Docstoc

IRB IRB Institutional Review Board

Document Sample
IRB IRB Institutional Review Board Powered By Docstoc
					    IRB


 Institutional
Review Board
Institutional Review Board – Human Subjects


                         Agenda
       What?
       Where?
       Who?
       How?
       When?
Institutional Review Board – Human Subjects


                  What is the IRB?
  Institutional Review Board

  Coordinates compliance administration in the
   protection of human subjects use in research

  Regulatory and ethical concerns

  Institutional and independent
Institutional Review Board – Human Subjects


Where do we get information about IRB?

  Office of Sponsored Programs
      Alumni Hall
      Room G-76
      http://www.gsu.edu/~wwwosp/
        • Click on “Research Compliance”
Institutional Review Board – Human Subjects


  Who has to comply with the IRB?
  Any researcher(s) proposing
   a study that involves human
   subjects that are associated
   with GSU

  Human Subjects
      Live individuals about
       whom the researcher obtains:
         • Data through interventional or
           interaction
         • Identifiable private information
Institutional Review Board – Human Subjects


   How do we comply with the IRB?
                New Project Application

 Submit the following (original + 1 copy):
     1. Application
     2. Summary
             subjects
             of
                1 page describing your project and treatment

     3. Consent form
            Plain English
     4. Proposal sections
            Questionnaire or interview material
            Subject treatment
                        See Application

    Institutional Review Board – Human Subjects


       How do we comply with the IRB?
                 Continuing Project Application

     Submit the following (original + 1 copy):
         1. Application
                Marked as “renewal”
         2. Summary
                 1 page describing your project and treatment
                 of subjects
         3. Consent form
                Plain English

    Institutional Review Board – Human Subjects


       How do we comply with the IRB?
                 Continuing Project Application (2)
         4. Statement
                # of subjects studied
                Any problems involving risk
                Withdrawal
                Complaints
                New findings
                Changes in the Research Procedure
                Subject Sample
                Instruments


     Minor Changes – Submit Memo
     Major Changes – Submit New Application
Institutional Review Board – Human Subjects


      How does the process work?

                           Dept Chair
               If exempt                If not exempt



         IRB Auditor                      IRB Chair

            48 hours                          2 weeks


                           Researcher

    Institutional Review Board – Human Subjects


                 Exemption Categories
     Research involving…
          Commonly accepted educational settings
           involving normal educational practices
          Use of educational tests, survey
           procedures, interview procedures, or
           observation behavior, except….
          Collection or study of existing data,
           documents, records, pathological
           specimens if….
          Taste and food quality evaluation and
           consumer acceptance studies if….
Institutional Review Board – Human Subjects

               Criteria for Approval
  Are risks minimized?

  Are risks reasonable, relative to the benefits
   and knowledge expected to accrue?

  Is selection of subjects equitable?

  Are subjects adequately informed about the
   research and their rights?

  Is consent appropriately documented?

  Is the safety of subjects Protected?

  If appropriate, is confidentiality of data
   protected?
Institutional Review Board – Human Subjects


 When do we have to hand in IRB apps?

                              Deadline date for IRB
                               Application
                                  the Monday before the 2nd
                                   Thursday of each month
                                  10 days before the IRB
                                   meeting

                              IRB Review Committee
                               Meeting
                                  the third (3rd) Thursday of
                                   each month
Institutional Review Board – Human Subjects

 When do we have to hand in IRB apps?
 IRB Application Deadlines            IRB Meeting Dates
          July 8, 2002                    July 18, 2002
        August 5, 2002                   August 15, 2002
      September 9, 2002                September 19, 2002
        October 7, 2002                 October 17, 2002
      November 11, 2002                November 21, 2002
       December 9, 2002                December 19, 2002
        January 6, 2003                 January 16, 2003
       February 10, 2003                February 20, 2003
        March 10, 2003                   March 20, 2003
          April 7, 2003                   April 17, 2003
          May 5, 2003                     May 15, 2003
          June 9, 2003                    June 19, 2003
Institutional Review Board – Human Subjects


             Unaddressed Issues?
  Guidelines for online data
   collection
      web-based and email
       surveys
  Happy
Researching

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:22
posted:3/5/2012
language:English
pages:15