IRB Communications
Read communications sent to the research community in the past year. For any older communications, contact irb@umn.edu.
Research News from the IRB
A newsletter featuring important news and information for the research community.
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Research News from the IRB (May 2020)
Collaborating to Address COVID-19 Challenges; Collaborating to Address COVID-19 Challenges; Ancillary Review, Your Feedback is Requested; Toolkit Updates; IRB Metrics; Research Community Feedback; FDA Part 11 Compliant Electronic Consent; IRB Submission Tips; Educational Opportunities
Research News from the IRB (March 2020)
Routine FDA Inspection of UMN IRB; AAHRPP Visit Scheduled; Ancillary Review Process Improvements; University Policy Update: University Sponsor and Sponsor-Investigator IND/IDE and FDA Pre-Submission Requirements; Regulatory Ancillary Review; ETHOS Enhancements: Changes to RNI Process; IRB Submission Tips; Educational Opportunities
Research News from the IRB (December 2019)
Step 1: Renewal of Accreditation Update; Single IRB Updates; HIPAA Updates; Free Volunteer Resource; Lapses in IRB Approval; Study Anniversary Emails; Participant Educational Resources; Who should be listed in the ETHOS study record?; Single IRB; UMN Day of Data; Speaking Science Conference
Research News from the IRB (November 2019)
Research Participant Experience Survey Results Now Available; HRPP Quality Assurance Program News; HRPP Committee Meeting Held in October; Work Towards Goals Highlighted in OVPR's Inquiry; Minor Updates to Protocol Templates and Combined HIPAA and Consent Template; IRB Support Services; What Data Specimen Activities Require IRB Review and Approval?; Can an Investigator De-identify Data or Specimens Under Their Control for Future Research Use Without IRB Review and Approval?; Using Art in Data Collection and Dissemination; Requirements of Data Safety Monitoring Boards; Making Your Research Accessible to Community Partners; Want to Know More about Working with Advara?
Research News from the IRB (August 2019)
HRPP Applies for AAHRPP Re-Accreditation; Reminder: Planned Protocol Exception Requirements; Toolkit Updates; ETHOS Updates; Do I need IRB review?; What do I do if I receive a Just-in-Time (JIT) notice?; Ethical Issues in Genetics Research; Working with Advarra (Webinar Only); IRB Town Hall - Toolkit Revision Review (Webinar Only)
Research News from the IRB (05/06/2019)
Recruiting non-English Speaking Participants: New Requirement for Short Form Method of Consent; New Cost Language Included in the Consent Template; Toolkit Updates; Research Community Feedback; IRB Submission Tips: When Do I Use the Determination Form; Research Involving Non-English Speakers, Vulnerable Populations: Principles and Practice, Five-Day Boot Camp for Clinical Research Coordinators
Research News from the IRB (03/08/2019)
Research Participant Survey; Ancillary Review, Feedback Needed; FDA Guidance on Principles of Premarket Pathways; Feasibility Review Service Now Available; Toolkit Updates; IRB Performance and Metrics; Research Community Feedback; Quality Improvement vs. Research; Recording of Therapeutic Misperceptions: Deficiencies of Understanding & Appreciation in Clinical Research; “I Have a Concern” How Participant Complaints and Questions are Submitted to the HRPP and What Happens Next
Email Updates
Email updates about timely topics sent to the research community.
2019 QA Semi-Annual Report (3/6/2020)
The HRPP's Quality Assurance program shares the Semi-Annual Report for July - December 2019.
Important Information about Single IRB (sIRB) Review (1/17/2020)
Debra Dykhuis explains changes to the use of a single IRB (sIRB) for federally funded research involving more than one institution, including requests for UMN to serve as sIRB.
Annual Report of HRPP Quality Assurance Program (6/26/2019)
The HRPP's Quality Assurance program shares the Annual Report for 2018.
Feedback Wanted: IRB Semi-Annual Experience Survey (6/12/2019)
The Human Research Protection Program requests feedback from the research community.
Michael Oakes Named Institutional Official for Institutional Review Board (4/30/2019)
VPR Cramer announces the appointment of AVP Michael Oakes, PhD, as the deputy institutional official.
Research Ethics: BOR Policy Changes, Annual Conference, and More (2/11/2019)
Board of Regents approved an updated policy for Research Involving Human Participants with a set of Guiding Principles and announcement of research ethics educational opportunities.
Revised Common Rule Implementation (01/22/2019)
Debra Dykhuis explains changes to the Common Rule and answers questions about change impacts.