This study aims to examine issues arising when reviewing on research using healthcare big data and discuss ways to improve it to create a review environment that meets the intrinsic values of the Institutional Review Board.
The issue of review was derived by analyzing domestic laws and guidelines related to healthcare big data. Accordingly, improvement plan were proposed on issues related to 'de-identification', 'waiver of informed consent' and 'Personal Information Protection'.
The summary of the study is as follows.
First, it was confirmed that the effectiveness of de-identification, a way to utilize healthcare big data for purposes other than the consent of the subjects, was raised. Since it is important to determine whether a person is identified in the process of review on research using healthcare big data, it is necessary to prepare criteria for the judgment of the Institutional Review Board based on the degree of de-identification. For the clear judgment of the Institutional Review Board, it is necessary to consider both how experts judge individually and how to remove identifiers by applying the HIPPA privacy rules in the United States.
Second, it was found that the criteria for the review of the Institutional Review Board need to be established because the legislation governing matters related to waiver of informed consent is not clear. The Institutional Review Board will also need to provide criteria for waiver of informed consent and waiver of documentation of informed consent, respectively, like the 45 CFR 46 regulation in the United States, and additional regulations to judge the risk of waiver of informed consent.
Third, the protection of healthcare information is regulated by the Personal Information Protection Act and individual laws, indicating that the Institutional Review Board is confused during the review process. Accordingly, the enactment of individual laws will be urged, and individual laws will have to cover the specificity of healthcare information, the authority and responsibility, and the effective guarantee of autonomy.