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:
• 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.)
• 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