The history of clinical research is, unfortunately, filled with examples of research studies that took advantage of and harmed research participants, to fulfill the research goals of scientists. Over time, we have created a system of ethical codes, principles, and regulations that are designed to prevent these abuses and to ensure that the rights and welfare of research participants are protected and honored. This review article will provide a brief history of clinical research ethics and ethical codes, outlining how those codes developed into the current regulatory requirements for the ethical oversight of clinical research. Understanding the current human subject protection systems will allow researchers to use best practices for planning and conducting rigorous, scientifically valid and ethical clinical studies. Understanding the history, principles, and foundations of the development of this system will equip researchers to understand what resources are available to them and how to make the best decisions when confronted with unique ethical situations in the conduct of their research.
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http://dx.doi.org/10.1177/15353702221078216 | DOI Listing |
Front Med (Lausanne)
January 2025
Gispen4Regulatory Science Consultancy, Bilthoven, Netherlands.
The ethical governance of pharmaceutical clinical trials in Europe, particularly under Regulation 536/2014, is intended to ensure the safety, rights, and well-being of participants. Despite this regulatory framework, significant gaps in ethical oversight remain. This paper identifies five key deficiencies: (1) European regulations only partially address ethical imperatives set by international guidelines, thereby restricting the ethical mandate of relevant entities; (2) the role of research ethics committees is largely limited to pre-approval activities, reducing continuous oversight during trials; (3) GCP inspectors operate within a narrow scope regarding ethical oversight, which limits their ability to identify a broad range of unethical practices; (4) there is insufficient transparency and collaboration between RECs and regulators, specifically GCP inspectorates, leading to fragmented oversight; and (5) there is minimal integration of ethical findings into the marketing authorization decision process by entities such as clinical assessors and the CHMP.
View Article and Find Full Text PDFFront Nephrol
January 2025
Department of Surgery, University of Colorado Anschutz Medical Campus, Aurora, CO, United States.
Background: This study assesses the impact of human leukocyte antigen (HLA)-DR mismatch and donor-estimated glomerular filtration rate (eGFR) on outcomes of living donor kidney transplantation (LDKT), which are especially relevant to the availability of multiple donors and paired kidney exchanges.
Methods: Using data from the Scientific Registry of Transplant Recipients (SRTR), we retrospectively analyzed graft survival in adult LDKT recipients transplanted between January 2013 and September 2022. Recipients with 0 HLA-DR mismatches were compared to those with 1-2 HLA-DR mismatches.
Cureus
December 2024
Obstetrics and Gynecology, ESI Hospital and Postgraduate Institute of Medical Sciences and Research (PGIMER) Basaidarapur, New Delhi, IND.
Preeclampsia is one of the leading causes of maternal and perinatal morbidity and mortality. Early prediction is the need of the hour so that interventions like aspirin prophylaxis can be started. Nowadays, machine learning (ML) is increasingly being used to predict the disease and its prognosis.
View Article and Find Full Text PDFJ Clin Transl Sci
December 2024
Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.
Introduction: Local context is the most common concern regarding use of a single institutional review board (sIRB). Yet what "local context" constitutes remains underspecified. Developing a shared understanding of the goals of local context review, the categories of information that should be considered, as well as the types of studies for which sIRB review may be inappropriate, are critical for ensuring that sIRB review provides adequate protections for human subjects.
View Article and Find Full Text PDFSci Rep
January 2025
Department of Mechanical & Industrial Engineering, Montana State University, Bozeman, MT, 59717, USA.
We hypothesized that daily exercise promotes joint health by upregulating anti-inflammatory mediators via adaptive molecular and metabolic changes in the infrapatellar fat pad (IFP). We tested this hypothesis by conducting time-resolved analyses between 1 and 14 days of voluntary wheel running exercise in C57BL/6J mice. IFP structure and cellularity were evaluated by histomorphology, picrosirius red collagen staining, and flow cytometry analysis of stromal vascular fraction cells.
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