Chapter 2 Review of Research Portocols
Prior to conduct a research, the principal investigator shall submit the research protocol for review and approval by the Institutional Review Board (hereinafter “IRB”). However, the research protocol within the scope of exemption categories for IRB review, as announced by the competent authority, shall not apply.
The review in the preceding Paragraph shall be conducted by the research entity’s IRB. Where an entity does not have an established IRB, the review may be conducted by IRB of other entity.
Amendments of an approved research protocol shall be submitted for IRB approval prior to its implementation.
The research protocol in the preceding Article, shall include the following matters:
1. Protocol title, principal investigator, and research entity.
2. Abstract of the protocol, research subjects and experimental methods.
3. Estimated timetables.
4. Ways and content of human subject protection and consent obtaining.
5. Research personnel and equipment requirements.
6. Research funding requirements and sources.
7. Expected results and primary benefits from the research.
8. Attribution of research results and uses thereof.
9. Disclosure of any conflicts of interest affecting research personnel.
The IRB shall consist of five or more members, including legal expert and other persons of disinterested community members; more than two-fifths shall not be affiliated with the research entity; and no gender shall constitute less than one-third.
During IRB meetings, the IRB may invite the attendance of experts familiar with the research field, or representatives of any appropriate group affiliated with the human subjects, to attend and provide comments.
The competent authority shall stipulate regulations to govern matters related to the IRB organization, meetings, review processes and scope, conflict of interest principles, supervision, administration, and other matters of compliance.
Review of research protocol shall be conducted in accordance with the degree of risk presented, as docketed for standard review or expedited review.
Expedited review procedures under the preceding Paragraph shall only be available if the scope of the research lies within the categories announced by the competent authority.
Where research personnel are unaffiliated with a research entity or not engaged in cooperative research with a research entity, they shall nevertheless be required to obtain IRB approval from one research entity or approval from a non-research entity affiliated independent IRB, prior to engaging in a protocol.
Where the research protocol involves two or more research entities, it may be approved by one of those IRBs agreed by the research entities involved, as well as to be responsible for the review, supervision and auditing.
An IRB shall conduct review processes independently.
Research entities shall ensure that the IRB review is not subject to any untoward influence of any research entity, principal investigator or protocol consignor.