Any activity that meets either (a) the Department of Health and Human Services (DHHS) definition of both “research” and “human subjects” or (b) the Food and Drug Administration (FDA) definitions of both “clinical investigation” and “human subjects” requires review and approval by the University of Kentucky (UK) IRB.
Quick overview of What Needs IRB Review (5:10 minutes)
In cases in which any other federal agency applies, institutional oversight of the activity follows the definitions for “research” and “human subjects” as defined by the relevant agency, as appropriate.
To jump to the applicable section, click the section below:
| Does Need IRB Approval | Does Not Need IRB Approval |
If unsure whether IRB review and approval are needed:
For a determination on whether your project constitutes human research and is therefore subject to review by the University of Kentucky IRB, submit a Not Human Research (NHR) Form available on REDCap. Upon completion of the questionnaire, your responses are submitted to the Office of Research Integrity (ORI). Someone may contact you with additional questions to help qualify the official determination.
Involves research to increase scientific understanding about normal or abnormal physiology, disease states, or development, and to evaluate the safety, effectiveness, or usefulness of a medical product, procedure, or intervention. Vaccine trials, medical device research, and cancer research are all types of clinical research.
Both clinical and investigational use of a HUD device.
Preliminary activities are typically designed to help the Investigator refine data collection procedures. This data is to be included in the analysis or publication.
A storage site or mechanism by which identifiable human tissue, blood, genetic material, or data are stored or archived for research by multiple Investigators or multiple research projects.
Submit a Not Human Research (NHR) Request Form to ORI for a determination of need for IRB review. If the subject population has received notification that private information will be used for research purposes (e.g., HIPAA Privacy Notice), IRB review may not be required.
Focuses on health outcomes, interventions, disease states, and conclusions about cost-effectiveness, efficacy, efficiency, interventions, or delivery of services to affected populations. This may include secondary research with data collected through surveillance, monitoring, and reporting programs. Other methods are retrospective review of medical, public health, and/or other records.
Research involving fetal tissue.
COE research in early childhood, special education, counselor education, etc., by nature, involves small numbers of participants from specialized populations. These projects are often designed to contribute to generalizable knowledge, such as informing evidence-based practice (EBP), including potential future EBP. As such, these projects meet the criteria as human subject research.
Federal guidance on QA/QI activities
A QA/QI activity that involves introducing an untested or innovative practice or intervention, for not only the purpose of improving quality, but also for establishing scientific evidence to determine how well the practice/intervention achieves its intended results.
Federal guidance on QA/QI activities
A QA/QI activity that involves introducing an untested or innovative practice or intervention, for not only the purpose of improving quality, but also for establishing scientific evidence to determine how well the practice/intervention achieves its intended results.
Systematic investigation of innovations in diagnostic, therapeutic procedures, or instructional methods in multiple participants [more than three (3)]. The investigation is designed to test a hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge.
Activities with the purpose of recruiting subjects for future research studies.
Pilot studies involving human subjects are considered human subjects research.
Research that falls under the NIH Genomic Data Sharing (GDS) Policy: Research that generates large-scale data includes genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data.
Examples can be found in the Supplemental Information to the NIH Genomic Data Sharing Policy.
Focuses on individual and group behavior, mental processes, or social constructs and usually generates data by means of surveys, interviews, observations, studies of existing records, and experimental designs involving exposure to some type of stimulus or environmental intervention.
Activity involves collecting and using information about individuals for the purpose of drawing generalizations about such individuals or a population of which they are members, Studies using methods such as participant observation and ethnographic studies which gather information from individuals in order to understand the beliefs, customs, and practices, not only of those individuals, but also of the community or group to which they belong.
Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements
Graduate studies that involve human subjects or a clinical investigation, which results in a thesis, dissertation, research, or a capstone. NOTE: Students are advised to confirm whether the individual program permits "Not Human Research" determinations. Select colleges allow exceptions from IRB review when the activity is otherwise not Human Research.
(May qualify for exception when activity does not include identifiable information about or from living individuals.)
(Professional schools within UK which actively seek opportunities for their students to become involved in "real world" activities or work assignments that will introduce them to and, in some cases, provide practical experiences in their chosen profession)
Determinations for specific cases are nuanced. For an official determination, submit a Not Human Research (NHR) request.
Standard practice, innovative care, or off-label use of FDA-approved drugs, biologics, devices and other articles or substances that are used in the normal course of medical practice, provided the activity does not involve systematic collection of safety or efficacy data, and is limited to prevention, diagnosis, mitigation, treatment, or cure of disease in affected individuals.
Activities (e.g., review of medical data, queries, etc.) are intended only to assess the feasibility of future research.
Note that a UK or other "covered entity" will need to obtain researcher certifications for a review preparatory to research for HIPAA compliance purposes.
The collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
Research involving only data or tissue obtained from individuals who are deceased prior to the conduct of the research. There must not be any interaction or intervention with living individuals, or collection of private data or specimens associated with living individuals. Under HIPAA regulations, researchers within the UK or other "covered entity" must obtain a HIPAA waiver of authorization for review of identifiable protected health information (PHI).
An established and accepted diagnostic, therapeutic procedure, or instructional method, performed only for the benefit of a patient or student but not for the purposes of research.
See Case Reports for exceptions:
Report about three or fewer clinical experiences or observations identified in the course of clinical care, provided that it does not involve safety or efficacy data on FDA-regulated products (e.g., drugs, devices, biologics) that have not been approved for use in humans; articles requiring exemption from FDA oversight; articles under an IND/IDE. Case reports are generally done by retrospective review of medical records and highlight a unique treatment, case, or outcome. Please note: UKMC HIPAA policies apply to this project.
Report about experiences or observations associated with three or fewer individuals.
Federal guidance on QA/QI activities
Systematic, data-guided activities designed to improve clinical care, patient safety, and health care operations. The activity is designed to bring about immediate positive changes in the delivery of health care, programs, or business practices at the University of Kentucky. The individual conducting the activity is in a position to effect change. If there is an intent to disseminate results beyond UK, please contact ORI for further guidance.
Federal guidance on QA/QI activities
Data collected with the limited intent of evaluating and improving existing services and programs or for developing new services or programs at the University of Kentucky. The individual conducting the activity is in a position to effect change. Examples include teaching evaluations or customer service surveys. Contact ORI with questions or additional guidance.
The use of innovative interventions that are designed solely to enhance the well-being of an individual patient or client and have a reasonable expectation of success. The intent of the intervention is to provide diagnosis, preventive treatment, or therapy to the particular individual.
(Unless FDA regulations requiring IRB approval apply, such as use of: articles (e.g., drugs, devices, biologics) that have not been approved for use in humans; articles requiring exemption from FDA oversight; articles under an IND/IDE)
Use of publicly available data sets that exist without identifiers, or where individuals identified would not have an expectation of privacy. “Publicly available” is defined as information shared without conditions on use. This may include data sets that require payment of a fee to gain access to the data.
Information gathering about organizations, including information about operations, budgets, etc., from organizational spokespersons or data sources. Does not include identifiable private information about individual members, employees, or staff of the organization.
Donated service or activity that is performed by someone or a group of people solely for the benefit of the public or its institutions.
(If human subjects data are collected during the activity to be used for research protocols, submission is required to the IRB.)
Analysis of data gathered for a previous research protocol not related to the current proposal, and the data are de-identified.
Investigator and study personnel cannot ascertain the identity of subjects who initially provided the data.
De-identified means removal of the 18 identifiers recognized by the HIPAA regulations, which can be found under the HIPAA De-identification Certification Form at the following link:
Interviews concerning the past that collect and interpret the voices and memories of people as a method of historical documentation and that are preserved by placement in some form of repository or archive for access by other researchers. Includes the collection and use of information that focuses directly on the specific individuals about whom the information is collected without extending that information to draw generalizations about other individuals or groups. Research activities conform to the Principles of Best Practices of the Oral History Association.
(Exercise of professional ethics is expected.)
Scholarly and journalistic activities (e.g., journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected; or on the collection, verification, reporting, and analysis of information or facts on current events, trends, issues or individuals involved in such events or issues. There is no intent to test hypotheses, and activities cannot reasonably be characterized as comprising systematic investigation. Research activities should be consistent with the Code of Ethics of the Society of Professional Journalists.
(Exercise of professional ethics is expected.)
(Professional schools within UK which actively seek opportunities for their students to become involved in "real world" activities or work assignments that will introduce them to and, in some cases, provide practical experiences in their chosen profession)
A practicum/internship that falls within the work scope of a local, state, or federal agency (e.g., Public Health Agency) or employment by private industry involving data collection for non-research purposes. No a priori research design or intent.
(Professional standards apply)