Institutional Review Board (IRB) Membership

**IMPORTANT NOTICE**

Please remember to sign and return your new Confidentiality Agreement to ORI. Thank you. 

REMINDER: IRB Member Confidentiality

Since IRB members and ORI staff have open access to all protocol information in E-IRB, required confidentiality measures must limit such access.  Access is permissible only to protocols you are authorized/assigned for review or consultation purposes. This policy provides protection of intellectual property and proprietary information equivalent to our previous paper files.  In order to remind IRB members of the scope of these protections, the member Confidentiality Agreement has been updated, parts of which now specifically reference E-IRB.  ORI is in the process of collecting signed updated agreements from all members. 

Please contact Pam Stafford via email or at 859-323-7399 if you have any questions.

REMINDER: IRB Member Conflict of Interest

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.

OHRP-approved Medical & Nonmedical IRB Rosters

  • Combined Medical & Nonmedical Roster [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).
    • UK Medical IRB Official Memorandum [PDF]
  • Nonmedical IRB Roster [PDF]

Medical and Nonmedical IRB Meeting Dates

  • Medical IRB Meeting Dates September - December 2019 [PDF]
  • Medical IRB Meeting Dates January - December 2020 [PDF]
  • Nonmedical IRB Meeting Dates [PDF]

Forms/Checklists/Guidance/SOPs

Forms/Checklists

  • Criteria for IRB Approval: Reviewer Checklist [F26.0000] [PDF]
  • IRB Continuation Review: Primary Reviewer Checklist [F28.0000] [PDF]
  • IRB Annual Administrative Review: Primary Reviewer Checklist [F28.0050] [PDF]
  • Consent/Assent Checklist - Quality Improvement Review [O1.0000] [PDF]
  • Emergency Use Checklist  [F8.0000] [PDF]
  • Exemption Certificate Signature Page [F21.0000] [PDF]
  • Expedited Reviewer Signature Page [F20.0000] [PDF]
  • Modification Reviewer Signature Page [F29.0000] [PDF]
  • Prisoner Representative Reviewer Signature Form [F23.0000] [PDF]
  • Consultant Signature Page  [F22.0000] [PDF]
  • HIPAA Authorization Checklist [F24.0000] [PDF]
  • HIPAA Waiver of Authorization Checklist [F25.0000] [PDF]

Guidance

  • IRB Survival Handbook (IRB Guidance from A to Z)
  • Primary Reviewer Responsibilities [PDF]
  • UK Guidance to Criteria for Institutional Review Board (IRB) Approval  [D6.0000] [PDF]
  • Guidance on whether convened IRB request should be designated as minor (vote #2) or major (vote # 3 or 4)  [D71.0000] [PDF]
  • University of Kentucky Research Risk Assessment Guidance [D8.0000] [PDF]
  • IRB Review and Digital Data Considerations [D131.0000] [PDF]
  • ORI Guide for IRB Review of Phase I Drug Trials [D136.0000] [PDF]

UK IRB/ORI Standard Operating Procedures Pertaining to IRB Membership

  • Membership of IRB [C1.0150] [PDF]
    • IRB Member Confidentiality Agreement [F18.0000] [PDF]
  • IRB Member & Consultant Conflict of Interest [C1.0200] [PDF]
    • IRB Member Conflict of Interest Statement [F17.0000] [PDF]
    • Consultant Conflict of Interest Statement and Confidentiality Agreement [F19.0000] [PDF]
  • IRB Members/ORI Staff Training [C1.0250] [PDF]
  • IRB/ORI Recordkeeping [C4.0250] [PDF]

IRB Member Training Resources

Expedited Review Fundamentals for IRB Members

Expedited Initial Review Training [HTML]

Tips for Conducting Expedited Review [PDF]

E-IRB Video Tutorials for IRB members - available for viewing at your convenience online

Learn E-IRB Basics, navigation and procedures for Primary Reviewers and for Required Reviewers and Other Reviewers (video coming soon!). For more E-IRB tutorials, visit the E-IRB Video Tutorial Library.

IRB In-Service Dates

April 25, 2019

102 Mining & Minerals Resources Bldg

Breakfast available at 8:30 am
In-Service starting at 9:00 am

"IRB Member Minute"

  • Social Media and Recruitment Advertising [PDF]
  • Pre-Screening Potential Subjects to Determine Eligibility Using REDCap [PDF]
  • Data Reproducibility [PDF]
  • FDA Informed Consent Waiver for Minimal Risk Investigations [PDF]
  • IRB Review of the New Consent Template [PDF]
  • Informed Consent Key Information for Banks & Repositories [PDF]
  • Inclusion of Pregnant Women in Clinical Trials [PDF]
  • Research Repositories [PDF]
  • FDA Real World Data Guidance for Device Research [PDF]

Other Training Resources (inc. New IRB Member)

  • Fast-Pass Video Training: IRB REVIEW Recruitment and Advertising (YouTube)
  • IRB Introduction [D47.0000] [PDF]
  • UK IRB Member Orientation Module [PDF]
  • Collaborative Institutional Training Initiative (CITI) New Member Training: "What Every New IRB Member Needs to Know"
    • On the Link Blue Resources page, choose CITI from the menu on the left
    • Log in to CITI through the Single Sign-On page using your Link Blue ID and current Link Blue password
    • Under Institutional Courses, click the "View Courses" button to the right of the words University of Kentucky
    • Scroll to the bottom of the page, Under " Learner Tools for University of Kentucky", click "Add a Course"
    • Choose IRB, then click Next
    • Choose Institutional Review Board (IRB) Members, then click Next
    • Choose IRB Member Training, then click Next (This adds the course to your University of Kentucky Courses on your Courses page)
    • Scroll down to find "Courses Ready to Begin"
    • Under IRB Member Training, click the "Start Now" button
    • Complete the Assurance Statement
    • Click the "Start" button next to "The IRB Member Module - 'What Every New IRB Member Needs to Know' (ID: 816)" to access the module 
    • Complete the quiz at the bottom of the page (The rest of the course modules are optional)
  • Collaborative Institutional Training Initiative (CITI) IRB Member Training
    • On the Link Blue Resources page, choose CITI from the menu on the left
    • Log in to CITI through the Single Sign-On page using your Link Blue ID and current Link Blue password
    • Under Institutional Courses, click the "View Courses" button to the right of the words University of Kentucky
    • Scroll to the bottom of the page, Under " Learner Tools for University of Kentucky", click "Add a Course"
    • Choose IRB, then click Next
    • Choose IRB Chair Training, IRB Member Training, or IRB Community Member Training, then click Next (This adds the course to your University of Kentucky Courses on your Main Menu)
    • Scroll down to find "Courses Ready to Begin"
    • Click the "Start Now" button next to your chosen training
    • Complete the Assurance Statement in the box at the top of the page
    • Click the "Start" button for the first module

Nuts & Bolts of Being an IRB Member

Regular IRB Membership

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 committee's assigned weekday. Medical IRB meetings are currently held on either Monday, Tuesday, Wednesday or Thursday and average about 1.5 hrs each. Nonmedical IRB meetings are currently held on Fridays and average about 2 hrs each. 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).

  • Medical IRB Meeting Dates Schedule [PDF]
  • Nonmedical IRB Meeting Dates Schedule [PDF]

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 to Regular IRB Membership 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 in more detail.

For more information about volunteering to serve on an IRB, contact Pam Stafford at (859) 323-7399 or pastaf3@uky.edu.

Community IRB Membership (Unaffiliated and/or Nonscientist)

Refer to Regular IRB Membership for Training, Duration of Term, Meeting Schedule, and Workload.

Federal regulations state that IRBs must be diverse and must include three kinds of members: scientists, nonscientists, and people not affiliated with the institution.

The nonscientist is vital – research review cannot proceed without a nonscientist present. This member’s role is to ensure that research materials are readable and that participants will understand what they are volunteering for. This committee member must be:

  • A nonscientist (training, background, and occupation are in nonscientific fields);
  • Able to prepare for and attend most committee meetings; meetings are set for a particular weekday and are held about 3-4 weeks apart;
  • Able to attend occasional education sessions; and
  • Comfortable with basic computer operations.

Nonscientist Member Brochure [PDF]

The unaffiliated member brings a unique perspective to the table. This member’s role is to represent the public’s concerns – to serve the public community’s interests rather than the university’s. This committee member must be:

  • Not affiliated with the University of Kentucky, either directly or through an immediate family member;
  • Able to prepare for and attend most committee meetings; meetings are set for a particular weekday and are held about 3-4 weeks apart;
  • Able to attend occasional education sessions; and
  • Comfortable with basic computer operations.

Unaffiliated Member Brochure [PDF]