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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 Tracked Changes 08.23.2022
Advertisements Tracked Changes 

09.09.2020

Assent Tracked Changes

10.14.2019

Basic Physiological Research   09.19.2019
Certificates of Confidentiality Tracked Changes 05.16.2019
Compensation of Research Subjects Tracked Changes 04.13.2021
Concise Summary Tracked Changes 02.03.2022
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

05.26.2016

Expedited Review of Research   06.07.2016
Gender Inclusive Language in Research   08.01.2019
Genetic Research Tracked Changes  02.02.2021
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 08.09.2022
IND Exemption Criteria Tracked Changes 08.14.2019
International Research Tracked Changes 08.22.2022
Investigators and Key Study Personnel Tracked Changes

07.08.2022

Investigator Responsibilities for Device Studies Tracked Changes 08.01.2019
Investigator Responsibilities for Drug Studies Tracked Changes 08.01.2019
Mandatory Reporting Tracked Changes

01.20.2021

Multimedia Recordings Tracked Changes

10.17.2019

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 04.28.2021
Privacy and Confidentiality Tracked Changes 04.05.2016
Recruitment and Enrollment of Employees in Research Tracked Changes 08.24.2022
Recruitment Methods Tracked Changes 09.04.2020
Regulatory References - Consent Language for Future Use of Information or Biospecimens Tracked Changes 07.16.2021
Required Documents and Forms for IRB Applications

Tracked Changes

05.28.2019
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

02.02.2022

Research Involving Economically or Educationally Disadvantaged Individuals Tracked Changes

08.10.2022

Research Involving Individuals with Decisional Impairment Tracked Changes

08.30.2019

Research Involving Neonates Tracked Changes 04.08.2022
Research Involving Pregnant Women and Fetuses Tracked Changes 04.11.2022
Research Involving Prisoners Tracked Changes 08.22.2022
Research Involving Risk of Suicide  

09.14.2021

Research Involving Wards of State Tracked Changes

08.11.2016

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

01.20.2022

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 Tracked Changes 04.06.2022
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  04.05.2022

Board Member Guidance Series

Last Updated: 9/15/22