Introduction
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Research Activities That Do Not Require IRB Review
When activities do not meet the definition of human subject research but "people" are involved, PIs should use common ethical standards and best practices to make sure that the volunteers are properly informed and their rights are protected. Internal business surveys and interviews or usability evaluations that test a product but not the person's ability to use the product and do not reveal the subject's identity in any way, or activities that do not result in scientific publication generally do not meet the definition of human subject research. The following are some examples of activities conducted at PNNL that do not require IRB review. When in doubt, contact the IRB.
- Quality assurance or assessment of off-the-shelf work place equipment or clothing, for instance, where no element of research exists.
- Internal or external surveys, interviews, or focus groups (when no element of research exists and the results will not lead to generalizable scientific knowledge). For instance, the PNNL Quality of Life survey or a survey or questionnaire to evaluate the usability of a software program, or focus groups to assess the Laboratory's reputation within the community or to discuss potential research with workers or members of a local Tribal community.
- Taking photographs, video or audio taping. For instance, photographs or audio taped interviews conducted by PNNL public relations or other staff when the activities are not conducted for research purposes.
- Software or hardware usability testing when conducted for standard quality assurance purposes before delivery of a product if staff privacy or job performance will not be jeopardized. The use of Best Practices most always applies with some form of simple consent considered, where appropriate.
- Routine occupational health surveillance activities that contain no element of research.
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Site Reviewed: May 2008
Page updated: October 2007