The IRB in the New Millennium: Changes in the IRB Process That May Impact Your Research Dr' Jim Cann

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The IRB in the New Millennium Changes in the IRB
Process That May Impact Your Research Dr. Jim
Cannady
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Agenda

• Introduction
• IRB Responsibilities
• Overview of the process
• Steps in the process
• Documentation
• Reviews
• Questions

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IRB Introduction

• Research involving human subjects must be
  reviewed by law
• The National Research Act Public Law 99-158
• Title 45, Part 46 of the Code of Federal
  Regulations
• University-level Board
• Representative from each center/school
• Outside representative

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IRB Responsibilities

• Review and approve any research that involves
  human subjects conducted by NSU faculty, staff or
  students, whether funded or unfunded
• The IRB is responsible for determining and
  assuring under the auspices of NSU faculty,
  staff, and students that
• The welfare and rights of human subjects are
  adequately protected and informed consent given,
  if necessary
• Human subjects are not placed at unreasonable
  physical, mental, or emotional risk as a result
  of research
• The necessity and importance of the research
  outweighs the risks to the subjects
• The researcher(s) is/are qualified to conduct
  research involving human subjects.

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Does your research fall under the IRB?

• Does it involve human subjects?
• Examples
• Surveys/Questionnaires (e.g., phone,
  face-to-face, email, snail mail, web-based forms)
• Interviews
• Review of documentation that contains identifying
  information

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The IRB Process

• Approved Preliminary Proposal
• Email Dr. Cannady of your intention to submit IRB
  forms (ESET entry will be created)
• Complete and submit IRB documentation to ESET
• IRB Submission Form
• Research Protocol
• Additional Documentation (as requested)
• Consent forms
• Example questionnaires
• Notification of status
• AFTER receipt of IRB approval,
• initiate research

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IRB Submission Form

•  
• I. General Information
• II. Funding Information
• III. Cooperative Research
• IV. Subject/patient Information
• V. Continuation or Renewals

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Research Protocol

• Description of Study
• Purpose and Potential Benefits
• Location of Study
• Dates of study
• Subjects
• Methods and Procedures
• Participant Payments or Costs
• Subject Confidentiality
• Potential Risks to Subjects
• Risk/Benefit Ratio
• Informed Consent

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Types of Review

• Full
• Requires review of proposed research by full
  University-level IRB.
• Expedited
• Abbreviated review process of research where
• The research must involve no more than minimal
  risk to the human subjects
• Exempt
• Does not require review by University-level IRB

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Research Requiring Full Reviews

• Any research that involves the collection of data
  from a child (e.g., interviews, surveys,
  questionnaires, etc.)
• Research which involves the administration of
  drugs or other substances to subjects
• Research involving pregnant women and/or fetuses
  in utero
• Research involving subjects with life-threatening
  physical conditions
• Research involving physically intrusive
  procedures
• Research which previous experience (by the
  particular investigator or other investigators)
  has shown to create a potential of risk to
  subjects
• Research which potentially could put the subject
  at risk for legal or civil liability or invade a
  subject's privacy in regard to sensitive aspects
  of his/her behavior

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Special Populations

• Additional restrictions are placed on certain
  human subjects
• Pregnant Women and Fetuses
• Prisoners
• Children
• Minimal risk
• Assent of children/parents
• More than minimal risk
• The risk is justified by the anticipated benefit
  to the subjects
• Assent of children/parents

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Exempt from Full Review

• Research in which the risks of harm reasonably
  anticipated are not greater than those ordinarily
  encountered in daily life or during the
  performance of routine procedures in education
  and/or in the practice of psychology and medicine
  
• Research on the effectiveness of educational,
  classroom, and/or instructional strategies,
  provided that these strategies are familiar, and
  nonintrusive in their implementation
• Research using educational tests (cognitive,
  diagnostic, aptitude, achievement) if subjects'
  identities are thoroughly protected
• Research using survey procedures or interview
  procedures where subjects' identities are
  thoroughly protected and their answers do not
  subject them to criminal and civil liability
• Research involving the collection or study of
  existing data, documents, records, specimens, or
  other products, if these sources are publicly
  available or the information is recorded by the
  investigator in such a manner that the subjects
  cannot be identified directly or indirectly.

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Additional Reviews

• Continuation/Renewal
• Reviews are good for one year. Continuing review
  of research must be conducted at intervals
  appropriate to the degree of risk, but not less
  than once per year.
• Revisions
• If there are revisions to the research protocol
  (e.g., changes to the informed consent form,
  survey instruments used, number and nature of
  subjects, etc.) the IRB must be notified
  immediately.

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Considerations

• If the identity of the human subject can be
  associated at any point with the data being
  collected a consent form must be used.
• Most GSCIS research ultimately falls within the
  Exempt category
• Faculty are responsible for obtaining approval
  for course-related research
• IRB process must be started at least 60 days
  before research initiation date
• Additional information
• http//www.nova.edu/cwis/ogc/irb/manual.html

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Questions??Dr. Jim Cannadycannady_at_nova.edu954.
262.2085