Challenges encountered during the process of obtaining informed consent in human subject research: A Scoping Review

Informed consent is a procedure to encourage and invite participants by providing information when making research decisions. However, implementing informed consent is considered unfeasible and imposes constraints on the value of research inquiries. Obtaining informed consent is also seen as a potential bias in acquiring knowledge. In other words, research participants and researchers face many challenges in the process of informed consent. This comprehensive study aimed to map the challenges encountered while obtaining informed consent in human subject research. Methods: The electronic databases search using PubMed, MEDLINE (EBSCO), and ScienceDirect (Elsevier). Relevant studies were chosen using inclusion criteria, such as those published in 2014-2024 with “full text,” English, human research subject, quantitative, qualitative, and mixed methods articles. JBI guidelines are a checklist used to assess eligibility. Data from studies described challenges encountered while obtaining informed consent in human subject research extracted and synthesized. Processes are supported by MeSH term, PCC worksheet, and convidence.org. Results: Twenty-one studies were identified to provide information about the challenges of obtaining informed consent in human subject research. Conclusion: This study categorizes three themes within eight subthemes related to challenges in obtaining informed consent: 1. Communication Issues, 2. Respondents’ Issues, and 3. Ethical Considerations.