01 Check List of Documents for Initial Review of New Protocols (新案)

For those required to submit an initial ethics review application to a Research Ethics Committee (REC), the following is a checklist of the materials you will need to provide. The electronic files of the submission documents should be arranged in the order of this check list and first sent to nthurec@my.nthu.edu.tw. Once it is confirmed that no additional documents/modifications are needed, upload them to the review system. Some documents uploaded to the review system must have signatures as indicated in the check list’s remarks section.

Check List of Documents for Initial Review of New Protocols

Form		Remarks
Required00	Document Submission Check List	(PI Sign)
0-1	Exempt and Expedited Review Self-Assessment	If applying for exempt or expedited review, this must be attached. (PI Sign)
Required.01	New Protocol Review Application	Please indicate version date. (PI Sign)
Required. 02	Research Protocol	Please indicate version date (PI Sign)
Required.03	Informed Consent □Use the committee template for the consent form (3-1) □Use self-designed consent form: Please attach the consent form and the “Application for Exemption from Signing or Amendment to the Informed Consent Content” (3-2) □Applying for exemption from research subjects signing/oral notice/webpage notice: Please attach the consent form content and the “Application for Exemption from Signing or Amendment to the Informed Consent Content” (3-2) □Applying for full exemption from informed consent: Please attach the “Application for Exemption from Informed Consent” (3-3)	Please indicate version date Please use the yyyy-mm-dd format to indicate the version date at the footer of each page. For self-designed, oral/webpage consent, the required information must follow Article 14 of the Human Subjects Research Act. (PI Sign)
04	Research Tools □Research Questionnaire □Interview Outline □Data Collection	If applicable, please indicate version date. (PI Sign)
05	Recruitment of research subjects advertisement materials	If applicable, please indicate version date. (PI Sign)
06	Relevant References by PI or others	If applicable, please provide two articles from the last five years.
Required.07	CV and publication check list of the principal investigator, co-investigator, and sub-investigator.	(PI Sign)
Required. 08	Proof of research ethics training (including principal investigator, co-investigator, sub-investigator, research assistants, graduate students, and all members involved in the research protocol)	Please provide copies of research ethics training certificates from within the last 2 years, covering at least 6 hours of training.
09	Notification of Affiliated Institution Record (for externally commissioned protocols)	Copies of documents proving the external PI has notified their affiliated institution’s research protocol management office.
Required. 10	Principal Investigator Agreement	(PI Sign)
11	Other supplementary documents or relevant certifications If the research involves secondary data, please attach supplementary documents explaining the legality of the original data, such as certification of approval from other IRB/REC reviews. If instruments are used in the research, please attach safety or certification documents for the instruments.

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