1. Basis
This regulation is formulated based on Articles 7, 56, and 57 of the Medical Act and Articles 2, 3, 50, 51, and 52 of the Medical Act Implementation Rules.
2. Scope
All new drugs, new medical devices, or new medical technologies that require human trials must be submitted to the Human Experimentation Committee for review.
3. Scope of “new drugs, devices”
This regulation’s Article 2 defines new drugs and medical devices as the following drug ingredients or medical devices that have not been approved, inspected, and registered by the central health authority:
（1）Drug ingredients or medical devices that have already been studied in laboratories and animal experiments domestically or abroad, with substantial literature published, and can be tested in humans.
（2）Drug ingredients or medical devices that are still in the human trial stage in major international countries (including those recognized by the Health Department: United States, Japan, Canada, Australia, Germany, France, United Kingdom, Switzerland, Belgium, Sweden).
（3）Drug ingredients or medical devices approved for market entry in the country of manufacture, but whose safety and medical efficacy have not been recognized by our country and therefore still require human trials.
（4）Drugs provided as new efficacy combinations or for new routes of use.
4. Scope of “new medical technology”
This regulation’s Article 2 defines new medical technology as the following situations:
（1）Medical technologies that have already been researched in laboratories and animal experiments domestically or abroad, with substantial literature published, and can be applied to human trials.
（2）Medical technologies that are still in the human trial stage in major international countries.
（3）Medical technologies announced by the central health authority as requiring human trials.
5. Applicants
Research teams submit applications to this committee in accordance with the application regulations and forms of the Human Experimentation Committee of the National Kaohsiung Armed Forces General Hospital.
6. Review method
Applications are administratively reviewed by the Secretariat, which replies to the project leader within 2 working days; those passing administrative review are assigned by the chairperson to relevant members for preliminary review, and after recommendation are forwarded to the review committee for meeting deliberation.
7. Review content
The review committee examines the following items:
（1） Is the project’s topic and content suitable for human research?
（2） Are the drugs or medical devices used in the project approved for manufacture and sale by the Health Department?
（3） If the drugs or medical devices used in the project are not approved by the Health Department, are animal or human toxicity and side‑effect reports attached?
（4） Do the principal investigator and co‑researchers have appropriate knowledge, ability, and training to conduct this human trial?
（5） Are the planned steps and methods detailed and feasible?
（6） Is there a control group?
（7） Are the basic dignity and personhood of the human research participants respected?
（8） Are the rights and interests of the human research participants protected?
（9） Is the burden among participants evenly distributed? Are benefits equitable?
（10） Is the contribution to scientific advancement proportionate to the risks to participants?
（11） Other related items.
8. Preliminary review principles
When the review committee deliberates jointly, the preliminary reviewer first presents their opinion, after which all attending members review.
9. Review principles
Cases submitted to the Human Experimentation Committee may be implemented only after approval by the committee meeting (and, if necessary, submission to the central authority for approval).
10. Appeal procedure
If an application fails the preliminary review, the applying physician must submit an appeal or supplement within one month of receiving the notice; otherwise, it is considered a waiver.
