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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 designed to develop or contribute to generalizable knowledge. One key part of he definition is systematic investigation, which means that you have a plan to answer a question. Another key part is designed to contribute to generalizable knowledge, which means that you intend to arrive at some conclusion that can apply to different situations and that you will disseminate the conclusions in some way. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Some research development or testing and evaluation may also meet this definition.

What is a human subject?

A human subject is defined as: A living individual about whom a researcher conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, saliva collection) and manipulations of the participant or the participant's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between researcher(s) and participant(s).

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e. the identity of the participant is or may readily be ascertained by the researcher or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Examples of HSR and not HSR

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.

Not HSR

  • 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).