Does my activity require IRB review?

IRB Equation

Use this decision tree to determine if your study is research and, if it is research, if it involves human subjects. Use the steps below to assist in clarifying terms.

IRB Decision Tree

What is research?

Within the context of human subjects research, research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

What is a "systematic investigation"?

The term systematic investigation is generally thought of as a predetermined method for answering certain questions or studying a specific program or topic. Usually, to be a systematic investigation, a research design would meet all of the following criteria:

  • Attempts to answer research questions (in some research, this would be a hypothesis).
  • Is methodologically driven, that is, it collects data or information in an organized and consistent way. 
  • The data or information is analyzed in some way, be it quantitative or qualitative data.
  • Conclusions are drawn from the results.

What is "generalizable knowledge"?

An activity may be thought to develop or contribute to generalizable knowledge if the information collected can be applied beyond a particular subject group or situation in time. 

The vast majority of scholarly work in academia is intended to be shared, published, presented to colleagues, and is intended to have an impact (theoretical or practical) on others within one’s discipline. Activities that are disseminated with the intent to influence behavior, practice, theory, future research  designs, etc. are contributing to generalizable knowledge.

Generally, the IRB definition of "research" does NOT include:

Student course work or undergraduate honors theses, unless they are to be made available to the public, used by other researchers, or there is a possibility that the research may lead to a formal presentation or publication. However, even when student work involving human subjects does not constitute research, the faculty members who assign or supervise the work are responsible for educating their students to safeguard the well being of the subjects. If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review.

Oral History Projects are considered research only when they are intended to contribute to generalizable knowledge.

Program Evaluation, Quality Assurance and Quality Improvement Activities are considered research only when they are intended to contribute to generalizable knowledge. When the evaluation is undertaken to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective and will be shared as a program that can be used elsewhere (i.e. generalizing the outcomes for broader implementation), the activity is research.

When the purpose of an activity is to assess the success of an established program in achieving its objectives and the information will be used to provide feedback to improve that program, the activity is not human subjects research. Data may be used for research purposes in the future and will be the responsibility of the person intending to use the data for research to obtain IRB approval, if data are identifiable.

Research vs. Evaluation ImageAmerican Evaluation Association - http://aea365.org/blog/?p=222

Who is a human subject?

A human subject is defined as:

(1) a living person about whom a researcher obtains data, either with identifiers or anonymously, through:

  • Interaction (i.e. interviews or surveys) with the person, AND/OR
  • Intervention (i.e. cognitive or physical tests or collecting biospecimens), AND/OR

(2) A living person about whom a researcher obtains identifiable private information (i.e. medical records or a privately owned dataset containing identifiers). This identifiable private information may be owned by the researcher or another party, and this also falls under the definition of human subject if that data is to be used for research purposes.

 

What does "about whom" mean?

In order for a study to be considered human subjects research, the data obtained must be about the living individual. In some cases, a researcher may interact or intervene with a living individual, but the purpose is to obtain data about a topic other than the individual (i.e. office procedures). These studies may not be considered human subjects research.

What is "intervention"?

An intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

What is "interaction"?

An interaction includes communication or interpersonal contact between investigator and subject. This includes in-person, by phone, email, text, social media, etc.

What is “private identifiable information"?

In this context, identifiable means that the identity of the subject may readily be ascertained by the investigator or associated with the information obtained as part of the research.

There are two kinds of private information included in the federal definition:

  • 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 that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public, such as a medical or school record

Some examples of research that is NOT considered human subjects research:

Asking a nongovernmental organization about its source of funding.

Asking an employee to describe the different functions performed by different positions at an organization and communication processes between departments, as long as no private, personally identifiable information is collected about individuals who have filled different positions.

Asking a teacher to describe common teaching methods or techniques used in the classroom.

Receiving de-identified data for analysis that was originally collected for research or other purposes and which cannot be linked back to a subject.

The purpose of the research is to determine whether System A or B is better. The researchers ask 30 engineers who have used both systems to evaluate the systems (e.g., with instructions to rate each system on a scale of 1 to 10). The researchers perform an analysis that determines statistically which system is better. The research is about the system, not the subjects (see above section on the meaning of "about whom").


Some examples of research that IS considered human subjects research:

Asking a teacher to describe her or his personal experience using different teaching methods or techniques. Note: This would be considered human subjects research even if the overall purpose of the study were about teaching methods.

Asking a political scientist who is the strongest candidate in a political race. Note: This opinion question is about the individual because it seeks a general attitude from—that is, something about—the individual, and not a concrete assessment of something within their realm of expertise.

The purpose of the research is to determine within-rater reliability. The researchers ask engineers who have used Systems A and B to evaluate the systems (e.g., with instructions to rate each system on a scale of 1 to 10). The researchers perform an analysis that determines the engineers have low within-rater reliability.

Are you conducting human subjects research?

If your activity fits the definition of research and your intended study population fits the definition of human subjects, you must submit an application for IRB review and approval.

Next Step: See Investigator page.

Non-Human Subjects Research Activities

If your activity does not fit the definition of research and/or your intended study population does not fit the definition of human subjects, your activity is not considered human subjects research and does not require IRB oversight.* However, this does not excuse the ethical and responsible conduct of research or activities involving human subjects.

Resources for possible non-research activities:

Program Evaluation/ Assessment guidance 

Office of Academic Program Assessment

Office of Institutional Research

Data Transfer guidance

Office of Research Affairs

*Undergraduate and Master's Students: Please note that if your department or college has a research review committee, they may expand their reviews beyond human subjects research. Please consult with your committee as these reviews fall outside of IRB oversight.