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Chapter
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Title
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Chapter 1
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The information previously found in Chapter 1 of the IRB Reference Manual has
been incorporated into the IRB Policy and Procedure Manual.
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Chapter 2
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Chapter 2 has been incorporated into the IRB Policy and Procedure
Manual as follows: Chapter IX includes information about the “No Human Subjects”
and the “Not Research” designations; Chapter X includes information about Exempt
Reviews; Chapter XI includes information about Expedited Reviews; Chapter XII includes
information about Full Board Reviews; and Chapter XVI includes information about
Emergency Use.
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Chapter 3
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Information regarding continuing review of research protocols can be found in
the IRB Policy and Procedure Manual.
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Chapter 4
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Chapter 4 has been incorporated into the IRB Policy and Procedure
Manual, Chapter VIII.K.
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Chapter 5
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Information regarding research subject and patient recruitment can be found
in the IRB Policy and Procedure Manual.
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Chapter 6
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Information regarding special subject populations can be found in Chapter XIV
of the IRB Policy and Procedure Manual
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Chapter 7
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Information related to submission of research studies through OSIRIS can be
located at http://www.irb.pitt.edu/osiris/instructions/PI-Info.pdf.
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Chapter 8
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Information regarding the informed consent process and document - requirements
and format has been incorporated into the Guidance section
of the IRB website.
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Chapter 9
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Chapter 9 has been incorporated into the OSIRIS application under Investigator
Responsibilities.
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Appendices
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Appendix A
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IRB forms are accessible from the IRB Forms section
of the IRB website.
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Appendix B
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Information regarding the requirements and procedures for the emergency use
of an unapproved investigational drug, biologic Or device has been incorporated
into the Guidance section of the IRB website.
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Appendix C
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"Off-Label" and investigational use of approved drugs and biologics
guidance has been incorporated into the Guidance section
of the IRB website.
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Appendix D
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The Human Use Subcommittee, Radiation Safety Committee, And The Radioactive
Drug Research Committee information has been incorporated into the
Guidance section of the IRB website.
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Appendix E
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Guidance regarding special considerations for the collection and use of tissue
samples for genetic studies and other research purposes has been incorporated into
the Guidance section of the IRB website.
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Appendix F
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Investigational devices guidance has been incorporated into the
Guidance section of the IRB website.
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Appendix G
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Standard screening instruments not requiring submission with research protocols
are listed in the Resources section of the IRB website.
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Appendix H
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Sample consent forms can be found in the Model Consent Documents
section of the IRB website.
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Appendix I
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A glossary of lay terms can be found in the Resources
section of the IRB website.
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Appendix J
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Common abbreviations are listed in the Resources section
of the IRB website.
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Appendix K
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Some definitions of common terms can be found in the Resources
section of the IRB website.
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Appendix L
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Data and safety monitoring plans guidance has been incorporated into the Guidance section of the IRB website.
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Appendix M
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Information about obtaining written informed consent of family members when
research involves the collection of their private info has been incorporated into
the Guidance section of the IRB website.
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Appendix N
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Humanitarian device exemptions guidance has been incorporated into the Guidance section of the IRB website.
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Appendix O
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The Research Participant Information Sheet can be found in the
Resources section of the IRB website.
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Appendix P
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Coordinating center guidance has been incorporated into the
Guidance section of the IRB website.
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Appendix Q
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Information related to conflict of interest can be found at
http://www.coi.pitt.edu/.
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