IRB Meetings
政策
CPHS的完全召集的会议必须审查不具备豁免或加急审查的人类主题研究。beplay苹果手机能用吗只有在存在法定人数时，会议上的行动才能采取。法定人数被认为超过一半的投票成员。法定人数必须包括至少一个主要关注的成员，其主要问题是在非科学区域。如果会议失去法定人数，则应将其关闭，以进行进一步的投票，直到重新建立法定人数为止。
程序
Meeting Agenda- IRB工作人员将在每次会议之前准备会议议程并分发给IRB成员。议程和会议材料在IRIS中维护。所有IRB成员都可以访问IRIS的会议材料，以允许他们进行实质性审查。
会议过程: When quorum is met, the IRB chair shall call the meeting to order. While a non-affiliated member is not essential for quorum to be met, the IRB staff will make an effort to ensure that non-affiliated members attend at least 9 of the 12 meetings held each year for each panel. When the agenda includes research involving vulnerable populations, IRB staff will ensure that at least one or more members who are knowledgeable about or experienced in working with such participants are present. The IRB chair will remind members that all discussions during the meeting are confidential. The IRB chair will also remind members that anyone who is involved in research listed on the agenda may not be present during discussions or voting, except to provide information about that research. The meeting minutes shall specifically document the names of members who left the room due to a conflicting interest.
For each item on the agenda, the subcommittee chair, or designee, shall present a summary of the research submission. The subcommittee chair will make a motion to approve, approve pending, defer or disapprove the submission and the motion is seconded. The IRB chair shall then open the item for discussion by the Committee. Following discussion, the IRB chair calls for a vote for all in favor of the motion, all opposed and any abstentions. The IRB staff records the vote.
After all the items on the agenda are discussed, the IRB chair shall open the meeting for any other discussion(s). The meeting shall be adjourned by the IRB chair.
虚拟会议：通过电视会议或虚拟会议平台召集的IRB会议，就像在会议上一样。当IRB成员的利益冲突时，他们可能会留下来回答任何问题，但必须在审议和投票期间签字。投票结束后，IRB工作人员将邀请冲突成员回到会议。
Principal Investigator: The Principal Investigator and/or any member of the study team may be invited to attend the meeting to provide information on any aspect of a research project submitted to CPHS for review and approval. The PI and/or any member of the study team however, shall not participate in the deliberation, decision-making and voting.
分钟: The IRB staff will prepare the meeting minutes. The minutes will include the following general information:
- Date and time the meeting begins and ends.
- Members present at the meeting.
- Guests, staff, and ex-officio members that are present.
- Any announcements made by those present.
- 讨论的任何旧业务。
- 提供给CPHS成员的任何信息/教育文件。
对于经过初步审查，持续审查和审查变更请求，协议偏差，数据和安全监控报告以及议程上其他其他项目的协议，会议记录应包括以下详细信息：
- Summary of discussions of controverted issues and their resolution, even when the resolution of the issue is to accept the protocol as submitted.
- 采取的行动。
- The basis for requiring modifications to the research as presented including, but not limited to, application, informed consent document, advertisements, etc.
- The basis for disapproving research.
- For initial and continuing reviews, the decision for the period of approval.
当审查紧急研究要求根据知情同意要求提供例外的紧急研beplay苹果手机能用吗究时，会议记录应专门记录许可的医师的肯定投票，并记录该研究符合FDA标准以批准了对紧急研究的知情同意要求的批准。
当CPH做出特定的确定时，这些发现应在会议分钟内充分记录，并应包括特定于协议的信息，以证明每项确定是合理的。具体确定的示例包括以下内容：
- 更改或放弃知情同意书
- 放弃知情同意的文件
- Research involving children as participants
- beplay苹果手机能用吗涉及囚犯的研究
- 涉及设备的研究的重大风险 /不重要风险确定的基本原理记录beplay苹果手机能用吗
表决: IRB员工将包括投票res的摘要ults for each protocol item discussed. The minutes will document votes on each action taken including the number of members voting for, against, and abstaining. The names of those members not present for vote due to conflict of interest will be documented.
投票应在会议记录中使用以下格式记录：
Total: NN : For-NN, Against -N, Abstain-N, Recused– N (Name of person who recused and reason if COI)
传播和批准：The draft minutes shall be distributed to IRB panel members and the VP HRPP for review and comment. Following review and comment, the IRB staff will forward the finalized minutes to the IRB chair for approval and signature. IRB staff will file the signed minutes in the IRB office.
适用的法规
REFERENCES TO OTHER POLICIES
- 101-B04 Conflict of Interest CPHS Members and Consultants.
ATTACHMENTS
- 议程模板
- 分钟模板
If you find errors in this document, contact cphs@uth.tmc.edu
Document Number: |
101-B03 |
Document Name: |
CPHS会议 |
审核者： |
研究合规执行董事beplay苹果手机能用吗 |
有效的： |
2008年8月1日 |
修订记录： |
1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021 |
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
Committee for the Protection of Human Subjects 虹膜支持713-500-7960 |
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