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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
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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