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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 Tracked Changes 08.23.2022
Advertisements Tracked Changes 

09.09.2020
Basic Physiological Research N/A 09.19.2019
Certificates of Confidentiality Tracked Changes 04.26.2024
Compensation of Research Subjects Tracked Changes 04.13.2021
Concise Summary Tracked Changes 02.03.2022
Consent During the COVID-19 Public Health Emergency N/A 09.22.2020
Data & Biospecimens, Future Use    
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 09.29.2022
Elements of a Safety Monitoring Plan Tracked Changes 09.29.2022
Exempt Research Tracked Changes 03.06.2024
Exercise Testing in Research Tracked Changes

05.26.2016
Expedited Review of Research Tracked Changes 02.21.2023
Gender Inclusive Language in Research N/A 08.01.2019
Genetic Research Tracked Changes  02.02.2021
Help Sheet for Exemption Umbrella Protocol Applications N/A 03.21.2014
HIPAA Privacy Rule and Authorization Tracked Changes 10.21.2019
Human Tissue Transfer Tracked Changes 08.09.2022
Including Spanish-Speaking Individuals in Research Tracked Changes 07.22.2024
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 02.22.2023
Investigator Responsibilities for Drug Studies Tracked Changes 02.22.2023
Mandatory Reporting Tracked Changes

01.20.2021
Multimedia Recordings Tracked Changes

10.17.2019
Parental Permission and Child Assent Tracked Changes 02.16.2024
Payments for Referrals to Research Studies  Tracked Changes 02.06.2024
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

 07.03.2023
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

02.16.2024
Research Involving Neonates Tracked Changes 04.08.2022
Research Involving Pregnant Women and Fetuses Tracked Changes 04.26.2024
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
Short Form Consent Process Instructions for Use Tracked Changes

12.13.2022
Sponsor-Investigator Guidelines and Responsibilities Tracked Changes 08.07.2019
Summary Guidance: Creating and Managing Tissue Banks for Research   09.15.2013
Surrogate Consent by a Legally Authorized Representative N/A 02.16.2024
The 18 Protected Health Information (PHI) HIPAA Identifiers   03.20.2013
Tissue Banking: See "Data and Biospecimens"    
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  07.18.2024

Board Member Guidance Series

Document Tracked Changes Version Date
     
Applicable State Laws Tracked Changes 02.16.2024
Biopsies for Research Purposes Tracked Changes

05.26.2021
Considerations for Pregnancy Testing Prior to Radiation Exposure for Research Purposes N/A

03.01.2016
Equitable Selection of Participants Tracked Changes 08.26.2019
Ethical Considerations for Surrogate Consent N/A 02.16.2024
Expedited Category 8(a) Decision Chart N/A 03.21.2022
Expedited Category 9 Decision Chart Tracked Changes 11.20.2020
IRB Authority: Observation of Consent & Conduct of Research Tracked Changes 08.25.2019
SIRB Site-Control Review Instructions Tracked Changes 11.17.2020
Verification from Other Sources N/A 04.30.2019
Virtual IRB Meetings N/A 03.16.2020
Waivers of Consent for Research with Prospective Data Collection Tracked Changes 07.18.2024
Writing a Review Summary Tracked Changes 07.15.2020
Last Updated: 10/22/24