IRB Decision Aid SUNY Downstate Medical Center University Hospital of Brooklyn (Application for a Determination Letter College of Medicine to that IRB Approval is NOT College of Health Related Professions REQUIRED) College of Nursing School of Graduate Studies Graduate Program in Public Health Whenever you are not sure how to answer a question, contact the IRB for help. Questions may be directed initially to: IRB Phyllis G. Supino, EdD at (718) 613-8355 Executive Director, Kevin Nellis at (718) 613-8461 IRB Staff at (718) 613-8480 For additional guidance on human subjects research, see: Privacy and HIPAA related questions may be directed to the Downstate Privacy Officer, Shoshana Milstein, at (718) 270-7470. Information Security related questions may be directed to the Downstate Information Security Officer, David Loewy at (718) 270-2431. For animal research, see: This guidance incorporates HHS regulatory definitions as well as HIPAA, FDA, and other Federal and NY state regulations. SIX TYPES OF REVIEW: REQUIRED FORM: Determination Letter (indicates IRB review is NOT required) Use this form to document and request such a determination. Exempt Review Follow the instructions on the for Exempt Review” “Application Expedited Review Follow the instructions on the for Expedited or Full Review” “Application Convened (Full) IRB Review Follow the instructions on the for Expedited or Full Review” “Application Use of a Humanitarian Use Device (HUD) for clinical purposes Follow the instructions on the for HUD for Clinical Purposes” “Application External IRB Review (some multi-site research) Follow the instructions on the for External IRB Oversight” “Application Three Key Definitions: means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to Research generalizable knowledge. Research participant means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. Human Research (also known as Human Subjects Research) means any activity that involves a research participant in a research activity. An IRB application is required for all Human Research.
SUNY Downstate Medical Center University Hospital of Brooklyn College of Medicine College of Health Related Professions College of Nursing School of Graduate Studies Graduate Program in Public Health IRB Decision Aid (Application for a Determination Letter to that IRB Approval is NOT REQUIRED) Whenever you are not sure how to answer a question, contact the IRB for help. Questions may be directed initially to: IRB Phyllis G. Supino, EdD at (718) 613-8355 Executive Director, Kevin Nellis at (718) 613-8461 IRB Staff at (718) 613-8480 For additional guidance on human subjects research, see: Privacy and HIPAA related questions may be directed to the Downstate Privacy Officer, Shoshana Milstein, at (718) 270-7470. Information Security related questions may be directed to the Downstate Information Security Officer, David Loewy at (718) 270-2431. For animal research, see: This guidance incorporates HHS regulatory definitions as well as HIPAA, FDA, and other Federal and NY state regulations. SIX TYPES OF REVIEW: REQUIRED FORM: Determination Letter (indicates IRB review is NOT required) Use this form to document and request such a determination. Exempt Review Follow the instructions on the “Application for Exempt Review” Expedited Review Follow the instructions on the “Application for Expedited or Full Review” Convened (Full) IRB Review Follow the instructions on the “Application for Expedited or Full Review” Use of a Humanitarian Use Device (HUD) for clinical purposes Follow the instructions on the “Application for HUD for Clinical Purposes” External IRB Review (some multi-site research) Follow the instructions on the “Application for External IRB Oversight” Three Key Definitions: Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Research participant means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. Human Research (also known as Human Subjects Research) means any activity that involves a research participant in a research activity. An IRB application is required for all Human Research.
IRBDecisionAid-ApplicationforIRBDeterminiationLetter07032017.docx