Research Education Events with Active Registration
Updates to Common Rule - IRB Regulations
Changes to the Common Rule, the primary rule regulating human subjects research, go into effect on January 19, 2018. A number of USA IRB policies and procedures will be updated as a result of the changes to the rule. Please note that only studies approved after 1/19/18 will be governed by the new rule; currently existing studies will not transition to the new rule.
Investigators will see a number of changes required under the new rule:
· Consent forms will now require a concise summary of study activities, risks, and
benefits presented to research participants in advance of the body of the consent
document. The IRB will not require re-consent, except when other significant changes
· Additional elements of informed consent are required to be included in consent forms – these will be included in the USA sample consent template document.
· 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 will require a very brief check-in with the IRB each year. The requirement to submit amendments and reportable safety events to the IRB has not changed.
· The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed, so FDA still requires annual continuing review for FDA-regulated studies, even those relatively rare Minimal Risk FDA-regulated studies.
Click HERE for information session dates, times, and location (including registration).
2017-2018 Responsible Conduct of Research Training Series
Education in the responsible conduct of research provides a shared understanding of the rules and ethical norms to perform research. Researchers have both professional and regulatory-related responsibilities to conducting research responsibly, such as practicing scholarly activities and research with integrity. RCR training aims to develop commonality in building shared values in order to promote a culture of compliance, and empowerment to continue conversations within the work environment.
Participation: Faculty, Postdoctoral Students, and Senior Graduate Students are encouraged to participate.
For more information (including registration), click HERE.
If you don't see a research training topic/session open for registration, please check the events calendar for information about the next session being offered.