University of Nebraska Kearney

Federal regulations do not specifically list categories that would require full-board review; however, certain criteria may initiate a full-board review: 

• Studies using vulnerable subjects 
• Studies taking place internationally 
• Studies where information may be disclosed that could require mandatory legal reporting (for example, child/elder abuse, criminal activity, drug use) 
• Studies involving deception which raises the risk level of the subjects 
• Studies that fall under the jurisdiction of the Food and Drug Administration 

The IRB schedules regular monthly meetings to review all protocols that do not fall into the Exempt or Expedited categories.  The deadline for submitting protocols to the IRB for a full-board meeting is the first Wednesday of each month. The Board meets the third Wednesday of each month.  Should the IRB require revisions to the project, you will receive formal notification from the IRB director explaining the revisions required before your research can be approved. The review process may require up to one month after it is received by the IRB.  You may wish to consult with a member of the IRB staff or Board member prior to submitting your proposal. 

Although the use of vulnerable persons as subjects is not prohibited by federal regulation, justification for involving vulnerable persons in research generally becomes more difficult as the degree of risk and vulnerability increases. 

Furthermore, because certain populations of vulnerable subjects may be at greater risk than others, the IRB will take into consideration the potential risk characterization of subjects. Victims of child abuse, spouse abuse or assault, for example, may be at increased risk in sociological or psychological studies.