Clinical research ; Research subject ; Human Research Protection Program ; Institutional Review Board
Abstract
Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital
or a research institute in Korea.
Methods: Survey was conducted during June 12th–21th 2019. Survey was distributed to the members of Korean Association of
IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26.
Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86
respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits
such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8%
answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the
respondents, 66.3% performed 'Help desk.'
Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry
of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities
according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the
cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical
trials and to stably establish the HRPP, efforts at the individual institution level will be required