice Shri H. R. Khanna. On the other hand, a parallel exercise focusing on the ethics in social science research, particularly in the field of health, was commenced in early 1998 at the Centre for Enquiry into Health and Allied Themes (CEHAT), Mumbai. In 1999, a National Committee for Ethics in Social Science Research in Health (NCESSRH) was constituted. The NCESSRH formulated the draft guidelines for discussion, and after national level consultation, including a national meeting of concerned experts in May 2000, the revised and final draft of the guidelines was adopted by the NCESSRH and published by the CEHAT in November 2000, under the title "Ethical Guidelines for Social Science Research in Health. These guidelines for health research were widely distributed in India and internationally, the printed copies as well as in electronic format through the Internet. The NCESSRH guidelines are now being reprinted as by mid-2003 all 2000 copies of the first print were exhausted, and there is an increasing demand for more.
Ethical guidelines for biomedical research
2009
Concerning the justification for the creation of a registry for biomedical Concerning the organisation of a registry for biomedical research purposes Concerning the ethical requirements for anonymous data collections Concerning the ethical requirements of records that contain data Concerning the use of historical records and information about dead people research purposes .
Knowing what constitutes ethical research is important for those who conduct research and the researcher should be familiar with the basic ethical principles and policies designed to ensure the safety of the research subjects. Research must be ethically conducted, trustworthy, and socially responsible for the results to be valuable. Ignorance of policies designed to protect research subjects is not considered a viable excuse and the researcher needs to fully understand the ethical code and guidelines to guarantee upstanding research practices. In the last decade medical research in India saw emergence of difficult ethical issues and intervention from the Supreme Court of India. The different socio-cultural ethos and the varying standards of health care in India pose unique challenges to the application of the universally prevailing ethical principles and guidelines. This necessitated the Indian Council of Medical Research (ICMR) to revise their 2006 ethical guidelines for biomedical research as ‘National Ethical Guidelines for Biomedical and Health Research on Human Participants 2016’. These guidelines are applicable to all biomedical, socio-behavioral and health research conducted in India which involves human subjects. This article gives an overview of the evolution and principles of research bioethics, and helps to understand and disseminate the general principles of the Declaration of Helsinki 2013 of World Medical Association and the National Ethical Guidelines 2016 of ICMR.
Research Ethics Codes and Guidelines
Handbook of Research Ethics and Scientific Integrity, 2020
Although the origin of professional codes of ethics can be traced back to ancient Greece, their peak was in the late twentieth century with more than 70% of codes of ethics being created after 1990. Today professional ethical standards are formulated as codes of ethics, sets of principles or guidelines, declarations, conventions, charters, or laws, and they differ in scope, form, and content. As there is no consensus on what is meant by "research ethics" and "research integrity," both concepts are clarified here.
2014 05 Article-Research-Ethics-J R Soc Med-2014-Zielinski-70-76.pdf
Objective: To describe the state of research ethics policies and practices in health research institutions in sub-Saharan African countries. Design: A structured questionnaire was used to solicit information on research ethics from health research institutions. Setting: Forty-two sub-Saharan African countries. Participants: Key informants from the health research institutions. Main outcome measures: Existence of institutional ethics review policies and mechanisms. Results: About half (51%) of respondent institutions reported having policies on research ethics and 58% had written policies requiring that researchers obtain informed consent of research participants. About one-third of respondent institutions (34%) had established ethics review committees, 42% required that studies went through ethics review committees and 46% had linkages with national or regional ethics organisations. Regarding operating procedures for ethics review committees, 53% had adopted standard operating procedures. Less than one-quarter of respondent institutions reported having policies in place to monitor ongoing research. Of the institutions that monitored ongoing research, 34% did an annual ethical review and 74% required a periodic written report. Only 36% provided any type of ethics training for staff, including those conducting health research and those who were not members of the ethics review committee. Conclusions: There are substantial gaps in the capacity of health research institutions in the WHO African Region to undertake ethical review of studies before, during and after studies conducted. There is a need to strengthen such capacity in order to ensure the wellbeing of individuals enrolled in studies and that of communities that host these studies.