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The university's IRB has assured federal regulatory agencies that the institution will review and approve all research that meet the federal definition of human subjects research.
Determining whether or not a project meets the federal definition of human subjects research is a two-step process. The investigator must determine if the project meets the federal definition of research and, if so, determine if the project includes human subjects. The information below will help you assess whether IRB review is required.
Note: Projects including the use of drugs or devices (either approved or unapproved by the FDA) require submission to the IRB. Please complete a medical IRB application for these projects.
The Federal Policy for the Protection of Human Subjects (Common Rule) defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge...”
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Systematic Investigation is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory.
Systematic investigations include observational studies, interview or survey studies, group comparison studies, test development, and interventional research.
Projects that are not systematic investigations include oral histories, journalism, phenomenological activities. If you need to understand more about the rationale behind this see Decision Making Guide for Oral History or Case Studies.
Gray areas: Case studies prepared and disseminated for educational purposes are not systematic investigations and therefore are not considered research. If you are unable to prepare the case study report without disclosing information that would make it possible to identify the patient, you must obtain permission from the patient before using their data. Please note the important difference between a case study that is not research and an experimental research study, with an “n-of-1,” (a research study with only one subject) that is human subjects research. Program evaluation may also fall into or out of this definition based on design and intent.
Developing or contributing to generalizable knowledge means that intent or purpose of the systematic investigation is dissemination of findings. Common ways of disseminating results include publishing or presenting.
To help determine the intent or purpose of the activity ask this question: would this project be conducted as proposed if the principal investigator knew that he or she would never receive any form of academic recognition for the project including publication of results in a medical journal or presentation of the project at an academic meeting? If the project would remain exactly the same, the activity is likely not research.
Gray areas: Quality Improvement (QI) is not considered research if the primary intent of the QI is to inform or improve a local process. However, if your primary intent is to generalize the results outside of your local area the activity is research.
IRB review is not required if your project does not match the definition of research. You do not need to submit an application. If your project matches the definition of research, go to Step Two below.
The Federal Policy for the Protection of Human Subjects (Common Rule) defines human subjects as “…a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
Notice that the definition of human subject focuses on what information or material is obtained from people. If either of the following is true, your research activity involves human subjects.
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Data about living individuals through intervention or interaction
An intervention may be physical procedures (e.g. venipuncture) or manipulations of living individuals or the living individuals’ environments.
An interaction may be communication or interpersonal contact between the investigator (or research team) and the living individual. Examples include interviews, questionnaires, surveys, observations, manipulations of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), and administration of experimental drugs or devices.
Why “about whom” is key
Consider if the project focuses on the person or if the focus is on policies, practices or procedures about which the person is knowledgeable. Projects which collect information about policies, practices or procedures – even if the person who provided that information is identified – do not constitute human subject research.
Identifiable private information about living individuals
Identifiable means if 1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator; or 2) the identity of the individual from whom the information was obtained is associated or may be readily associated with the information.
Private Information is information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g. medical record, employee or student records).
Examples of identifiable, private information include the subject’s name, address, phone number, social security number, medical record number, student or employee identification number, or in some cases, the combination of data such that they can identify a single individual through deductive reasoning. For example, data about employer, job title, age and gender may not individually identify a subject, but when combined, could in certain cases, identify a specific individual.
What is NOT considered identifiable, private information: If the information cannot be linked to a living individual, or is considered public or is given with the expectation that it will be made public and that it will be linked to the individual (e.g. biography or news story), then it would not be considered private identifiable information. For example, use of a publicly available data set that does not contain identifiers or codes linked to individuals does not involve human subjects research. However, use of a publicly available data set that does contain identifiers or codes linked to individuals does involve human subject research.
If you obtain/purchase/are given specimens/cells/material/data that has already been collected by someone else for some other purpose, and the specimens/cells/material/data are not linked to any identifiers that would make reasonably possible to identify an individual, the activity is not considered research with human subjects.
If your activity is research but does not involve human subjects as defined in the regulations your activity does not fall under the purview of the IRB. You do not need to submit an application.
If you have determined that your research does meet the federal definition for human subjects research, you will need to apply for IRB review and approval before you begin (the IRB will not review projects retrospectively).
The following links will help you determine which application form to complete:
If you are unsure if your project meets the definition of research or if you require documentation that your project does not require IRB review, complete and submit the determination form below.
• Searches of existing literature
• De-identified data analysis
• Quality assurance activities or evaluation projects designed for self-improvement or program evaluation, not meant to contribute to "generalizable" knowledge
• Oral History
If you have questions about this please contact us at 612-626-5654 or firstname.lastname@example.org.