March 23, 2018, 8 a.m. – 4 p.m.
Join us at Allina Health for this one-day workshop to learn about revisions to the Common Rule directly from the Office for Human Research Protections (OHRP) and network with research professionals. Topics include changes to the Common Rule as well as a panel discussion on reporting unanticipated events and an interactive protocol review session.
Who should attend
- IRB administrators and members
- Investigators and research staff
- Research managers and others members of the research community
Continuing Education credits
See note in Learn More section for complete information on CME, CIP, and SOCRA CE credits.
Space is limited. Register now.
All food and beverages for the conference are independently sponsored by Allina Health.
8 – 8:30 a.m. Registration and Continental Breakfast*
8:30 – 8:45 a.m. Welcome and Logistics (Local host/ OHRP)*
8:45 – 10 a.m. Overview of the Revised Common Rule (75 min., OHRP)
This presentation will provide an overview of the major changes in the revised Common Rule on human research protections with a focus on changes to the exempt and expedited review categories.
10 – 10:45 a.m. Regulatory Flexibilities for Conducting Secondary Research under the Revised Common Rule (45 min., OHRP)
This is an interactive session where OHRP staff will explore the regulatory flexibilities for conducting secondary research with data and biospecimens permissible under the revised Common Rule with the audience.
10:45 – 11 a.m. Break (15 min.)*
11 – 12:15 p.m. Local Speakers Panel (75 min., OHRP/Local speakers)
Panel discussion on Identifying and Reporting Unanticipated Problems
Local experts from Allina Health will discuss reporting unanticipated problems; OHRP staff will discuss institutional reporting responsibilities and share educational resources.
12:15 – 1:15 p.m. Networking Lunch (60 min.)*
1:15 – 3 p.m. Let’s Review a Protocol Together (105 min., OHRP)
OHRP staff will present one or more research protocols and invite the audience to review them together using the principles and guidance provided by the HHS regulations and OHRP policies.
3 – 3:15 p.m. Break (15 min.)*
3:15 – 4 p.m. Overview of the Key Changes to Informed Consent in the Revised Common Rule (45 min., OHRP)
This presentation will examine the regulatory changes related to informed consent under the revised rule.