The particular dynamics of public health emergencies urge scientists and Ethics Committee (EC) members to change and adapt their operating procedures to function effectively. Despite having previous pandemic experiences, ethics committees were unprepared to adapt to COVID-19 pandemic challenges. This survey aims to learn and thoroughly discuss the most salient issues for ECs during the COVID-19 pandemic. The results indicate that the main problems faced by ECs were lack of/insufficient regulations, lack of data/experience/knowledge, sloppy review, poor research design, and poor adaptation to quarantine measures. Coping with factors that threaten the autonomy and independence of ECs, the ethical dilemma regarding maximizing common good versus protecting the rights and well-being of study participants, comprehending the change in the context of vulnerable populations, and redefining the role of ECs to strengthen trust in science and vaccine confidence were outstanding issues.
Background
The coronavirus disease (COVID‐19) treatment must be based on scientific methods such as clinical trials. Trials involving human subjects and those requiring a risk‐benefit analysis may occasionally face challenges owing to the time limitations in the pandemic.
Methodology
This study analyses the WHO's International Clinical Trials Registry Platform and
clinicaltrials.gov
, where most COVID‐19 clinical trials are registered, according to ethical criteria including study design, conflicts of interest, enrollment of healthcare workers, study locations, site‐, design‐, and participant‐related issues. The discussion is based on three aspects: the quality of the information to be produced, the relevance to significant health problems, and the creation or evaluation of interventions, policies, or practices that promote individual or public health.
Results
There were significant differences between the two platforms regarding the investigational medicinal product (IMP), the comparator, ethics committee/institutional review board approval, plan to share individual participant data, study phase, site, IMP, and design‐related issues. Conflict of interest, sponsor information, and management of vulnerable groups were the main areas wherein both platforms lacked sufficient information.
Conclusion
With this analysis, we aimed to define a minimum set of ethical criteria for clinical trial platforms to obtain standardization between these two platforms.
ABS TRACT Objective:The Imported Medicine List was published for the first time on October 11, 2013 by the Ministry of Health of the Republic of Türkiye. The purpose of importing drugs from abroad is to supply the human medicinal products that are not licensed in our country and/or that are not available in the market for various reasons despite being licensed, on prescription for use in the diagnosis and treatment of diseases in emergencies. The aim of this qualitative research is to examine the information presented about these medicines on the imported medicine list and to evaluate the possible ethical problems that may be caused by insufficient information presentation. Material and Methods: The medicines on the 25/02/2022 Turkish Medicines and Medical Devices Agency imported medicine list were included in the analysis. First, between the dates 07-27 February 2022, it was determined whether these medicines had short product information and instructions for use on the Turkish Medicines and Medical Devices Agency website by searching for active substances. Then, all medicines were searched in the RxMediaPharma database by the active substance name, and those not found by this method were searched by the ATC code. Finally, the ethical implications of the issue were discussed and suggestions were presented. Results: The change in the number of active substances in the imported medicine list by years and the presence of generic and medicine-specific information in different Informed Consent Forms have been determined. The ambiguity of the criteria for keeping the unlicensed essential drugs used to meet the priority health needs of the population in the foreign-dependent list has been determined. Conclusion: The risks to patients' right to autonomy have been determined as the result of the lack of sufficient, adequate, and accurate information in the Informed Consent Forms carries risks for patients' rights to autonomy.
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