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Investigator Guidance Series (IGS)

This page serves as a central hub for all of the IGS documents. Topics are updated regularly; this page should be the starting point for any coordinator with a question about IRB policy on a specific topic.

All documents are in PDF format unless otherwise noted.

Document Tracked Changes Version Date
Adverse Event Flowchart   10.09.2013


Assent Tracked Changes


Assessing Risk for Human Participants   01.11.2008
Audio Recordings   02.16.2010
Certificates of Confidentiality Tracked Changes 04.11.2016
Compensation of Research Subjects Tracked Changes 02.16.2018
Concise Summary   12.04.2018
Deception and Debriefing Tracked Changes 06.25.2012
Devices: Review the indexed guidance documents on this topic    
Elements of a Data Monitoring Plan Tracked Changes 05.01.2014
Elements of a Safety Monitoring Plan Tracked Changes 05.01.2014
Exempt Research Tracked Changes 02.03.2014
Exercise Testing in Research Tracked Changes


Genetic Research   08.22.2015
Help Sheet for Exemption Umbrella Protocol Applications   03.21.2014
HIPAA Privacy Rule and Authorization Tracked Changes 01.29.2014
Human Tissue Transfer Tracked Changes 02.24.2015
IND Exemption Criteria   08.06.2014
International Research Tracked Changes 12.05.2014
Investigator Qualifications Tracked Changes


Investigator Responsibilities for Device Studies Tracked Changes 04.29.2014
Investigator Responsibilities for Drug Studies Tracked Changes 06.16.2015
Multimedia Recordings Tracked Changes


Parental Permission Tracked Changes 03.21.2014
Payment Arrangements to Research Personnel  N/A 04.24.2009
Placebo Comparators Tracked Changes 07.31.2017
Pregnancy During Research Participation  Tracked Changes 03.08.2018
Privacy and Confidentiality Tracked Changes 04.05.2016
Recruitment and Enrollment of Employees in Research Tracked Changes 01.11.2014
Recruitment Methods Tracked Changes 06.06.2018
Regulatory References for Tissue Banking Consent Language   07.03.2014
Reportable Diseases N/A


Required Documents and Forms for IRB Applications

Tracked Changes
Tracked Changes

Research Conducted in Elementary and Secondary Schools Tracked Changes 08.30.2017
Research Conducted in Post-Secondary Schools Tracked Changes 08.30.2017
Research Design Tracked Changes 04.22.2016
Research Involving Children Tracked Changes


Research Involving Individuals with Decisional Impairment Tracked Changes


Research Involving Neonates Tracked Changes 03.08.2016
Research Involving Pregnant Women and Fetuses Tracked Changes 03.05.2018
Research Involving Prisoners Tracked Changes 08.28.2014
Research Involving Wards of State Tracked Changes


Risk Assessment Tracked Changes 04.22.2016
Secondary Analysis of Existing Datasets Tracked Changes


Sponsor-Investigator Guidelines and Responsibilities Tracked Changes 03.17.2016
Summary Guidance: Creating and Managing Tissue Banks for Research   09.15.2013
The 18 Protected Health Information (PHI) HIPAA Identifiers   03.20.2013
Tissue Banking: Review the indexed guidance documents on this topic    
Transplantation of Fetal Tissue Tracked Changes 06.25.2012
UPDB Consent and Authorization Requirements Tracked Changes 09.14.2015
Waiver or Alteration of Consent   10.23.2018

Board Member Guidance Series

Last Updated: 12/7/18