IRB - Does this Activity Require IRB Review?

All research conducted by any TWU faculty member, staff member, or student using human subjects must be approved by the TWU IRB prior to study initiation (see definitions below). You may use OHRP's Chart 01: Is an Activity Human Subjects Research? to determine if a project is considered to be research involving human subjects and, therefore, requires IRB review.

Research is a systematic investigation designed to test hypotheses, evaluate programs, draw conclusions, or contribute to generalizable knowledge. Research is usually described in a formal protocol that sets forth objectives and a set of procedures designed to reach those objectives.

Human subjects in research are living individuals about whom investigators (professionals or students) conducting research obtain (1) data through intervention or interaction with individuals, or (2) identifiable private information. Identifiable private information includes any acquired information via self-report, behavior, or observation in which the identity of research subjects is or may readily be ascertained by the investigators or be associated with the information.

Below are some of the types of activities conducted at TWU that may not be considered human subjects research using the OHRP definition; therefore not requiring TWU IRB review.

• Quality Improvement (QI): QI activities attempt to measure the effectiveness of programs or services. Such activities may constitute human subject research, and require IRB review, if they are designed or intended to contribute to generalizable knowledge. Quality assurance activities that are designed solely for internal program evaluation purposes with no external application or generalization may not require IRB review. In the event that a disagreement arises about whether a quality assurance activity constitutes human subject research, the IRB, not the individual investigator, will determine when IRB review of such activities is required.
  
  
• Course-related Activities/Class Projects: The IRB is only required to review student course-related activities and projects that meet the Federal definitions of research and human subject, or “engaged in research” as stated above. If there is a possibility that researchers may use data for research purposes, IRB approval is required prior to initiation of the project. Class projects conducted by students in which data are gathered strictly for educational purposes do not require IRB approval. The TWU IRB generally does not review course-related/educational activities designed specifically for educational or teaching purposes in which information about human subjects is collected as part of a class exercise or assignment and the data are not used outside the classroom. Despite the fact that the applicable activities do not require IRB review, course instructors and students are still ethically obligated to provide full disclosure in all recruitment and data collection efforts.
  
  
• Oral History: Oral history activities are typically designed to record, preserve and at times, interpret specific historical events or the experiences of individuals. If the oral history activities, such as open-ended interviews, are done without any intent to draw conclusions or generalize findings, then this research would NOT constitute "research" as defined in 45 CFR 46. Having said this, there are times when there are oral history activities, such as a systemic investigation involving open-ended interviews, that are designed to develop or contribute to generalizable knowledge (e.g., the creation of archives to provide a resource for others to do research) that WOULD constitute "research" under 45 CFR 46. These types of activities would then require formal review and approval by the IRB before such activities could begin.
  
  
• Case Study: A case study is a report about experiences or observations associated with up to three individuals. Case studies typically involve the collection and presentation of detailed information about a particular patient/person or small group (up to 3 subjects) to highlight an interesting condition, treatment, presentation or outcome. To determine whether a case study or case series requires IRB review, recall the definition of human subjects research; specifically, that it is designed to contribute to generalizable knowledge. A case study, in contrast, tends to highlight one or a few particular cases for purposes of demonstration rather than for purposes of drawing generalized conclusions.