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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
Chatfield, Kate; Schroeder, Doris; Guantai, Anastasia; Bhatt, Kirana; Bukusi, Elizabeth; Adhiambo Odhiambo, Joyce; Cook, Julie; Kimani, Joshua – Research Ethics, 2021
Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the…
Descriptors: Ethics, Research Problems, Research Administration, Advisory Committees