To jump to a topic, click on your choice below:
General Questions | Do I need IRB Review? | Consent | Continuation/Annual Administrative Review/Closure |
To jump to a topic, click on your choice below:
General Questions | Do I need IRB Review? | Consent | Continuation/Annual Administrative Review/Closure |
The IRB reviews research studies involving human subjects. The IRB is federally mandated to ensure that proper safeguards are in place to protect human subjects enrolled in research studies.
Research (DHHS): “A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities”. [45 CFR 46.102(l)]
Human Subject (HHS): “A living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains uses studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)]
See the Getting Started webpage for guidance and resources to navigate the IRB submission and review process.
See the IRB Survival Handbook for topical guidance documents and more.
Announcements, events, and newsletters will be distributed on the IRB listserv and posted on the News & Announcements webpage.
Also see the Training & Education webpage for information on mandatory training, workshops and conferences.
To be added to ORI/IRB email distribution list, complete the subscription form.
The IRB considers a subject enrolled in a study when the subject signs a consent document. Any screening or testing done for research purposes to determine subject eligibility should not be conducted prior to the subject agreeing and documenting their consent to participate in the research (except where waiver approved).
In cases where the IRB approves a waiver from the requirement for obtaining informed consent and/or a waiver from the requirement for documentation of informed consent, any individual on whom data has been collected should be counted as an enrolled subject.
*Reminder: Ensure compliance with clinicaltrials.gov registration requirements for applicable clinical trials
NIH defines human clinical research as research with human subjects that is: (1) Patient-Oriented Research. Research Conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical studies, or (d) development of new technologies. (2) Epidemiologic and Behavioral Studies. (3) Outcomes Research and Health Services Research. Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition.
The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Faculty, staff or students from the Colleges of Medicine (UK Medical Center's Basic and Clinical Sciences Departments), Dentistry, Health Sciences, Public Health, Nursing, and Pharmacy, should present any research involving use of human subjects to the Medical Institutional Review Board (IRB) for review and approval prior to initiation of the project.
Faculty, staff, or students from the Colleges of Agriculture, Arts & Sciences, Business & Economics, Communication & Information, Design, Education, Engineering, Fine Arts, Law, Social Work or other Lexington Campus department should present any research involving the use of human subjects to the Nonmedical Institutional Review Board (IRB) for review and approval prior to initiation of the project. Please note the Nonmedical IRB does not review studies that involve administration of drugs or studies that involves invasive medical procedures.
The IRB conducts the following types of reviews:
Additional information is available through the Human Research Forms web page. Please call ORI at 257-9428 if you have questions.
The University of Kentucky (UK) uses a web-based IRB application system called E-IRB for review and approval of proposed research. E-IRB automatically generates an application specific to the researcher’s selections in the Protocol Type section (Medical IRB vs. Nonmedical IRB; Full Review vs. Expedited Review vs. Exemption Review). Additional sections within the E-IRB application prompt the researcher to answer required questions and provide pertinent information for the IRB to consider for approval. Materials the researcher may be required to attach to the application, if applicable, include (but not limited to):
For frequently asked questions (FAQs) regarding system, navigation, and procedural topics, see E-IRB Frequently Asked Questions and/or review applicable video tutorials in the secure online Video Tutorial Library.
When you submit your IRB application to the Office of Research Integrity (ORI), your protocol materials will be assigned to an IRB meeting date. When the agenda for that meeting date is processed by ORI staff (approximately 10 days prior to the meeting date), your materials will be listed on the agenda. Information about meeting dates is available on the Medical IRB meeting calendar or the Nonmedical IRB meeting calendar. [HTML, under IRB Meeting Dates]
Full reviews generally take longer to approve because the IRB must conduct the initial review (and sometimes subsequent reviews) at a convened meeting. A typical turnaround time for full review submissions includes:
Factors That Can Impact the Review and Approval Process
Generally, IRB approval can take between 4-6 weeks. However, not all submissions will take that long, and some approvals may take longer. General turnaround for an exempt or an expedited approval includes:
Factors That Can Impact the Review and Approval Process
Send protocol questions to IRBSubmission@uky.edu with the IRB protocol number and your email will be routed to the appropriate staff member. You may also call the department at 859-257-9428 or reference the ORI staff directory for individual contact information.
Yes. All investigators, and study personnel who interact and/or intervene with human subjects or handle personally identifiable data of a human subject must be trained in the protection of human subjects before IRB approval will be issued. Additional information is available on ORI's Human Subject Protection (HSP) Training FAQs web page.
In July 2020, the University issued a Responsible Conduct of Research (RCR) training mandate for active faculty, graduate students, and UK personnel/students engaged in research at UK (i.e., listed on a grant, sponsored project, or research protocol). Additional information is available on the Responsible Conduct of Research & Scholarly Activity website.
For high school students who want to work with UK researchers, a process has been established to verify that these students adhere to institutional guidelines.
Review the University of Kentucky's Administrative Regulation on "Minors Involved in University-Sponsored Programs or Programs Held at the University" and UK Risk Management Instructions for UK requirements. At a minimum, for the IRB, you should:
University of Kentucky researcher responsibilities are outlined in the guidance/policy document entitled "A Principal Investigator's Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research"(PDF). See also ORI's IRB Survival Handbook web page.
A student investigator (undergraduate, graduate, and postdoctoral students) must add a faculty advisor as study personnel to their protocol to meet the requirement of a University of Kentucky academic program. Additionally, faculty advisors must sign the Assurance Statement on the protocol to certify the scientific merit of the study, the qualifications of investigators, and the adequacy of the facility and resources needed to conduct the research.
As a student’s faculty advisor, you accept a supervisory role in guiding the student in conducting regulatory compliant research. You must be certified in HSP and RCR training. You will sign the protocol assurance statement certifying that you have reviewed the research and attest to the scientific merit of the study, qualifications of the personnel, and adequacy of the facility and resources needed to conduct the research. For full review protocols, you are encouraged to accompany the student to the IRB meeting. Keeping an eye on requested revisions can enhance your IRB knowledge for the benefit of current and future students. See the ORI video training “Faculty Advisor Responsibilities” which includes ORI tools to help your students succeed with human subject research.
Studies are regulated by the UK HIPAA Privacy Rule if the investigator obtains protected health information from a UK covered entity department. A detailed explanation is available at the HIPAA in Human Research web page.
See the FDA-Regulated Research website FAQ [HTML]. The ORI Interactive Medical Device Trials and Drugs/Biologics Trials Flow Charts can help in determining if and which regulations apply.
For assistance contact the ORI Research Education Specialist Belinda Smith at 859-323-2446 or belinda.smith@uky.edu or Sam Bell at 859-323-6744 or scbe223@uky.edu.
Yes. All changes (including study personnel changes) to a study must be approved by the IRB. Please use ORI's modification form when submitting changes to the IRB. The modification form is available on the Modification Requests web page.
Universities are now charging a fee to commercial/industry sponsors of clinical trials for IRB-related expenses. This is either a single flat fee, or a fee for initial review. The funds generated by this fee are used to support the IRB and related expenses (e.g. educational initiatives). The industry sponsors are accustomed to this as an expected fee for clinical trial research projects.
University policy specified that budgets for commercially funded clinical projects should include a one-time fee of $3,000 (amount effective 2/1/17), listed as "IRB Review Fee". ORI sends a separate invoice to the company for this fee and the income will be deposited in an account other than the grant account.
This fee is separate from any start-up costs that the department may apply or any costs incurred through the UK Center for Clinical and Translational Science (CCTS).
As we seek to accelerate UK's clinical research activities it is important that we have strong, well-supported systems for the protection of the individuals who participate in that research. By applying this fee, we help support these vital activities and place UK in the mainstream of how such systems function and are supported.
The IRB Policy on Unanticipated Problem and Safety Reporting [PDF] outlines prompt internal and external reporting requirements. To help understand how to differentiate between what needs to be reported as prompt vs. non-prompt, see the Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) - Prompt/Non-Prompt Reporting. [PDF]
Please see UK ORI's IRB Review Types webpage
IRB policy requires investigators to maintain their research records (signed documents and IRB records) for six years after completion of the study. For research which falls under authority of other agencies or statutes with longer research record retention requirements, the longer retention period applies. For more details on Investigator recordkeeping responsibilities, see the Investigator Records and Documentation section in "A Principal Investigator’s Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research"(PDF).
When transferring IRB review and oversight of human research protocols from one IRB to another IRB, Federal Guidance recommends that a plan for the transfer process be documented. A written agreement between the original and receiving IRB should address how each will handle, and document as appropriate, the following eight steps:
Additional protocol specific actions may be necessary on a case-by-case basis.
Data Transfer:
Consult the University’s Data Retention and Ownership Policy for restrictions and requirements regarding data transfer.
For additional details regarding Study Closure, see the ORI/IRB Study Closure SOP (PDF).
When a Principal Investigator (PI) leaves the University of Kentucky (UK), he/she should close his/her protocol(s) in E-IRB, or submit an E-IRB Modification Request (MR) to transfer the protocol to another UK researcher. Transfer of a study to a different PI is considered a modification to the study and will require IRB review and approval. The PI or researcher designated as an editor (DP)* on the E-IRB application can create a new MR and edit the "PI Contact Information" section of the application to reflect the new PI's contact information. When a PI or designee transfers a protocol, wherever applicable, the new PI or designee submits appropriate changes to consent forms, advertisements, etc. to the IRB for review. Additionally, the new PI and his/her Department Chair (or equivalent) completes a new Signature Assurance Statement in the “Signatures (Assurances)” section of the E-IRB application. An investigator assuming the role as PI should have applicable training and credentials to assume responsibility [PDF] for the study.
*It is recommended to have at least one study personnel designated as editor (DP) in case the current PI is not available. If the PI fails to transfer the protocol to another PI, no study personnel have access to perform a study closure, or extenuating circumstances warrant closure, ORI staff may administratively close the protocol before the end of the approval period in response to the request of or approval by the department chairperson or equivalent.
Data Transfer:
Consult the University’s Data Retention and Ownership Policy for restrictions and requirements regarding data transfer.
For additional details regarding Study Closure, see the ORI/IRB Study Closure SOP (PDF).
For IRB determination issues, contact the applicable IRB Committee. Go to the ORI Staff web page to contact a specific staff member or submit feedback anonymously on our customer service form. If the issue is regarding ORI or administrative procedures, contact ORI Director, Dr. Helene Lake-Bullock.
You can also request a consultation if you aren’t sure who to ask. Consultations are offered for studies in development as well as approved research projects. Provide the E-IRB protocol number for approved or submitted studies.
Submit a request for a consultation
We host Office Hours events as well, for your convenience. You’re welcome to drop in with any questions about current research, developing projects, the E-IRB system, and more! A variety of staff will be available to answer questions and provide support in real time.
Any activity that meets the federal definition of both "Research" and "Human Subjects" or the Food and Drug Administration (FDA) definition of "Clinical Investigation" requires review and approval by the University of Kentucky (UK) IRB. Additional information on this topic is available at the What Needs IRB Review webpage and in ORI's Guidance/Policy Document: When do activities involving human subjects need Institutional Review Board (IRB) review and approval? (PDF).
Research (DHHS): “A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities”. [45 CFR 46.102(l)]
Human Subjects (Department of Health & Human Services definition) - Human Subject (HHS): “A living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or Obtains uses studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)]
Human Subjects (FDA definition) - "An individual who is or becomes a participant in research either as a recipient of a test article or as a control. A subject may be either a healthy human or a patient". [21 CFR 56.102(e)] (Drug, Food, Biologic)
Human Subjects (FDA for medical devices definition) - "A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or who participates as a control. A subject may be in normal health or may have a medical condition or disease" [21 CFR 812.3(p)] (Device).
Additional information on this topic is available in ORI's Guidance/Policy Document: When do activities involving human subjects need Institutional Review Board (IRB) review and approval? (PDF)
If the study meets the definition of "research" and "human subjects", the study requires IRB review. See the Guide for Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of "Human Research" (PDF). Please note that all studies involving fetal tissue require IRB review even if they don't meet the definition of "research" and "human subjects".
See the ORI Emergency Use webpage for guidance on procedures before or after a Single-Patient Emergency Use and Contacts. [HTML]
If you are completing the study as a UK student or UK faculty member, your research should receive review by UK's IRB.
Graduate work (thesis or dissertation) which involves research on human subjects requires IRB Review.
Class project or assignments involving collection of data from human subjects may or may not meet the definition of research. Course instructors are responsible for making the decision whether the activities meet the definition of research. Course instructors are encouraged to call ORI if they have any questions.
Basically a consent form is a written document that explains the research study to potential subjects. This document is signed by the subjects and must contain information/statements to ensure that subjects are fully informed about the study. ORI's Informed Consent/Assent web page contains consent templates. The Investigator should use the templates when developing a consent form.
Please note that the IRB may waive consent procedures for some research proposals.
Upon approval, the E-IRB system stamps Informed Consent documents with an Approved Stamp indicating the Approval Date. Each time you receive a newly approved consent/assent document, all previously approved consent/assent documents are then considered invalid for enrollment of subjects.
The system does not add an Expiration Date to the stamp. Generally, researchers are not permitted to make changes in consent/assent form(s) without prior IRB review and approval. However, the IRB does allow researchers to add text that serves as an internal tracking mechanism as long as it does not affect the information in the consent document or confuse potential research participants. For example, researchers may add version numbers or consent form expiration dates in the footer of the document for tracking purposes or to facilitate compliance.
See the brief video, "Waiver of Consent vs. Waiver of Documentation of Consent" [Video, 04:15 minutes], or call ORI at 859-257-9428 for guidance.
See the Informed Consent Development web page. [HTML]
If the IRB has not reviewed and approved a research study by the end of the approval period specified by the IRB, all research activities must cease, including recruitment and enrollment of subjects, consent, interventions, interactions and data collection, unless the IRB concludes it is in the best interests of individual subjects to continue participation in the research interventions or interactions. The protocol may expire even if the investigator has provided the continuing information before the expiration date, if the IRB was unable to review the materials due to the time of receipt, non-inclusion of required information or other delays ensue.
Full-Board and FDA-Regulated studies may be approved by the IRB for up to one year. Continuing review (CR) must be conducted to prevent a protocol approval from expiring. If a protocol expires, the investigator must cease all research activities and may not enroll new subjects in the study. Approximately 90 days before the approval period expires, the principal investigator will receive a reminder notice which will recur monthly until the project is submitted or expires. to give investigators ample time to submit and disperse submissions so that the IRB can accommodate the volume.
How the CR approval date works:
So, while a study is approved for up to a year, some of that time must be used to obtain CR approval. The next cycle starts on the date of the convened meeting in which the study was approved or approved pending minor revisions. Therefore, the next annual cycle will not have identical dates to the first cycle. However, this should not be a concern, as the investigator can continue to conduct research while the CR is pending.
Why submitting your CR submission early is best practice?
To save time, download a sample CR form in advance to begin collecting the information that will be requested with the CR.
Non-FDA regulated Expedited protocols approved after January 21, 2019, qualify for an Annual Administrative Review. The review consists of four items:
The IRB reviewer may request additional information or request a complete continuation review submission.
The principal investigator (PI) is responsible for promptly submitting a closure request of an IRB-approved study to the Office of Research Integrity if any of the following conditions exist:
4. The PI plans to leave the University and intends to continue the research activities at another institution;
5. The study has been open for a period of three (3) or more years and the PI has enrolled no subjects in the study, collected no data from records, and/or collected/received no specimens.
A PI cannot close an active IRB approval if:
To submit a study closure, log into E-IRB. Click “Continuation (CR) or Study Closure” and complete the application process.