What's New? (2007)

At a glance...

This page highlights updates to IRB/ORI policy, procedures, and guidelines in the year 2007. 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:

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December 2007

12/1/07: The University of Kentucky (UK) won the Health Improvement Institute (HII) Award for Excellence in Human Research Protection in the Best Practice category for its online Principal Investigator (PI) Self-Assessment (SA) form. Winning the Best Practice Award demonstrates UK's excellence in promoting the well being of people who participate in research. For more details, see HII's press release [PDF].

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November 2007

• 11/16/07: The National Institutes of Health (NIH) issued a notice that a new law has been enacted which expands the scope of clinical trials that must be registered in ClinicalTrials.gov. The trials that must be registered generally include (1) Trials of Drugs and Biologics and (2) Trials of Devices. The responsibility for registering applicable clinical trials lies with the sponsor of the clinical trial or the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee. For more details, please see the NIH announcement Guidance on New Law (Public Law 110-85) Enacted to Expand the Scope of ClinicalTrials.gov: Registration available on the web: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html. For Frequently Asked Questions (FAQs) and answers, see: http://grants.nih.gov/grants/policy/hs/faqs_aps_clinical_trials.htm

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October 2007

• 10/11/07: The Institutional Review Board (IRB) and Office of Sponsored Projects Administration (OSPA) agreed to eliminate the policy which required protocols to remain under IRB approval while a sponsored program account (ledger 4) remained active. For details, see the updated Closure of Studies policy guidance document and/or the Study Closure SOP.

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September 2007

• 9/4/07: ORI released revised versions of the medical and nonmedical informed consent templates (ICF). The ICF template ("Form C" of the IRB application) is meant to be used as a guide when developing the informed consent document.

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August 2007

• 8/7/07: The ORI strengthens outreach efforts with a new web page providing information and resources aiming to help the potential subject make a decision about whether or not to participate in research. The ORI home page has a link (third from the bottom of the Human Research column) to the new Research Participants web page [http://www.research.uky.edu/ori/human/participants.html].

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July 2007

• 7/24/07: Various revised IRB documents were put into production including but not limited to Medical and Nonmedical IRB application Form A, Form A-1, and Form B. Educational/guidance documents relating to a PI holding a sponsor function also incurred changes (go to topics Investigational New Drugs/Devices and Investigator Responsibilities). For more specifics, see the July listserv announcement.

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June 2007

• 6/25/07: The revised guidance document outlining principal investigator (PI) responsibilities, qualifications, records, and documentation was posted to ORI's Educational Materials, Regulations, and Policy Guidance web page under the topic Investigator Responsibilities.



• 6/22/07: A link to OHRP's "Frequently Asked Questions (FAQs) on Informed Consent" web page was added to ORI's Educational Materials, Regulations, and Policy Guidance web page under the topic Informed Consent.
  
  
• 6/15/07: The University of Kentucky became a fully accredited institution by the Association for the Accreditation of Human Research Protection Programs, Inc (AAHRPP)! For more details, see UK's press release [PDF].

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May 2007

April 2007

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March 2007

• 3/16/07: UK's response to the AAHRPP observations in the final site-visit report were submitted to AAHRPP.

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February 2007

• 2/19/07: UK received the final AAHRPP site-visit report and immediately initiated steps to respond to the observations.
  
  
• 2/19/07: The UK Board of Trustees approved revisions to two Administrative Regulations -- Administrative Regulation III-4.0-6 (Human Subject Protection and Institutional Review Boards) [PDF] and Administrative Regulation II-4.0-2 (Research Misconduct) [PDF].

January 2007

• 1/29/07: A new resource for prospective research participants was added to the Educational Materials, Regulations and Policy Guidance web page under the topic Subjects (Prospective): Human Subject Protection - Know your rights & understand the researcher's responsibilities (FDA-CDER) [HTML]. Additional resources for prospective research participants are also available under the topic Clinical Trials on the same ORI web page.

• 1/19/07: The AAHRPP site visit was finalized with a close-out session in the afternoon. UK's HRPP (Human Research Protections Program) needs a little more fine-tuning, but overall we are looking good!
  
  

• 1/18/07: A requirement was added for changing the PI on a currently approved protocol. The new PI needs to complete Form Z (Signature Assurance Sheet) [WORD] and submit it with the modification request. The Modification Request Form [WORD] was revised to reflect this new requirement, as was the information provided under the modifications section on the IRB Review Types web page.

• Preparations for the human research accreditation site visit, January 17 - 19, 2007 come to a head with the last of the general trainings and individual trainings for the interviewees.

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