Review Submission Guide

IBC Review Process

Review Request

  • Prepare detailed information on the research project to be reviewed and the names of the biohazards, pathogens, living modified organisms, or high-risk pathogens, and inquire with the staff by e-mail (21389@snuh.org)
  • Send the biosafety research plan, risk assessment, training completion certificate, PSDS, IACUC documents, references, etc. to the IBC staff

Review

  • The IBC staff and a specialized reviewer conduct an initial review, request revisions, and provide guidance if a government response is required
  • After revisions are completed, the final version is sent to the four reviewers
  • Reviewers are selected as experts in the relevant field with no conflict of interest in the research, and confirmed by the chairperson
  • The identities of the selected reviewers are kept confidential, and external disclosure of review-related documents is restricted.

Preparation of Review Reports

  • Each reviewer reviews their documents, prepares a review report, and sends it to the IBC staff
  • Revisions or additional materials/documents may be requested if necessary
  • If reviewers' opinions differ or a meeting is needed to review the agenda, an ad hoc meeting is held in consultation with the chairperson to reconcile opinions
  • Once all review opinions are received, an approval document is prepared based on the results and submitted to the chairperson for confirmation

Issuance of Approval

  • Based on the review results, a research-plan approval document is prepared, an approval number is generated, and final confirmation is obtained from the chair of the Biosafety Committee
  • The researcher confirms the final biosafety research plan and risk assessment and submits the signed original to the IBC staff
  • The final approval of the biosafety research plan is produced as a PDF, and the committee-sealed copy is e-mailed to all participating researchers and the facility manager

LMO Import Notification Process

The end user of a research-use LMO files the import notification directly = the principal investigator

Complete the MSIT online notification form

(Researcher) Complete the online notification form

Submit documents to the Division of Laboratory Safety

(Researcher) LMO notification, utilization plan, import contract, transport plan

Approval

(Division of Laboratory Safety) Approval by the biosafety officer and the facility operation manager (Director of the Translational Medicine Research Institute)

Submit to MSIT

(Researcher) Submit the approved documents to the Ministry of Science and ICT (MSIT)