Full Board Review

Full Board review

 

​Studies that expose subjects to more than minimal risk must be reviewed at a convened Full Board meeting. Minimal risk is defined as those risks and discomforts to which a person is commonly exposed in the ordinary course of daily life, including routine visits to physicians.

Examples of studies that qualify for Full Board review:

​SBER
HBR​
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•  Research that involves sensitive, protected populations (e.g. children, or cognitively-disabled individuals) or marginalized population (e.g. like prisoners, prostitutes)
•  Research involving sensitive information (e.g., child abuse, violence, sexual conduct/misconduct, mental health/status information, HIV, alcohol, compulsive disorders, etc.).
•  Procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).
•  Projects that involve possible coercion or undue influence that induces or entices consent (e.g., excessive compensation, inequitable relationship, etc.)

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•  Punch biopsies
•  X-rays, DEXA scans
•  MRIs when contrast media and/or sedation is used for research purposes
•  Research on investigational drugs or devices
•  Mobile medical applications that use health information to directly inform care of the research subject (e.g., applications that provide insulin dosing recommendations)
•  Research in which the identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to their reputation or be stigmatizing to their group