What's New in 2019?
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December 17, 2019
The IRB Review Newsletter
In this issue:
- New NonMedical IRB Submission Prep Checklist
- ORI Closed December 23, 2019 - January 1, 2020
- Posting Federally Funded Clinical Trial Consent Forms
October 23, 2019
The IRB Review Newsletter
In this issue:
- Road to Re-Accreditation
- AAHRPP Training: Register Now
- Important Reminder: Reliance Requests
- Upcoming ORI Office Hours
September 27, 2019
The IRB Review Newsletter
In this issue:
- IRB Member Spotlight: Community Member Luncheon
- Updated Consent Templates
- Important Reminder: Reliance Request
- Upcoming ORI Office Hours
August 27, 2019
Access to CITI [HTML]
CITI may be accessed from the ORI's Human Subject Protection FAQ webpage. Click UK CITI Access to reach the sign-in portal. Repairs are in process to reestablish access on the UK Link Blue page.
August 23, 2019
General IRB Announcement: The new Fall Semester is around the corner! Which Human Subject Protection Training course should be in your curriculum? [HTML]
If your students are NOT serving as study personnel on an IRB protocol, the "Students in Research" course is the perfect introduction to Human Subjects Protection.
This is an abbreviated course available under the Optional Courses menu on UK’s CITI subscription.
The course provides an introduction to human research protections and describes what students can expect when asked to participate as a research subject.
This course DOES NOT meet the IRB training mandate for any type of research submitted to the IRB.
Faculty may use the course as a classroom assignment although it will not qualify a student to serve as study personnel for any research reviewed by the UK IRB.
My students don't have CITI accounts. Are there instructions?
ORI has an FAQ that will walk your students through the steps of creating a new account. (Question 2)
How do my students enroll in the "Students in Research" course?
We have an FAQ for that as well!! ORI has provided step by step instructions on how to enroll in the course once they have a UK CITI account.
August 8, 2019
General IRB Announcement: New Online "Not Human Research (NHR)" Determination Form
Individuals seeking a determination whether an activity requires IRB review will now submit requests online via the new NHR Determination Form.
The form is housed on REDCap, which is a secure web application. It includes a series of updated questions based on new regulatory definitions.
Please bookmark the new online NHR Form [HTML] for future requests. As of September 9th, ORI will no longer accept the old PDF version of the form sent to the IRBSubmission email address.
August 6, 2019
The IRB Review Newsletter
In this issue:
- Single IRB Review in 2020 - Ceded Protocols Reviewed by External IRBs
- Unable to attend Office Hours or want one-on-one assistance from ORI staff? Request a Consult
- Additional Office Hours Have Been Added
July 11, 2019
The IRB Review Newsletter
In this issue:
- The Road to Re-accreditation: New AAHRPP Re-accreditation Website
- 21st Annual Human Subject Protection Conference Registration Open
- Next ORI Office Hours
June 11, 2019
The IRB Review Newsletter
In this issue:
- Updated Informed Consent Templates
- The Road to Re-accreditation
-
General Data Protection Regulation (GDPR) Guidance
- Clinical Investigator Training
- 21st Annual Human Subject Protection Conference
- Next ORI Office Hours
May 9, 2019
The IRB Review Newsletter
In this issue:
- IRB Member Spotlight: Dr. Roger Humphries
- Preparing for Re-accreditation
- Research Involving Economically or Educationally Disadvantaged Persons
- 21st Annual Human Subject Protection Conference
- Next ORI Office Hours
April 1, 2019
IRB Review Newsletter
In this issue:
- Biobank Consent - NIH Genomic Data Sharing (GDS) Policy Update
- Remembering Dr. William "Bill" Jenkins
- First Continuing Review (CR) in E-IRB?
- Is your research eligible for Exempt Review?
- OCR Requests for Information on HIPAA's unnecessary burdens
March 5, 2019
IRB Review Newsletter
In this issue:
- IRB Member Spotlight: Dr. Avinash Bhakta
- IMPORTANT REMINDER for research approved under the Pre-2019 (previous) Common Rule Regulations
- New ORI Revised Common Rule web page
- New and Expanded Exempt Categories
- Office of Research Integrity Office Hours
- Award of Excellence for Best Practice in Human Research Protection
February 6, 2019
Office of Research Integrity (ORI) Office Hours
Investigators, research staff, and/or students are encouraged to drop in with questions about ongoing research, developing research projects, the E-IRB system, and general IRB operations. A variety of staff from the ORI will be available to answer questions and provide in-person support. Both medical and non-medical researchers are welcome to attend. Light refreshments will be served.
When and Where:
12pm-1pm
February 22, 2019. College of Nursing 213
And
March 20, 2019, Patterson Office Tower 110
No RSVP Required
Contact Kasandra Lambert kvlamb2@uky.edu or (859) 257-2910 for questions.
Stay up-to-date by visiting the ORI Workshops & Conferences page
Additional sessions will be added!
January 31, 2019
Informed Consent Workshop Wins Best Practice Award
By Lisa Cassis
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. Belinda Smith, an ORI research education specialist and co-creator of the workshop, explained that informed consent is a process that provides individuals with the information needed to make an educated and voluntary decision about whether to participate in research. “Informed consent is a fundamental right for participation in all types of human research,” Smith said.
January 22, 2019
The Revised Policy for the Protection of Human Subjects (aka Revised Common Rule) has been implemented.
The Revised Federal Policy for the Protection of Human Subjects (aka the “Revised Common Rule”) was implemented on January 21, 2019. Any protocol approved prior to the 1/21/19 implementation date must comply with the previous Common Rule regulations (aka Pre-2019 Requirements) for its duration. Any protocol approved on or after January 21, 2019, must comply with the Revised Rule regulations.
Temporary Freeze on New (Initial Review) IRB Applications Ends
The temporary freeze on new initial review IRB applications has been lifted. If you submitted a new protocol after the accepted deadlines in December and had it returned to you, you are now able to re-submit the protocol in E-IRB. Be sure to go through the application and make sure all sections have a blue check mark next to them rather than a pencil. A blue check mark indicates the section is complete while a pencil icon signifies that additional information/verification is required. If any sections in the application have a pencil icon next to them (e.g., Informed Consent, Research Description), be sure to provide any missing information and then verify and save the data in those sections before re-submitting your application to the ORI.
In Summary:
- Research approved prior to January 21, 2019 must continue to comply with the previous Common Rule regulations through completion.
- Research approved on and after January 21, 2019, must comply with the Revised Common Rule. The Revised Common Rule regulatory changes were incorporated into the version of E-IRB that was released January 22, 2019.
- FDA-Regulations have not yet harmonized with all of the Revised Common Rule provisions. However, the changes that do not conflict with current FDA regulations have been implemented.
More information about the Revised Common Rule and its changes can be accessed here https://www.research.uky.edu/uploads/ori-uk-ori-common-rule-guidance-pdf