TY  - JOUR
T1  - Assessment of Informed Consent and Institutional Ethics Review in Published Case Reports and Case Series
A1  - Siti Nur Aisyah
A1  - Ahmad Firdaus
A1  - Nur Hidayah
JF  - Asian Journal of Ethics in Health and Medicine
JO  - Asian J Ethics Health Med
SN  - 3108-5059
Y1  - 2021
VL  - 1
IS  - 1
DO  - 10.51847/5ooQas6yE4
SP  - 152
EP  - 160
N2  - Research is expected to uphold strict safeguards for individuals’ privacy and personal information, yet many case reports and case series are produced without formal ethical review or consent that provides all essential details. This study set out to investigate how often these types of publications disclose obtaining patient permission and ethics committee involvement. This meta-research, using a cross-sectional design, examined open-access case reports and case series from 2021 that were indexed in PubMed. The study collected information such as author and journal characteristics, the country of origin, the number of patients described, and whether the publications reported obtaining informed consent or receiving approval from an ethics committee. The analysis covered 2,053 case reports and case series. The majority of publications (86%) described only one patient. Information regarding informed consent appeared in 79% of the articles, and in most of those instances (74%) the consent came directly from the patients. Mentions of ethics committee involvement were found in 46% of the publications, with 24% indicating that formal approval had been obtained. Case reports were substantially more likely than case series to include an informed consent statement, whereas case series were more likely to reference ethics committee oversight. The results show uneven reporting of ethical considerations: only 46% of publications referred to ethics committee involvement, and the reasons given for exemption were inconsistent. Although informed consent was documented in 79% of cases, there is still a need for better clarity and uniformity in how these details are presented. Establishing explicit standards for when ethical approval is required and how consent should be reported would help strengthen the transparency and ethical quality of case reports.
UR  - https://smerpub.com/article/assessment-of-informed-consent-and-institutional-ethics-review-in-published-case-reports-and-case-se-emnk5kedasuazll
ER  -