What's New in 2013?

December 3, 2013

IRB Review Newsletter [PDF]

  • Investigator Signature Line Clarification
  • 2014 Update to the International Compilation of Human Research Standards
  • Holiday Announcement

November 12, 2013

Holiday Schedule Announcement

ORI will be closed Wednesday, December 25 through Wednesday, January 1 and will reopen on Thursday, January 2, 2014.

For details and submission deadlines see: PDF

September 23, 2013

Human Research Protection Guidance:  FAQS on Community-Based Participatory Research (CBPR) 
The Office of Research Integrity (ORI), the Institutional Review Board (IRB), and the Center for Clinical and Translational Science (CCTS) have partnered with UK Community Engaged and CBPR researchers to promote and educate both researchers and IRB members on the unique ethical and regulatory challenges posed in this research.  Working together, they have developed a Community Engaged FAQs document [PDF] to assist in the design and implementation of research in the community and facilitate the IRB's review of CBPR.

The FAQs and other training resources are available in the IRB Survival Handbook under the topic Community Engaged/Participatory Research.  
Please email Belinda Smith (sbelin0@uky.edu) with questions and suggestions.  Additional questions, answers, and resources will be added as needed.

September 3, 2013

IRB Review Newsletter [PDF]

  • Frequently Asked Questions on Mandatory Human Subject Protections Training
  • Changes to "Off-Site" Research Requirements for IRB Application

August 13, 2013

The IRB Resource Guide is a compendium of resources from which the ethical principles for conducting human research originate, along with significant federal regulations. The 2013 edition includes content revisions and web-link updates to federal agencies including the Food and Drug Administration and Office for Human Research Protection. Bookmark the guide online at: 
http://www.research.uky.edu/ori/IRB-Survival-Handbook.html#Regulations (opens new page

July 2, 2013

IRB Review Newsletter [PDF]

  • Internet Research: human research protection in cyberspace
  • Changes to the Continuation Review Report Form
  • Human Subject Protection Regional Conference - registration opening soon!

May 14, 2013

IRB Review Newsletter [PDF]

  • FAQ: Community-Based Participatory Research (CBPR)
  • On-Line Education Resources
  • Clinical Research Coordinator 101 Enrollment
  • Human Subject Protection Regional Conference

March 25, 2013

IRB Review Newsletter [PDF]

  • When do Activities Need IRB Review?
  • IRB Review of Medical Device Research
  • Reminder: Download/use current IRB forms for new submissions
  • Continuation Review Tips

March 4, 2013

Investigators will fill out 1 less IRB form as a result of the New UK Financial Disclosure System
The University of Kentucky “Financial Conflicts of Interest in Research” (AR 7:2) policy has been revised recently to incorporate changes to Public Health Service (PHS) regulation. To ease the administrative burden on investigators, the Office of Sponsored Projects Administration under the direction of the Vice President for Research has developed an on-line Financial Disclosure Statement which will be completed annually. More information is available at this OSPA site. If you have questions about the regulations or the training and forms, please contact Deborah Davis, Office of Sponsored Projects Administration, 257-8311, ddavis@uky.edu.

As a result of the new institutional on-line financial disclosure, the IRB will no longer require an IRB Financial Disclosure Form (Form X or Y) with new IRB submissions. A key trigger question has been added to Form A (the General Information Sheet) regarding financial disclosure. The new Form A is now available for use with new IRB submissions. Investigators may start using the new Form A immediately. After a transition period, use of the new Form A will be mandatory for new submissions as of March 31, 2013.

March 4, 2013

Updated Single and Combined Informed Consent Form & HIPAA Authorization Form Now Mandatory
Updated versions of the UK Informed Consent Template and HIPAA Authorization forms, as well as a combined form were made available November of last year. The combined form was designed for use by medical researchers that are regulated by HIPAA to simplify the process and ensure that both consent and authorization is obtained from research participants at the time of enrollment. The transition to the new forms is mandatory as of March 1st for new submissions. Conversion to the new combined form for applicable studies has been well received as it will make the consent and authorization process easier on the part of both the researcher and the study participant and should potentially improve compliance with HIPAA. A listing of the revisions and versions of the templates with highlighted edits were provided for reference on the 2012 ORI ‘What’s New’ webpage.

February 14, 2013

IRB Review Newsletter [PDF]

  • Obtaining Valid & Effective Informed Consent?
  • Giving Research Participants Their VOICE - March 21st - Teach-Back Technique Educational Opportunity
  • Federal Agency Specific Requirements
  • ORI Q & A

January 9, 2013

IRB Review Newsletter [PDF]

  • January's Clinical Research Update: "Human Subject Protection"
  • FAQ's
  • Keys to an Effective Informed Consent/Assent Process
  • Informed Consent Training Session & "Teach Back" Workshop