UK Office of Research Integrity

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The Office of Research Integrity (ORI) appreciates all of
those who volunteer their time and expertise in
IRB service!

 

Interested in the ethical conduct of human research? Want to know more about the Institutional Review Board (IRB) process? Then become an IRB member! The Office of the Vice President for Research and ORI appreciate volunteers and are always on the look out for interested and committed members. Contact Judi Kuhl for more information (859-257-9764).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Institutional Review Board (IRB) Membership

To jump to a topic, click on your choice in the menu below:

Administrative Regulation
IRB Rosters
IRB Meeting Dates [new page]
IRB Survival Handbook

IRB Member Training Resources
Nuts & Bolts of Being an IRB Member
Alternate IRB Membership
Standard Operating Procedures

The FUTURE IS NEAR -- E-IRB: UK's in-house, customized, web-based IRB application system [new page]

 

REMINDER: IRB Member Conflict of Interest (COI)

In response to the Public Health Service updates for the investigator conflict of interest, the IRB member threshold has changed from $10,000 to $5,000. Detailed information is available in the IRB Member and Consultant Conflict of Interest SOP [PDF]. The $5000 threshold is also reflected in the Conflict of Interest Statement that members sign at IRB orientation and annually thereafter.

Please remember that it is the responsibility of each voting member or alternate member of the IRB to disclose any conflict of interest when conducting any type of review and to excuse him or herself from deliberations and voting if review occurs at a convened meeting.

As the institution implements the new investigator COI policy and disclosure procedures, additional changes may be forthcoming. We will keep you informed of any additional changes impacting IRB member COI.

Administrative Regulation 7:4 Human Research Subject Protection and Institutional Review Boards [PDF]

UK IRB/ORI Standard Operating Procedures Pertaining to IRB Membership

  • IRB Membership [PDF] [C1.0150]
  • IRB Member & Consultant Conflict of Interest [PDF] [C1.0200]
  • IRB Members/ORI Staff Training [PDF] [C1.0250]
  • IRB/ORI Recordkeeping [PDF] [C4.0250]

OHRP-approved Medical & Nonmedical IRB Rosters [PDF]

Medical IRB Roster [PDF]

The UK Medical Institutional Review Boards are registered with the Department of Health and Human Services (DHHS) in accord with federal regulations, and include information per requirements of the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA). For an official memorandum in PDF to this effect, click here --> UK Medical IRB Info Memo [PDF]

Nonmedical IRB Roster [PDF]

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IRB Member Training Resources


    TBA


  • Click on the year for a compilation of "IRB Member Minute" educational listserve messages issued during that calendar year:
  • IRB New Member Orientation Module [PDF, 128KB, 14 pgs.]

  • IRB Member Online Training

    The Ethical Research Oversight Course (E-ROC) [new page], presents an in-depth exploration of the function and purpose of institutional review boards (IRBs) through an interactive, realistic interface including ethical cases and mock IRB meetings. Developed by the Public Responsibility in Medicine and Research (PRIM&R) [new page], the course addresses the roles of IRB members who tackle the challenging, ethical, and regulatory issues of human subjects research. ORI purchases the annual course subscription to use as part of the New IRB Member Orientation. However, any IRB member may complete the course as human subject protection training recertification. To obtain an access account, UK IRB members may contact Belinda Smith at 859-323-2446 or belinda.smith@uky.edu.

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Nuts & Bolts of Being an IRB Member

As federally mandated, the IRB is comprised of diverse members with varying backgrounds to promote complete and adequate review of research activities. IRB members learn about a variety of interesting research studies, the ethical issues surrounding human participation, and the mechanisms in place to protect human subjects. If you've ever wondered about the process or criteria for serving as a volunteer on the IRB, the following summary provides a snapshot of what is involved.

Eligibility:
IRB members are officially appointed by the Executive Vice President for Research. Non-tenure track faculty, or tenure track Associate Professors or higher are eligible for consideration as an IRB member or IRB alternate (this stipulation is the Vice President for Research’s (VPR) to help ensure a commitment to the IRB does not prevent someone on a tenure track from getting tenure). Individuals need to be willing to invest the time involved for performing IRB member/alternate responsibilities. For regular members this involves a commitment to regularly attend convened meetings and periodically serve as an Exemption or Expedited reviewer. Candidates must also acquire approval from their department chair or individual to whom they report.

Training:
The Office of Research Integrity (ORI) provides initial IRB member orientation and assigns an experienced IRB member to serve as a mentor. Ongoing continuing education is provided through various venues including quarterly IRB in-service sessions, topic-related educational materials attached to protocols, or education updates at regular IRB meetings.

Duration of Term:
A typical appointment term is three years (and starts Sept. 1).

Meeting Schedule:
Normally, regular IRB members have one meeting every three weeks on their committtee's assigned weekday. Medical IRB meetings are currently held on either Monday, Tuesday, Wednesday or Thursday and average about 1.5 hrs each; the schedule can be downloaded from ORI's IRB Meeting Dates [new page] web page or by clicking this link: [PDF]. Nonmedical IRB meetings are currently held on Fridays and average about 2 hrs each; the schedule can be downloaded from ORI's IRB Meeting Dates [new page] web page or by clicking this link: [PDF]. Periodically, a regular member of an IRB may be asked to serve as an alternate for any comparably qualified member on another IRB (e.g., none of the alternate IRB members have equivalent expertise or are available to substitute, so ORI needs to seek equivalent expertise from another committee).

Workload:
Current members report varying times involved in preparation for the meetings – anywhere from one hour to five hours. The time involved depends on the complexity of the study, existence of regulatory issues, and organization of the materials. Trained ORI staff do their best to ensure appropriate materials have been included with the protocol to help reviewers address applicable regulatory criteria. Materials for review are disseminated to members approximately ten days before a meeting.

Alternate IRB Membership:

Refer above for Eligibility, Training, and Duration of Term

Schedule:
Should a regular member be unavailable for an IRB meeting, an IRB alternate who has equivalent expertise with the regular member may be called upon to review protocol materials and attend the IRB meeting in that regular member's place. There is no pre-determined schedule for this, and sometimes ORI only finds out a week or so in advance of the meeting that a substitute is needed.

Workload:
The time commitment for an alternate varies considerably, depending on the demand for the specific area of expertise and the availability of the IRB member with whom the alternate is paired. It's possible an alternate could go an extended period without being asked to conduct a review. However, IRB alternates may also serve on a monthly rotation as an Expedited Reviewer and/or Exemption Reviewer. Additional training is provided to enable members to become proficient in these streamlined review mechanisms. The IRB and ORI have Standard Operating Procedures (SOPs) describing policies and procedures for IRB reviewers [new page] in more detail.

For more information about volunteering to serve on an IRB, contact Judi Kuhl at (859) 257-9764 or judi.kuhl@uky.edu

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