IRB Approval

Is Institutional Review Board (IRB) Review Needed?

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 Pikeville IRB.

Research: “A systematic investigation designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)]

Human Subjects (DHHS): “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)]

1. Intervention: includes physical procedures such as blood samples, x-rays; or the manipulation of the environment in order to stimulate certain types of behavior.
2. Interaction: includes interpersonal communication between the investigator and subject through surveys, interviews, administration of educational tests, etc.
3. Identifiable: the identity of the subject is or may readily be ascertained by the investigator with the information obtained as part of the research.
4. Private information: a context in which an individual can reasonably expect that no observation or recording is taking place or information that is provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.

Clinical Investigation: “Involves use of a test article (i.e., drug, device, food substance or biologic), one or more human subjects, meets requirements for prior submission to FDA, or results are intended to be part of an application for research or marketing permit.” [21 CFR 56.102]

Human Subjects (FDA): “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.” [21 CFR 56.102(e)] (Drug, Food, Biologic)

Human Subjects (FDA for medical devices): “A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.” [21 CFR 812.3(p)] (Medical Devices) NOTE: This definition includes use of tissue specimens even if they are unidentified.

In cases in which any other federal agency apply, institutional oversight of the activity follows the definitions for “research” and “human subjects” as defined by the relevant agency as appropriate. For Department of Defense-supported research, institutional oversight of the activity follows the definitions of “research” and “experimental subject” as defined by Department of Defense regulations. [DoD Directive 3216.02]

Activities that do not require IRB Approval: Examples of activities that do not require UPIKE IRB review are listed on the following chart. If you are in doubt whether or not the planned activity requires IRB approval, please contact the IRB administrator: Rita Thacker (ritathacker@upike.edu).

Examples of What Does Not Require IRB Review and Approval Prior to Initiation of Research.

Activities	Description
Classroom Assignments/ Research Methods Classes	Activities designed for feedback to the teacher, or educational purposes that teach research methods or demonstrate course concepts. The activities are not intended to create new knowledge or contribute to generalizable knowledge (e.g. published or disseminated at a capstone or conference). Note: Instructors have an obligation to ensure students meet professional and ethical standards.
Research on Organizations	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.
Research Using Publicly Available Data Sets	Use of publicly available data sets that do not include information that can be used to identify individuals. “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.
Quality Assurance and Quality Improvement Activities – Non-Clinical	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 Pikeville (UPIKE). There must be no plans to disseminate the knowledge beyond UPIKE. Examples include teaching evaluations or customer service surveys.
Quality Assurance and Quality Improvement Activities – Clinical or Procedures	Systematic, data-guided activities designed to implement promising ways 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 Pikeville’s Kentucky College of Osteopathic Medicine (KYCOM), or its clinical rotation sites. There must be no plans to disseminate the knowledge beyond KYCOM and its clinical rotation sites.
Medical Practice	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.
Research Involving Only Decedents	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. Note: This does not apply to research involving fetal tissue. HIPAA regulations apply.
Standard Diagnostic or Therapeutic Procedures	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. Note: See Case Reports
Case Report – Clinical	Report about three or less clinical experiences or observations identified in the course of clinical care. Note: IRB approval is required if 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).
Case Report – Other	Report about experiences or observations associated with three or less individuals.
Innovative Procedures, Treatment, or Instructional Methods	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. Note: IRB approval is required if 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).
Community Service Projects	Donated service or activity that is performed by someone or a group of people solely for the benefit of the public or its institutions. Note: IRB approval is required if human subjects data are collected during the activity to be used for research protocols.
Secondary use of research data	Analysis of data gathered for a previous research protocol not related to current proposal and the data are de-identified. De-identified means removal of the 18 identifiers recognized by the HIPAA regulations. Note: If data has direct or indirect identifiers, IRB submission is required.
Oral History	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. Research activities conform to the Principles of Best Practices of the Oral History Association: http://www.oralhistory.org/about/principles-and-practices.
Journalism	Activities focused 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 http://www.spj.org/ethicscode.asp.

Adapted from the University of Michigan Vice President for Research Operations manual (http://www.hrpp.umich.edu/om/Part4.html).