[{"subject":"Regulations Governing Establishment of Institutional Review Boards (IRBs) of National Yang Ming Chiao Tung University","dataClassName":null,"pubUnitName":"Research Ethics Center for Human Subject Protection","posterDate":null,"updateDate":"2024-01-30","detailContent":"\r\n
Regulations Governing Establishment of Institutional Review Boards (IRBs) of National Yang Ming Chiao Tung University
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Approved at the 2nd Administrative Affairs Meeting of NYCU for Academic Year 2020 on February 24, 2021
\r\nAmended and approved at the 1st Special Administrative Affairs Meeting of NYCU for Academic Year 2021 on July 20, 2022
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\r\nArticle 1 Purpose
\r\nIn order to regulate the right protection of human subjects research and human research subjects and execute the human-oriented research, including research involving obtaining, investigating, analyzing, or using human specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information in line with the related laws and ethical requirements, NYCU hereby establishes the Institutional Review Board (hereinafter referred to as the “IRBs”).
\r\nNYCU establishes two institutional review boards:
\r\n I.國立陽明交通大學人體研究倫理審查委員會A, English name: Institutional Review Board A (IRB-A) of National Yang Ming Chiao Tung University (hereinafter referred to as “IRB-A”)
\r\n II.國立陽明交通大學人體研究倫理審查委員會B, English name: Institutional Review Board A (IRB-B) of National Yang Ming Chiao Tung University (hereinafter referred to as “IRB-B”)
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\r\nArticle 2 Mission and Responsibility
\r\n I.Establish the research ethics review policy, regulations and scope related to human research and human subjects research.
\r\n II.Determine the contents and review highlights to be included in the human research and human subjects research protocol, which, subject to the risk level, are divided into the full-committee review, expedited review and exempt review.
\r\n III.Review and audit the interest and right of the subjects in human subjects research and human research projects, and ethics and legality of the research protocols, and follow up the management status and report the same to NYCU regularly, and assist in any investigation, if necessary.
\r\n IV.Monitor the corrective actions against any violations of any matters related to human research ethics, and terminate the human subjects research and human research if necessary.
\r\n V. Other matters related to the human subjects research and human research.
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\r\nArticle 3 Independence of IRBs
\r\nIn order to exercise the right to review independently, the IRBs are free from any undue influence posed by NYCU, Principal Investigator and Contract Research Organization (CRO). They shall also follow up the management status of the research project and report the same to NYCU regularly, and assist in any investigation if necessary.
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\r\nArticle 4 Organization of IRBs
\r\nEach of the IRB-A and IRB-B has 7–21 members, and appoints one chairman and one vice chairman. The chairman shall be appointed by the President of NYCU, while the other members are recommended by the chairman and selected and appointed by the President of NYCU. The vice chairman may be elected among the members. The chairman may appoint 1–3 persons out of the other members to serve as the executive secretary to help the chairman take charge of the overall planning about the IRB.
\r\nEach IRB’s members shall comply with the following background requirements:
\r\n I.Each IRB’s members shall consist of persons with the background in biomedical science or humanities and social science. At least one of them shall have background in laws, and also at least one of them is a disinterested community member or representative of any related private group.
\r\n II.The number of each IRB’s members outside NYCU shall attain two-fifths of the whole members, and no gender shall constitute less than one-third.
\r\n III. The member shall possess the certificates related to subjects’ protection, human research ethics or medical ethics seminars and conferences.
\r\nThe members shall hold the term of office for two years, and may be re-engaged for successive terms, provided that the number of re-appointed members shall be no more than one-half of the total members.
\r\nVacancies of the member, if any, shall be filled by others appointed by the President of NYCU upon the IRB’s request separately.
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\r\nArticle 5 Qualifications of the chairman
\r\nThe chairman shall meet any of the following qualifications:
\r\n I. Has been served as a member of the institutional review board reviewed and approved by the competent central authority for each industry concerned, or the institutional review board promoted by related ministries/departments for more than two years.
\r\n II.Has passed the qualification certification for the profession in research ethics by any international research ethics organization.
\r\n III.Has academic or practical experience in research ethics.
\r\nThe post of chairman shall be assumed by the management in charge of research operations directly, other than Dean of Research and Development or Deputy Dean of Research and Development of NYCU.
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\r\nArticle 6 IRBs Meeting
\r\nSubject to the need for review of cases, the IRB may convene a meeting regularly, and a special meeting whenever necessary.
\r\nAn IRB meeting may be convened only if a majority of the members attend it. At least one of the present members shall have a background in biomedical science or humanities and social science, and at least one of them who is a non-professional disinterested community member with a background in law. A resolution may be made only upon approval of a majority of the present members. No meeting shall be called to order if all of the present members are of a single gender.
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\r\nArticle 7 Dismissal and replacement for vacancy of the member
\r\nWhere a member meets any of the following circumstances, NYCU may notify him/her in writing to discharge him/her from the job duty per resolution of the IRB meeting.
\r\n I. Absent from meetings for more than three times consecutively without justified cases or for more than one-half of the required frequency of attendance cumulatively during his/her term of office.
\r\n II. The meeting is postponed more three times cumulatively due to the cases reviewed by him/her with the causes attributed to him/her.
\r\n III. Materially violating the principles of recusal for conflict of interest.
\r\nWhere a member position becomes vacant with causes, the current Chairman shall search and inquire the member candidate and the IRB shall disclose any qualified member candidates recommended by various schools of NYCU.
\r\nAccording to Article 4 of the Regulations for Establishment of Institutional Review Board, upon expiration of any member’s term of office, the President of NYCU will be proposed to appoint a new chairman and select the name list of the new IRB members, and convene the IRB meeting to have the new members elect one vice chairman among them. The chairman may designate 1–3 persons from the members to serve as the Executive Secretary.
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\r\nArticle 8 Source of budget of the IRBs, and operations of the budget
\r\nNYCU shall ensure that the IRBs have sufficient and stable operating fund. The sources of such fund include the fixed fund contributed by NYCU, subsidy from government ministries/departments, or other self-financing.
\r\nNYCU also establishes the Research Ethics Center for Human Subject Protection (REC) separately, and appoints full-time and part-time staff to handle the overall planning about the IRBs’ administrative affairs, help the IRBs’ audit and monitoring over the execution of the human subject research and human research projects, and handle the adoption and coordination mechanism for ethical review standards among various institutional review boards.
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\r\nArticle 9 In order to perform the duties required herein, a standard operating procedure shall be established separately, and implemented upon approval and promulgation by the IRBs.
\r\nAnything not mentioned herein shall be governed by other applicable laws or the competent authority’s requirements.
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\r\nArticle 10 The Regulations shall be promulgated and enforced upon approval of the Administrative Affairs Meeting of NYCU. The same shall apply where the Regulations are amended.
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National Yang Ming Chiao Tung University Regulations Governing Establishment of Research Ethics Center for Human Subject Protection (REC)
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Approved at the 2nd Administrative Affairs Meeting of NYCU for Academic Year 2020 on February 24, 2021
\r\nAmended and approved at the 1st Special Administrative Affairs Meeting of NYCU for Academic Year 2021 on July 20, 2022
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\r\nArticle 1 Purpose
\r\nIn order to help the operation of “Institutional Review Boards of National Yang Ming Chiao Tung University” (hereinafter referred to as the “IRBs”), protect the research subjects’ interest and right, and execute the mission and related administrative operations assigned by the IRBs, the “Research Ethics Center for Human Subject Protection (“REC”) of National Yang Ming Chiao Tung University” is established in accordance with the “MOE Directions for Audits by Research Ethics Committees.”
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\r\nArticle 2 Mission and Responsibility of the REC
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\r\n\t- Execute various administrative affairs about the IRBs;
\r\n\t- Help the operations of IRBs and enactment/revision of various laws and regulations;
\r\n\t- Help the IRBs supervise and audit ethics cases, and also help the compilation of related documents and reports;
\r\n\t- Plan and execute the human research ethics training courses, conferences, forums or related activities;
\r\n\t- In response to business needs and important issues, invite personnel from related units inside/outside NYCU to convene the communication meeting to facilitate establishment of the research ethics policies or promotion and execution of related business;
\r\n\t- Execute the tasks assigned by the IRBs.
\r\n\t- In order to perform the duties required herein, a standard operating procedure shall be established separately.
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\r\nArticle 3 Organizational Division of Job and Staffing
\r\nThe REC shall appoint one Director and at least one Deputy Director, and several administrative staff. The Director shall be appointed by the President, while the Deputy Director and administrative staff shall be recruited by the Director. The Director shall recommend the full-time faculty of NYCU as the candidate for the Deputy Director, who shall also be appointed subject to approval of the President.
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\r\nArticle 4 Qualifications of the administrative staff
\r\nThe REC’s administrative staff may be selected from the units inside/outside NYCU. The staff shall hold the academic background for university degree or above and the experience in plan management, and have undertaken human research ethics-related administrative affairs, or attended the human research ethics training courses or related conferences for more than 12 hours within 1 year.
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\r\nArticle 5 The Director’s authority and power
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\r\n\t- Oversee the REC’s operations;
\r\n\t- Convene the REC meeting regularly to discuss and execute the missions assigned by the IRBs;
\r\n\t- Help take charge of and supervise the REC’s administrative work;
\r\n\t- Allowed to attend the IRBs meetings.
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\r\nArticle 6 The Deputy Director’s authority and power
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\r\n\t- Help the Director supervise the business his immediate staff are committed to promoting;
\r\n\t- Serve as the Director’s functional substitute;
\r\n\t- Responsible for the special mission assigned by the Director.
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\r\nArticle 7 Functions of the administrative staff
\r\nThe REC’s administrative business requires the special operations including the plan (research project) management, activity planning and advisory services, subject to the nature of work. Various special operations may be promoted by taskforces. Various forces may support each other in response to important meetings or activities. The related functions are stated as following:
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\r\n\t- Plan management: Application, submission, continuing review, authorization, amendment, and SAE reporting, with respect to study projects; follow-up, audit, visit, interim (final) report management and establishment of related SOPs, with respect to the protocols under execution;
\r\n\t- Activity planning: Collection of related important cases, education & training, planning and organization of conferences, forums or related activities, network maintenance, and establishment of related SOPs, etc.;
\r\n\t- Advisory services: Business consulting services, acceptance of complaints, inquiry on human research ethics-related laws & regulations, organization of cross-functional communication meetings, and establishment of related SOPs, etc.;
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\r\nArticle 8 Right and obligation of the REC personnel
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\r\n\t- Required to attend important subject protection or human research ethics meetings or attend related educational training programs at home or abroad from time to time, for no less than 12 hours per year.
\r\n\t- All of the personnel shall execute the agreement on recusal for conflict of interest and confidentiality.
\r\n\t- The administrative staff shall accept the evaluation each year. Those who are found with poor performance or unwilling to respond to the evaluation may be dismissed, or succeeded by the personnel recommended by related units of NYCU separately.
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Article 9
\r\nThe REC Director shall hold the term of office for two years, which may be renewed upon expiration. Whether the administrative staff’s term of office may be renewed shall be decided based on their performance each year.
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\r\nArticle 10
\r\nNYCU provides the REC with independent premises where the REC personnel perform job duties and store documents and files. The funds for the REC’s operations are sourced from the revenue from government subsidies, organization of conferences and educational training programs, or other self-raised expenditures.
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\r\nArticle 11
\r\nAny matters not covered herein shall be resolved in accordance with the relevant SOPs of the IRBs and REC, and also the competent authority’s laws and other related laws and regulations.
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\r\nArticle 12
\r\nThe Regulations shall be promulgated and enforced upon approval of the Administrative Affairs Meeting. The same shall apply where the Regulations are amended.
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Enforcement Rules of Application Processes of Institutional Review Boards (IRBs) of National Yang Ming Chiao Tung University
\r\n Resolved and passed by IRB-A on September 22, 2022
\r\n Resolved and passed by IRB-B on November 1, 2022
\r\n Resolved and passed by IRB-A on November 17, 2022
\r\n Resolved and passed by IRB-B on April 12, 2023
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\r\nArticle 1
\r\nThe Enforcement Rules of Application Processes of Institutional Review Boards (IRBs) of National Yang Ming Chiao Tung University (hereinafter referred to as the “Enforcement Rules”) are established in accordance with the Human Subjects Research Act.
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\r\nArticle 2
\r\nAny personnel of NYCU who wish to conduct human research or human subjects research shall apply with the Institutional Review Boards (IRBs) of NYCU for review, in order to protect the subjects’ rights.
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\r\nArticle 3
\r\nThe terms used herein are defined as following:
\r\nhuman subjects research: refers to research involving obtaining, investigating, analyzing, or using human specimens or an individual person’s biological behavior, physiological, psychological, genetic, or medical information.
\r\nHuman research: refers to the systematic or academic knowledge exploration activity targeting “human beings” (single person or group) and in the manners including observation, intervention or interaction, or using the personal data of which the identifying link has not been removed with the personal consent.
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\r\nArticle 4
\r\nThe IRB research review is categorized into the following three types:
\r\nExempt review: Applicable to the human subjects research which may be exempted from the IRB review according to the public notice made by Ministry of Health and Welfare.
\r\nExpedited review: Applicable to the human subjects research which may apply the expedited review according to the public notice made by Ministry of Health and Welfare.
\r\nFull-committee review: The projects which request the full-committee review, excluding the human trial referred to in Article 8 of the Medical Care Act.
\r\nThe Principal Investigator shall file the application with the IRBs in accordance with the Enforcement Rules. The IRBs will render the final decision subject to the risk level.
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\r\nArticle 5
\r\nQualified applicants: Full-time/part-time faculty of NYCU, and full-time medical and administrative staff of the hospital affiliated to NYCU or hospital under the cooperative project of NYCU who have completed any human research-related training.
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\r\nArticle 6
\r\nWhen filing the application, the applicant shall pay the review fees to the Cashier’s Division based on the payment notice. For the fee rates, please refer to Schedule 1. If the research is self-funded without fund provided by any institution or manufacturer but subject to approval of the REC Director, the IRBs may reject the new application if the review fees are not paid in full without justified causes, provided that the review fees may be credited/exempted in the case of full-committee review cases.
\r\nFor the review fee payment, please refer to Schedule 2. The expenses for any necessary stationery, paper, reproduction, cups, meeting meals and other miscellaneous items shall be paid on a reimbursement basis.
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\r\nArticle 7
\r\nApplication documents:
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\r\n\t- Application form for review on human subjects research
\r\n\t- Expedited review checklist
\r\n\t- Informed Consent Form of a research subject (not required, in the case of the application for exemption from, or change in, the informed consent)
\r\n\t- Letter of undertaking by the research team
\r\n\t- The protocol shall consist of budget statement, Principal Investigator’s resume, main research HR form and related review data.
\r\n\t- English title and Chinese abstract of the protocol
\r\n\t- The Principal Investigator and Co- (Sub-) Investigator shall submit a photocopy of the certificate showing attendance to the human research and ethics training courses for 6 hours within 2 years, unless the foreign researchers are not those obtaining the informed consent form physically.
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Article 8
\r\nThe applications shall be identified by the REC Director and Executive Secretary subject to the risk level, and then related operating procedures may be carried out.
\r\nExempt review: For the case satisfying the exempt review requirements, an “exempt review certificate” will be awarded. If the case is held failing to satisfy the exempt review requirements, the Principal Investigator shall file the application for expedited review or full-committee review instead.
\r\nExpedited review: For the case satisfying the expedited review requirements, the Executive Secretary shall appoint 2 members to conduct the preliminary review, and send experts to conduct the review, if necessary. The Principal Investigator shall give response within 10 working days upon receipt of the preliminary review opinions. The Principal Investigator’s failure to do so shall constitute his/her waiver.
\r\nFull-committee review: For the cases other than those referred to in the preceding two paragraphs and the human trial referred to in Article 8 of the Medical Care Act, the Executive Secretary shall appoint 2 members to conduct the preliminary review, and send experts to conduct the review, if necessary. The Principal Investigator shall give response within 20 working days upon receipt of the preliminary review opinions. If the Principal Investigator fails to do so within specific time limit, he/she shall notify the case handler in writing, and may apply for an extension no more than twice. The Principal Investigator’s failure to do so shall constitute his/her waiver.
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\r\nArticle 9
\r\nAfter the research project is approved, the Principal Investigator shall be obligated to submit reports from time to time during the conduct of the research, upon the IRBs’ request. In the case of any safety concern, the IRB may suspend the research. Upon completion of the research, the Principal Investigator shall submit the case closure report in writing, and may be invited to attend a meeting to provide a statement, if necessary.
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\r\nArticle 10
\r\nWhere it is necessary to extend the term of the research project, the Principal Investigator shall submit the complete application documents for the extension within six weeks prior to the time limit in which the project is approved to be executed. Each extension requested shall be no more than one year.
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\r\nArticle 11
\r\nWhere it is necessary to change the research project, the Principal Investigator shall prepare relevant information and submit the same to the IRBs for review.
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\r\nArticle 12
\r\nThe Enforcement Rules shall be promulgated and enforced upon approval of the IRBs. The same shall apply where the Enforcement Rules are amended.
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