Lipscomb University Institutional Review Board (IRB)
What needs IRB Review and Approval?
Any research activity involving human subjects conducted by faculty, staff, and students must be reviewed and approved for compliance with regulatory and ethical requirements before the study or activity begins. These activities include a wide variety of procedures from collection of data through surveys or observation and interventions in school classrooms all the way across the spectrum to use of investigational drugs or devices and/or randomized clinical trials. Other examples of studies include research on medical records, research using existing pathological specimens, discarded tissue or secretions, and research requiring standardized tests from the fields of education, psychology or human performance.
Certain studies involving human subjects may be exempt from IRB review. Exempt projects fall into defined categories (see, Categories for Exempt Research) set forth in the Code of Federal Regulation, part 43, 45. Verification of a project’s exempt status must be verified by a designated official of the IRB.
The regulatory definition of human subjects research is as follows:
An activity which falls within the scope of the IRB’s review must meet the following criteria for both “Research” and “Human Subject”
Research is defined as: A systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge, or work that is intended to fulfill requirements for a master’s thesis, doctoral dissertation, or other research requirement of the University.
Human subject is defined as: A living individual about whom an investigator 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 or manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communications or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which the 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.
NOTE: The FDA additionally defines a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. Because the above definition excludes non-living humans, research that uses autopsy materials or cadavers is not 'human subjects research' and therefore is exempt from review.
Non-Research Activities ---IRB Review is Not Required
Examples of activities that typically are not generalizable include:
- Oral histories that are designed solely to create a record of specific historical events
- Service or course evaluations, unless they can be generalized to other individuals
- Services, courses, or concepts where it is not the intention to share the results beyond the internal community
- Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices*
- Quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the university community
*Extra notes about Course related activities and/or projects (e.g. research methods instruction) that involve the use of human participants but have no connection with research beyond the instructional function do not require IRB review. Course instructors are responsible for ensuring that students understand and abide by ethical obligations in carrying out their assignments. We suggest that, at a minimum, students complete the training modules available through NIH at http://phrp.nihtraining.com/users/login.php
Additionally, instructors are responsible for reviewing student class project proposals and consent procedures to ensure that the methods and procedures are ethical and appropriate, and for monitoring student activities during the conduct of the project to ensure that the rights and welfare of participants are adequately protected. Instructors who have any questions are encouraged to consult with the IRB Chair.