2021 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 (9/8/21 VPR Message) |
October | November | December |
December 15, 2021
The IRB Review Newsletter [HTML]
In this issue:
ORI wishes you safe and happy holidays!
- ORI Closing for the Holidays
- ORI Position Opening
- Remote Informed Consent Video
- New Consolidated Frequently Asked Questions (FAQs) webpage
- IRB Member Spotlight
- UK Electronic Research Notebook (LabArchives) Webinars
- Upcoming ORI Office Hours
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
September 8, 2021
Message from the Vice President for Research (VPR)
Dear Colleagues,
The safety and health of our research community is our priority. We understand due to the recent rise in COVID-19 cases, you have questions about potential policy changes.
We are currently conducting research at UK at 100% capacity. We are not in a limited capacity as was prescribed in our previous Resumption of Research Phased Plan, which we ended in June 2021.
Vaccination remains our most powerful tool in battling this pandemic. We encourage all members of our community to get vaccinated.
We are continuing to follow university guidance with respect to the COVID-19 pandemic - masking and distancing as much as possible by limiting numbers of people in close proximity in our research settings.
To assist you in continuing research in your settings as safely as possible, we have updated the FAQs on our COVID-19 Guidance For Researchers site to answer pressing questions on topics that you have sent our way, including high school students in research laboratories, research with human participants, and vendor and site monitor policies.
In general, if you are conducting research that is NOT taking place at a UK HealthCare facility, you must follow institutional guidance for masking, distancing and testing presented in the Fall 2021 Guidebook.
If you are conducting research at UK HealthCare facility, you must follow UK HealthCare requirements as described under Tier 4.
Please take a few moments to review the new FAQs. In coordination with the University of Kentucky Screening, Testing and Tracing to Accelerate Restart and Transition (START) team, research leadership will continue to evaluate our policies.
If you have questions or concerns related to COVID-19 research operations, please contact the Office of the Vice President for Research at research-covid@uky.edu.
Lisa A. Cassis, PhD
Professor, Department of Pharmacology and Nutritional Sciences
Vice President for Research
University of Kentucky
Updated VPR Guidance on High School Students engaging in research at UK [HTML]
Can I host high school students in my research laboratory? (Updated 9/8/2021)
Research that is NOT being conducted in a UK HealthCare (UKHC) clinical setting is currently operating under institutional guidelines as addressed in the Fall 2021 Guidebook for UK students. The guidebook requires that prior to being allowed access to in-person facilities and programs, UK students must provide the institution with their vaccine verification or be subject to weekly testing. For high school students who want to work with UK researchers we have established the following process to verify that these students adhere to institutional guidelines:
- Principal Investigator (PI) interacts with high school student and agrees to oversee their research within the PI’s program.
- PI communicates to the high school student that they will need to have their school certify that the student complies with UK requirements and provide to the student the following instructions to obtain verification.
- Student’s school, using official letterhead, directly submits certification for the student (or group of students) to the OVPR:
- Certification should include the name of the PI and name of the high school student.
- This certification does NOT require the actual vaccination record, but instead a statement indicating certification that: “This individual is in compliance with University of Kentucky requirements to have students vaccinated or tested weekly for COVID-19 in order to be on UK’s campus and/or conduct research with UK faculty, students or staff.”
- If the high school chooses not to certify (for example, because they do not have testing capabilities), then a parent should provide this certification letter.
- Certification letter should be sent from the high school to OVPR at research-covid@uky.edu.
- OVPR receives the certification request and then provides approval to the PI to proceed.
- PI and students should follow all other required paperwork from Environmental Health and Safety in order to have a minor in a laboratory and student must follow university policies related to mask wearing, etc. as outlined in the playbook.
Please note: High school students are not permitted to do research in a UKHC facility (clinics or other UKHC spaces) as defined here: https://ukhealthcare.uky.edu/hospitals-clinics
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.