Definitions

Clinical Investigation: The Food and Drug Administration (FDA) defines clinical investigations as: a) use of a drug other than the use of an approved drug in the course of medical practice; b) use of a medical device other than the use of an approved medical device in the course of medical practice; c) gathering data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product. In the above criteria “approved” means “approved by the FDA for marketing.” FDA has defined clinical investigation as synonymous with research.

Generalizable knowledge: Information that expands the knowledge base of a scientific discipline or other scholarly field of study.

Human Subject: The definition of a human subject in DHHS regulations is a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information.

Interaction: Communication or interpersonal contact between investigator and subject.

Intervention: Physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.

Protected Health Information: Protected Health Information (PHI) is any personal health information that can identify someone and is created, received, or shared by healthcare providers, such as University of Utah Health.

PHI includes details like:

• A person’s physical or mental health (past, present, or future)
• Health care services they’ve received
• Payment information related to their health care

If the information includes identifiers like name, address, birth date, or Social Security number – and it can be used to figure out who the person is – it’s considered PHI and is protected by privacy laws.

Research: The definition of research in Department of Health and Human Services (DHHS) regulations is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The Food and Drug Administration (FDA) defines research as activities that meet the definition of “clinical investigations”.

Systematic Investigation: An activity that is planned in advance that uses data collection and analysis to answer a question.

Guidance

The University of Utah Institutional Review Board (IRB) reviews projects conducted at the University of Utah and is affiliates when they involve human subjects research, as defined by either FDA or DHHS regulations – regardless of the funding source. Projects that do not meet the definitions of research, human subject, or clinical investigation are considered Non-Human Subject Research (NHSR). Also see At-a-Glance: Is IRB Review Required?

To secure a formal determination of Non-Human Subject Research from the University of Utah IRB, you must submit a Non-Human Subject Research Request as part of the New Study Application in the University of Utah Electronic Research Integrity and Compliance Administration system (ERICA). If you are unsure whether your project requires IRB submission after reviewing this guidance and/or IRB SOP 401a: Non-Human Subjects Research, you should submit a Non-Human Subject Research Request.

The activities listed in IRB SOP 401a: Non-Human Subjects Research are not considered research and do not require submission to the University of Utah IRB, including:

• Case Reports: Authors should complete the Case Reports Using Existing Data Worksheet Form and keep a copy for their records.
• Secondary Analysis of Public-Use Datasets: The University of Utah IRB maintains a list of pre-approved public-use datasets, available in the guidance, Secondary Analysis of Public-Use Datasets. Research projects involving analyzing secondary data from these pre-approved datasets do not require prior IRB approval.
• Scholarly and Journalistic Activities: Oral history, 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.

Is my program evaluation or quality assurance project considered research?

Program evaluation assesses the effectiveness of a program using data to determine if goals are met and to guide improvements. It does not test hypotheses or involve experimental interventions. Data collected solely to improve or inform programs – such as teaching evaluations or customer service surveys – typically does not qualify as research.

Quality assurance ensures that processes and procedures meet established standards, emphasizing compliance and operational integrity. These activities aim to improve local systems and are not typically designed to produce generalizable knowledge. Examples include curriculum reviews or compliance checks.

Program evaluations and quality assurance projects are generally not considered human subject research, as described in this policy.

Is my health care improvement project considered research?

The University of Utah Health Care Improvement Self-Assessment is a quick, user-friendly resource designed to help faculty and staff whether their project qualifies as human subjects research and requires IRB review. Use this tool before submitting any project to the IRB if your work involves:

• Quality Improvement (QI)
• Operational or clinical workflow changes
• Data collection for internal performance evaluation

If not considered human subjects research, no IRB submission is required. Save a copy of your self-assessment results. Consult the IRB if your project involves identifiable data, interventions, aims to produce generalizable knowledge, or the scope of the project changes or expands.

I intend to publish the results. Does that mean that my project is research?

The intent to publish does not necessarily mean that the project fits the definition of research. While results from a non-research project may be published, the term research should not be used in the publication. An alternative would be to call the activity, “quality improvement initiative”, or “program evaluation”.

What are the expectations when conducting a project that is Non-Human Subject Research?

Investigators are expected to adhere to ethical principles for non-human subject research projects, including the following when appropriate:

• Sound design and procedures: Good design ensures that the research produces valid, reliable, and interpretable results. Poorly designed studies can lead to misleading conclusions, even if the project is considered non-human subject research.

• Informed consent: Although an activity may not constitute human subjects research, the University of Utah IRB expects that consent will be obtained, when appropriate. The consent document should not use the word, “research”.
• Privacy and confidentiality protections: Projects using protected health information (PHI) must still follow HIPAA regulations for authorization and confidentiality protection, including projects using PHI about non-living individuals.

Access to Protected Health Information (PHI) to design a research study or to assess the feasibility of conducting a study requires IRB approval prior to beginning research preparation. The Research Preparation Form should be completed and emailed to the IRB (irb@hsc.utah.edu) for review.

Research involving data from individuals who are deceased requires IRB review to obtain a HIPAA authorization waiver for review of protected health information (PHI). The Research Using Decedents’ Information Form should be completed and emailed to the IRB (irb@hsc.utah.edu) for review.

Documents and References

At-a-Glance: Is IRB Review Required?

Case Reports Using Existing Data Worksheet Form

DHHS Decision Chart: Is an Activity Human Subjects Research Covered by 45 CFR 46

DHHS Quality Improvement Activities FAQ

Research Preparation Form

Research Using Decedents’ Information Form

VHA Operation Activities That May Constitute Research

Points to Consider