Excluded Research

Non-Research Information for Excluded Activities

Exclusion Review Form

IRB Determination of Excluded (non-research) Activities

The UNLV IRB may determine that a project involves activities that are not considered research or “excluded” under the definition of research [45 CFR 46.102 ( d )]. since it may be, for example, conducted for evaluation purposes for an entity (e.g., a government agency, commercial enterprise, workshop evaluation, or administrative review), but about which the investigator has no intention of publishing results or distributing the information outside the institutional setting. It is therefore, not designed to contribute to generalizable knowledge.

Another situation where the determination of “excluded research” might occur is when the researcher has been hired by an outside agency as a consultant to conduct the research for the agency. The researcher would be required to write a report for the agency and turn all the data back to the agency. If the researcher is hired on his/her own time holds no rights in the work, and neither the researcher nor the University retains any rights to the data, this activity is also not designed to “contribute to generalizable knowledge.”

Implications of Excluded Activities: A Note of Caution
The UNLV IRB is concerned that investigators fully understand the implications of having their work classified as non-research and excluded from review.  Results from such studies may not be disseminated; to do so is in violation of the UNLV Human Subjects Policy.  If there is a reasonable likelihood that data and data analysis will be disseminated, the study is, in fact, research and requires prior review and approval. Further, some scholarly journals will not publish studies involving human subjects without an assurance of IRB approval (and excluded studies have not received IRB approval).  In rare circumstances, investigators may submit a new protocol and request to do human subjects research using the data that was previously collected under an excluded study. Be aware that the IRB may disapprove the application.  In such situations, the IRB will require investigators to show that they could not reasonably have foreseen having an interest in publishing the results of the excluded study.  The IRB will not approve such applications where it feels that the investigator has attempted to circumvent human subjects policies by collecting data as “non-research” and then applying to use the same collected data as “human subjects research.”  It is therefore in the investigator's best interest to consider carefully the likelihood that data collected may need to be used for research purposes in the future, and to seek IRB approval prior to beginning the activity.