IRB Basics

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IRB Basics

• Helen Panageas
• New York University School of Medicine
• Institutional Review Board
• Portion of slides courtesy of Suzanne M. Smith,
  University of Pennsylvania

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Introducing the NYU SoM IRB

• The Institutional Review Board (IRB)
• Operates under federal regulations.
• Charged with protecting the rights and welfare
  of people involved in research.
• Keeps pace with the ever changing environment
  of human subjects research.
• Facilitates and strengthens human subjects
  research conducted by investigators at the
  institution.

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What does the IRB do?

• Oversees all research that involves human
  subjects.
• Mandated by
• HHS 45 CFR 46
• FDA 21 CFR 50 56
• Ethical Guidance
• Nuremburg Code
• Declaration of Helsinki
• Belmont Report

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When is IRB review required?

• IRB review is required for all human subjects
  research
• Federally funded research
• Research involving FDA regulated products
• Research not federally funded or not involving
  FDA regulated products, i.e. in house studies,
  not funded, research conducted under departmental
  grants

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How is a Human Subject defined?

• Definition of HUMAN SUBJECT according to 45 CFR
  46
• living individual (s) about whom an
  investigator (whether professional or student)
  conducting research obtains
• (1) data through INTERVENTION or INTERACTION
  with the individual OR
• (2) identifiable PRIVATE INFORMATION obtained
  for this research in a form associable with the
  individual (that is, the identity of the subject
  is or may readily be ascertained or associated
  with information)

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Is the activity Research?

• regulations define research as a systematic
  investigation, including research development,
  testing and evaluation, designed to develop or
  contribute to generalizable knowledge.
• Systematic means that research methods are
  employed to test a hypothesis and draw
  conclusions.
• Generalizable refers to the dissemination of
  or intent to disseminate findings to a scientific
  or professional audience. This generally
  includes the following
• Masters and doctoral theses
• Presentation at a scientific or professional
  meeting or conference, including poster
  presentation and abstract submissions
• Submission to or publication in a professional or
  scientific journal
• Generalizable knowledge is usually that which is
  disseminated through presentation and/or
  publication, put in the public domain, or
  innovative

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How does the IRB review research?

• Initial Review 3 Types
• Exempt
• Expedited
• Full Board
• Continuing Review
• IRB decides renewal term
• At least once annually
• Amendments
• Changes to study protocol, consent, ads, etc.
• Unanticipated Problems
• Protocol Deviation, Adverse Events, New
  Information, Subject Complaint
• Terminations
• Study end, final report

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Review Types Risk Level

• Exempt
• All research procedures must fall into one or
  more of the exemption categories
• Do not need to inform IRB of any changes that
  occur during the course of an exempt study unless
  the change affects the review level and/or risk
  to subject.
• Use the Request for Exemption form (found on IRB
  website)
• Expedited
• Reviews studies that are no more than minimal
  risk AND where are research procedures fall
  within one of the expedited categories of
  research
• Full Board
• Any study that is considered more than minimal
  risk is reviewed by a fully convened IRB (8-15
  people)

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Submission Basics

• Cover Letter
• IRB Submission Application
• Protocol Summary
• Full Protocol
• Informed Consent
• HIPAA Authorization or Waiver
• Human Subjects protection training for PIs and
  study staff (CITI)
• Recruitment materials ads, radio announcements,
  brochures
• Study questionnaires and surveys
• IND/IDE information
• Investigational brochure or product labeling
  (drug/device studies)
• Conflict of interest documentation
• For federally funded research grant application
• For All Submissions (Administrative
  Acknowledgement, Exempt, Expedited Review, Full
  Board)
• Original 2 copies

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Helpful Submission Hints

• Include protocol number and PI name on all
  submissions
• Include fax and email of PI and primary study
  contact
• Ensure page numbers are on all documents
• Update version date on all revised documents
• Include both versions of revised documents
• Copy with changes highlighted or tracked
• Clean copy with changes incorporated but not
  highlighted
• Maintain communication with your IRB throughout
  the life of the study

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IRB New Happenings

• IRB Changes
• PI Attendance at Board Meetings
• Members receive small compensation
• Board C March 2008
• Electronic submission (InfoEd) Spring 2008
• PI Administrator access to summary screens -
  March
• CITI Tutorials Human subject and GCP
• Quality Improvement/Education Program
• 2008 Symposium coordinated by NYU SoM IRB and
  NYU Dental School

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Where is the IRB located?

• 423 East 23rd Street (VA Building) 10th floor
  West Wing
• For general questions, call the IRB Office at
  212-263-4110 or email
• irb-info_at_med.nyu.edu
• Website http//www.med.nyu.edu/IRB.html

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FAQs

• Where should I go if I have questions?
• Consult the IRB website
• When do I submit my protocol? How long will the
  review take?
• When submission packet is complete, you can
  submit to IRB for initial review. Allow IRB 2-3
  working days to process review packet.
• Turn around time frame depends upon the type of
  proposal, when it is submitted, and when the next
  committee review meeting will convene.
• When should I submit for continuing review?
• PIs will be notified by IRB when their study is
  due for continuing review.
• CRs should be submitted 8 weeks prior to the
  approval expiration date.
• What should I do if my approval expires?
• All study activities should stop (interviews,
  data collection, recruitment, etc.).
• If the study expires, you must contact the IRB
  administrator for further instruction on
  resubmission.

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THANK YOU