Non-Human Subjects Review

Kinds of inquiries involving humans that do not require IRB Review

If there is any question as to whether a project or activity constitutes human research, please contact the IRB office for an independent determination prior to initiation of the activity or project. 

Oral history interviews

Works of history, including oral histories, do not contribute to “generalizable knowledge.” Oral historians explain a particular past – they do not create general explanations about the past, nor do they predict the future. An interview gives a unique perspective on the topic at hand. A series of interviews offers a variety of particular perspectives on the topic. Historical projects typically do not collect Personal Health Information (PHI), making Health Insurance Portability and Accountability Act (HIPAA) rules inapplicable.

Quality Improvement (QI)/Quality Assurance (QA) activities designed solely for internal program evaluation purposes with no plans for external application or generalization

Most QI/QA activities are designed to improve local systems or processes and are limited to: (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice. Because QI/QA activities often are not designed to contribute to generalizable knowledge, most quality QI/QA efforts are not considered research subject to U.S. Department of Health and Human Services (HHS) regulations. 

HIPAA regulations allow for the use and disclosure of protected health information without authorization for the purpose of conducting quality assessment and improvement activities (including outcomes evaluation and development of clinical guidelines). For more information, see the U.S. Office for Human Research Protections (OHRP) guidance on Quality Improvement Activities.

Note: If, however, a project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project meets the definition of human research and requires IRB review.

Data or specimens with no code or link that could allow re-identification of subjects

One example would be a publicly-available, de-identified data set or commercially-available cell line. If the investigators are not obtaining either 1) data through intervention or interaction with living individuals, or 2) identifiable private information, then the research activity does not involve human subjects and is not regulated by OHRP.

Furthermore, HIPAA regulations do not apply to de-identified data or specimens. For more information, see the OHRP guidance on Research Involving Coded Private Information of Biological Specimens.

Note: If investigators will have access to identifiable health information such as a medical record or database, but the information is recorded by the investigator in such a manner that subjects cannot be identified, this would be considered “exempt” human research and would require IRB verification of exempt status prior to initiation of study-related activities.

Research conducted to satisfy a course requirement, with no intent to share the collected information outside the classroom setting

This includes activities involving the collection of data (identifiable or de-identified), or classroom exercises involving the use of particular methods or devices, for education and training purposes when the information is not intended for use outside of the classroom. As these educational activities are not generalizable, the definition of human subject research is not met. HIPAA regulations allow for the use and disclose protected health information without authorization for education and training purposes.

Note: Thesis or dissertation projects conducted to meet the requirements of a graduate degree are usually considered generalizable and therefore meet the regulatory definition of research. Such projects require IRB review and approval when the research being conducted involves human subjects or identifiable data about living humans.

Case reports

A single case report (or up to three cases) does not constitute a systematic investigation and therefore does not meet the definition of human research. If there is a possibility that publication of the case report or associated images could potentially identify an individual, authorization from the individual should be obtained. IRB review is required for a case series when there is intent to generalize the knowledge.

Research involving the deceased

Federal regulations governing human research pertain only to living individuals. Research that proposes only the use of cadaveric specimens or decedent data is not human research and does not require IRB approval. Furthermore, HIPAA regulations do not apply to the health information of decedents. However, if subjects will be identified while still alive, IRB review is required.

Medical practice

The off-label use of an FDA-approved drug or device intended for the treatment of an individual patient in the practice of medicine is not human research. HIPAA authorization requirements do not apply to the use of protected health information for treatment purposes.

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