Institutional Review Board

Is it Human Subjects Research?

Please review the information below to better understand which activities meet the definition of human subjects research. If you're uncertain whether your project qualifies as research, contact the IRB at irb@tamut.edu for assistance.

Human subjects research refers to any research or clinical investigation that involves human participants.

Investigators conducting human subjects research must comply with the Department of Health and Human Services (DHHS) regulations 45 CFR Part 46 and the Food and Drug Administration (FDA) regulations 21 CFR Part 50 and FDA Part 56 to ensure the protection of human subjects. When determining whether an activity qualifies as human subjects research under DHHS regulations, two federal definitions must be considered: (1) research and (2) human subject.

Is it Research?

Research is a systematic investigation designed to develop or contribute to generalizable knowledge. This includes research development, testing, and evaluation. 

A systematic investigation involves a planned approach that incorporates data collection (either quantitative or qualitative) and data analysis to answer a specific research question. 

Exceptions to Research

Federal regulations [45 CFR 46.102(l) identify four exceptions that are not considered research:

• Certain scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, historical scholarship)
• Public health surveillance activities to identify, monitor, assess, or investigate public health signals or outbreaks
• Collection and analysis of information or specimens by criminal justice agencies for investigative purposes
• Authorized national security operational activities

Examples of Systematic Investigations

The following are considered systematic investigations and would qualify as research:

• Surveys and questionnaires
• Interviews and focus groups
• Data analysis (existing data or biological specimens)
• Epidemiological studies
• Evaluations of social or educational programs
• Cognitive and perceptual experiments
• Medical chart review studies

Generalizable Knowledge

Research aimed at contributing to generalizable knowledge seeks to draw conclusions that can inform policy, practice, or extend beyond a single individual or internal program (e.g., publications, presentations).

Even if research is never published, it is still considered research if it is intended to contribute to general knowledge. The intent to share findings, regardless of whether they are ever published, means the activity is considered research, and the participants are entitled to protection.

Activities Not Considered Generalizable

Certain activities are not intended to contribute to general knowledge. These include:

• Biographies
• Oral histories created solely to document specific historical events
• Service or course evaluations (unless results are generalized beyond the immediate context)
• Services, courses, or concepts that are not intended to be shared outside of the A&M-Texarkana community
• Classroom exercises for fulfilling course requirements or training students
• Quality assurance activities designed to improve department or program performance, with no intention to generalize findings

Is it Human Subjects Research?

A human subject is a living individual about whom a researcher obtains:

1. Information or biospecimens through intervention or interaction, and uses, studies, or analyzes that information or biospecimens; or
2. Identifiable private information or identifiable biospecimens that are used, studied, analyzed, or generated by the investigator. 45 CFR 46.102(e)

 Key Definitions

• Intervention includes physical procedures (e.g., venipuncture) or manipulations of the subject or their environment performed for research purposes.
• Interaction refers to communication or interpersonal contact between the investigator and the subject. 45 CFR 46.102(e(2))
• Identifiable private information is data for which the subject’s identity is or may be readily ascertained by the investigator or associated with the data.
• Private information includes:
  • Behaviors observed in contexts where individuals expect privacy (e.g., not being recorded),
  • Data provided for specific purposes with a reasonable expectation of confidentiality (e.g., medical records).
    (45 CFR 46.102(f)) 45 CFR 46.102(f)
• Identifiable biospecimen means a biospecimen for which the subject’s identity is or may be readily ascertained or linked to the biospecimen.

Note: Thesis or dissertation research involving human subjects conducted to fulfill a graduate degree requirement is typically considered generalizable knowledge and therefore requires IRB review and approval.

Educational Activities that are not Human Subjects Research

While all human subjects research requires prior IRB approval, not all classroom data collection constitutes human subjects research. For an activity to be considered research, it must be designed with the intent to develop or contribute to general knowledge.

Many educational exercises, such as simulations or course-assigned data collection, are intended solely to teach research methods. These activities do not constitute human subjects research if all of the following apply:

• The data are not intended to be generalized beyond the classroom (sharing results within the class is acceptable).
• The data will not be used in a thesis, dissertation, poster session, abstract, publication, or presentation.
• Participants are clearly informed that the activity is an instructional exercise, not a research study.

Exception: Any activity involving a clinical investigation or medical procedure is considered human subjects research and requires IRB review and approval, even when conducted as part of a course.

Educational Activities that Are Human Subjects Research

If a student project may result in formal dissemination, such as a conference presentation, publication, or thesis, the project should be submitted for IRB review before collecting data.

In addition, if data were originally gathered for educational purposes and someone later decides to analyze them for research, the IRB must review the project before the data are used to contribute to general knowledge.

Examples:

• An instructor conducts a classroom survey for a teaching activity. After discovering interesting results, they decided to analyze the data for publication. Because the intent has changed, an IRB application is required, even though the data were originally collected for a non-research purpose.
• A psychology major designed an experiment, recruited participants, and hoped to publish the results to strengthen her graduate school application. Because the project is intended to contribute to generalizable knowledge, it qualifies as human subjects research and requires IRB approval.

Who Needs to Submit?

You need to submit to the IRB if:

• Your project meets the federal definition of "research" and involves "human subjects."
• You intend to publish or present your findings beyond A&M-Texarkana.
• Your activity involves intervention, interaction, or access to identifiable private information or biospecimens.
• You're conducting a thesis, dissertation, or capstone involving human participants.

You likely do not need to submit if:

• You're conducting classroom activities solely for instructional purposes.
• You're doing internal program evaluations without intent to generalize.
• Your data are fully de-identified and not about living individuals.

Research Funded by the Federal Drug Administration (FDA)

The FDA defines a clinical investigation as any experiment involving a test article and one or more human subjects, and that is either:

• Subject to FDA requirements for prior submission, or
• Not subject to those requirements, but the results are intended to be submitted to or held for inspection by the FDA as part of a research or marketing application.

A test article includes any drug (including a biological product), medical device for human use, human food additive, color additive, electronic product, or any article regulated under the Federal Food, Drug, and Cosmetic Act.

If your research is regulated or funded by the FDA, the FDA defines a human subject as an individual who is or becomes a participant in research, either by receiving a test article or serving as a control. Subjects may be healthy individuals or patients.

Examples of FDA-regulated clinical investigations include:

• Clinical trials involving investigational drugs or biologics
• Research testing the safety or effectiveness of an investigational medical device
• Medical outcomes studies comparing FDA-approved drugs or devices

Important Note:
Research that tests the safety or effectiveness of an in vitro diagnostic (IVD) device using human tissue specimens, whether identifiable or not, requires IRB review under the Food and Drug Administration (FDA) regulations 21 CFR Part 50 and FDA Part 56. This is true even if the same research would not require IRB review under DHHS regulations.