Saint Louis University strives to conduct research of the highest quality and integrity. The 院校覆核委员会 supports this goal by ensuring that all 博彩网址大全 research involving humans is conducted in accordance with the regulations, laws and policies in place to protect the rights and welfare of human research volunteers.
博彩网址大全 has established three IRB committees, supported by an administrative team in the Research Integrity and Safety Group within the Office of the Vice President for Research, to review and oversee human research studies conducted at 博彩网址大全 or by 博彩网址大全 researchers.
Researchers are assumed to need 博彩网址大全 IRB approval if they are conducting human research 除非中央或外部内部审查委员会已获批准. IRB团队支持 博彩网址大全 researchers with the IRB process requirements, and through our education and quality 保证项目. 如果您需要IRB团队的帮助，请拨打314-977-7744，电子邮件 irb@lkmjfh.com 或者去 IRB的员工 页，以确定您的学术单位的IRB联系人.
To receive notifications about news and updates, policy changes, training opportunities,
and other pertinent information, you can join the IRB Listserv by clicking the link
below:
订阅IRB邮件列表
To receive the 博彩网址大全研究双周更新, click the link below:
新闻及最新消息
Check here for the latest news and updates from the 院校检讨委员会.
Navigating the 博彩网址大全 research 企业 can be tricky, especially if you're new or 你在另一个研究机构工作过. 这个站点尝试导航 this process easier and prepare research staff for the necessary levels of oversight 需要在博彩网址大全进行人体实验研究.
The site content defines the components that make up the 博彩网址大全 research machine, and describes important steps, considerations, and tips for navigating the 博彩网址大全 research 企业.
请注意: This site is internal, so you must log in to your 博彩网址大全 Google account 要访问它. You can do this by logging into My博彩网址大全 or (when prompted after clicking the link) using your My博彩网址大全 username (called a 博彩网址大全 NetID) followed by @lkmjfh.com and 你的My博彩网址大全密码.
公开征求意见
这只是博彩网址大全新研究网站的测试版. 我们期待您的评论 和反馈，以帮助改善网站向前发展. Please 在这里提交评论或反馈.
As 博彩网址大全 transitions from using ClinCard to CCPay for study participant payments, the informed consent template now includes revised payment language to generalize the 卡类型和供应商名称.
For previously approved informed consent documents that specify the use of ClinCard, 如果过渡到CCPay, IRB将提供一个 信息备忘录 to be discussed and given to the participant to serve as notification of the change. 请注意: participant signature is not required for the memo.
Researchers should provide participants with both the 信息备忘录 and CCPay’s 条款与条件.
If a study is still enrolling and is approved by the 博彩网址大全 IRB, study teams may want to consider updating the informed consent language to generalize the card type and vendor name at the time of the next Amendment or Continuing Review submission. For existing central IRB studies, to prevent fees for 博彩网址大全-initiated changes, the informed 同意用语不需要修改.
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have revised the Federal Policy for the Protection of Human Subjects (通用规则)，于2019年1月21日生效. 这些修订是为了现代化， 简化和加强现行监管体制. 最终规则和其他相关规则 有关资料可在以下网址查阅: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.
研究人员需要知道什么?
博彩网址大全 IRB创建了一个 通用规则变更网站, an internal Google Site with information and updates regarding the forthcoming changes
一般规则. Guidance documents and other resources released by the IRB will
be stored on the Release Tracking page of the site to allow researchers to quickly
locate released items, associated release notes, and other helpful information.
该网站可通过 谷歌网站. You will need to log into 博彩网址大全 Google Applications to gain access.
请联系 irb@lkmjfh.com 对这个过程有任何疑问.
As of Oct. 1, 2017, NIH-funded human subjects research that began or was ongoing on 或在十二月之后. 13, 2016 is now covered by a Certificate of Confidentiality, which requires 在研究同意书中使用的具体语言.
Contact the IRB for assistance if your study needs to comply with this new policy (不,od - 17 - 109).
快速访问
The time to process an application depends on the complexity of the research study
and the quality and completeness of the application submitted. 其他变量包括
whether the application can be approved by the IRB Chair or Designee (exempt/expedited
评审)或全体评审.
*请注意: Estimated review times may vary during times of high volume.
Depending on the type of review, you should anticipate the following response times:
新协议
- 豁免审查:在两到三周内通知
- 加急审查:在四到六周内通知
- Full Board Review: Notification within two weeks of IRB meeting date
修正案
- 豁免/加急审查:在一到两周内通知
- Full Board Review: Notification within a week of IRB meeting date
表单/报告
- Continuing Review Forms: Notification within 30 days of expiry date
- 报告形式:各不相同
- SAE报告:不同
- 期末报告表:一周内通知
For questions about the status of the review, please contact the IRB Office at 314-977-7744, irb@lkmjfh.com，或浏览 聘管局职员网页 查看部门特定的联系信息.
The 研究人员项目计划核对表 to can help navigate the different offices responsible for ensuring research safety 和合规规定在博彩网址大全得到满足.
新来的IRB? The IRB样本协议归档, an internal Google site containing examples of approved applications, can be used
作为起草IRB申请时的参考.
请注意: This is an internal site, so you need to be logged into your 博彩网址大全 Google account to
访问它. You can do this by logging into My博彩网址大全 or (when prompted after clicking
the link) using your My博彩网址大全 username (called a 博彩网址大全 NetID) followed by @lkmjfh.com and
你的My博彩网址大全密码.