Fundamental Study for Establishing Standardized e-IRB Computer System in Healthcare

Abstract

The Ministry of Health and Welfare in Korea has been obliged to establish the IRB. However, in many cases,
items that should be included in the review process are omitted in the process of modification. Therefore, this
study analyzes the IRB-related deliberations and evaluation forms of the institutional bioethics committee
members of public and private universities that were announced for evaluation and certification of the
institutional committee in 2016. The data were collected the new review documents and the review exemption
documents that are open to the homepage. Then, we analyzed the items included in the paper form for new
deliberation and exemption from each university, and analyzed for form standardization of the institutional
bioethics committee based on the data. Most of the research proposal and bioethical compliance pledges were
included in the new application form, but the manuals for the subjects, the consent form, and the consent form
for the use of personal information were often omitted. The e-IRB standardized system should be developed
which not only include the form, but also provide information about the contents for protection of research
subject and personal information for the researcher or the deliberation committee member.