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Shafiq, Nusrat; Kumari, Savita; Kumar, Vivek; Suri, Vinita; Jayashree, Muralidharan; Duseja, Ajay; Bansal, Arun; Malhotra, Samir – Research Ethics, 2021
Monitoring of clinical trials is important to ensure adherence to protocol, to safeguard the rights of research participants and to achieve compliance with principles of good clinical practice. Recent regulatory changes in India require Ethics Committees to keep an oversight of ongoing clinical trials including on-site monitoring. In this article,…
Descriptors: Ethics, Medical Research, Outcomes of Treatment, Foreign Countries
Kumar, Nandini K.; Muthuswamy, Vasantha – Research Ethics, 2020
The COVID-19 pandemic has brought unprecedented, major challenges to the ethical conduct of research including challenges for the rapid and robust ethical review of biomedical research. The Indian Council of Medical Research's "National Guidelines for Ethics Committees Reviewing Biomedical and Health Research during COVID-19 Pandemic"…
Descriptors: COVID-19, Pandemics, Medical Research, Ethics
Nelson, Cameron R. – Journal of Research Administration, 2012
This year the world commemorates the beginning of the tragic USPHS syphilis experiments that occurred in Tuskegee, Alabama from 1932 to 1972. In light of this sobering anniversary, this article will briefly examine four studies: the already mentioned USPHS syphilis studies in Tuskegee, the Nazi Holocaust Experiments and the resulting Doctors'…
Descriptors: Ethics, Medical Research, History, Informed Consent