Results 51 to 60 of about 167,079 (162)

Exploration of Ethical Review Disputes and Regulatory Pathways of Off-label Drug Use

Yixue yu zhexue
The ethical risks of off-label clinical use of drugs include many risks, incomplete laws and regulations, difficulties in risk-benefit assessment, and challenges in managing conflict of interest management and obtaining informed consent.
Xuelian TANG, Jue WU, Xiaoyan LI, Jiyin ZHOU   +3 more
doaj   +1 more source

Commented review of the Colombian legislation regarding the ethics of health research

Biomédica: revista del Instituto Nacional de Salud, 2017
The scope of ethics in health research transcends its legal framework and the regulations established in Resolution 8430 of 1993. These norms represent a fundamental tool to determine the minimum protection standards for research subjects, and, therefore,
Mónica María Lopera
doaj   +1 more source

Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey

BMC Medical Ethics, 2019
Background The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess.
Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, Alejandro Salcido-Montenegro, Neri Alejandro Álvarez-Villalobos, Victoria González-Nava, José Gerardo González-González   +6 more
doaj   +1 more source

Clinical governance and research ethics as barriers to UK low-risk population-based health research?

BMC Public Health, 2008
Background Since the Helsinki Declaration was introduced in 1964 as a code of practice for clinical research, it has generally been agreed that research governance is also needed in the field of public health and health promotion research.
Douglas Flora, van Teijlingen Edwin R, Torrance Nicola   +2 more
doaj   +1 more source

Perspectives of non-specialists on the potential to serve as ethics committee members

Journal of International Medical Research, 2019
Objective In Japan, under the new Clinical Trials Act pertaining to investigator-initiated clinical trials that came into effect on 1 April 2018, review boards should review proposed clinical trials while considering written opinions from specialists ...
Chikako Kane, Kenshi Takechi, Masayuki Chuma, Hiroshi Nokihara, Tomoko Takagai, Hiroaki Yanagawa   +5 more
doaj   +1 more source

Ethical Entities and Regulatory Compliance in Biomedical and Clinical Research in India: Bridging Gaps in Awareness and Practice across Biological Samples

Journal of Preventive, Diagnostic and Treatment Strategies in Medicine
BACKGROUND: Biomedical and clinical research in India ranges from human, animal, microbial, and plant studies, as well as cadaveric research and is subject to various regulatory and ethical parameters, which include Indian Council of Medical Research ...
Mohammad Nadeem Khan
doaj   +1 more source

The role of the Ethics Committees in Scientific Research in Italy: from research protocols to publication – A narrative review of the regulatory framework.

Journal of Biomedical Practitioners
OBJECTIVE The growing volume of scientific research and the increasing methodological complexity of clinical trials have made a robust ethical and regulatory framework essential; however, some uncertainties persist.
Elisa Piccolo, Agnese Frola, Jonathan Nora, Irene Nieri, Luigi Collovà, Claudio Pobbiati, Domenico Riccardo Cammisa, Francesco Paolo Sellitti   +7 more
doaj   +1 more source

Ethical issues in clinical research

Indian Journal of Plastic Surgery, 2007
Thatte Urmila
doaj   +1 more source

Clinical Ethics Consultation and Hospital Ethics Committees*

Korean Journal of Medical Ethics, 2017
This article addresses the question of what is an appropriate Korean translation of “clinical ethics consultation” and also interprets clinical ethics as a branch of medical ethics. Three models of clinical ethics consultation are introduced: an authoritarian approach, a pure facilitation approach, and an ethics facilitation approach.
openaire   +1 more source

Treatment of patellofemoral osteoarthritis with nasal chondrocyte-based engineered cartilage implantation in a randomised, controlled, multicentre phase II clinical trial: protocol for a randomised controlled trial

BMJ Open
Introduction Knee osteoarthritis often starts in the patellofemoral compartment of the knee and is diagnosed in about 39% of people with knee pain aged above 30 years. Patellofemoral osteoarthritis plays a crucial role in the reduction of quality of life
Corina Schuster-Amft, Marcus Mumme, Sabine Schaedelin, Sarina Seitz, Gyözö Lehoczky, Anke Wixmerten, Sylvie Miot, Kristin Shrestha, Ivan Martin   +8 more
doaj   +1 more source