IRB – Human subjects research incoming staff orientation 2017

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Presentation transcript:

IRB – Human subjects research incoming staff orientation 2017 11/21/2012 Kevin L. Nellis, MS, CIP Executive Director, Human Research Protections and Quality Assurance IRB – Human subjects research incoming staff orientation 2017

Objectives Understand when activities require IRB approval Know how to start the IRB application process.

Institutional Review Board (IRB) Protects the rights and welfare of research participants. Empowered to approve, require modifications, or disapprove Human Research. Ensures Human Research is scientifically/scholastically valid, ethical, and in compliance with all requirements. Ensures compliance through oversight functions.

Activities Requiring IRB Review Clinical Trials involving drugs, biologics, devices; including use of specimens to validate a medical device, diagnostic instrument, or laboratory test (FDA) Research involving Protected Health Information (PHI) from living or deceased patients or employees (HIPAA) Human (Subjects) Research as defined by “Common Rule” (45 CFR Part 46)

IRB Decision Aid

Is IRB Review Required for Human Research? (Under the Common Rule) 1) Is it research? If “NO” to either question, consult “IRB Decision Aid” or call IRB @ extension 8480 2) Does it Involve Research Participants (Human Subjects)? YES Submit an IRB Application

Is it Research? (Under the Common Rule) A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

Does it Involve Research Participants (Human Subjects) Does it Involve Research Participants (Human Subjects)? (Under the Common Rule) Living* individuals about whom an investigator conducting research, obtains either… Data through intervention or interaction with the individual, or Individually identifiable private information** * HIPAA Exception: Includes PHI from deceased patients or employees ** Includes identifiable specimens

HOW is IRB approval obtained? Follow instructions on IRB Electronic Submissions website: http://research.downstate.edu/irb/irb- electronic-submissions.html

Electronic Submissions

IRB Contacts Phyllis G. Supino, EdD, IRB Chair (718) 613-8355 Daniel Cukor, PhD, Vice Chair, Board A (718) 270-2077 Stanley Friedman, MD, Vice Chair, Board B (718) 270-1335 Kevin L. Nellis, MS, CIP, Executive Director, Human Research Protection & Quality Assurance (718) 613-8461 Diann Johnson, MPH, Associate IRB Administrator (718) 270-4341 Danielle Lewis, MD, MPH, IRB Management Analyst (718) 270-4454 Nikol Celestine, BA, CIP, IRB Management Analyst (718) 270-4411 Nakih Gonzales, IRB Assistant (718) 270-4372 IRB Office (BSB 3-26) IRB@downstate.edu (718) 613-8480

Summary Know when IRB approval is required Submit online application Follow instructions and guidance Call the IRB for help