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. Sign up for Research News from the IRB.
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
Research News from the IRB (12/04/2018)
Two-Factor Authentication Requirement Begins; FDA Guidance on Drug Development; New Online Courses Available; Toolkit Updates; 45-Day Response Requirement; Social-Behavioral IRB Committee; Continuing Review Submissions; Resignations and Leaves of Absence; IRB Town Hall: Revised Common Rule; Ethical Issues Related to Novel Biotechnologies
Research News from the IRB (09/26/2018)
Travel Approval for Students Conducting Research Abroad; Community Oversight Board Seeking Candidates for Membership; Revised Common Rule Coming; Changes to the ETHOS Smart Form; Expanded Options for Commercial IRB Use for Review of Business and Industry Sponsored Research; Recruiting Students as Research Participants; ETHOS Tips and Tricks; Quality Assurance Program – Investigator Performance
Research News from the IRB (08/31/2018)
OHRP Releases Compilation of European GDPR Guidance; Clinical Research Support Center; HRPP Central File Requirements; Welcome Baby Jarboe!; When Must a 1572 be Updated and Submitted to the FDA?; Quality Assurance Program – Investigator Performance
Research News from the IRB (07/27/2018)
Revised Common Rule Update; HRPP Launches Interactive Online Training Modules; CTSI Launches Clinical Research Professional Mentoring Program, Fall 2018; Toolkit Updates; Updates to ETHOS: New Functionality and Questions; IRB Performance and Metrics; Continuing Review Submissions; Securing Research Data
Research News from the IRB (07/3/2018)
Additional Delay of the Revised Common Rule; Michelle Biros to Serve as Deputy IO for Biomedical Research; HRPP/IRB Office Relocates to McNamara Alumni Center; FDA Pre-Submission Program; Use of CTSI Monitoring Services; Toolkit Updates; ETHOS Add Comment Notification Issues; How to Prepare and Submit a Reportable New Information Submission to the IRB; IND Exemptions
Email Updates
Email updates about timely topics sent to the research community.
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.