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What to consider before you agree to participate in a research study and other resources.
Phase 4 of the University of Kentucky Resumption of Research Phased Plan
Message from the Vice President for Research
April 2, 2021
Dear Researchers,
We are pleased to announce that we are moving forward to Phase 4 of the University of Kentucky Resumption of Research Phased Plan. Phase 4 places us at research activity up to 100% of pre-pandemic levels while continuing to follow CDC and institutional guidelines of 6-ft physical distancing, mask wearing requirements in research workspaces, washing hands and disinfecting workspaces. We understand that the requirement of 6-ft physical distancing may not allow 100% research capacity within your workspace depending on the number of research personnel and space considerations. We encourage you to continue to use staggered work schedules and other measures to stay within our policies and procedures. We will inform you if requirements for physical distancing change.
As you will see in the revised 13-page Resumption of Research Phased Plan, if you have already submitted and received approval for a PI plan through Phase 4 you do not need to submit additional materials. However, some changes to the revised Resumption of Research Phased Plan may require you to submit revised PI plans. These include changes in human participants research on page 8 within the Human Subjects Research Phases Table (see row 9). If you perform in-person research in which transmission risks cannot be fully controlled by the research teams, please submit a revised plan to receive pre-approval for such research. The revised plan should describe how you will work to reduce risks for your in-person studies. This revised plan will go through the standard approval process: Chairs and/or unit Directors, Associate Deans for Research, and Deans will review and approve your plan, then it will be filed with the Office of the Vice President for Research.
Please note that even though we are moving to Phase 4 of our resumed research, until further notified, high school students or other volunteers are not permitted in research and creative workspaces. If you wish to include high school students or other volunteers in your research and creative work, you must request pre-approval in your revised PI plan. Pre-approval requests should be sent to the Office of the Vice President for Research at research-covid@uky.edu. Following pre-approval, your plan will go to the Associate Dean for Research for final approval.
We encourage all research personnel to be vaccinated. However, we remind you that it is not permissible to ask researchers or participants if they have been vaccinated with emergency use authorized vaccines.
Upon receipt of this email, please move forward with Phase 4 research, and as always, be safe and well as your important research and creative work resume.
The Phased Resumption Working Group
Lisa A. Cassis, PhD
Professor, Department of Pharmacology and Nutritional Sciences
Vice President for Research
University of Kentucky
COVID-19 Human Research Resources
Vice President for Research (VPR) COVID-19 Guidance
Human Subjects Research Phases Table
University of Kentucky Resumption of Research Phased Plan
COVID-19 Human Research Updates
"Waiver of Consent vs. Waiver of Documentation of Consent"
Not sure what type of waiver to ask for? Click for a quick overview. For further guidance, please visit our Informed Consent/Assent page [HTML] page.
[HTML Video]
"Primary Research & Future Use"
The time to consider future use of research data is when you are initially planning the primary research study. This ORI tool allows you to consider plans for keeping, using, and sharing data or material for future use and ensure the consent language is consistent with your plan. [HTML Interactive Video]
Need help with a research or IRB related topic? Find answers and A-Z guidance in the IRB Survival Handbook.
About ORI
ORI supports the institution in promoting ethical conduct of human research and educating University of Kentucky (UK) faculty, staff, and students regarding human research compliance and research ethics.
ORI provides research support services including IRB review, policy development, web-based IRB submission (E-IRB), HIPAA/FERPA research reviews, protocol review management, ethical and regulatory education, quality improvement review, reliance agreement management, and research misconduct prevention and allegation management. ORI provides support for six federally mandated review committees: four Medical and one Nonmedical Institutional Review Boards (IRB), and the Radioactive Drug Research Committee (RDRC).
The UK Human Research Program is fully accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP). Read about the 2020 AAHRPP Re-accreditation here.
UK Human Research Protection Program (HRPP) Comprehensive Plan (PDF, 22 pgs)
In December 2018, the University of Kentucky Office of Research Integrity (ORI) won an Award of Excellence for Best Practice in Human Research Protection for the “Informed Consent Workshop: From Perception to Process.” The four-hour, hands-on workshop assists researchers in adopting new informed consent rules. Read more…
