A new optional human subjects training module, titled “IRB Risk Assessment of Technologies in Human Subjects Research,” is now available on the Collaborative Institutional Training Initiative (CITI) web-based training platform.<\/p>\n
IRB Risk Assessment of Technologies in Human Subjects Research<\/strong><\/p>\n
The use of technologies, such as mobile apps, wearable devices, artificial or augmented intelligence (AI), machine learning, and nanotechnology, will soon be standard in biomedical and\u00a0social-behavioral-educational human subjects research. The use of such technologies enables researchers to electronically capture research data that could help to control data reliability, ensure data integrity, perform\u00a0remote monitoring, and comply with the requirements for regulatory documentation. These technologies also present new privacy, confidentiality, safety, and social challenges. This module provides IRB members and administrators with a framework for assessing the risks of technologies, whether the technology is helping conduct the research or is\u00a0itself the subject of the research. It also identifies strategies to\u00a0mitigate such risks. For researchers, this module provides context for how the IRB will review their work on and\/or involving technology. It\u00a0identifies ethical and regulatory dimensions of novel technology and\u00a0considers ways to assess the risk of technology in research. The case\u00a0studies in this module illustrate examples of using a risk assessment framework for both social-behavioral-educational and biomedical research.<\/p><\/blockquote>\n
How to Access the Module<\/h4>\n
This optional module is available within either of the human subjects training courses on CITI: “Social & Behavioral Research – Basic\/Refresher” or “Biomedical Research – Basic\/Refresher.” For guidance on how to access CITI and enroll in either of these courses, see Instructions for CITI Training (Word)<\/a>. Once you are enrolled and viewing the course, this optional module can be found by scrolling down on the page and looking for “IRB Risk Assessment of Technologies in Human Subjects Research,” under the “Optional Modules” list, and clicking “Start.”<\/p>\n
For those who are already enrolled in the “Social & Behavioral Research – Basic\/Refresher” course or the “Biomedical Research – Basic\/Refresher” course, including those who have already previously completed the course, you can complete this optional module by following these steps:<\/p>\n