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What's New? (2016)

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 2016. 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

 

November

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August


July

7/22/16: IRB Regulatory Reminder: Study Personnel [PDF]

7/15/16: IRB Review Newsletter [PDF]

        • NIH Finalizes Policy on the Use of a Single IRB of Record for Multi-Site Research
        • Registration Open for 18th Annual HSP Conference
        • Clinical Trial News

June

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May

5/31/16: IRB Review Newsletter [PDF]

  • June 1 - Date for ALL IRB Applications to be Submitted by Email
  • Clinical Trial News
  • Seeking a Few Good Members
  • Save the Date!

5/27/16: General Announcement: JUNE 1 - Date for ALL IRB Applications to be Submitted by Email

The option to submit IRB applications by email has been well-received by the research community.  As of June 1st, ORI will accept only email IRB submissions.  We will continue to ask that you follow the email submission with ONE paper copy for Initial Full or Expedited IRB applications ONLY.  For all other submissions, (e.g., continuing review, modifications, etc.), ORI staff will print out the PDF version for the master file.

Updated instructions will be available on June 1.  The step-by-step instructions cover everything from downloading Adobe Acrobat Software to creating readable, searchable, and bookmarked PDFs.  The updated instructions will be posted on the ORI main forms webpage and each submission type webpage.

Upon emailing the completed PDF submissions to irbsubmission@uky.edu, the investigator will receive an automated notification of receipt by email.  IRB approvals and correspondence will be sent to investigators by email as well. 

Please contact Heather Gozzard (Heather.Gozzard@uky.edu or 257-9118) or Michelle Hill Michelle.Hill@uky.edu, 257-9428) with any questions.


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April

4/12/16: IRB Review Newsletter [PDF]

  • Updated IRB Forms and Policy on Unanticipated Problem and Safety Reporting
  • Submit IRB Applications by E-mail!
  • Clinical Trial News: Opportunities for Providing Feedback

4/4/16: General Announcement: EMAIL ALL IRB SUBMISSIONS

The IRB is going electronic!

Beginning Monday, April 11th, all new protocol submissions, modifications, adverse events, violations and continuation reviews may be submitted electronically.  This is an initial step in the shift from paper to electronic submission as the web-based E-IRB program is being developed. 

To submit electronically, all IRB forms and study documents should be submitted as one PDF that is readable, searchable, and contains standardized bookmarks.  Step-by-step instructions on how to prepare your submission will be posted on the web page that corresponds to the type of application you plan to submit (e.g., for a medical protocol eligible for expedited review, go to the Medical Expedited Review Application webpage).  Instructions will also be available on the main human research forms website.  Email completed PDF submissions to irbsubmission@uky.edu.  You will receive an automated notification of receipt by email. Please contact Heather Gozzard at Heather.Gozzard@uky.edu or Michelle Hill at Michelle.Hill@uky.edu with any questions.

March

3/21/16: General Announcement: SUBMITTING EXEMPT PROTOCOLS BY EMAIL

Effective March 1, 2016, we are accepting ALL Exempt Electronic submissions via email @ IRBSUBMISSION@UKY.EDU (no paper copies are required). ***THIS INCLUDES INITIAL APPLICATIONS, MODIFICATIONS, AND REVISIONS***

Effective April 1, 2016, we will NO LONGER accept paper copies. Sending the application through IRBSUBMISSION@UKY.EDU, will be the only way to submit Exempt Protocol applications.

See the Exemption Certification Application web page for further instructions.

3/8/16: IRB Review Newsletter [PDF]

  • Community Engaged Research (CEnR)

Expanding Options for Ethics and Human Subject Training of Community Partners

Educational Resources for Researchers: From new introductory CEnR modules on CITI to comprehensive curriculums for getting started in community-based participatory research

Select UK Community Engagement Resources

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February

2/26/16: General Announcement: IRB Protocol Number Change

A small percentage of protocols have undergone a change in the last three characters of the IRB number (e.g., 87-00211 is now 87-0021-1F3; 15-0143-P6A is now 15-0143-P6J) .  The last three characters of the IRB number have always been for ORI internal use, and the change is a result of shifting staff responsibilities in the Office of Research Integrity.  The shift is being made to equalize workload and to enhance continuity of review and administration as protocols will remain with the assigned ORI team from initiation to closure.  Future correspondence on impacted protocols will bear the new number effective immediately.  If you have questions, please contact ORI at (859) 257-9428.

2/23/16: General Announcement: Access to CITI Online Training Program

Single Sign On (SSO) using the UK Link Blue ID and password is now the sole route to access the CITI online learning management program. The link to CITI is displayed on the Link Blue webpage alongside links to Canvas, Exchange, myUK, etc. CITI, short for Collaborative Institutional Training Initiative, houses several research-related courses including human research protection training required by the Institutional Review Board (IRB) for human research personnel. The SSO with the UK Link Blue account is more convenient for UK researchers and improves traceability of training records by eliminating multiple and duplicate accounts.

The Office of Research Integrity (ORI) and Research Information Services (RIS) began this transition over a year ago, working with CITI to establish the portal, perform data clean-up on existing accounts, and conduct considerable outreach through newsletters, list serve announcements, and presentations to inform IRB study personnel.

The ORI website contains quick links, FAQs, and instructions. Below are some reminders and tips for new and existing CITI users.

  • Current users with multiple CITI accounts may contact ORI before using the UK Link Blue SSO to facilitate reconciling the Link Blue with the CITI account of their choice.
  • All UK employees and students are assigned a Link Blue directory account. New users should not use another person’s Link Blue information or list another person’s email address anywhere in their CITI account profile.
  • When referring to a training on the CITI learning management program, please specify the name of the desired training (e.g., “human subject protection”, “good clinical practice”, etc.).
  • For non-UK study personnel on human research protocols, the IRB will accept human subject training from the individual’s institution or the publically available National Institutes of Health (NIH) Protecting Human Research Participants training (HTML).

Detailed instructions are available on the ORI Training FAQ webpage, or by contacting the following ORI staff members for assistance: Jennifer Hill (Jen.hill@uky.edu, 859-257-2978), Michelle Hill (michelle.hill@uky.edu, (859) 257-9428), or Belinda Smith (Belinda.smith@uky.edu, 859-323-2446).

2/11/16: IRB Review Newsletter [PDF]

  • Coercion, Undue Influence, and Protections in Participant Recruitment
  • Transition to electronic review: Incremental steps

January

 

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