Researcher

Researcher Qualifications and Responsibilities

Researchers must clearly understand their responsibilities and roles, and must be familiar with and comply with the ethical principles of the Belmont Report, the relevant laws and regulations, and the HRPP SOPs when conducting human-subject research and the like.

Researchers must receive the education and training necessary to conduct research and possess sufficient experience and qualifications; all medical decisions related to a clinical trial involving research participants must be made by a researcher holding a physician's license. The IRB recognizes only one person as the principal investigator for each human-subject study, and the principal investigator bears ultimate responsibility for the conduct of the research, including all communication with the IRB.

Planning Human-Subject Research

A researcher who intends to conduct human-subject research may not begin the research without IRB approval or confirmation of review exemption. For research that requires review and approval by a regulatory agency such as the Ministry of Food and Drug Safety, the research may begin only after the regulatory agency's approval has been obtained.

The definitions of human-subject research and human-derived material research under the Bioethics and Safety Act are as follows.

Human-Subject Research

· Research that physically intervenes in humans: research that obtains data by directly manipulating the research participant or the participant's environment
· Research conducted through interaction such as communication or interpersonal contact: research that obtains data through behavioral observation, face-to-face surveys, and the like
· Research using personally identifiable information: research that uses information by which a research participant can be identified, directly or indirectly

Human-Derived Material Research

· Research that directly investigates and analyzes human-derived materials (constituents of the human body collected or harvested from a human body, such as tissue, cells, blood, and body fluids, or serum, plasma, chromosomes, DNA, RNA, and proteins separated from them)

IRB Approval of Human-Subject Research

Researchers conducting human-subject research must prepare a research protocol and submit it to the IRB.

A protocol is a document that describes the purpose of the research, its content and methods, statistical aspects, and the relevant organization in order to provide the background or rationale for the research; it must serve as a manual that specifically records the entire process of the research from beginning to end. Researchers must comply with the IRB-approved protocol and may not conduct the research differently from the protocol until they have received IRB approval for a protocol amendment.

Detailed instructions for preparing a protocol are available in the IRB resources section.

Registration in a Public Database

In accordance with the Declaration of Helsinki (Article 35), a researcher who intends to conduct human-subject research must disclose the research information in a publicly accessible database (Primary Registry) before enrolling the first research participant. This is intended to correct the information bias that arises when only the literature of clinical research with positive or promising results is selected for publication; registration of clinical research is an obligation that all researchers and sponsors must observe.

Detailed information on clinical research registration is available in the IRB resources section.

Conducting Ethical Clinical Research and Communicating with the IRB

Researchers must comply with the IRB-approved protocol, and if they wish to amend the protocol, they must obtain IRB approval in advance before making the change.

The reports that must be submitted to the IRB during the conduct of research are as follows.

Further details beyond what is mentioned above are available in the IRB resources section.

Reports to be submitted to the IRB during the conduct of research
Report	Submission deadline	Report content
Protocol amendment review request	Before implementing the protocol amendment	Change comparison table All forms to be amended, including the protocol
SAE report (in-house — death, life-threatening)	Within 7 days of becoming aware (if not all detailed information is reported, report with full details within 15 days; follow-up reports also within 15 days)	Includes detailed information for in-house participants only
SUSAR report (in-house)	① Death or life-threatening: within 7 days of becoming aware (if not all detailed information is reported, report with full details within 15 days; follow-up within 15 days) ② Otherwise: within 15 days of becoming aware >> If additional information exists, report until the adverse event is resolved	Includes detailed information for in-house participants only
SUSAR report (external — domestic/overseas)	(For the same clinical trial only) Compiled and reported every 6 months after study approval	Participant information is entered directly on the report form or completed in the provided Excel template and uploaded to the system
Safety information report	1) SAE report (in-house — other than death/life-threatening) >> Compiled and reported every 6 months after study approval 2) Other safety information reports >> No fixed deadline	1) Attach an Excel (provided template) list of SAEs (in-house — other than death/life-threatening) 2) No separate form
Annual continuing-review request	1) Studies above low risk Accepted from 45 days before the approval expires 2) Minimal-risk studies Accepted from 30 days before the approval expires	Research progress checklist Final approved protocol Final approved consent form
Interim research progress report	1) Studies with a 3-month reporting cycle >> 3 interim reports/year + 1 annual continuing review 2) Studies with a 6-month reporting cycle >> 1 interim report/year + 1 annual continuing review	Research progress checklist Final approved protocol Final approved consent form
Non-compliance report	1) Serious non-compliance >> Within 15 working days of the researcher becoming aware 2) Non-serious non-compliance >> Reported at least once a year if any cases exist (compiled and reported annually after study approval)	1) Includes detailed information for in-house participants only 2) For non-serious non-compliance, if reporting two or more cases, complete and attach an Excel (provided template)
Unanticipated problem (UP) report	Within 15 working days of the researcher becoming aware	Includes detailed information about the unanticipated problem
Other protocol reports	No fixed deadline	Various documents determined to require reporting to the IRB during the conduct of research

Study Completion Report

Please submit a study completion report when all three of the following are satisfied.

· All interventions and interactions related to the study are complete after enrollment of research participants (or human-derived materials) is finished
· Collection of all data related to the study is complete
· Only data analysis remains

For drug and medical device clinical trials, the completion report must be submitted within 20 days of the final participant's end-of-observation date.

Study Result Report

A result report must be submitted within one year of the study completion report. The result report submits the final outcome of the research and must be accompanied by the research paper or the clinical study report (CSR).

However, if the result report cannot be submitted within one year, the reason must be reported to the IRB in advance.

Early Study Termination Report

If the study could not be started or was discontinued, an early termination report must be submitted along with the reason. The researcher may report voluntarily, or the study may be terminated early at the decision of the IRB or a regulatory agency.

The reports that must be submitted to the IRB upon study completion are as follows.