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What's New? (2015)

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 2015. 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

12/14/15: IRB Review Newsletter [PDF]

  • Seeking IRB Members...
  • Holiday Announcement
  • Save the Date!
  • New Faculty FAQ
  • CITI Account Transition
  • Clinical Research Coordinator Course

 

November

11/6/15: New Faculty Frequently Asked Questions handout [PDF]

11/6/15: Recent draft guidance and proposed regulatory changes soliciting comment:

November 5, 2015 (comments due by January 4, 2016)

Food and Drug Administration (FDA) & Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) Minutes of Institutional Review Board Meetings - Draft Guidance for Institutions and IRBs

Provides joint guidance regarding the preparation and maintenance of meeting minutes to show attendance; actions; votes; basis for change or disapproval; and controverted issues with resolution. Details documentation of regulatory findings/determinations and review responsibilities either in the minutes or elsewhere in the IRB records with inclusion of protocol-specific information justifying the finding or determination.

October 29, 2015 (comments due by December 28, 2015)

Food and Drug Administration (FDA) Using Technologies and Innovative Methods To Conduct FDA-Regulated Clinical Investigations of Investigational Drugs

Seeks specific input from stakeholders regarding use of new technologies and innovative methods of communication and data collection that may enhance the efficiency and effectiveness of clinical trials. FDA requests feedback on experience with implementation of technology including successes, barriers, and lessons learned.

October 23, 2015 (comments due by December 22, 2015)

Food and Drug Administration (FDA) Notice of Extension of Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

Proposed extension of the 2006 in vitro guidance which outlines specific conditions in which FDA plans to exercise enforcement discretion with the requirement to obtain informed consent in IDE exempt in-vitro device studies using de-identified, leftover human specimens.

September 28, 2015

The Food and Drug Administration (FDA) International Conference on Harmonization- E6(R2) Good Clinical Practice Guideline.

The guideline has been amended in effort to increase efficiency and respond to increased clinical trial complexity and cost, technological advances, electronic records and document standards. Addendum sections are designed to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and data integrity. 

September 8, 2015 (comments due by December 7, 2015)

Health and Human Services (HHS) Notice Of Proposed Rulemaking (NPRM) Federal Policy for the Protection of Human Subjects

The goals of the NPRM are to increase human subjects' ability and opportunity to make informed decisions; reduce potential for harm and increase justice by increasing the uniformity of human subject protections in areas such as information disclosure risk, coverage of clinical trials, and coverage of IRBs; and facilitate current and evolving types of research that offer promising approaches to treating and preventing medical and societal problems through reduced ambiguity in interpretation of the regulations, increased efficiencies in the performance of the review system, and reduced burdens on researchers that do not appear to provide commensurate protections to human subjects.

 

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October

 

September

9/2/15: IRB Review Newsletter [PDF]

  • New UK Portal to Access CITI Online Research Training Website
  • CITI Optional Course Offerings
  • Annual Human Subject Protection Conference Registration
  • Resources for Investigator-Initiated Research with Investigational Drugs
  • Notice of Proposed Rulemaking (NPRM) Regarding Revisions to the Common Rule to Improve Human Research Protections

August


July

7/2/15: General IRB Announcement: 17th Annual Human Subject Protection Regional Conference; "Takin' Care of Business"

      • Registration now open! Details & Registration Info: [PDF]

June

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May

5/14/15: General IRB Announcement: Using Social Media or Online Advertising Venues for Participant Recruitment

Online Recruitment: Using Social Media or Online Advertising Venues for Research Participant Recruitment

Social media and on-line advertising venues can be useful tools for reaching potential research participants. However, using these highly accessible online techniques should be approached with caution and regard for applicable policies and guidance such as the UK Social Media Policies and Guidelines (AR 1-4) and the online platform’s Terms of Use and Conditions or established policies and procedures. Also, IRB review and approval requirements apply to social media or online advertising just as they do for any method used to recruit participants. 

REMINDERS FOR USING SOCIAL MEDIA OR ONLINE ADVERTISING FOR RESEARCH PARTICIPANT RECRUITMENT:

  1. Ensure the IRB has reviewed and approved the advertisement and the recruitment plans, including the specific social media platforms or on-line advertising venues, prior to use.
  2. At initial IRB review, describe proposed plans in question number five, “Subject Recruitment Methods and Privacy”, of the Form B Research Description.
  3. To request IRB review of social media or online advertising venues for recruitment in previously approved research, submit a Modification Request for approval prior to implementation.
  4. Identify and comply with the Terms of Use or policies and procedures of any social media platform or on-line advertising venue. Privacy policies, prohibited content, and limitations on location and frequency of postings may be found in the user instructions or FAQs instead of the Terms of Use (e.g., Craigslist FAQ).
  5. Use practices that protect privacy and avoid the perception of undue influence.

April

4/28/15: Important Announcement for CITI Users

TRANSITION to CITI SINGLE SIGN ON (SSO) using UK LINK BLUE accounts

The University of Kentucky is transitioning to CITI Single Sign On (SSO) access through the institution using individual’s UK Link Blue account. Link Blue is the directory account assigned to all UK employees and students. It is used to connect to many campus-wide systems, including myUK, Exchange email, Blackboard, and APEX Degree Planner. 

BEGINNING MAY 2015 ALL CURRENT AND NEW CITI USERS SHOULD FOLLOW THE INSTRUCTIONS BELOW TO ACCESS TRAINING COURSES ON CITI.

  • CURRENT CITI USERS – Users that have an existing CITI account affiliated with UK
    Follow instructions to link your UK Link Blue account with your course history and past completion reports. 
  • NEW CITI USERS – UK employees or UK students that have never created a CITI account at UK
    Follow instructions to create your CITI account.
  • NON-UK Personnel – Instructions for individuals listed as study personnel on a UK protocol that are NOT UK employees or students.

onlineDetails and additional FAQs are available at the ORI Mandatory Training website;
callContact Belinda Smith (Belinda.smith@uky.edu, 859-323-2446) or Jennifer Hill (Jen.hill@uky.edu, 859-257-2978) with questions regarding IRB training on CITI and the new Single Sign On;
callContact Catherine Anderson at OSPA for questions regarding RCR training records (ceande3@uky.edu, 859-257-4826);
callContact the UKAT Service Desk for assistance with the UK Link Blue account at (859) 218-HELP(4357) or request help online.

March


February

2/24/15: IRB Review Newsletter [PDF]

  • Accreditation (AAHRPP) Site Visit Summary
  • NIH Revised Definition of "Clinical Trial"

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January

1/16/15: General IRB Announcement - Changes made for Step 2 of reaccreditation

As noted in previous UK Office of Research Integrity (ORI) announcements (June 2014, October 2014), ORI is in the process of re-accreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP).  The process involved submission of a re-accreditation application for Step 1, which AAHRPP reviewed and responded to with requests for changes to be implemented for re-accreditation Step 2.  ORI was pleased that very few changes were requested by AAHRPP to be included in the application for Step 2, and incorporated them into various documents available on ORI web pages. 

The changes made to meet Domain 1: Organization, Standard I-1: The Organization has a systematic and comprehensive Human Research Protection Program (HRPP) with appropriate leadership included:

  1. [Element I.1.A.]  Addition of a definition for “generalizable knowledge” in the University of Kentucky (UK) Human Research Protection Comprehensive Plan under Activities Covered Under the UK HRPP:

“Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, advance scientific knowledge, or generalize findings beyond a single individual or an internal program. Certain quality assurance or quality improvement activities designed to measure the effectiveness of programs or services may constitute human research.”

  1. [Element I.1.C.]  To supplement IRB/ORI policy as stated in the Quality Improvement Program (QIP) Directed Review Standard Operating Procedures (SOP) that “The IRB may request measures to monitor the consent process to determine whether procedures for administration of informed consent are proper.” (General Description & Procedure #10), ORI added to the UK IRB policy What can and does an IRB do? In the IRB Member Orientation Module [D41], that the “IRB has the authority to observe, or have a third party observe, the consent process.”

The changes made to meet Domain 1: Organization, Standard I-8: The Organization works with public, industry, and private Sponsors to apply the requirements of the HRPP to all participants included:

  1. [Element I.8.B.] Updating the Office of Sponsored Projects Administration (OSPA)/IRB Coordination SOP to indicate that the sponsor must report to the University, promptly, any findings from monitoring activity that could affect the safety of participants or influence the conduct of the study or alter the IRB’s approval to continue the study (Negotiation of Clinical Trial Agreements #11), and what is meant by “promptly” (i.e., within 30 days).
  2. [Element I.8.E.] When participant safety could be directly affected by study results after the study has ended, contracts or other funding agreements now mention a timeframe after closure of the study during which the sponsor will communicate findings to the researcher or organization in order to inform participants of results (timeframe is determined on a case-by-case basis).

ORI is now in the process of pulling requested documents and study files in preparation for the AAHRPP site visit, scheduled for January 21 – 23, 2015.  

Stay tuned for updates on re-accreditation status after the site-visit.

 

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