IRB Process Overview

1
IRB Process Overview

• Ling Wang
• IRB Representative
• Graduate School of Computer and Information
  Sciences

2
Agenda

• Introduction
• IRB Responsibilities
• Overview of the Process
• Steps in the Process
• Documentation
• Additional Reviews
• Additional Information
• Questions and Answers

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Introduction

• Research involving human subjects must be
  reviewed by Institutional Review Board (lRB)
• The National Research Act Public Law 99-158
• Title 45, Part 46 of the Code of Federal
  Regulations
• Guidelines are provided for research with human
  subjects to ensure their protection in the design
  and conduct of research
• 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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Overview of the Process (1)

• Does your research 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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Overview of the Process (2)

• Types of Review
• All research studies involving human subjects are
  reviewed in one of three ways
• Center Level Review (previously labeled Exempt
  Research)
• Expedited Review
• Full Review
• Every research protocol begins with a complete
  submission to the principal investigators
  respective Center Representative.
• The Center Representative, not the principal
  investigator, is charged with reviewing the
  submission to determine the appropriate level of
  review for the study as well as assuring that all
  necessary documents are included.

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Overview of the Process (3)

• Types of Review
• Full Review
• Full review by the entire IRB panel (full
  University-level IRB) is reserved for studies
  that have potential risk to human subjects.
• The Center Representative will ask that the PI
  provide 23 copies (and one original) of the
  complete IRB submission to be reviewed at the
  monthly IRB meeting.
• Expedited Review
• In some circumstances, if there is no more than
  minimal risk, expedited review can be conducted
  even on studies involving minors.
• The Expedited Review is conducted by the IRB
  Chair or his/her designee.
• Center Level Review
• Research that represents no more than minimal
  risks to participants and does not involve
  special populations (such as the mentally
  retarded, some types of studies with children,
  prisoners, etc.).
• Does not require review by University-level IRB

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Steps in the Process

• Approved Idea Paper
• Work with your dissertation advisor to determine
  when it is the time to submit IRB documents
• Complete and submit IRB documents to the IRB
  portal in the DTS
• CITI Completion Report (Who? When? How?)
• IRB Submission Form
• Additional Documentation (as applicable)
• Informed Consent forms
• Data Collection Instruments (surveys,
  questionnaires, etc.)
• Evidence of approval by cooperative IRBs at other
  sites
• Brochure/recruitment materials
• Notification of status
• AFTER receipt of IRB approval, initiate research

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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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Additional Information

• Course project involving human subjects IRB
  approval not required if both conditions are met
• The research is required by a course
• The student realizes that they can NEVER publish
  the results of the research outside of class.
  This includes a prohibition of use in
  dissertations.
• Informed Consent Form When a waiver can be
  granted?
• Timing
• Useful Links
• http//www.scis.nova.edu/program/irb.html
• http//www.nova.edu/irb/manual/forms.html

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Questions ??

• Ling Wang
• lingwang_at_nova.edu
• 954-262-2020
• http//scis.nova.edu/lingwang/