PATHOLOGY GUIDANCE DOCUMENT FOR IRB SUBMISSIONS

SOME GROUND RULES

PURPOSE OF THE GUIDELINES

CLASSES OF RESEARCH

GENERAL STRUCTURE OF  PATHOLOGY GUIDANCE DOCUMENT

GENERAL RULES

CASE REPORT

CASE REPORTS

CASE REPORT

METHODS DEVELOPMENT
Scenario 1

METHODS DEVELOPMENT AND VALIDATION

METHODS DEVELOPMENT
Scenario 1b

METHODS DEVELOPMENT AND VALIDATION

QUALITY ASSURANCE VS RESEARCH
Nat’l Bioethics Advisory Committee

QUALITY ASSURANCE VS RESEARCH
Nat’l Bioethics Advisory Committee

METHODS DEVELOPMENT
Scenario 2

METHODS DEVELOPMENT

POINTS TO NOTE

METHODS DEVELOPMENT
Master Protocol

PROTECTION OF IDENTIFIERS

METHODS DEVELOPMENT
Scenario 2

METHODS DEVELOPMENT
Scenario 3

METHODS DEVELOPMENT

METHODS DEVELOPMENT
Scenario 3

STUDIES ON ARCHIVAL TISSUE
Scenario 1

STUDIES ON ARCHIVAL TISSUE

STUDIES ON ARCHIVAL TISSUE
Scenario 1

REQUESTS FOR EXEMPTION
Key points to note in letter/email

Slide 29

STUDIES ON ARCHIVAL TISSUE
Scenario 2

STUDIES ON ARCHIVAL TISSUE

STUDIES ON ARCHIVAL TISSUE
Identifiers retained

WAIVER OF INFORMED CONSENT
Four Requirements under 45 CFR 46.116

STUDIES ON ARCHIVAL TISSUE
Identifiers retained

PROCEDURE FOR AMENDING MASTER PROTOCOL

STUDIES ON ARCHIVAL TISSUE
Scenario 3

STUDIES ON ARCHIVAL TISSUE

STUDIES ON ARCHIVAL TISSUE
Scenario 3

STUDIES ON ARCHIVAL TISSUE
Scenario 3

AUTOPSY STUDIES
Scenario 1

AUTOPSY STUDIES

AUTOPSY STUDIES

KEY POINTS

ASK ?