臨床試驗會審案件
English translation: full-board (clinical trial) review
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| 22:15 Jan 10, 2010 |
| Chinese to English translations [PRO] Medical - Medical (general) / 人体试验, 台湾 | |||||||
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|  Selected response from: Shirley Lao Taiwan Local time: 10:11 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 4 +5 | full-board (clinical trial) review |
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Answers
20 mins confidence: 
peer agreement (net): +5
peer agreement (net): +5full-board (clinical trial) review Explanation: Review Process Expedited review 一般審查案件 * Expedited review:2 members Full-board review 會審案件 * Full-board review:2-3 members http://74.125.153.132/search?q=cache:9KnNoPCpR2sJ:teach.med.... Clinical trials review categories include: Exempt, Expedited, Full Board: 2. Expedited Review Applicability (A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. (B) The categories in this list apply regardless of the age of subjects, except as noted. (C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. (D) The expedited review procedure may not be used for classified research involving human subjects. (E) Investigators are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB. 3. Full Board Review Human subjects research that is not classified as exempt or expedited requires review by the full IRB at a convened meeting. IRB-A meets and IRB-B meet bi-weekly. Applications are placed on a meeting's agenda provided they meet the scheduled submissions deadlines. Due to the volume for IRB-A and IRB-B, investigators are advised to allow a minimum of three weeks for an application to be scheduled for review at a convened meeting. A full board meeting may be canceled by the chair due to a) insufficient number of applications requiring full board review, b) University holiday, c) inability to secure a quorum, or d) other reasons as may arise that make a scheduled meeting unnecessary or otherwise inappropriate. http://irb.med.nyu.edu/forms-guidance-waivers/categories-rev... -------------------------------------------------- Note added at 26 mins (2010-01-10 22:41:11 GMT) -------------------------------------------------- Should be: 臨床試驗會審案件 = applications under full-board clinical trial review |
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Grading comment
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Notes to answerer
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