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Submission Guidelines

Submission Guidelines (Please note before submitting)

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1. Application Location and Processing Hours (Contact Information)

  • Location: Our Institute's Human Research Committee Office (2nd Floor, Environmental Protection Building)

  • Hours: Monday to Friday, 08:30–12:00 and 13:30–17:00.

  • Contact Phone: 0906-728137

  • E-mail:[email protected]

  • Responsible Staff: Ms. Huang Yaxuan

  • Acting Officers: Ms. Xu Fangci 0906-728296, Sergeant Lai Junhan 0906-728139

2. Fee Standards

  1. Submitted to the Military Medical Bureau for approval of our institute's “Human Research Committee Member List and Review Fee Standards”.

  2. Handled in accordance with the Ministry of Defense Military Medical Bureau Order No. 1000003616 dated May 17, Year 100 (2011).

  3. The Military Medical Bureau has approved our institute's Human Research Committee member roster and review fee standards, effective immediately.

3. Application Format

Materials are attached

4. Submission Requirements for Our Institute's Cases

The principal investigator must prepare the following documents for submission to the committee for review:

  1. Human Research Project Review Application Form.

  2. Version- and date-specified trial protocol and related literature and attachments.

  3. Project abstract, summary, or trial flowchart.

  4. Case report forms, log cards, and other questionnaires for participants.

  5. If the trial involves a product, provide summarized data on the product's safety, pharmacology, manufacturing, and toxicology, as well as the latest clinical trial summary for the product (e.g., the most recent investigator's brochure or manual, published data, or a summary of product characteristics).

  6. The principal investigator's latest curriculum vitae.

  7. Methods for recruiting potential participants.

  8. Description of the process for obtaining and recording participant consent.

  9. Written and other forms of information provided to potential participants. Must indicate version and date, and be in language understandable to participants; other languages may be used if necessary.

  10. Informed consent form written in language understandable to participants, with version and date indicated; other languages may be used if necessary.

  11. Statement of compensation for participants, including expense reimbursement and medical care.

  12. Explanation of related injury compensation and insurance.

  13. Statement of agreement to comply with the Helsinki Declaration.

  14. Description of relevant ethical issues.

  15. If the same project has been submitted to the central health authority or another human research review board, include the important decisions made by that review body. If it was not approved or required revisions, attach the reasons for disapproval or the requested modifications.

  • Our committee reviews cases on a submission‑upon‑receipt basis. General review cases submitted for committee discussion must be submitted at least three weeks before the meeting; the principal investigator must provide initial review comments within one month, otherwise it will be considered a withdrawal.

  • Submit one week before the meeting:
    (1) Paper copy of the response to review comments: one original and two copies; late submissions will be moved to the next meeting.
    (2) Response form, Chinese abstract, and electronic files of the participant consent form before and after revisions.

5. Committee Site‑Visit Qualification

Ministry of Health and Welfare Letter No. 1131671653 dated December 30, 2024

Validity period: from January 1, 2025 to December 31, 2029

Ministry of Health and Welfare announcement

Ministry of Health and Welfare Announcement