803: Selection of Studies for Quality Review

The majority of studies will be selected at random for review. However, consideration for selection of projects or for increased frequency of reviews, may be given to: 

1.      Higher risk studies 
2.      Investigator-initiated protocols
3.      Studies that include vulnerable populations such as UNR employees and students, terminally-ill and decision-impaired, or identified in 45CFR46 subparts C and D, pregnant women, fetuses, neonates, prisoners, and children. 
4.      Potential for conflict of interest
5.      "Directed" interests of the IRB or UNR RIO
6.      Investigator history of noncompliance that suggests a lack of understanding about the protection of human participants
7.      Research involving investigational drugs or devices for which a new safety warning or changes in labeling suggest increase risks
8.      Data confidentiality or security concerns