Institutional Review Board

Institutional Review Board
  • The Institutional Review Board (IRB) is a committee that reviews and supervises human-subject research, embryonic stem cell research, and research involving human-derived materials conducted by researchers affiliated with KAIST.
  • Scope of IRB review
    • General ethical considerations for human-subject research in research projects specified by law among projects conducted at KAIST
    • Ethical and scientific validity of research proposals, including human-subject research
    • Verification of proper procedures for obtaining consent from research subjects and sample providers
    • Safety measures and information protection measures for research subjects, sample providers, and other subjects of genetic information
    • Matters urgently raised by the president as posing or likely to pose a significant risk to bioethics or safety due to human-subject research conducted by KAIST
    • Other matters based on legal provisions or raised by the chair of IRB
Scope of research (subject to IRB review)
  • Human-subject research :

    Research involving direct physical intervention with individuals, studies conducted through interaction such as communication or interpersonal contact, and research utilizing personally identifiable information

  • Human-derived material research :

    Research involving the direct investigation and analysis of tissues, cells, body fluids, and other human components collected or obtained from the human body, or those separated from them, including serum, plasma, chromosomes, DNA (deoxyribonucleic acid), RNA (ribonucleic acid), proteins, etc.

  • Human embryonic stem cell research :

    Research utilizing cell lines (registered with the Ministry of Health and Welfare) derived from embryos, somatic cell nuclear transfer embryos, or single-cell embryos, and capable of continuous proliferation under suitable culture conditions and differentiation into various cell types

IRB review application
  • Review application: Submit documents within the period specified in the portal announcement or e-mail
  • Required documents
New projects
Classification Required documents
General
  • [Form 1] Research plan review application (*submit CITI completion certificate)
  • [Form 2] Summary of research plan
Additional
(where applicable)		 Human-subject research
  • [Form 3] Research plan for human-subject research
  • [Form 4] Consent of subjects in human-subject research
  • Other supporting documents such as subject recruitment notice, full survey, etc.
Human-derived material research
  • [Form 7] Research plan for human-derived material research
    • Direct collection: [Legal form 34] Consent for human-derived material research, [Form 4] Consent of subjects in human-subject research
    • Provided by external institution: Institutional IRB approval and copy of consent form
Human embryonic stem cell research
  • [Form 8] Research plan for human embryonic stem cell research
  • (Where applicable) Copy of MTA by responsible/importing institution
Approved projects (ongoing)
Classification Required documents
Change of research plan [Form 10] Application for change of research plan
(Where applicable) Other supporting documents
Continuing review
  • [Form 11] Continuing review request
  • Current research plan
  • Current consent of subjects (including signatures)
  • Approved change of research plan (where applicable)
  • Copy of bioethics education completion certificate
Application for review exemption confirmation
Classification Required documents
Review exemption confirmation
  • [Form 1] Research plan review application (*submit CITI completion certificate)
  • [Form 12] Application for review exemption
  • [Form 3 or 7] Research plan
  • [Form 13 or 14] Self-check table for review exemption
  • (Where applicable) Other documents provided to subject of investigation e.g. survey
Research exempt from review
Human-subject research Human-derived material research
  • Research involving direct manipulation of research subjects or their environment, and falling under one of the following categories
    • Studies that do not involve invasive actions such as drug administration or blood collection
    • Research employing non-intrusive measurement devices or observational equipment without inducing physical changes
    • Studies evaluating taste or quality using food or food additives permitted for sale under Article 3 of the Enforcement Rules of the Food Sanitation Act
    • Research investigating the sensory experience or satisfaction using cosmetics that comply with safety standards under Article 8 of the Cosmetics Act
  • Research involving direct interaction with research subjects but not identifying them and not collecting or recording sensitive information as defined in Article 23 of the Personal Information Protection Act.
  • Research utilizing existing data or documents related to research subjects
  • Research in which researchers do not collect or record personal information, and falling under one of the following categories
    • Research utilizing human-derived materials and genetic information (hereinafter referred to as "human-derived materials, etc.") provided by a human-derived material bank, and the individual from whom the human-derived materials were obtained cannot be identified without going through the human-derived material bank
    • Research using remaining human-derived materials obtained for therapeutic and diagnostic purposes in medical institutions to conduct accuracy testing, laboratory quality management, and testing method evaluations
    • Research that does not involve direct collection of human-derived materials but uses research materials (including pathogens, cell lines, etc.) separated and processed from human-derived materials for general public use
    • Research in which researchers cannot identify the personal information of human-derived material donors, and the results obtained from the research are unrelated to the genetic characteristics of the donor individuals. However, research using embryonic stem cell lines is excluded
  • Research conducted by educational institutions designated by the Minister of Education under Article 2 of the Elementary and Secondary Education Act and Article 2 of the Higher Education Act within the scope of the usual curriculum related to practical work
  • Research directly conducted or entrusted by the national or local government in situations requiring urgent public health measures

Eligibility for review exemption to be confirmed by IRB, not researchers.

Re-review and closure review application
Classification Required documents
Re-review
  • [Form 9] Re-review application
  • Updated documents
  • (Where applicable) Other supporting documents
Early closure report review
  • [Form 17] Early closure report
  • Supporting documents for early closure
Closure and results review
  • [Form 18] Research closure report
  • Results report (may be substituted by academic papers and conference presentations)
IRB review classification
Classification Review details Review cycle
Expedited review
  • Research with minimal risk or minor changes to approved research
  • Confirmation of review exemption
 1 month
Regular review
  • Research that exposes subjects to greater risk or exceeds minimal risk, major changes to approved research, etc.
  • Human embryonic stem cell research
  • Research involving vulnerable subjects (patients, minors, etc.)
  • - Provision of human-derived material or personal information
 2 months

Review type to be determined by IRB.

Guidelines
  • The IRB follows the principle of pre-review. Researchers must apply for review before initiating any research involving human subjects.
  • The principal investigator and participating researchers must complete bioethics education before submitting an IRB review application.
  • Any principal investigator intending to provide human-derived materials or personal information collected through research to a third party must obtain IRB approval for the provision of human-derived materials or personal information.
  • Research approved by the IRB should only proceed within the approved scope, and any necessary changes must be submitted for review and approval. The research should then proceed with the plan reflecting the approved modifications.
  • Projects confirmed to be exempt from review are prohibited from modifying their research plans.
  • The final report must be submitted to the IRB for both approved projects and projects confirmed to be exempt from review upon completion of the research.
Related information
  • Bioethics and Safety Act, Ministry of Health and Welfare
  • IRB Information Portal http://irb.or.kr/
  • Standard Operating Guidelines of Bioethics Committee