Kim, Jongho
Park, Kyoung Sun
Lee, Yoon Jae
Kim, Koh-Woon
Cho, Jae-Heung
Ha, In-Hyuk
Funding for this research was provided by:
Korea Health Industry Development Institute (HB16C0059)
Article History
Received: 28 October 2019
Accepted: 23 May 2020
First Online: 15 June 2020
Ethics approval and consent to participate
: The study protocol, ICF, all information given to the patients, and other relevant information, have been submitted to and received approval from the Ministry of Food and Drug Safety and from the IRBs which belong to Jaseng Hospital of Korean Medicine and Kyung Hee University Korean Medicine Hospital at Gangdong. All investigators participating in this study will be educated in the tenets of the Helsinki Declaration and the Korean Good Clinical Practice Guidelines, the study plan, and the SOP to protect the patients participating in the trial. All personal information of participants in the trial will be strictly managed under the supervision of the IRBs, and privacy and protection of participants’ personal information will be guaranteed. All data collected from patients who consent to participate in this study will be anonymised, and if requested by other institutions for research purposes, will be provided as an arbitrary code that omits all personal information. Separate approval by an IRB will be required if the data is to be used for purposes other than the current study.Before starting the clinical trial, the investigators will thoroughly explain the study contents and give information about treatment to participants, before obtaining voluntarily signed consent forms. On the consent form, participants will be asked if they agree to use of their data. Participants will also be asked for permission for the research team to share relevant data with people from the hospitals taking part in the research or from regulatory authorities. Participants will be given a copy of the signed consent form. In addition, if personal information is necessary, such as a copy of the participant’s passbook showing travel expenses, this will be explained to the participant, and we will obtain consent to collect such personal information. This trial does not involve collecting biological specimens for storage, so relevant consent will not be necessary.
: Not applicable.
: The authors declare that they have no competing interests.