Human Research Protections (IRB)
We have created this page to communicate the upcoming changes to human subjects research regulations. to regulations governing human subjects research, as outlined in the Common Rule, were issued by the Department of Health and Human Services (HHS) on January 19, 2017. HHS has issued a Final Rule which delays the general compliance date of the new regulations for an additional 6-months and are scheduled to take effect on January 21, 2019.
Feel free to contact the IRB Coordinator with any questions at [email protected] or 111-111-6340.
Major Regulation Changes
As of July 19, 2018 the federal government 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.
- Research data must be handled and stored securely
- All members of the research team must be current on human subjects training
- Participation must be voluntary
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.
Researchers are still required to submit the following:
- Amendments for project changes
- Reports of adverse or unanticipated events
- Closure reports when the study is complete
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 .
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. See Templates, Forms and Guidance for more information.
The Final Rule includes some new and revised definitions. We suggest that you visit the , which is a great resource for information on the revised common rule, including slides on the new and revised definitions.
Beginning January 25, 2018 all multi-center NIH-funded studies will be required to use single IRB review for the domestic sites. . 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 , 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." According to the NIH, 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 NIH requires that all NIH-funded investigators and staff involved in the conduct, oversight, 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!
**The new regulations do not impact studies approved prior to January 21, 2018. In most cases, ongoing research will remain under the current regulations and researchers are not required to make any changes. The IRB Coordinator will provide guidance on how to transition to the new rules and when this transition might be beneficial.
News & Announcements
The IRB is now requiring the use of the online CITI course for the completion of Human Subject Training.
All investigators, staff and students with Human Subjects training greater than three years old (from any training source) are required to update their training through the CITI Training module. All new protocol submissions may be held for approval until the training has been updated. Please note that all personnel listed on protocols must complete the human subjects training. Please contact the IRB Coordinator at 111-111-6340 with any questions.
Note: It is important to verify research activities and the status of protocol submissions with the Office of Research Assurances (ORA) before beginning any human subjects research.