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
Research News from the IRB (05/31/2018)
European Union General Data Protection Regulation; Assessing Capacity to Consent; Research Compliance Office Launches RCR Course; Toolkit Updates; Get Help From IRB (Submissions); How to Prepare and Submit Modification to an Approved Study in ETHOS
Research News from the IRB (05/4/2018)
OHRP Proposes Additional Delay of the Revised Common Rule; Protecting Research Data; Toolkit Updates; Hiring for IRB Analyst Positions; Preparing and Submitting a New Study in ETHOS; Modifications to IRB Approved Studies
Research News from the IRB (03/29/2018)
HRPP Committee; Toolkit Updates; Monthly HRPP Toolkit Meetings; Celebrating the One Year Anniversary of ETHOS; IRB Performance and Metrics; Training Requirements for UMP Research Staff; Continuing Review Submissions
Research News from the IRB (02/16/2018)
New Conflict of Interest Provision Applicable to Human Participant Research Studies; UMP agreement; IRB Toolkit Updates; ETHOS updates; When to Submit "modification" vs "report of new information;"
Research News from the IRB (11/2/2017)
HRPP and IRB Prepares for the Revised Common Rule; Toolkit Updates; ETHOS Notifications; Final Migration – November 9, 2017; Participant-Facing Education Materials Available for Research Use; FDA Updates Guidance on Medical Device Submissions; NIH Changes Certificate of Confidentiality Policy; Validation Submissions Require Protocol; IRB Training Requirements for Validation Submissions; Responding to IRB revision requests
Email Updates
Email updates about timely topics sent to 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.
Michelle Biros to Serve as Deputy IO for Biomedical Research (06/18/2018)
Allen Levine’s announcement of Michelle Biros as deputy institutional official for biomedical studies for the IRB
Five-Day Boot Camp for Clinical Research Coordinators (04/9/2018)
The Human Research Protection Program is excited to announce a five-day program for study coordinators to be held June 11 - 15, 2018 at the University of Minnesota. Please share this opportunity with your colleagues, especially study coordinators.
Training for Reliance and Single IRB Submissions (02/6/2018)
In December 2017, the IRB sent a targeted communication to the research community regardingreliance agreements and single IRB review (sIRB). Since then, ETHOS was upgraded and the NIH sIRB policy for single IRB review is now in effect. We invite you to review the following updates and upcoming training offerings for these submissions.
ETHOS Toolkit Changes (01/26/2018)
Based on feedback from the research community and recent regulatory changes, we have updated and enhanced several HRPP Toolkit documents (below). As you know, anticipated revisions to the Common Rule have been delayed until July 19, 2018. Please note that changes to these Toolkit documents do not conflict with the current Common Rule and they can be used regardless of the delay in the implementation of the revised Common Rule.
Important Information - Revised Common Rule Delay (01/19/2018)
On January 19, 2018, changes to regulations for protecting human research participants (also known as the revised “Common Rule”) were scheduled to take effect. We learned on January 17 that the revised Common Rule will be delayed for six months. The new compliance date is July 19, 2018.