CIOMS cited

This study addresses these bioethical implications in the use of digital technologies to conduct mental health research, as noted by the Research Ethics Committee of the Ramón de la Fuente Muñiz National Institute of Psychiatry during the social distancing measures during the COVID-19 pandemic in Mexico. The increased use of digital tools abruptly transformed the manner in which studies were conducted, especially for those not familiar with this modality. The transition to these new digital technologies must include consideration of the bioethical implications of these strategies, and ethics committees must work with researchers to identify the best ways to safeguard the dignity, autonomy, and rights of participants.

Real-world data and real-world Evidence in regulatory decision making: report summary from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.

During the 2014–2016 Ebola epidemic in West Africa and the Ebola outbreaks between 2018 and 2020 in the Democratic Republic of Congo, vaccines and other tools for prevention and treatment had to be taken through trials in exceptional circumstances using accelerated processes. Members of ethics committees, health authorities, health professionals, and political authorities were interviewed in the Democratic Republic of Congo and a workshop held with ethics committee members and regulatory authorities from Sierra Leone and Guinea, in order to document their experiences of reviewing, approving, and regulating current and new studies during epidemics and outbreaks, and to document lessons learnt and their recommendations for the rapid review of clinical trial protocols during public health emergencies.

This study explores the perspectives of researchers and research ethics committee (REC) members in Tanzania regarding post-trial obligations and their alignment with key ethical frameworks such as the Belmont Report, CIOMS guidelines and the Declaration of Helsinki. Findings revealed significant gaps in post-trial care, particularly in maintaining access to interventions. RECs and researchers face challenges in fulfilling post-trial responsibilities, calling for clear guidelines and sustainable post-trial mechanisms in resource poor settings.

Based on a 2018 study to assess training needs of research ethics committees (RECs) in Colombia,Costa Rica, Guatemala, and Mexico, this paper describes information on RECs operating procedures related to biobank research reported by 55 participants. The study concluded that RECs in Mesoamerican countries lack clear policies on biobanks and have deficiencies in informed consent and governance. Regulatory advances and ongoing training are needed to protect participants’ rights.

This study explores stakeholders’ perspectives on post-trial access (PTA) in clinical trials and its feasibility in Ethiopia. Research participants considered that trial participants and communities should benefit from clinical trials and that multi-stakeholder collaboration was key in PTA planning and arrangements. However, they were uncertain of PTA feasibility in Ethiopia mostly due to a lack of legislation, regulations and guidelines on PTA and fear of losing sponsors because of increased costs resulting from them being obligated to provide PTA. It was recommended that Ethiopia establishes legislation and guidelines to govern PTA.

Social and scientific value is a sine qua non for the ethical justification of medical research involving human participants. A favorable balance of individual benefits and risks does not render clinical research ethically justifiable if it lacks the potential to generate new knowledge that may improve health or well-being. Additionally, the inclusion of collateral benefits in the evaluation of clinical research may lead to or aggravate therapeutic misconception, and be harmful to research participants and to the research community. Collateral benefits may motivate individuals to take part in clinical research, but should be treated with caution.