News & Announcements
This page offers news-worthy topics, helpful regulatory tips, and updates to IRB/ORI policy, procedures, and guidelines for IRB Members and others involved in human research. Note: Due to the nature of web page evolution, some links may be broken.
| January | February | March | April | May | June |
| July | August | September | October | November | December |
November 18, 2021
The IRB Review Newsletter [HTML]
In this issue:
ORI wishes you a safe and happy Thanksgiving!
- Use of Gender-Inclusive Language Video
- FDA Launches a Video Focused on Patient Cybersecurity Best Practices
- New E-IRB Frequently Asked Questions (FAQs) Interactive Tool
- New Researcher Frequently Asked Questions (FAQs) Interactive Tool
- New Responsible Conduct of Research (RCR) Refresher Course FAQs
- New Research Misconduct News webpage
- New Research Misconduct 1 Minute Videos
- UK Electronic Research Notebook (LabArchives) Webinars
- Upcoming ORI Office Hours
October 20, 2021
The IRB Review Newsletter [HTML]
In this issue:
- Newly updated ORI "Getting Started" webpage
- Short Form Consent Process
- The Short Form Consent Process for Non-English-Speaking Participants Overview Video
- Short Form Consent Process Frequently Asked Questions (FAQs) Interactive Tool
- New Researcher Frequently Asked Questions (FAQs) Interactive Tool
- New Responsible Conduct of Research (RCR) Refresher Course FAQs
- New Research Misconduct News webpage
- Upcoming UK Electronic Research Notebook (LabArchives) Webinars
- Upcoming ORI Office Hours
October 8, 2021
EPIC Electronic Health Record and Your Research Participants [HTML]
EPIC Electronic Health Record impact on Federally Funded Human Research
The Care Everywhere feature in EPIC may be used to securely share patient records with healthcare providers at organizations on the Care Everywhere Network. The purpose is to coordinate and facilitate informed clinical care.
However, the sharing practice may conflict with the protections afforded by a federal Certificate of Confidentiality (CoC).
A CoC limits the release of research information beyond the authorized research team. While most research data is separate from clinical information, some sensitive material is accessible, which limits the CoC’s protections.
This impacts most National Institutes of Health (NIH)-funded projects, since NIH began automatically issuing CoCs in December 2016.
The EPIC team is continuing efforts to resolve this issue. In the interim, the Office of Research Integrity (ORI) has revised the CoC language in the informed consent templates and added language to the HIPAA Authorization to disclose that information may be shared with health care providers outside of UK with whom the participant has a treatment relationship.
View the updated Informed Consent templates here.
October 5, 2021
Henrietta Lacks’ Estate Sues for Profits Derived From Tissue (News Article) [HTML]
Bloomberg Law
Mary Anne Pazanowski
"The estate of a woman who represents how Black patients have been exploited by the medical establishment sued a large biotechnology firm for the money it made by selling products derived from her tissue."
September 13, 2021
The IRB Review Newsletter [HTML]
In this issue:
- Submission Tips in Under 10 Minutes
- New Researcher Frequently Asked Questions (FAQs)
- UK Electronic Research Notebook Webinars - Schedule an event for your team
- Upcoming ORI Office Hours
July 26,2021
The IRB Review Newsletter [HTML]
In this issue:
- ORI Secondary Use Tool
- Registration OPEN for the 22nd Annual Human Subject Protection Conference
- UK Electronic Research Notebook Webinars - Schedule an event for your team
- Upcoming ORI Office Hours
June 22, 2021
The IRB Review Newsletter [HTML]
In this issue:
- "Researchers should now operate based on University guidance." - Message from Dr. Cassis, VPR
- New UK ORI Guidance: Gender Inclusive Language
- "Hey, I'm adding you to my study."
- Registration OPEN for the 22nd Annual Human Subject Protection Conference
- Calling all Research Faculty Advisors
- Upcoming UK Electronic Research Notebook Webinars
- Upcoming ORI Office Hours
May 20, 2021
The IRB Review Newsletter [HTML]
In this issue:
- EPIC Coming Soon!
- Update UK Guidance on NIH Certificates of Confidentiality
- Save the Date for the 22nd Annual Human Subject Protection Conference
- Calling All Faculty Advisors
- Publicly Available HSP Training Course for Non-UK Collaborators Serving as IRB Study Personnel
- Non-English Speaking Participants Facility vs. IRB Policies: Does the IRB require a certified translator or interpreter?
- Happy Clinical Trials Day!
- Upcoming UK Electronic Research Notebook Webinars
- Upcoming ORI Office Hours
Please note: Individuals conducting human subjects research must review and comply with the requirements of the VPR’s Resumption of Research Phased Plan before initiating or resuming any in-person research.
May 13, 2021
NOTICE: LICENSES ARE REQUIRED AND MUST BE APPROVED THROUGH THE UNIVERSITY LEGAL OFFICE FOR USE OR REFERENCE TO THE MORISKY MEDICATION ADHERENCE SCALES (MMAS-4, MMAS-8) OR IT'S SCORING ALGORITHMS
Please contact the UK Office of Legal Counsel (OLC) at (859) 257-2936 and request to speak to research or intellectual property counsel if you wish to reference or use the Morisky Medication Adherence Scales* sometimes known as MMAS-4 and the MMAS-8, and its scoring algorithms (collectively known as the “Medication Adherence Tools” or the “Tools”) or if you receive an inquiry or communication from anyone associated with the Tools or scoring.
Failure to obtain those licenses can result in fees, claims of copyright infringement, breach of contract lawsuits, and/or demands for retraction of publications or other published materials to researchers, collaborators, co-authors, institutions, publishers, and others.
You may want to consider using, or requesting permission to use, one or more of these alternatives instead of the Tools. Please be sure to obtain written permission or a signed license from an authorized licensor before using any copyrighted measurement tool, and as with the Tools and their scoring, the OLC may assist you with this.
The MMAS-8 Scale, content, name, and trademarks are claimed to be protected by US copyright and trademark laws.
* ("Morisky MMAS-4 Copyright") (Reg. No.TX0008285390, Reg. date June 12, 2016) and ("Morisky MMAS-8 Copyright") (Reg. No. TX0008632533, Reg. date September 21, 2018). "MMAS" trademark is the subject of Federal Trademark Application Serial No. 87775045 and is claimed to have been used in commerce since at least as early as February 2006.
April 27, 2021
Five Reasons Why You Should Close a Protocol Instead of Letting it Expire [HTML]
Formally closing the protocol is an investigator responsibility. The process signals the date IRB oversight is no longer required. Allowing a protocol to expire is not an acceptable alternative to submitting a closure request.
When submitting a closure request, E-IRB asks a series of questions to determine whether the study meets regulatory criteria for closure. FDA, pre-2019 Common Rule, and 2019 Common Rule regulations differ in this regard.
The answers to the closure questions also tell you whether a Final Review is needed. Many studies will be able to close without completing a Final Review.
Closing the protocol allows the audit and records retention timelines to begin. UK IRB policy requires investigators to maintain their research records (signed documents and IRB records) for six years after completion of the study.
IRB closure records have been relied upon by investigators as a source of information for funding organizations, regulatory agencies, and reporting in ClinicalTrials.gov.
To submit a closure request for your study, select “Continuation (CR) or Study Closure” on the PI/Researcher Dashboard under CREATE NEW.
See ORI's E-IRB Video Tutorial "How to Create and Manage Study Closures"
For questions, email: IRBSubmission@uky.edu
April 23, 2021
The IRB Review Newsletter [HTML]
In this issue:
- Phase 4 of the UK Resumption of Research Phased Plan
- Remote Informed Consent: Available in UK CITI
- Future Use Tool
- Tools to identify applicable local regulations, laws, and/or ethics requirements for International Research
- Five Reasons Why You Should Close a Protocol Instead of Letting it Expire
- Upcoming UK Electronic Research Notebook Webinars
- Upcoming ORI Office Hours
Please note: Individuals conducting human subjects research must review and comply with the requirements of the VPR’s Resumption of Research Phased Plan before initiating or resuming any in-person research.
March 25, 2021
The IRB Review Newsletter [HTML]
In this issue:
- IRB Member Spotlight
- What guidance is available on Remote Informed Consent?
- New ORI Short Videos
- New OHRP Research Participation Video Tutorials
- Updated CITI COVID-19 Course
- Upcoming UK Electronic Research Notebook Webinars
- Upcoming ORI Office Hours
Please note: Individuals conducting human subjects research must review and comply with the requirements of the VPR’s Resumption of Research Phased Plan before initiating or resuming any in-person research.
February 15, 2021
The IRB Review Newsletter [HTML]
In this issue:
- Curious about what is required to conduct human research?
- CCTS Clinical Research Update: Human Subject Protection: Times Like These
- Upcoming UK Electronic Research Notebook Webinars
- Upcoming ORI Office Hours
Please note: Individuals conducting human subjects research must review and comply with the requirements of the VPR’s Resumption of Research Phased Plan before initiating or resuming any in-person research.
January 21, 2021
The IRB Review Newsletter [HTML]
In this issue:
- UK CITI Access Link has moved
- Office of Research Integrity (ORI) Support Email Addresses
- Save the Date: CCTS Clinical Research Update - Human Subjects Protection: Times Like These
- Upcoming UK Electronic Research Notebook Webinars
- Upcoming ORI Office Hours
Please note: Individuals conducting human subjects research must review and comply with the requirements of the VPR’s Resumption of Research Phased Plan before initiating or resuming any in-person research.
