What's New? (2013)
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 in the year 2013. Note that due to the nature of web page evolution, some links may be broken. For the most current document links, search for the name of the document using the following search tool:
In order to receive electronic issues of the IRB Review Newsletter, or to receive a hard copy of past issues, contact the Office of Research Integrity at 859-323-2446 or e-mail Belinda.Smith@uky.edu and provide your name, e-mail address, department, campus address and phone number.
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- 3/25/13: 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
3/4/13: 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.
3/4/13: Updated Single and Combined Informed Consent Form & HIPAA Authorization Form Now MandatoryUpdated 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.
- 2/14/13: 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
- 1/9/13: 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