Keeping the Community Informed
This newsletter is designed to get timely and useful information to the Institutional Review Board (IRB) research community.
Please email HRPO@umaryland.edu if you have suggestions and topics for future newsletters.
From the IRB Chair
Need assistance with your IRB protocol design, scientific and regulatory issues, or personalized research guidance for human research studies? Submit a request to the Clinical Research Training Mentoring Program: https://www.umaryland.edu/hrp/for-researchers/crtmp-request-form/
Study Closures
Studies must be closed via a Closure Report. Voluntarily suspending does not replace the requirement for study closure. Closure reports must still be submitted six weeks prior to the expiration of IRB approval.
Please see the "How do I close out a study?" section of the Investigator Manual.
Non-Human Subjects Research (NHSR)
As a gentle reminder, please be sure to explain why the research is not generalizable in your project summary. If the research is generalizable, please state if the data/specimen being provided is already de-identified or if the principal investigator/study team will be de-identifying.
Did You Know?
If you cannot find someone in CICERO’s dropdown box when populating the study team, please request a CICERO account for that person. Go to cicero.umaryland.edu, click the “Create Login Account” on the right hand side, and follow the prompts.
Research vs. Human Subjects Research
Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subjects Research: “Engaged” in human participants’ research when you 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes. Further, a site is considered to be “engaged” in human participants’ research when it receives a direct federal award to support the research.
Reminder
If your study involves cancer research, please be aware that CICERO will send reviews to the Cancer Center automatically when you submit the application.