Full Board Review

Human subjects research that targets vulnerable populations and/or involves greater than minimal risk to participants requires review at a convened IRB meeting. Minimal risk is defined as risks the targeted population may reasonably face on a day-to-day basis. Additionally, 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 membership 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 the study, approve the study subject to verification of required modifications, approve with conditions, table, and disapprove research procedures or the study. The board meets every two weeks during the academic year, with the exception of University closure during the Christmas break, and as needed during summer months. Please see submission deadlines for the current meeting schedule.

Vulnerable Populations

The Institutional Review Board may designate any research population as vulnerable based on the characteristics of the group in the context of the research study. The following researcg populations have been designated vulnerable by the Department of Health and Human Services (HHS):

  1. Minors/children (in the State of Minnesota, individuals under the age of 18);
  2. Pregnant women (the fetus);
  3. Prisoners or incarcerated individuals;
  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 that may prevent full comprehension of informed consent.

Research Subject and Method
High school juniors and seniors, some 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?
Some participants are considered minors since they are under the age of 18, so the investigator is targeting a vulnerable population for research. Consent will be needed from parents or guardians for participants under the age of 18 and from participants themselves if they are 18 or older. 

Research Subject and Method
An investigator wishes to interview victims of sexual assault about their experiences using specific types of therapy. 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 severe emotional distress, this study involves greater than minimal risk and must be reviewed by the full board.