Human Subject FAQs
What is a consent form?
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 Human Research Forms 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.
How do I know which version of the IRB approved consent/assent form to use?
When the IRB approves a consent/assent document, the Office of Research Integrity stamps the document with an "IRB Approval" stamp. The stamp on the first page will also contain the approval period for which the document is valid. Each time you receive a newly approved consent/assent document, all previously approved consent/assent documents are then considered invalid for enrollment of subjects. Note the first date in the approval period in the "IRB Approval" stamp (i.e., In the approval period 5/29/10 – 5/28/11, the “first date” is 5/29/10 ); the consent/assent document with the most recent "first date" is the currently approved version.
How can I waive consent procedures for my research proposal?
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 Human Research Forms web page.
- 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 Human Research Forms web page.
If you have any questions, please call ORI at 859-257-9428 for guidance.
Continuation Review FAQs
When should I submit my continuation request?
Approximately 90 days before the approval period expires, the principal investigator will receive a reminder notice of the expiration of the approved project. A reminder will be provided monthly until the project is submitted or expires. See also Continuation Review Tips. [PDF]
If the project is not reviewed and approved by the expiration date, new enrollment to the project must cease. Current study subjects who remain in follow-up or active therapy may continue to do so only if they are placed at an increased risk and the IRB has approved continuation of the research activities to protect subjects. The PI must submit a memo to the IRB requesting that the currently enrolled subjects be permitted to continue to receive study drug or intervention.
What if my continuation was not submitted on time and approval has lapsed?
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. A lapse may occur 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.
"Do I need IRB Review?"
When do activities involving human subjects need Institutional Review Board (IRB) review?
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]
How does the University of Kentucky define research?
A systematic investigation designed to develop or contribute to generalizable knowledge.
How does the University of Kentucky define human subjects?
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]
Does my master's thesis/doctoral dissertation require IRB review?
Graduate work (thesis or dissertation) which involves research on human subjects requires IRB Review.
I plan to conduct my research at another institution. Does UK's IRB need to review my research proposal?
If you are completing the study as a UK student or UK faculty member, your research should receive review by UK's IRB.
My research involves tissue/specimens. Do I need IRB review?
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".
Do class projects require 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.
Is use of drug, device or biologic with a single patient in an emergency situation within IRB purview?
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:
- approved, and
- does not need an IND or IDE, and
- 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.
What is an IRB (Institutional Review Board)?
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.
UK has a Medical & Nonmedical IRB. Which IRB will review my research?
Faculty, staff or students from UK Medical Center's Clinical Science Departments, College of Health Sciences, College of Public Health, Basic Sciences Departments, Communicative Disorders, 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.
What type of reviews does the IRB conduct?
The IRB conducts the following reviews:
- Initial IRB Review for new protocols. Review types include Exemption Certification, Expedited or Full.
- Modification Review for changes made to IRB approved studies.
- Continuation Review is usually an annual review conducted by the IRB for ongoing approved studies.
- Review of Unanticipated/Anticipated Problems/Adverse Events associated with the study.
Additional information is available in the IRB's Introduction Packet [PDF] and through the Human Research Forms web page. Please call ORI at 257-9428 if you have questions.
What do I include with my IRB submission?
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):
- Informed Consent Documents (For additional information, see Instructions for Informed Consent Document.)
- HIPAA forms to obtain protected health information (For additional information, see the HIPAA in Research.)
- Forms for study materials such as data collection instruments, recruitment materials (e.g., advertisements), off-site letters of support, etc. (Links for additional information pertaining to these materials are contained in the corresponding section of the E-IRB application.)
- A form for adults with impaired consent capacity (For additional information, see “Research Involving Adults with Impaired Consent Capacity").
- Copy of grant(s), product related documents, other required committee reviews/approvals such as IBC, RDRC, etc.
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.
How do I get on an IRB agenda?
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 [PDF] or the Nonmedical IRB meeting calendar [PDF].
How long does it take to get a study approved by the IRB?
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 - 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 - 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 - 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 & Nonmedical Full 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 [PDF] 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 [PDF]. Investigators should receive requested revisions (sometimes approval) within 1 week after the IRB meeting. If the study requires minor 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 study requires major revisions, the investigator’s response will be scheduled for review at the next available convened meeting (up to four weeks). Investigators should receive the IRB’s determination within 1 week after the IRB meeting.
I have some questions about my IRB submission. Who can I talk to?
The Office of Research Integrity staff directory is available online at: https://www.research.uky.edu/office-research-integrity/contact-us or you may call the department at 859-257-9428.
Do I need to take/complete a training program/class to conduct research at UK?
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 web page.
What are my responsibilities as a human subject researcher?
Do I need to notify the IRB every time I make a change to the study?
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.
How do I know if my study is regulated by UK HIPAA requirements?
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.
Does the IRB charge for review of industry sponsored clinical trials?
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.
How does UK define an enrolled subject?
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.
I don't understand UK's Prompt Reporting Policy. Where can I find additional information?
A detailed explanation is available through the Other Reviews web page under Policies and/or Unanticipated Problem/Safety Reporting.
How long does data collected from a human research project need to be maintained by the PI?
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].
I'm leaving the University; how do I close my study or transfer the study to another investigator?
When a Principal Investigator (PI) leaves the University of Kentucky (UK), he/she should close out his/her protocol(s) or notify the ORI in writing to transfer the protocol(s) to another PI who will take responsibility for the research. This transfer of a study to a different UK PI may require a modification request and/or further IRB review and approval. The MR can be submitted through IRBsubmission@uky.edu if the study has not already been established in E-IRB. If the study has already been established in E-IRB, the research can create a new MR and edit the PI Contact Information section of the protocol application to reflect the new PI's contact information. When a PI transfers a protocol, wherever applicable, the new PI submits appropriate changes to consent forms, advertisements, etc. the the IRB for review. Additionally, the new PI completes a new Signature Assurance Statement (for submission via IRBsubmission@uky.edu, see instructions HERE; if using E-IRB, the researcher will be automatically prompted to re-do the Signatures (Assurances) section.)
An investigator assuming the role as PI should have applicable training and credentials to assume responsibility for the study. For an outline of general investigator responsibilities see the guidance document, Principal Investigator's Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research [PDF].
The PI bears primary responsibility for the overall conduct of the research and is responsible for retaining or ensuring retention of research data and providing access to it If applicable. 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].
What is the definition of clinical research vs. a clinical trial*?
*Reminder: Ensure compliance with clinicaltrials.gov registration requirements for applicable clinical trials
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 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.
- The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.
- An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and, treatment, prevention, and diagnostic strategies.
- A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life.
- Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases:
Phase I. Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
Phase II. Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the interventions to be used safely.
Phase IV. Studies conducted after the intervention has been marketed. These studies are designed to monitor the 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.
What if I have a high school student volunteer who is going to serve as study personnel on my project?
Review the University of Kentucky's Administrative Regulation on "Minors Involved in University-Sponsored Programs or Programs Held at the University" [PDF] for possible UK requirements. At a minimum for the IRB, you should:
- obtain IRB approval for the individual to be included as study personnel on your project (e.g., Modification Request (MR));
- have the individual complete mandatory human subject protection (HSP) training as well as any protocol-specific procedural training; and
- contact Amy Kolasa in ORI (email@example.com or 859-257-9425) to complete an Individual Investigator Agreement (IIA).