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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 Events/Unanticipated Problems Assessment Flowchart   07.02.2019
Advertisements Tracked Changes 


Assent Tracked Changes


Basic Physiological Research   09.19.2019
Certificates of Confidentiality Tracked Changes 05.16.2019
Compensation of Research Subjects Tracked Changes 02.16.2018
Concise Summary   12.04.2018
Consent During the COVID-19 Public Health Emergency   09.22.2020
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 07.31.2019
Elements of a Safety Monitoring Plan Tracked Changes 06.08.2019
Exempt Research Tracked Changes 08.13.2019
Exercise Testing in Research Tracked Changes


Gender Inclusive Language in Research   08.01.2019
Genetic Research Tracked Changes  01.21.2019
Help Sheet for Exemption Umbrella Protocol Applications   03.21.2014
HIPAA Privacy Rule and Authorization Tracked Changes 10.21.2019
Human Tissue Transfer Tracked Changes 04.15.2019
IND Exemption Criteria Tracked Changes 08.14.2019
International Research Tracked Changes 05.20.2019
Investigator Qualifications Tracked Changes


Investigator Responsibilities for Device Studies Tracked Changes 08.01.2019
Investigator Responsibilities for Drug Studies Tracked Changes 08.01.2019
Multimedia Recordings Tracked Changes


Parental Permission Tracked Changes 03.27.2019
Payment Arrangements to Research Personnel  N/A 04.24.2009
Placebo Comparators Tracked Changes 09.04.2020
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 07.09.2019
Recruitment Methods Tracked Changes 09.04.2020
Regulatory References for Tissue Banking Consent Language   07.03.2014
Reportable Diseases Tracked Changes


Required Documents and Forms for IRB Applications

Tracked Changes

Research Conducted in Elementary and Secondary Schools Tracked Changes 09.22.2020
Research Conducted in Post-Secondary Schools Tracked Changes 09.10.2020
Research Design Tracked Changes 09.10.2020
Research Involving Children Tracked Changes


Research Involving Economically or Educationally Disadvantaged Individuals N/A


Research Involving Individuals with Decisional Impairment Tracked Changes


Research Involving Neonates Tracked Changes 01.21.2019
Research Involving Pregnant Women and Fetuses Tracked Changes 01.21.2019
Research Involving Prisoners Tracked Changes 04.01.2019
Research Involving Wards of State Tracked Changes


Risk Assessment Tracked Changes 08.14.2020
Secondary Analysis of Public Use Datasets Tracked Changes


Sponsor-Investigator Guidelines and Responsibilities Tracked Changes 08.07.2019
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    
Transitioning to the Final Rule   01.15.2019
Transplantation of Fetal Tissue Tracked Changes 06.25.2012
UPDB Consent and Authorization Requirements Tracked Changes 10.02.2019
Waiver or Alteration of Consent Tracked Changes  01.21.2019

Board Member Guidance Series

Last Updated: 9/24/20