Transcript IRB介紹
The Recent Status of Institutional Review Boards and Clinical Investigators in Medical Centers with Well-Equipped General Clinical Research Center Martin M-T Fuh MD, DMSci. Institutional Review Board China Medical University Hospital China Medical University Taichung, Taiwan, ROC The IRB Forum The IRB is and appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. Human Protection in Human Research What, Why, How, When and Where The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. IRB Review Process revised version Martin M-T Fuh MD, DMSci. 新案/修訂案/延長試驗案 申請審查作業流程 人體試驗委員會 廠商/主持人 確認資料，收取費用並 開立收據 檢送申請案件，同時繳 交審查費用 快速審查約七天通過。 委員進行初審 回覆審查意見 一般審查平均約一個月通過 進入審查會議 委員複審 通過發予證明 存檔列管 稽查/定期追蹤 通報衛生署 Approval Letter 人體試驗委員會人體試驗計劃同意書 Tel: 886-4-22052121 ext: 4132 Fax: 886-4-2207-1478 中國醫藥大學附設醫院 台中市北區育德路 2 號 中國醫藥大學附設醫院○○科○○○○所提臨床試驗「○○○○○」之研究 案已獲同意。 計畫編號：○○○ 本院編號：DMR96-IRB-○○ 中國醫藥大學附設醫院人體試驗委員會已審查通過上述預計為期十二三十六 個月的研究案。 計劃有效期限到 2008 年 04 月 15 日為止。此計畫預訂執行期間自 2007 年 月 日至 2010 年 月 日，在有效期屆滿之前，研究計劃主持人應至少每年向人體試 驗委員會報告研究計劃的進行狀況。若屆時在尚未完成研究期間，每年應重新申請。 該計劃任何部分若欲更改，需向人體試驗委員會重新提出申請。計劃主持人對 受試者任何具有危險而且未能預期之問題，例如：對藥物、放射性元素或對醫療器 材產生不良反應等，需立即向人體試驗委員會主任委員提出書面報告。 主任委員 中 華 民 國 九 十 六 年 四 月 十 六 日 Approval Letter The Institutional Review Board China Medical University Hospital, Taichung, Taiwan Tel: 886-4-22052121 ext: 4132 Fax: 886-4-2207-1478 Date：Apr. 16, 2007 Expedited Approval To：○○○ , ○○ of ○○○, China Medical University Hospital From：Martin M-T Fuh MD, DMSci. Chairman, Institutional Review Board Subject：○○○○○ The Institutional Review Board has recommend the approval of the protocol number ○○ ○; ICF version dated 3 April 2007; CMUH IRB No.: DMR96-IRB-○○○, date: Apr. 16, 2007, for the protocol identified above, and has determined that human subjects will be at risk. Approval of your research project is, therefore, granted until Apr. 15, 2008 from Apr. 16, 2007 to Apr. 15, 2010. You are reminded that a change in protocol in this project requires its resubmission to the Board. By the end of this annual period you may be asked to inform the Board on the status of your project. If this has not been completed, you may request renewed approval at that time. Also, the principal investigator must report to the Chairman of the Institutional Review Board promptly, and in writing, any unanticipated problems involving risks to the subjects of others, such as adverse reactions to biological drugs, radio-isotopes or to medical devices. Submission Note 中國醫藥大學附設醫院人體試驗委員會 Tel: 886-4-22052121 ext: 4132 Fax: 886-4-2207-1478 中國醫藥大學附設醫院 台中市北區育德路 2 號 茲收到中國醫藥大學附設醫院○○科（系）○○○主持人所提臨床試驗「○○○○○」之研 究案，此案正受理審查中。 本院編號：DMR96-IRB-○○ 中 華 民 國 九 十 六 年 ○ 月 ○ ○ 日 The Institutional Review Board China Medical University Hospital, Taichung, Taiwan Tel: 886-4-22052121 ext: 4132 Fax: 886-4-2207-1478 Date：mm. dd, yyyy Submission Note To：○○○ , ○○ of ○○○, China Medical University Hospital From：Martin M-T Fuh MD, DMSci. Chairman, Institutional Review Board Subject：○○○○○ We would like to inform you that your above-mentioned protocol has been received in the Institutional Review Board Submission System. It has been forwarded to the Review Committee on mm. dd, yyyy. https://register.clinicaltrials.gov/ chinamuh cmuh cmuh66 View Protocol Record Main Menu Select Preview Spelling Download XML Check Records Record Status: Released In Progress | Completed | Approved | Released Owned by: CMUH Last updated: 05/09/2007 14:32 by PRS_QA Initial release: 05/08/2007 Last release: 05/09/2007 Download Receipt (PDF) Comments: Unique Protocol ID: DMR96-IRB-41 Secondary IDs: ClinicalTrials.gov ID: NCT00471926 ClinicalTrials.gov Archive Publication Status Brief Title: Diabetes Quality Improvement Program on Diabetes Case Management Program 2001 (DQIP-DCMP) Official Title: Diabetes Quality Improvement Program on Diabetes Case Management Program 2001 Study Type: Observational IND/IDE Protocol? No Sponsor: China Medical University Hospital Collaborators: Review Board: Approval Status: Approved Approval Number: DMR96-IRB-41 Board Name: Institutional Review Board, China Medical University Hospital Board Affiliation: China Medical University Phone: 886-4-22062121 Email: [email protected] Data Monitoring Committee? Yes Oversight Authorities: Taiwan: Department of Health Brief Summary: Detailed Description: Record Verification Date: May 2007 Overall Status: Recruiting Study Start Date: April 2007 Last Follow-Up Date: April 2008 Study Characteristics: Primary Purpose: Natural History Duration: Longitudinal Selection: Defined Population Timing: Retrospective/Prospective Study Enrollment: 20000 [Anticipated] Conditions: Diabetes Mellitus Keywords: Diabetes Care [Anticipated] Interventions: Eligibility Criteria: Inclusion Criteria: All of Diabetes Cases Gender: Both Minimum Age: Maximum Age: Accepts Healthy Volunteers? No Central Contact: Martin Fuh, MD, DMSci. Telephone: 886-4-22062121 Ext. 4124 Email: [email protected] Study Officials/Investigators: Martin Fuh, MD,DMSci Study Principal Investigator [email protected] Locations: Martin M-T Fuh Taichung, Taiwan Facility: Martin Fuh, MDSci Telephone: 886-4-22062121 Ext. Contact: 4124 Email: [email protected] Investigator: Martin Fuh, MD,DMSci Role: Principal Investigator Recruitment Status: Recruiting Martin M-T Fuh Taichung, Taiwan Facility: Contact: Martin Fuh, MDSci Telephone: 886-4-22062121 Ext. 4124 Email: [email protected] Martin Fuh, MD,DMSci Role: Principal Investigator Investigator: Recruitment Status: Recruiting Citations: Links: Main Menu Select Preview Spelling Download XML Check Records The Institutional Review Board Forum What is expedited review? Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The Agency's IRB regulations [21 CFR 56.110] permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk. The Institutional Review Board Forum What is expedited review? The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval. Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer(s) may exercise all the authorities of the IRB, except disapproval. Research may only be disapproved following review by the full committee. The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review. The Institutional Review Board Forum CRITERIA FOR QUALIFYING FOR A FAST TRACK DRUG DEVELOPMENT PROGRAM A. Serious or Life-Threatening Condition 1. Whether a condition is serious 2. Whether the drug is intended to treat a serious condition The Institutional Review Board Forum CRITERIA FOR QUALIFYING FOR A FAST TRACK DRUG DEVELOPMENT PROGRAM B. Demonstrating the Potential to Address Unmet Medical Needs 1. Evaluation of whether the drug development plan addresses unmet medical needs 2. Demonstration of the drug's potential The Institutional Review Board Forum THE SELF-MONITORING ASSESSMENT PROGRAM FOR IRB CONTINUOUS QUALITY IMPROVEMENT (CQI)