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Direct linkHugh Davies; Simon E. Kolstoe; Anthony Lockett – Research Ethics, 2024
Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals (n = 44) indicated confirmation of understanding would take place during an…
Descriptors: Participation, Research Problems, Informed Consent, Comprehension
Maduka-Okafor, Ferdinand Chinedum; Okoye, Onochie Ike; Oguego, Ngozi; Udeh, Nnenma; Aghaji, Ada; Okoye, Obiekwe; Ezegwui, Ifeoma R.; Nwobi, Emmanuel Amaechi; Ezugwu, Euzebus; Onwasigwe, Ernest; Umeh, Rich E.; Aneji, Chiamaka – Research Ethics, 2022
School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent…
Descriptors: Recruitment, Elementary School Students, Secondary School Students, Children
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
