Clinical Research Ethics Application Guidelines

To protect the rights and safety of clinical research subjects and to standardize the organization and operation of this Ethics Committee, these guidelines are formulated in accordance with the National Medical Products Administration and the National Health Commission's "Good Clinical Practice for Drug Clinical Trials" (2020), "Good Clinical Practice for Medical Device Clinical Trials" (2022), "Guiding Principles for Ethical Review of Drug Clinical Trials" (2010), and the National Health Commission's "Measures for Ethical Review of Life Sciences and Medical Research Involving Humans" (2023).

I. Purpose and Scope

To establish guidelines for submitting applications/reports for ethical review of clinical research, guiding applicants in submitting applications/reports for ethical review of life sciences and medical research involving humans, ensuring clear and defined procedures for ethical review applications/reports, and guaranteeing the smooth progress of ethical review work.

These guidelines apply to all applications for review of life sciences and medical research involving humans within this institution. The principal investigator of the project shall submit an application/report for ethical review to the Ethics Committee in accordance with these guidelines.

II. Procedures

(I) Initial Review

An initial review application is the first application for review submitted by the applicant of a life sciences and medical research project involving humans to the Ethics Committee. The applicant shall submit an application for ethical review before the start of the research and may only proceed after obtaining approval. Scientific research projects involving life sciences and medical research involving humans must obtain approval from the Ethics Committee before project initiation.

(II) Follow-up Review

A follow-up review application refers to an application/report for review of all life sciences and research projects involving humans that have been approved by the Ethics Committee. This includes amendment applications, annual follow-up reviews, reports of serious adverse events, reports of study suspension/termination, and study completion reports.

1. Amendment Application

An amendment review application refers to an application for review of any modifications during the research process, including changes to the principal investigator or any modifications to the research protocol, informed consent form, recruitment materials, etc., of the medical research project. The applicant shall submit an amendment application to the Ethics Committee and may proceed only after obtaining approval.

In emergency situations concerning a subject's condition, the researcher may modify the research protocol before submitting it to the Ethics Committee for review and approval. Afterwards, the details and reasons for the modification shall be promptly submitted to the Ethics Committee for review in the form of an amendment application. Information submitted in the report includes (but is not limited to):

(1) The content of the modification and the reasons for the modification;

(2) The impact of the modification on expected risks and benefits;

(3) The impact of the modification on the rights and safety of subjects.

2. Annual Follow-up Review Report

An annual follow-up review report refers to a research progress report submitted to the Ethics Committee for filing within one month before the first anniversary of the project's initiation, after the medical research project has obtained approval from the Ethics Committee. If the medical research is completed within a follow-up review period, an annual follow-up review is not required. Information submitted in the report includes (but is not limited to):

(1) Research progress.

(2) Number of subjects enrolled.

(3) Confirmation that serious adverse events are reported promptly and handled appropriately.

(4) Any events or new information that may affect the risk-benefit balance of the study.

3. Serious Adverse Event SAE/SUSAR/DSUR Reports

A serious adverse event report refers to a report of serious adverse events submitted by the applicant. When a serious adverse event occurs, the researcher shall report it to the Ethics Committee within 24 hours of becoming aware of it. Information submitted in the report includes (but is not limited to):

(1) The severity and scope of the serious adverse event.

(2) The impact of the serious adverse event on the risk-benefit balance of the trial.

(3) Medical protection measures for the subject.

(4) Report of Study Suspension/Early Termination

Other clinical research safety reports: Suspected Unexpected Serious Adverse Reactions (SUSAR), Development Safety Update Reports (DSUR), and new information that may adversely affect subject safety or the conduct of the clinical trial. Safety events should be reported to the Ethics Committee promptly, following the SAE reporting procedures.

4. Report of Study Suspension/Early Termination refers to a report submitted by the applicant for the suspension/termination of medical research. Information submitted in the report includes (but is not limited to):

(1) Reasons for the suspension/early termination of the study.

(2) Follow-up arrangements for subjects.

(3) Whether the safety and rights of subjects are guaranteed.

5. Study Completion Report

A study completion report refers to a summary report document of the institution submitted by the applicant after the completion of a medical research project. Information submitted in the report includes (but is not limited to):

(1) Study title and project leader;

(2) Name of the institution and name of the principal investigator;

(3) Number of subjects screened, number enrolled, number who completed the study, and number who did not complete the study;

(4) SAEs occurring during the study period;

(5) Subject rights and protection status;

(6) Study completion status.

(III) Re-review

 After the initial review, based on the ethical review opinion of "Approved after Modification" or "Re-review after Modification", after modifying the protocol,

the applicant shall resubmit for review by applying for re-review. Implementation may only proceed after obtaining approval from the Ethics Committee. If there are differing views on the ethical review opinion, dissenting opinions may be submitted through a re-review application, requesting the Ethics Committee to reconsider its decision.

III. Process for Submitting Ethical Review

(I) Submitting Review Documents: Applicant/Principal Investigator for review documents.

1. Prepare Review Documents:

(1) The applicant for medical research prepares the review documents according to the checklist of materials for ethical review application (Appendix 1: Checklist of Submitted Documents).

(2) Documents such as the research protocol and informed consent form must indicate the version number and version date.

2. Complete Application/Report Forms: Complete the corresponding application or report according to the category of the ethical review application/report.

(1) Application Category:

a. Initial Review Application (see Appendix 02: Initial Review Application Form, Appendix 03: Expedited Review Application for Publication).

b. Re-review Application (Appendix 04: Re-review Application).

c. Amendment Application (see Appendix 05: Amendment Application).

(2) Report Category:

a. Serious Adverse Event Report (see Appendix 06: Serious Adverse Event Report Form).

b. Report of Study Suspension/Early Termination (see Appendix 07: Study Suspension/Termination Application Form).

c. Annual Follow-up Review Report (see Appendix 08: Annual/Periodic Follow-up Review Application Form).

D. Study Completion Report (see Appendix 09: Study Phase (Summary) Report Form).

3. Submission:

For review requiring a meeting: First, submit 1 electronic copy of the review documents. After passing the formal review by the Ethics Committee, prepare 2 stamped paper copies of the review application materials and deliver them to the Ethics Committee. Simultaneously, send the complete final electronic set of review documents to the Ethics Committee Secretary's email at lily189@hyhospital.com.

For expedited review for publication: First, submit 1 electronic copy of the review documents to the Secretariat. After passing the formal review by the Ethics Committee Secretary, print 2 copies of the relevant paper materials as required and deliver them to the Ethics Committee Secretariat.

(II) Receiving Notifications

1. Notification for Supplementing/Modifying Submitted Materials:

After the Ethics Committee Secretary accepts the submission, if the submitted documents are incomplete or have deficiencies in document elements, the applicant will be informed of the missing documents and deficient elements and asked to supplement and improve the materials.

2. Notification of Acceptance:

Once the completeness and elements of the submitted documents pass the formal review, the Ethics Committee Secretary will send a notification of acceptance and inform the applicant of the scheduled review date.

(III) Preparation for Review

1. Meeting Time/Location:

The Ethics Committee Secretary will notify the applicant of the meeting time and location via email, phone, or SMS.

2. Prepare for Presentation to the Meeting:

The applicant prepares a project presentation of approximately 5 minutes (see Appendix 10: Key Points for Project PPT Presentation) and sends the PPT to the Ethics Committee Secretary's email at lily189@hyhospital.com for formal review one week before the meeting. The presenter must be the principal investigator or project leader. If the project leader cannot attend, they must request leave from the Chairperson of the Ethics Committee in advance. Upon approval, a senior physician from the research team familiar with the project content may be delegated to present. The presenter must arrive at the meeting venue 15 minutes before the scheduled time according to the Ethics Committee meeting agenda.

IV. Ethical Review Timeline

(I) Ethical review meetings are held regularly. Emergency meetings may be convened temporarily when necessary. Applicants must submit the review documents, ethics presentation PPT, and ethics review technical service fee within one week before the meeting. Submissions after this deadline will be deferred to the next meeting. If the applicant still wishes to participate in the current ethics meeting, double the ethics review fee will be charged.

(II) If major or serious problems arise during the research that endanger subject safety, or if other situations requiring an emergency meeting for urgent review and decision occur, the Ethics Committee will convene an emergency meeting for review.

V. Communication of Review Decisions

(I) The Ethics Committee will communicate the review decision in writing, such as an Ethical Review Opinion Letter/Approval Document, within one week of making the ethical review decision.

(II) The review decision from an emergency meeting shall be communicated within 3 days after the decision is issued.

(III) If the applicant requests early communication, it should be communicated as soon as possible.

(IV) If there are differing opinions on the ethical review decision, a re-review application may be submitted to the Ethics Committee.

VI. Registration in the Medical Research Registration and Filing Information System

Before implementing a research project approved by the Ethics Committee, the project leader must register the main content of the research project and the ethical review decision in the Medical Research Registration and Filing Information System before the research can commence.

VII. Medical Research Ethics Review Technical Service Fee

(I) Fee Schedule for Ethical Review of Clinical Research Projects

(II) Fee Schedule for Sponsor Project Ethical Review

Initial Review: RMB 6,000/project (after tax), applicable to both expedited and full board review;

Re-review/Amendment Review: RMB 2,000/project (after tax), applicable to both expedited and full board review;

Follow-up Review (Annual/Periodic, Protocol Deviation, Adverse Event, Suspension/Termination, Study Completion, etc.): RMB 500/project (after tax).

Account Name: Guangdong Heyou Pinnacle Medical Center Co., Ltd.;

Account Number: 44477701040025147;

Bank: China Agricultural Bank Co., Ltd. Shunde Yuejin Sub-branch.

The sponsor shall deposit the relevant fees into the account within 5 working days after receiving the notification of acceptance.

VIII. Contact Information

Ethics Committee Phone: 18373529378, Email: lily189@hyhospital.com.

IX. Appendices

Appendix 1: Checklist of Submitted Documents

Appendix 2: Initial Review Application Form

Appendix 3: Expedited Review Application for Publication

Appendix 4: Re-review Application Form

Appendix 5: Amendment Application Form

Appendix 6: Serious Adverse Event Report Form

Appendix 7: Study Suspension/Termination Application Form

Appendix 8: Annual/Follow-up Review Application Form

Appendix 9: Study Phase (Summary) Report Form

Appendix 10: Key Points for Project PPT Presentation