人类研究保护(IRB)

截至7月19日, 2018 the federal 政府ernment will change the types of human subjects research that are considered “exempt.” Some research that previously required expedited review may now qualify for exempt review. The new categories will be listed on the IRB application in VERAS and can be viewed here.

Basic ethical standards still apply even if the research is exempt from further requirements of federal regulations.

• 研究数据必须安全处理和存储
• All members of the research team must be current on human subjects training
• 参与必须是自愿的

Minimal Risk studies reviewed via the expedited procedure after the new rule goes into effect will no longer require annual continuing review under the new rule, but U of I will still require a very brief check-in with the IRB annually to keep our records accurate.

研究ers are still required to submit the following:

• 项目变更的修订
• 不利或意外事件的报告
• 研究完成时的结束报告

All expedited studies will still be sent an annual notification for a status update prior to the anniversary approval date for the study.

Remember that studies qualifying for expedited review must be of no more than minimal risk and meet on of the OHRP快速审查类别.

Informed consent must begin with a concise and focused presentation of “key information” to facilitate a potential subjects’ understanding of the reasons why one might or might not want to participate in the research. A revised consent form template has been created to comply with these requirements. 看到 模板、表格和指南 了解更多信息.

请浏览 联邦法规网站, which is the resource for the new and revised definitions.

1月25日开始, 2018 all multi-center NIH-funded studies will be required to use single IRB review for the domestic sites. Additional information is available on the NIH website. Single IRB review for studies conducted or supported by other federal agencies will be required starting in January 2020.

The Final Rule adds a requirement for posting clinical trial consent forms on a publicly available website such as 临床试验.政府, a registry and results database administered by the NIH. One consent form for each study must be posted on the federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by a subject.

NIH-funded studies that meet the NIH definition of a clinical trial must be registered and have results reported to comply with the NIH policy. The NIH definition is expansive and includes research not typically thought of as a "clinical trial.根据美国国立卫生研究院的说法, a clinical trial is "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes."

The full definition and more guidance can be found on the NIH website.

The NIH requires that all NIH-funded investigators and staff involved in the conduct, 监督, or management of clinical trials must be trained in Good Clinical Practice (GCP). GCP training can be completed using the CITI program.

Please build in time for you and your team to meet these NIH requirements!