What is Human Subjects Research?
Some activities that researchers engage in may not be considered human subjects research (HSR) and if not, it may not be subject to IRB oversight. Keep in mind that the IRB has the authority to make the ultimate determination if an activity is subject to IRB oversight. The researcher may not conduct HSR without prior IRB approval.
What is research?
Research is defined as: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. For example, some demonstration and service programs may include research activities. The following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., 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.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.”
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.”
What is a human subject?
A human subject is defined as: “a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” or for the FDA as “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy individual or a patient.”
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between researcher and participant.
Identifiable private information is private information for which the identity of the participant is or may readily be ascertained by the researcher or associated with the information.
Identifiable biospecimens is a biospecimen for which the identity of the participant is or may readily be ascertained by the researcher or associated with the biospecimen.
Examples of HSR and not HSR
- Graduate studies which involve human subjects or a clinical investigation which results in a thesis, a dissertation research or a capstone.
- Research involving online interactions with human subjects where identifiers are known or can be ascertained such as email addresses, certain websites and bulletin boards. Also includes data collected where an individual cannot be directly identified but data are collected through intervention or interaction with research subjects.
- Pilot studies involving human subjects are considered human subject research studies.
- An established and accepted diagnostic, therapeutic procedure or instructional method, performed only for the benefit of a student or patient but not for the purposes of research.
- Data collected with the limited intent of evaluation and improving existing services and programs or for developing new services or programs at the University of New Mexico. There must be no plans to disseminate the knowledge beyond UNM. Examples include teaching evaluations or customer service surveys.
- A practicum/internship that falls within the work scope of a local, state, or federal agency (e.g. Public Health Agency) or employment by private industry involving data collection for non-research purposes. No a priori research design or intent.
Tools to help you decide whether you need to submit to the IRB:
If you have questions about whether an activity is HSR, email details of the activity to IRBMainCampus@unm.edu and we will respond with whether or not you need to submit for IRB review. If you wish to receive a formal determination, you must submit documentation via IRBNet as described in the IRB Submission Checklist (p.8).