Q4: Does the activity involve obtaining, accessing, using, disclosing, or sharing any of the following? Individually identifiable private information from a living individual Education records that can be linked to any living individual Protected Health Information (PHI) about any individual (living or deceased) Substance information that can be linked to any individual (living or deceased) Genetic information that can be linked to any individual (living or deceased) HIV related information that can be linked to any individual (living or deceased) Identifiable specimens (living or deceased) Use of human specimens to validate a medical device, diagnostic instrument, or laboratory test Answer to Q4: (a) YES, FOR RESEARCH PURPOSES. If you selected FOR RESEARCH PURPOSES,” the activity meets the definition of research;” therefore, complete an IRB “YES, “human Application. (b) YES, FOR RESEARCH & OTHER PURPOSES. If you selected FOR RESEARCH & PURPOSES,” the activity meets the definition of research;” therefore, complete an “YES, “human IRB Application. (c) YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN HUMAN RESEARCH. If you selected FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN RESEARCH,” go to Q6. “YES, (d) YES, FOR NON-RESEARCH PURPOSES ONLY (e.g., for quality improvement, healthcare operations) If you selected NON-RESEARCH PURPOSES ONLY,” go to Q5. “FOR (e) NO. If you selected go to Q5. “NO,” GUIDANCE FOR Q4:
Q4: Does the activity involve obtaining, accessing, using, disclosing, or sharing any of the following? Individually identifiable private information from a living individual Education records that can be linked to any living individual Protected Health Information (PHI) about any individual (living or deceased) Substance information that can be linked to any individual (living or deceased) Genetic information that can be linked to any individual (living or deceased) HIV related information that can be linked to any individual (living or deceased) Identifiable specimens (living or deceased) Use of human specimens to validate a medical device, diagnostic instrument, or laboratory test Answer to Q4: (a) YES, FOR RESEARCH PURPOSES. If you selected “YES, FOR RESEARCH PURPOSES,” the activity meets the definition of “human research;” therefore, complete an IRB Application. (b) YES, FOR RESEARCH & OTHER PURPOSES. If you selected “YES, FOR RESEARCH & PURPOSES,” the activity meets the definition of “human research;” therefore, complete an IRB Application. (c) YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN HUMAN RESEARCH. If you selected “YES, FOR RESEARCH; HOWEVER, THE INSTITUTION IS NOT ENGAGED IN RESEARCH,” go to Q6. (d) YES, FOR NON-RESEARCH PURPOSES ONLY (e.g., for quality improvement, healthcare operations) If you selected “FOR NON-RESEARCH PURPOSES ONLY,” go to Q5. (e) NO. If you selected “NO,” go to Q5. GUIDANCE FOR Q4:
IRBDecisionAid-ApplicationforIRBDeterminiationLetter03.07.2017.docx