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What's New? (2012)

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 2012. 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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December 2012

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November 2012

  • 11/30/12: IRB Review Newsletter [PDF]
    • Revised Informed Consent Form Templates, HIPAA Authorization Form and a new combined Medical Informed Consent and HIPAA Authorization Form
    • Holiday Announcement – updated
    • Nuts and Bolts of Being an IRB Member

 

  • 11/29/12: 2013 Update to the International Compilation of Human Research Standards - Now Available The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations. The Compilation is designed for use by IRBs, researchers, sponsors, and others. Many of the listings embed hyperlinks to the source document.

    The 2013 edition is now available, and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html  One new country is featured in the 2013 Edition: Ecuador.

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October 2012

  • 10/30/12: NEW!! Revised Informed Consent Form Templates, HIPAA Authorization Form and a new combined Medical Informed Consent and HIPAA Authorization Form

    The IRB periodically updates the University of Kentucky informed consent form templates based on regulatory changes or new human subject protection initiatives.  New versions of the Medical and Nonmedical Informed Consent Form templates and the HIPAA Authorization Form template are now available.  In addition, there is now a combined Medical Informed Consent Form and HIPAA Authorization Form for use by medical researchers that are regulated by HIPAA to simplify the process and ensure that subjects sign both the consent and HIPAA required language in one form.

    1. The revised Medical Informed Consent Form template contains, in addition to minor edits, several significant changes which include:

    • Sections for potential future use of tissue, blood specimens, and genetic research or banking;
    • Clarification of confidentiality limitations for online surveys;
    • Permission to be contacted for future research; and
    • Reminder to include applicable requirements for submitting or obtaining data from the Genome-Wide Association Studies (GWAS) database.

2. The revised Nonmedical Informed Consent Form template has several significant changes in addition to minor edits which include:

  • Clarification of confidentiality limitations for online surveys;
  • Permission to be contacted for future research; and
  • Reminder to include applicable requirements for submitting or obtaining data from the Genome-Wide Association Studies (GWAS) database.

3. The new combined Medical Informed Consent and HIPAA Authorization Form contains combined language from the two stand alone forms.  The IRB has agreed to combine the consent and HIPAA documents in order to enhance investigator compliance with obtaining both the subject's consent and authorization upon enrollment.  There are minor edits to the wording in the original forms that were combined as well as several significant changes which include:

  • Sections for potential future use of tissue, blood specimens, and genetic research or banking;
  • Clarification of confidentiality limitations for online surveys;
  • Permission to be contacted for future research; and
  • Reminder to include applicable requirements for submitting or obtaining data from the Genome-Wide Association Studies (GWAS) database.

4. The revised HIPAA Authorization Form template includes minor edits:

  • Reference to research subject as “you”/“your” instead of  “I”/“my”;
  • Statement that “use and sharing of your information has no time limit” instead of “this form has no expiration”.

Use of the templates for NEW initial submissions is effective immediately.
The updated templates are now available on the ORI forms pages [HTML].
Each template will have a revision date next to the title on the webpage and in the footer of the document itself.

Please do not use old versions of IRB forms you have previously saved to your personal computer. If you wish to see what changes have been made to the templates, you may view copies with highlighted edits below.

    • Template copies with changes highlighted:
    • Medical IRB ICF - English [PDF] Spanish [PDF]
    • Medical IRB ICF & HIPAA Authorization Combined - English [PDF] Spanish [PDF]
    • Nonmedical IRB ICF - English [PDF] Spanish [PDF]
    • Cover Letter Template - English [PDF]
    • HIPAA Authorization - English [PDF] Spanish [PDF]

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September 2012

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August 2012

  • 8/28/12: IRB Review Newsletter [PDF]
    • Off-site Research: why does the IRB need to know?
    • GOT KIDS?: Enrolling children doesn't always require "Full" Review
    • Educational Opportunity: 2012 Human Research Protection Regional Conference

 

  • 8/15/12: Update: Change in number of Nonmedical IRB submission packets

    The ORI Forms website provides instructions regarding the number of copies of applicable forms to include in a submission. NOTE: As of September 1st the Nonmedical IRB will need 13 copies of full submissions, due to our increased number of IRB members.

Packets

Medical IRB

Nonmedical IRB

Initial Full IRB Review

20*

13 *

Initial Expedited Review

3 *

6 *

Initial Exempt Review

3*

3*

Continuation Review

2

2

*2-3 copies of Section 6 additional attachments such as full industry protocol, grant application, investigator brochure, medical device labeling, etc.

Initial review forms are identified alphabetically. Once the appropriate number of copies have been printed, please collate into packets so that each IRB reviewer will receive a copy of each form included in the submission—A-Z. A complete packet is sent out to each member to review in advance of the convened meeting.  At Continuation Review, submit two complete copies of the Continuation Review Form and attachments.

The Office of Research Integrity staff process approximately 15,000 reviews yearly and maintain records for over 3000 active protocols. With this volume it is not feasible for the administrative staff to make additional copies or assemble un-collated materials. Un-collated or insufficient number of applications are subject to being sent back to the PI.

For guidance regarding whether to submit to the Medical or Nonmedical IRB see the ORI Frequently asked Questions or contact ORI at (859) 257-9428. Send IRB materials to: Office of Research Integrity, 315 Kinkead Hall,  University of Kentucky, Lexington, KY 40506-0057  Hours of Operation: 8am-12pm; 1pm-5pm

 

  • 8/13/12: Cultural Competence Module added to UK CITI Human Subject Protection (HSP) courses

    CITI's new Cultural Competence in Research module has been added as an optional module to the Biomedical HSP course and a required module for the Social/Behavioral course.  It will also be included in every other offering of the refresher course.  

    This module provides learners with an overview of the essentials of practicing cultural competence in research. It describes the importance of understanding the subject demographics, historical contexts, communication styles, customs, values, and beliefs of research study populations. The module continues with a discussion of how institutional review boards (IRBs) and researchers can operate to support this work.

 

  • 8/6/12: Announcements for NIH Sponsored Projects

    • Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval
      Notice Number: NOT-OD-12-129 [HTML]  
    • Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards):
      Notice Number: NOT-OD-12-130 [HTML]

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July 2012

  • 7/5/12: IRB Review Newsletter [PDF]
    • Communication Component of the Data and Safety Monitoring Plan (DSMP)
    • UK Investigator Quick Guide to IRB Reporting Requirements
    • Policy for Scheduling Runner Pick-Ups

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June 2012

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May 2012

  • 5/30/12: ORI GENERAL ANNOUNCEMENT: Rescheduled Non-Medical IRB meeting date

The Nonmedical IRB meeting scheduled on Friday, June 22nd has been rescheduled for Friday, June 29, 2012.

The new deadline for nonmedical IRB submissions for inclusion in this meeting is now June 13th. Download a complete updated schedule of meeting dates and submission deadlines by clicking on the following link: [PDF]

For additional information, please contact the Office of Research Integrity at 859-257-1639.

April 2012

  • 4/10/12: IRB Review Newsletter [PDF]
    • Sponsor-Investigator Training now on CITI
    • Department of Defense Supported Research
    • 2012 Human Research Protection Regional Conference

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March 2012

February 2012

  • 2/1/12: IRB Review Newsletter [PDF]
    • Humanitarian Use Device (HUD): Clinical Care Under IRB Review
    • VAMC IRB Contacts
    • More Secure Survey Software
    • Time to Renew? (HRP Training)
    • Upcoming Events

January 2012

  • 1/19/12: Regulatory Reminder: Humanitarian Use Device (HUD)
    The UK IRB has asked that the following reminders and resource links be provided to health care providers who are or have been involved with the use of a Humanitarian Use Device (HUD).

IRB APPROVAL

Food and Drug Administration (FDA) allows HUDs to be marketed but FDA regulations require HUD use (even clinical use) to occur with IRB approval and oversight.

  • According to FDA regulations (21 CFR 814.124a), a HUD may be administered only to patients at health care facilities having a duly constituted IRB. The health care provider at such facilities is responsible for obtaining IRB approval before use of the HUD and for clearly labeling and storing the device to ensure accountability and traceability and prevent use outside of designated sponsor or IRB restrictions/ limitations.
  • HUD regulatory requirements vary depending on weather the situation involves clinical use of a HUD according to approved labeling, emergency or compassionate use, or investigational use. The UK IRB HUD SOP outlines the various use requirements.
  • Serious adverse events and deaths that a device has or may have caused or contributed to must be reported to the Humanitarian Device Exemption (HDE) holder/FDA and the IRB (Medical Device Reporting 21 CFR 803).

USE IRB APPROVED DOCUMENT (Modified O.R. Permit or Standard Consent Form) FOR INFORMED CONSENT

Obtain Informed Consent AS APPROVED by the IRB.

  • The healthcare provider obtains informed consent from the patient according as approved by the IRB which may range from a modified operating permit with an IRB stamp to a standard research informed consent if the HUD is being used for investigational purposes.
  • Informed consent must be obtained by study personnel listed on the protocol and using the IRB approved document.
  • In considering information to provide in informed consent, the healthcare provider may include information from the HDE holder’s patient information packet which may be obtained by selecting the HDE number on the FDA HDE website.

EMERGENCY OR COMPASSIONATE (OFF-LABEL) USE

Emergency or off-label compassionate use of a HUD requires IRB chairperson's concurrence and 5 day report to the IRB.

  • ***EMERGENCY USE*** Physicians should be cognizant that FDA has made a determination of safety and probable benefit for use of the HUD only within its approved indication(s). If a HUD is used outside its approved indication(s) in an emergency or compassionate situation, the UK IRB requires prospective IRB review and informed consent in a format appropriate for emergency or compassionate use.

    For emergency use, the health care provider or investigator follows the same procedures that govern emergency use of an unapproved device (21 CFR 814.124); that is obtaining IRB chairperson’s concurrence, informed consent from the patient or legally authorized representative; and a written report submitted to the IRB within five (5) working days of use including identification of patient involved, the date on which the device was used, the reason for use, and outcome of use.

    Emergency use in a situation where obtaining the patient’s informed consent is not possible requires regulatory conditions (21 CFR 50.23) be met and documented. Such instances should be included in the request to the IRB chairperson along with a corroborative assessment from an independent qualified physician. If use is required to preserve the life of the patient and time is not sufficient to obtain the assessment and chairpersons concurrence, the independent MD evaluation must be included in the five (5) day report.

DETAILED GUIDANCE AND RESOURCE DOCUMENTS

For detailed requirements and guidance see:

  • UK IRB HUD SOP [HTML]
  • UK IRB Summary Humanitarian Use Devices [PDF]
  • FDA 2010 Humanitarian Device Exemption (HDE) Regulation: Questions and Answers [HTML]
  • FDA Presentation IRB and HUD by Fabienne Santel, MD [PDF]