Is IRB Review Required?

Research

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Examples of systemic investigation:

• Analyses of existing data or biological specimens
• Cognitive and perceptual experiments
• Content analysis
• Descriptive, correlational, quasi-experimental, or experimental methods
• Epidemiological studies
• Evaluations of social or educational programs
• Interviews and focus groups
• Knowledge tests
• Medical chart reviews
• Observations
• Randomized controlled trials
• Surveys and questionnaires

Generalizable Knowledge

Generalizable knowledge is defined as knowledge that is "expressed in theories, principles, and statements of relationships" that can be widely applied to our experiences. The information is collected to share with other people within a discipline and is created to make a broad statement about a group of people, procedures, programs, etc. Generalizable knowledge includes one or more of the following concepts:

• The information contributes to a theoretical framework of an established body of knowledge
• The primary beneficiaries of research are other researchers, scholars, and practitioners in the field of study
• Publication, presentation, or other distribution of the results is intended to inform the field of study
• The results are intended to be replicated in other settings (Used with permission from
  Michigan State University)

If your project IS research, click to the next question.

Human Subject

A human subject is a living individual about whom an investigator (whether professional or student) is conducting research by:

1. Obtaining information or biospecimens through intervention or interaction with the individual, and using, studying, or analyzing the information or biospecimens or
2. Obtaining, using, studying, analyzing, or generating identifiable private information or identifiable biospecimens.

Definition of Related Terms

• Intervention:  both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
• Interaction: communication or interpersonal contact between investigator and subject.
• Private information: 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 that the individual can reasonably expect will not be made public (e.g., a medical record).
• Identifiable private information: information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
• An identifiable biospecimens: identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

If your research involves human subjects, you will need to submit an application. Click to the next question.

When a study qualifies for an exemption this means it is exempt from federal scrutiny. However, institutional policy requires that all human research studies are reviewed by BYU IRB. Exempt studies are reviewed by designated IRB staff. Exempt studies do not require an annual review and there is no expiration date. However, researchers are expected to submit modifications as needed to the IRB for review. These modifications must be approved before the changes are can be implemented.

Exempt Category Criteria

• Research is not more than minimal risk.
• Methods must fit in one of six categories.
  
  • Education research
  • Surveys, interviews, educational tests, and public observations (that do not involve children)
  • Benign behavioral interventions
  • Analysis of previously-collected identifiable information or specimens
  • Federal research or demonstration projects
  • Taste and food evaluation studies

More information regarding Exempt Reviews can be found here.

If your project does NOT qualify for an exemption, click to the next question.

Projects that do not involve research or human subjects as defined under questions 1 and 2, do not require IRB review.

Examples of Non-Human Subject Research

• Classroom projects that are not expected to contribute to generalizable data.
• Datasets: The analysis of de-identified, publicly available data.
• Oral History as defined by the Oral History Association (OHA). Oral history is excluded from IRB review as long as it falls under the category of “scholarly and journalistic activities that collect and use information about specific individuals themselves.” However, “studies using methods such as participant observation and ethnographic
  studies, in which investigators gather information from individuals in order to understand the beliefs, customs, and practices, not only of those individuals, but also of the community or group to which they belong” would represent “generalizable knowledge” and therefore not excluded from IRB review 1  .
• Scholarly and Journalistic Activities: Journalism, Biography, Literary Criticism, Legal Research, Historical Scholarship. The activities must focus directly on the specific individual about whom the information is collected.
• Quality Improvement, marketing and business analysis, program evaluations inasmuch as the project does not involve activities associated with the federal definition of
  research.

Expectations When Conducting Non-Human Subject Research

IRB is one of several compliance committees across campus. Approvals may be necessary from BYU administrative leadership, the University International Travel Office, department chairs, and oversight of student projects by course instructors. Researchers are expected to follow ethical principles of their discipline as well as institutional policies and applicable laws.