Kosin Medical Journal

Enacted on Jun 22, 2012
First revision Jul 1, 2017
Second revision Jan 1, 2022
Recently revised Sept 1, 2023

Before initiating the research, the principal investigator must obtain approval from the Institutional Review Board (IRB) for the consent form template, participant information sheet, and other documented data provided to research participants, unless the study falls under the exempt category designated by the IRB, in which case consent from research participants or documentation thereof may not be required.

A consent form should include a clear and concise description of the research to which the participant will consent. It should include the following information in the participant information sheet and informed consent document:

The fact that the study is being conducted for research purposes.
The purpose of the study.
Information about the investigational medicinal product/medical device for the research and the probability of being randomly assigned to the test group or control group.
Various tests or procedures that the participants will undergo during the research, including invasive procedures.
Instructions that the participants must follow.
The fact that it is an unproven study.
The anticipated risks or discomfort that may affect the participants (including fetuses in trials involving pregnant women and infants in trials involving lactating women).
Whether there are expected benefits or no expected benefits for subjects’ participation in the study.
Other treatment options or types available to the subjects, along with potential risks and benefits of those treatments.
Compensation or treatment that will be provided to the subjects in case of any trial-related injuries.
For any financial compensation for participating in the research, the estimated amount and the indication that this compensation may be adjusted based on the degree or duration of participation in the trial.
The expected costs for the subjects resulting from their participation in the research.
The decision to participate in the clinical trial must be voluntary, and the participants have the right to refuse or withdraw from the trial at any time without losing any benefits stipulated in the consent form.
The fact that monitoring personnel, inspectors, the review board, and the head of the Ministry of Food and Drug Safety have the authority, within the adherence of guidelines designed to protect the participants' confidentiality, to access the participants' medical records to verify the conduct and quality of data for the research, and that such access is permitted by the informed consent document signed by the participants or their representatives.
Records that can identify the subjects will be kept confidential, and the fact that the subjects' identities will remain confidential when the results of the study are published.
The commitment to inform the participants or their representatives promptly if any new information arises during the research that may influence their continued participation.
Contact information for individuals who can be reached in case additional information regarding the research and the participants' rights is needed or if trial-related injuries occur.
Conditions and reasons for discontinuing the individual's participation in the study if such situations arise during the trial.
The expected duration of the individual's participation in the research.
An approximate number of participants actively involved in the research.

To ensure ethical practices, it is essential that research participants receive proper instructions and provide their consent to participate in the study by completing the relevant informed consent documents. Authors may be requested to submit a sample consent form with all personal information removed. In cases where written consent is not obtained and verbal consent is given, or when consent cannot be obtained, authors must provide an explanation in the manuscript. It is important to note that the use of verbal consent or the absence of consent should be approved by the appropriate IRB or ethics committee. For further guidance on patient privacy, anonymity, and informed consent, authors can refer to the privacy and confidentiality guidelines of the International Committee of Medical Journal Editors (ICMJE).

Informed consent policy