About IRB

About the IRB

The IRB (Institutional Review Board) is an independent, collegial decision-making body that reviews the ethical and scientific aspects of all biomedical research involving humans, in order to protect the rights, safety, and welfare of research participants taking part in clinical research, and that may approve research plans.

Purpose

The main purpose of establishing an IRB is to protect research participants by reviewing the ethical and scientific validity of all biomedical research. To this end, the IRB receives the protocol, participant information sheet and consent form, case report forms, and other related materials from researchers, reviews and approves them, and manages and oversees the research so that it proceeds appropriately. The IRB also protects researchers by enabling them to conduct research in compliance with the relevant laws, alongside protecting research participants.

Authority and Duties

The IRB has the following authority over research plans and approved research.

1. 1

   The IRB reviews the following for research submitted by external institutions or researchers:

   • The ethical and scientific validity of the protocol
   • Whether consent was obtained from research participants and others through lawful procedures
   • Matters concerning the safety of research participants and others
   • Measures to protect the personal information of research participants and others
   • Other matters necessary for bioethics and safety
2. 2

   The IRB may require researchers to provide additional information in order to review a research plan.

3. 3

   Where necessary, the IRB investigates and oversees the progress and results of approved research projects during their conduct.

4. 4
   It carries out the following activities for bioethics and safety:

   • Education of the institution's researchers and staff
   • Establishment of measures to protect vulnerable research participants and others
   • Preparation of ethical guidelines for researchers
5. 5

   The IRB may delegate to the Center for Human Research Protection [the work of investigating and inspecting the progress and results of research being conducted at this institution] and [the work of educating this institution's researchers and staff on bioethics and safety].

6. 6

   Depending on the degree of risk to the research participants of a given study, the IRB requires the principal investigator to report at appropriate intervals and conducts continuing review. The continuing-review interval may not exceed one year.

7. 7

   The IRB must be able to appropriately protect research participants and others during the conduct of approved research.

8. 8

   If, during the investigation and oversight of ongoing research, the IRB determines that there is a serious threat to bioethics and safety — such as an unexpected serious risk or a serious violation of relevant laws — it may, after review, decide to restrict, suspend, or hold the research.

9. 9

   The IRB may perform other duties prescribed by the notifications of the Minister of Health and Welfare and take appropriate measures on such matters.