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Answers to Frequently Asked Questions (FAQ's)

"Do I need IRB review?" FAQs
Q. When do activities involving human subjects need Institutional Review Board (IRB) review? A. 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 in ORI's Guidance/Policy Document: When do activities involving human subjects need Institutional Review Board (IRB) review and approval? [PDF]
Q. How does the University of Kentucky define research? A. A systematic investigation designed to develop or contribute to generalizable knowledge.
Q. How Does the University of Kentucky define human subjects? A. Human Subjects (Department of Health & Human Services definition) - "A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information" [45 CFR 46.102(f)]

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]

Q. Does my master's thesis/doctoral dissertation require IRB review? A. Graduate work (thesis or dissertation) which involves research on human subjects requires IRB Review.
Q. I plan to conduct my research at another institution. Does UK's IRB need to review my research proposal? A. If you are completing the study as a UK student or UK faculty member, your research should receive review by UK's IRB.
Q. My research involves tissue/specimens. Do I need IRB review? A. If the study meets the definition of "research" and "human subjects", the study requires IRB review. Please note that all studies involving fetal tissue require IRB review even if they don't meet the definition of "research" and "human subjects".
Q. Do class projects require IRB review? A. 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.
Q. Is use of drug, device or biologic with a single patient in an emergency situation within IRB purview?

A. If the drug, device or biologic is investigational, then the IRB must confirm the FDA criteria for emergency use are met.

If the drug, device or biologic is:

  1. Approved, and
  2. Does not need an IND or IDE, and
  3. Is being used off label or as marketed for clinical care,

then the IRB does not need to confirm FDA criteria for emergency use are met.

Please call ORI at 859-257-9428 if you have questions.
General FAQs                                                                                           Back to Top
Q. What is an IRB (Institutional Review Board)? A. 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.
Q. UK has a Medical & Nonmedical IRB. Which IRB will review my research?

A. The Medical IRB reviews research emanating from the Colleges of Dentistry, Health Sciences, Medicine, Nursing, Pharmacy and Health Sciences, Public Health, and the Lexington Veteran Affairs Medical Center.

The Nonmedical IRBs review research originating from the Colleges of Agriculture, Arts & Sciences, Business & Economics, Communications & Information Studies, Design, Education, Engineering, Fine Arts, Law, and Social Work. Please note that the Nonmedical IRB does not review studies that involve administration of drugs or studies that involves invasive medical procedures or Veterans Affairs research.

Q. What type of reviews does the IRB conduct? A. The IRB conducts the following reviews:
  • Initial IRB Review for new protocols. Review types include Exemption Certification [HTML], Expedited or Full.
  • Modification Review [HTML] for changes made to IRB approved studies.
  • Continuation Review [HTML] is usually an annual review conducted by the IRB for ongoing approved studies.
  • Review of Unanticipated/Anticipated Problems/Adverse Events [HTML] associated with the study.

    Additional information is available in the IRB's Introduction Packet [PDF] and through the IRB Forms [HTML] web page. Please call ORI at 257-9428 if you have questions.
Q. What do I include with my IRB submission? A. Exempt protocols require an Exemption Certification Request application and if applicable HIPAA forms.

Full and Expedited Review applications usually require the following items (but not limited to):

  • General Information Sheet and Research Description. (For additional information, go to Section 1 of the Medical or Nonmedical IRB application linked through IRB Forms [HTML].)
  • Informed Consent Documents and/or request(s) to waive informed consent. (For additional information, go to Section 2 of the Medical or Nonmedical IRB application linked through IRB Forms [HTML].)
  • If applicable, HIPAA forms to obtain protected health information. (For additional information, go to Section 3 of the Medical or Nonmedical IRB application linked through IRB Forms [HTML].)
  • Forms for study materials such as data collection instruments, recruitment materials, offsite letters of support, etc. (For additional information, go to Section 4 of the Medical or Nonmedical IRB application linked through IRB Forms [HTML].)
  • If applicable, forms for vulnerable populations such as decisionally impaired subjects, minors/children, prisoners, pregnant women, fetuses and/or neonates. (For additional information, go to Section 5 of the Medical or Nonmedical IRB application linked through IRB Forms [HTML].)
  • Financial Interest Forms, Signature Assurance Sheet, copy of grant, etc. (For additional information, go to Section 6 of the Medical or Nonmedical IRB application linked through IRB Forms [HTML].)
  • If applicable, other required committee reviews/approvals such as IBC, RDRC, etc. (For additional information, go to Section 7 of the Medical or Nonmedical IRB application linked through IRB Forms [HTML].)
Q. How do I get on an IRB agenda? A. 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 [HTML] web page or the Nonmedical IRB meeting calendar [HTML] web page.
Q. How long does it take to get a study approved by the IRB? A. The time to get a study initially approved depends on the type of review conducted by the IRB and if applicable, the amount of time it takes for investigator to respond to the IRB's requested revision(s).
  • Exemption Certification Requests [HTML] - All exempt protocols (medical and nonmedical) are reviewed by one IRB Member. Generally investigators receive revisions (sometimes approval) within 2 to 3 weeks after submitting the study to the IRB. If the study requires revisions, the investigator can expect to wait another 2 to 3 weeks after submitting the IRB's requested revisions to determine the status of their study. If the IRB determines that the protocol does not meet exemption criteria, the IRB recommends a resubmission of the proposal as an expedited or full review study.
  • Expedited Medical Reviews [HTML] - All medical expedited protocols are reviewed by one IRB member. Generally investigators receive revisions (sometimes approval) within 2 to 3 weeks after submitting the study to the IRB. If the study requires revisions, the investigator can expect to wait another 2 to 3 weeks after submitting the IRB's requested revisions to determine the status of their study. If the IRB determines that the protocol does not meet expedited criteria, the IRB recommends a resubmission of the proposal as a full review study.
  • Expedited Nonmedical Reviews [HTML] - All Nonmedical expedited protocols are placed on an IRB agenda and reviewed by the Nonmedical IRB Subcommittee. Protocols should be submitted according to the deadlines outlined on the Nonmedical IRB agenda page. Investigators should receive revisions (sometimes approval) within 1 week after the IRB meeting. If the study requires revisions, the investigator can expect to wait another week after submitting the IRB's requested revisions to determine the status of their study. If the IRB determines that the protocol does not meet expedited criteria, the IRB recommends a resubmission of the proposal as a full review study.
  • Medical Full [HTML] & Nonmedical Full [HTML] Reviews - All Full Review protocols are placed on an IRB agenda and reviewed by the Full Committee at a convened meeting. Medical Full Reviews are assigned to meeting dates [HTML] on a first-come first-served basis.  Nonmedical Full Review protocol materials should be submitted according to the deadlines outlined on the Nonmedical IRB meeting calendar [HTML].  Investigators should receive requested revisions (sometimes approval) within 1 week after the IRB meeting. If the study requires revisions, the investigator can expect to wait another week after submitting the IRB's requested revisions to determine the status of their study.
Q. I have some questions about my IRB submission. Who can I talk to? A. The Office of Research Integrity staff directory is available online at: http://www.research.uky.edu/ori/staff.htm or you may call the department at 859-257-9428.
Q. Do I need to take/complete a training program/class to conduct research at UK? A. 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. Additional information is available in the documents available for downloading on ORI's Mandatory Education for Human Research Protections [HTML] web page.
Q. What are my responsibilities as a human subject researcher? A. 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 Educational Materials, Regulations, and Policy Guidance [HTML] web page.
Q. Do I need to notify the IRB every time I make a change to the study? A. 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 following web page: Modification of a Currently Approved Protocol [HTML].
Q. How do I know if my study is regulated by UK HIPAA requirements? A. 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 for Human Research [HTML] web page.
Q. Does the IRB charge for review of industry sponsored clinical research?

A. Universities are now charging a fee to commercial/industry sponsors of clinical research for IRB-related expenses. This is either a single flat fee, or a fee for initial review and continuing 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 research projects.

University policy specified that budgets for commercially funded clinical projects should include a one-time fee of $2,000, 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 CRDOC.

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.
Q. How does UK define an enrolled subject? A. 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.
Q. I don't understand UK's Prompt Reporting Policy. Where can I find additional information? A. A detailed explanation is available through the Unanticipated/Anticipated Problems/Adverse Events [HTML] web page.
Q. How long does data collected from a human research project need to be maintained by the PI? A. IRB policy requires investigators to maintain their research records (includes data collection form(s) including source documents and case report forms) 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].
Consent FAQs                                                                                           Back to Top
Q. What is a consent form? A. 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. Form C available through ORI's IRB Forms [HTML] web page contains a consent template. The Investigator should use the template when developing a consent form. 
Please note that the IRB may waive consent procedures for some research proposals.
Q. How can I waive consent procedures for my research proposal?

A. The most frequently used waivers are listed below:

  • Waiving Informed Consent - The IRB may waive the requirement for informed consent if it finds and documents that the research meets certain conditions. For example, if you are conducting research involving deception, or conducting medical record reviews, your research may meet the conditions for waiving informed consent. The IRB may also waiver informed consent when consent to participate in a study is assumed in the absence of an objection (passive consent). For additional information, please review Form E available through ORI's IRB Forms website.

  • Waiving Documentation Requirements for Informed Consent - The IRB may waive the requirement to obtain a signed consent document for some or all of the subjects if certain conditions are met. For example, your research may meet the conditions for this waiver if the research presents no more than a minimum risk to participants and involves procedures for which a signed consent form is normally required. Common examples include mail surveys, telephone surveys, internet research, or international research where recruitment of subjects would be inhibited based on cultural beliefs. For additional information, please review Form F available through ORI's IRB Forms website.

If you have any questions, please call ORI at 859-257-9428 for guidance.
Q. What is the definition of clinical research vs. a clinical trial? A. Clinical Research. 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.
Clinical Trial. The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits this definition of a clinical trial. Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision making for the subject or the test itself imposes more than minimal risk for subjects. Biomedical clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases: Phase I clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects). Phase II clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.
Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention PHS SF424 (R&R) Adobe Forms Version A Application Guide Part III: Policies, Assurances, Definitions, and Other Information III-29
to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely. Phase IV studies are conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.


NIH-Defined Phase III Clinical Trial. For the purpose of the Guidelines an NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.