Full Review Policy and Examples

Human subjects research that targets vulnerable populations and/or involves greater than minimal risk to the subject(s) requires review by the full board. Research that does not fit into any exempt or expedited categories must be reviewed by the full board. A quorum, or majority, of the Institutional Review Board will meet to discuss the risks to participants associated with the research project and will request revisions by the investigator before approval may be granted. The board has the authority to make the following actions: approve, approve subject to verification of required modifications, table, and disapprove research projects. The board meets every two weeks during the academic year, with the exception of University closure during the Christmas break, and as-needed in summer months. Please see Submission Deadlines for a meeting schedule.

Vulnerable Populations

The following populations of potential research participants have been designated "vulnerable" by the Department of Health and Human Services (HHS):

  1. Minors/children (individuals under the age of 18)
  2. Pregnant women (the fetus)
  3. Prisoners
  4. Educationally disadvantaged populations
  5. Economically disadvantaged populations
  6. Adults lacking capacity to consent and/or adults with diminished capacity to consent including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, or behavioral disorders

The Institutional Review Board may determine that any research population be considered vulnerable based on the characteristics of the group in the context of the research study.

Full Board Review Example #1

Research Subject and Method
High school juniors and seniors, all under the age of 18, are interviewed about their experiences with arts programs at their schools and how these programs have affected their academics. The interviews are audio recorded. 

Why does this qualify for full review?
The participants are considered children since they are under the age of 18, so the investigator is targeting a vulnerable population for research. There is an interaction with each child and the investigator during the interview. This study will require consent from a parent/guardian as well as assent from the child.

Full Board Review Example #2

Research Subject and Method
An investigator wishes to interview victims of sexual assault about their experiences after the trauma occured. The interview questions are sensitive in nature and may cause emotional distress among participants. 

Why does this qualify for full review? 
Due to the risk of possbily severe emotional distress, this study involves high risk and must be reviewed by the full board.