Date

12-4-2025

Department

School of Health Sciences

Degree

Doctor of Philosophy in Health Sciences (PhD)

Chair

Mona Fazzina

Keywords

data transparency, clinical research organizations, research ethics, protocol compliance, post-COVID, ethical guidelines, clinical research associates

Disciplines

Medicine and Health Sciences

Abstract

The purpose of this research is to examine the post-COVID ethical issues among clinical trials at clinical research organizations (CROs) in the Eastern region. This research is theoretically underpinned by the premise of evaluating the impact of post-COVID on data transparency, ethical guidelines, and protocol compliance. The institutional theory posits that insights gained from this comparative analysis will also contribute to the broader discourse on safeguarding research integrity. According to Yin, case studies are the most beneficial study design to be used, consisting of quantitative approaches (Yin, 2018). The data collected from clinical research associates (CRAs) with experience working with CROs determines the change in data transparency, ethical guidelines, and protocol compliance since the post-COVID of clinical trials. The sample of the study includes a range of 16-30 volunteered participants who will be selected from four different CROs in the East Coast. Randomly selected volunteered participants will then provide responses to the set of questionnaires developed by the researcher. The questionnaire data will undergo analysis utilizing both SPSS and Python system analysis. Specifically, the Analysis of Variance (ANOVA) test will be employed to confirm the significance and correlation between ethical compliance and the level of data transparency among CROs (Shen et al., 2022). In this research, while the CROs showed operational resilience by quickly adapting workflows, they exhibited a lack of ethical resilience, as evidenced by a notable decline in perceived data compliance. Therefore, strengthening ethical resilience should be a priority for CROs to sustain stakeholder confidence and organizational integrity.

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