Submitting Protocols with Special Populations/Concerns

 Special Population: Patients

Click on the topic below for more information

• Should this protocol be reviewed by the BioMedical IRB (IRB01) or NonMedical IRB (IRB02)?

  
Should this protocol be reviewed by the BioMedical IRB (IRB01) or NonMedical IRB (IRB02)?

• Protocols have to be reviewed by IRB01 (Biomedical IRB) if HIPAA protection of private health information is triggered. This threshold is fairly low if the research is being conducted either by a person under a HIPAA “covered entity”  (Shands/UF Health Science Center).
• For example, if the researcher within the HIPAA covered entity is collecting/recording HIPAA-sensitive information.and participants are going to be screened/selected for participation based on their medical records, this triggers the need for HIPAA compliance.
• Also, if the researcher within the HIPAA covered entity is collecting data that is protected health information, this also triggers the need for HIPAA compliance.
• The threshold for triggering HIPAA is significantly higher (more liberal) with investigators outside of the covered entity (the Health Center and affiliated programs and colleges) in our “hybrid institution,” but when that threshold is passed, these protocols then have to be reviewed by IRB01.
• This threshold is reached if waivers to access medical records are involved. This requies HIPAA compliance in management of these records.
• Testing a patient population does not necessarily mean that the protocol must go to IRB01, if the research is a behavioral and psychophysiological exploration of aspects of a patient population. 
• In a few cases, these protocols may be reviewed by IRB02 (non-medical IRB), but the board may seek the expert views of someone knowledgeable of the population and the issues of concern surrounding that group, so to determine if the population is at any specific risk or if the procedure is safe. 
• If the manipulation of interest has to do with treatment of the disorder, the research may be referred to IRB01, which contains individuals whose medical/physiological knowledge is better suited to judge safety/risks/benefits for participant populations or certain manipulations of treatment/diet/physical exercise etc. 
• Protocols that commonly reviewed by IRB01 include treatment studies and pharmacological interventions.