IRB互惠
Uthealth可以依靠对另一个组织的IRB审查，也可以根据书面IRB授权协议作为另一个组织的IRB。这些协议也称为IRB互惠协议或IRB依赖协议。2017年，由CPHS批准的研究中约有12％受到外部IRB的审查。
Resources
- NIH sIRB mandate
- 该过程的说明申请依赖IRB外部的许可。
- 该过程的说明要求Uthealth IRB成为审查IRB
- Guidance on working with a commercial IRB.
NIH要求SIRB：自2018年1月25日起，NIH资助的多站点研究将在其中每个站点将执行涉及非豁免人类受试者研究的相同协议，无论是通过赠款，合作协议，合同还是NIH内部研究计划的支持beplay苹果手机能用吗机构审查委员会（SIRB）。该要求适用于2018年1月25日或之后提交日期的所有竞争性NIH赠款申请（新的，续约，修订或重新提交）。有关有关该申请NIH SIRB任务。
依靠外部IRB：当Uthealth是依赖机构时，Uthealth PI必须提交IRIS的申请，以要求允许依靠外部IRB。该过程的说明申请依赖许可。
uthealth irb作为审查IRB：When the UTHealth PI is the lead PI of a multi-site study or a collaborative study, UTHealth IRB may be willing and able to be the reviewing IRB.该过程的说明要求Uthealth IRB成为审查IRB。
商业IRB清单：UTHealth has offered the option to rely on a commercial IRB for multi-site clinical trials since 2012.Guidance on working with a commercial IRB.
关键术语:IRB依赖环境中使用了一些新术语，例如依赖机构和审查IRB。关键术语的定义。
List of UTHealth Reliance Agreements
UTHealth has signed several IRB Authorization Agreements. Many of these agreements are individual IRB Authorization Agreements or reliance agreements signed for a particular research study. UTHealth also has signed multi-study agreements for studies done under the auspices of a consortium or network. Negotiating IRB reliance agreements takes time and effort, UTHealth IRB encourages researchers to use the SMART IRB Agreement.
SMART IRB Agreement:SMART IRB是一个平台，旨在缓解与启动多站点研究相关的共同挑战，并为机构提供路线图以实施beplay苹果手机能用吗NIH单人IRB审查政策(生效日期:2018年1月25日)。聪明的IRBis an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. More than 350 institutions have signed the SMART IRB reliance agreement. UTHealth and Memorial Hermann Health System are participating institutions. When you have a new multi-site study and would like to use the SMART IRB reliance platform, check to see if all the sites in your study are participants in SMART IRB platform by visiting the SMART IRB网站。
德克萨斯州大师IRB互惠协议：Uthealth已签署了德克萨斯州IRB互惠协议，该协议有助于减少重复的IRB审查。涉及多个参与机构之一的多站点研究（下面列出）可能要求依靠一个IRB。您在您与德克萨斯州的机构进行研究的任何时候都要考虑使用此协议。beplay苹果手机能用吗参与者：
- 贝勒医学院（联系人reliance@bcm.edu）
- Rice University (contact 713-348-3586)
- 德州理工大学
- 卫理公会医院系统（联系713-441-7887）
- The Texas A&M University System (contactirb@tamu.edu）
- The University of Houston (contactcphs@central.uh.edu）
- 北德克萨斯大学健康科学中心沃思堡
- 德克萨斯大学系统组件（所有14个组件）
商业IRB:UTHealth has offered the option to rely on commercial IRBs for multi-center industry sponsored trials since 2012. Currently, UTHealth has agreements with several commercial IRBs:
- Advarra IRB (including Schulman IRB and Chesapeake IRB)
- BRANY IRB
- Quorum IRB
- Sterling IRB
- WIRB（或西部IRB或WCG IRB - 包括哥白尼IRB）
More information can be found in theguidance on working with a commercial IRB。商业IRBmay be used as the sIRB for NIH funded multi-site studies. For more information on commercial IRBs assirb。
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 |
|
|
