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									Troy University
Institutional Review Board
    What You Need to Know

                Presented by
                Janet McNellis, Ph.D
                Chair, IRB

                           Troy Campus
                           April 11th, 2007
Introduction
 Definitions
    Research
    Human Subjects
 What is the Institutional Review Board?
 Federal Regulations
 Behavioral Research
 Application Process
 Student Research
What is Research?
  A systematic investigation, including research
   development, testing and evaluation,
   designed to develop or contribute to
   generalizable knowledge.
What is a Human Subject?
A living individual about whom an investigator
     conducting research obtains
     (1) Data through intervention or interaction
     with the individual, or
     (2) Identifiable private information.
What is the Institutional Review
Board?
 Mission Statement
 Reviews and approves all research studies
  involving human subjects across all Troy
  campuses and sites
Federal Regulations
 Basic HHS Policy for Protection of Human
  Research Subjects
 Belmont Report
 International Research
     Declaration of Helsinki - Medical
     The International Compilation of Human
      Subject Research Protections
     Other International Guidance Documents
Behavioral Research
 No physical intervention or risk
 Risks
   Social Harm
           Reputation
           Employability
      Psychological Harm
           Deception
           Unpleasant information about self
           Emotional stress
Application Process
1) Get certified - on-line training
2) Complete application, all additional
   materials
3) Convert to one electronic document, email
   to irb@troy.edu
4) Print out signature page, fax or send to IRB
   Office
How Do I Get Certified?
 Complete Training at
  http://www.research.umn.edu/consent/
 Have results of quiz sent to irb@troy.edu
 You will receive copy of results. Send with
  proposal.
 Working on recertification process.




11/9/2011                                       9
Application
 One application for all studies
 IRB Chair determines what type of review is
  needed
 Revised Application on Website
 Deadlines for review
Material to include with
application
 Research instruments - Interview Guides, Surveys,
  etc.
 Advertisements
 Informed Consent Documents
      Written or verbal consent
      Child’s assent script
 If thesis, the complete Methods Section
 Permission from school system
 Certificates of confidentiality
 Informed Consent
 Participants must understand the purpose,
  the procedures, the potential risks and
  benefits of their involvement, and their
  alternatives to participation.
 PROCESS, not a document
 Can be revoked at any time
 Must be at level participant can understand
 Training site has step-by-step instructions:
  Create a consent document
 Must use copy of form with IRB stamp
    After Submission
 Secretary begins file, passes to Chair
 Chair decides on type of review
 After review, email sent to PI
 Approved, or reasons for non-approval
 May revise and resubmit. Need in electronic form.
 Once approved, letter emailed, stamped consent
  form sent through hand mail.
 Continuing review -- at least once a year or as
  needed
 If unanticipated risks or changes, contact IRB
Student Research
 If solely for a class, does not need to be reviewed.
 If possibility of publication then it should be reviewed.
 All thesis work must be reviewed.
 Students should have training certificate sent to
  faculty supervisor, include copy with application.
 Instructors can aid students in constructing research
  that will be Exempt from review
Faculty Oversight
 Faculty member signs off on protocol stating that they
  will
      oversee the work described
      ensure that all of the PI responsibilities are fulfilled
      Check protocol for content, clarity, and methodology
 If co-author, get supervisor to sign
 Thesis Research -- submit “Human or Animal
  Subjects Review” form after IRB approval
Other Important Information
 Data and informed consent should be
  retained for at least three years
 Avoid doing research on own students
 Active consent for research on children.
 PIs may attend IRB meeting to present
  protocol, answer questions.
 Policy violations
Where to Get More Information
 Representatives at
  http://stars.troy.edu/troy_website/irb.html
 IRB Website at
  http://www.troy.edu/institutionalreview/index.h
  tml
 Email us at irb@troy.edu
 Call us at 334-670-3350

								
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