What's New? (2006)

At a glance...

This page highlights some of the updates to IRB/ORI policy, procedures, and guidelines in the year 2006.

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2009

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2008

2007

2005

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December 2006

• 12/8/06 Re-organization and re-formatting of the ORI web pages began. For details about the process, please see the December Announcement #1 (pdf) on the ORI Listserv Archives web page.  

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November 2006

• Weekly Human Research Accreditation Training messages continue throughout the month of November.  To see the listserv archive, visit: http://www.research.uky.edu/ori/hotline/listserve_archives_2006.htm  

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October 2006

• 10/2/06  The Office of Research Integrity (ORI) updated the IRB forms and will no longer collect Social Security numbers. The social security field has been replaced with the University of Kentucky (UK) employee ID number.  For more details, please see the October listserv announcement #1.
  
  
• 10/3/06 The Office of Research Integrity releases the new IRB Survival Handbook and updated IRB Resource Guide.  The contents of the IRB Survival Handbook focus primarily on UK policies and procedures for human research review, and the IRB application process.  The IRB Resource Guide includes sources from which the ethical principles for conducting human research originated, and significant federal regulations.  To obtain copies, please contact Jennifer Harris at
  jen.harris@uky.edu or 859-257-2978. 
  
  
• 10/16/06  ORI gears up for the AAHRPP site-review and invites everyone to join in the effort for obtaining accreditation.  Human Research Accreditation Training messages through the Listserv begin at the end of the month and continue weekly until the week AAHRPP arrives.  To see the listserv archive, visit: http://www.research.uky.edu/ori/hotline/listserve_archives_2006.htm

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September 2006

• 9/1/06  The final AAHRPP application was sent to AAHRPP!  One set of the AAHRPP application consists of seven paper copies of velo-bound volumes for Section A - D and a CD-ROM with copies of Sections A - G.  The Office of Research Integrity is providing copies of the AAHRPP application Sections A - D on CD-ROM.  Contact Jennifer Harris at 859-257-2978 or send e-mail to: jen.harris@uky.edu to request a copy.

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August 2006

• 8/9/06  The Office of Research Integrity (ORI)/Institutional Review Board (IRB) revised policies and IRB forms were posted on the ORI web pages. Most of the ORI/IRB documents were updated. For example, changes were made to Guidance/Policy Documents such as the "PI Guide to Responsibilities...", Decisionally Challenged/Impaired Subject Policy and the UK IRB Policy on Children in Research, the corresponding IRB application forms (Form T and Form W, respectively), and the UK ORI/IRB Standards Operating Procedures (SOPs). Also, new Guidance/Policy Documents and IRB application forms were added to the web pages. To access the various policy/guidance/educational materials and forms, visit the SOPs & Policies web page, the Guidance/Policy Documents web page, Educational Materials web page, and the IRB Forms web pages corresponding to the type of review applicable to your research. 

Please note, the IRB forms on the ORI web pages should be used for all future IRB submissions.

• 8/4/06  ORI's summary sheet on Reporting Requirements for Diseases and Conditions in Kentucky was posted to the Guidance/Policy Documents web page (scroll down to the "v" listing to download).
  
  

• 8/3/06  ORI added a new form, Form N, to the IRB application for off-site research.  New guidance for off-site research was also made available on the Guidance/Policy Documents web page ( scroll down to the "p" listing to download ).
  
  

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July 2006

• 7/28/06  The ORI/IRB Standard Operating Procedures (SOPs) were updated and put into production.  For copies of the most recent SOPs, visit ORI's SOPs & Policies web page.
  
  

• 7/13/06  To assist researchers with questions about human research at the University of Kentucky, ORI posted a new web page to help answer some Frequently Asked Questions (FAQ's).

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June 2006

• 6/23/06  The Continuation Review (CR) forms / Final Review (FR) forms were changed to address the Association for the Accreditation of Human Research Protection Programs (AAHRPP) recommendations which aim to help UK meet specific standards for human research protections.  Questions were added to the CR/FR forms in order to address Element II.2.D of the AAHRPP standards which requires the IRB to receive and consider relevant information when conducting continuation reviews of research studies. The IRB will need some time to evaluate the responses to these new questions and develop a better sense of what is relevant to the review of the research.  During this transition, we hope you can be patient and answer the questions to the best of your ability.
  
  

• 6/15/06  The new Unanticipated Problem/Adverse Event Policy (pdf) went into effect, requiring use of the new Forms.
  
  

• 6/9/06  ORI announces availability of the HIPAA Educational Module developed to provide a basic framework of the HIPAA Privacy regulations and insight on how to obtain PHI from the University of Kentucky [See Announcement].  Go to ORI's Educational Materials web page for the link to the module or click: HIPAA Educational Module to open Blackboard and complete the training.
  
  

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May 2006

• 5/18/06  ORI announces the upcoming unveiling of the revised Unanticipated Problem/Adverse Event Policy (pdf)  and Forms and invites researchers and IRB members to a presentation for additional information.  See Announcement.
  
  

April 2006

• 4/20/06  The Important Tips and Topics for Investigators Guidance/Policy Document was updated to be consistent with the changes made on 4/12/06 to the guidance provided on the Modification of a Currently Approved Protocol web page.  Also, a new Study Closure section was added to describe two new circumstances when IRB approved active protocols may be closed by the PI and/or the IRB (see also April 2006 Listserv Announcement #2).  The new closure circumstances were incorporated into UK IRB's Standard Operating Procedures for Study Closure as well.
  
  
• 4/12/06  Based on AAHRPP recommendations, additional requirements and instructions regarding reporting protocol changes to the IRB were added to the Modification Request Form, the Modification of a Currently Approved Protocol web page, and the Initial Review and Continuation Review IRB approval letters.

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March 2006

• 3/31/06 UK signs contract with API for the purchase and implementation of a web-based IRB system to upgrade the existing system. The web-based system will provide on-line status of pending protocol transactions, electronic notification of proposal status and review reminders, on-line committee review and electronic workflow. To view UK's BRAAN2 Project Plan, please go to http://www.research.uky.edu/ori/upcoming_events/BRAAN2_Project_Plan.pdf (pdf). To learn more about the BRAAN2 product, you can visit the API website at: http://www.apibraan.com/.  
  
  

• 3/27/06 ORI prepared a new document which summarizes the Office of Human Research Protection's (OHRP) Fall 2005 guidance regarding IRB review of study recruitment material in the form of clinical trial websites.  See Guidance/Policy Documents web page and scroll down to the "r" listing to download the document "Guidance on IRB Review of Clinical Trial Websites".
  
  

• 3/24/06  ORI revised the educational document "Issues to Be Addressed When Conducting Exempt Review" now available for downloading on ORI's Exemptions web page.  The document helps explain the exemption categories and the issues that IRB reviewers must address when making a determination about Exemption Certification.
  
  

• 3/21/06  Wendy Baldwin, Executive Vice President for Research, issued a memo regarding the Department Chairperson’s assurance statement on Institutional Review  Board applications.  The Guidance/Policy Document ( "m") "What Does the Department Chairperson's Assurance Statement on the IRB application mean?"  and the IRB Application "Form Z" have been revised to reflect the most recent changes in Department Chair responsibilities.

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February 2006

• 2/13/06  ORI's Guidance/Policy Document providing a summary of the Family Educational Rights and Privacy Act (FERPA) has been revised. This document gives guidance for researchers and IRB members on accessing educational records. See Guidance/Policy Documents web page and scroll down to the "q" listing to download the revised FERPA document.
  
  

• 2/10/06  "Obtaining and Documenting Informed Consent and/or HIPAA Authorization" section of the Important Tips and Topics for Investigators Guidance/Policy Document changed to reflect that the investigator or co-investigator can sign on the line provided for “Investigator” in the signature section of the consent document.  Medical IRB application Instructions for Informed Consent Process updated as well.
  
  

January 2006

• 1/13/06  New questions added to the Continuation Review (CR) request report forms based on VA requirements and to obtain information consistently requested by the IRB.  See Continuation Review web page for link to download current sample CR form. 

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