|
KMID : 1161620230050010021
|
|
Journal of KAIRB
2023 Volume.5 No. 1 p.21 ~ p.32
|
|
|
An Ethical Consideration on the Standard Operating Procedure Operation Status and the Ethical Review of the Vulnerable Research Subjects of Institutional Review Board, a Medical Institution in Korea
|
|
|
|
|
Abstract
|
|
|
Purpose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans.
Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 institutions which conduct clinical trials including 11 AAHRPP-accredited general hospitals in Korea, as well as the operation of the IRB deliberation.
Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why and for what reasons individuals are vulnerable. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 16 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 14 institutions classified subjects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 11 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were
not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 4 classified foreigners as vulnerable.
Conclusion: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs’ classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/ benefit, and a review using checklists and spokesperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.
|
|
|
KEYWORD
|
|
|
Vulnerable research subject, Institutional Review Board, Standard operating procedure, Clinical research, Clinical tria, Bioethic
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|