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Home 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.

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Adverse Events/Unanticipated Problems Assessment Flowchart
Last Updated: August 23, 2022
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Advertisements
Last Updated: September 9, 2020
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Applicable State Laws
Last Updated: February 16, 2024
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Basic Physiological Research
Last Updated: September 19, 2019
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Biopsies for Research Purposes
Last Updated: May 26, 2021
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Certificates of Confidentiality
Last Updated: April 26, 2024
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Compensation of Research Subjects
Last Updated: April 13, 2021
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Concise Summary
Last Updated: February 3, 2022
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Consent During the COVID-19 Public Health Emergency
Last Updated: September 22, 2020
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Data & Biospecimens, Future Use
Last Updated: October 22, 2024
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Deception and Debriefing
Last Updated: June 25, 2012
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Devices Guidance
Last Updated: October 22, 2024
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Elements of a Data Monitoring Plan
Last Updated: September 29, 2022
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Elements of a Safety Monitoring Plan
Last Updated: September 29, 2022
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Equitable Selection of Participants (BMGS)
Last Updated: February 26, 2025
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Ethical Considerations for Surrogate Consent
Last Updated: February 16, 2024
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Exempt Research
Last Updated: March 6, 2024
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Exercise Testing in Research
Last Updated: May 26, 2016
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Expedited Category 8(a) Decision Chart
Last Updated: March 21, 2022
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Expedited Category 9 Decision Chart
Last Updated: November 20, 2020
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Expedited Review of Research
Last Updated: February 21, 2023
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Gender Inclusive Language in Research
Last Updated: August 1, 2019
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Genetic Research
Last Updated: February 2, 2021
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Help Sheet for Exemption Umbrella Protocol Applications
Last Updated: March 21, 2014
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HIPAA Privacy Rule and Authorization
Last Updated: October 21, 2019
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Human Tissue Transfer
Last Updated: August 9, 2022
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Including Spanish-Speaking Individuals in Research
Last Updated: July 22, 2024
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International Research
Last Updated: August 22, 2022
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Investigator Responsibilities for Device Studies
Last Updated: February 22, 2023
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Investigator Responsibilities for Drug Studies
Last Updated: February 22, 2023
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Investigators and Key Study Personnel
Last Updated: July 8, 2022
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IRB Authority: Observation of Consent & Conduct of Research (BMGS)
Last Updated: August 25, 2019
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Mandatory Reporting
Last Updated: January 20, 2021
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Multimedia Recordings
Last Updated: October 17, 2019
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Parental Permission and Child Assent
Last Updated: February 16, 2024
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Payments for Referrals to Research Studies
Last Updated: February 6, 2024
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Placebo Comparators
Last Updated: September 4, 2020
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Pregnancy During Research Participation
Last Updated: April 28, 2021
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Pregnancy Testing Prior to Radiation Exposure for Research Purposes (BMGS)
Last Updated: February 27, 2025
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Privacy and Confidentiality
Last Updated: April 5, 2016
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Recruitment and Enrollment of Employees in Research
Last Updated: August 24, 2022
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Recruitment Methods
Last Updated: September 4, 2020
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Regulatory References – Consent Language for Future Use of Information or Biospecimens
Last Updated: July 16, 2021
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Required Documents and Forms for IRB Applications
Last Updated: July 3, 2023
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Research Conducted in Elementary and Secondary Schools
Last Updated: September 22, 2020
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Research Conducted in Post-Secondary Schools
Last Updated: September 10, 2020
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Research Design
Last Updated: September 10, 2020
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Research Involving Children
Last Updated: February 2, 2022
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Research Involving Economically or Educationally Disadvantaged Individuals
Last Updated: August 10, 2022
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Research Involving Individuals with Decisional Impairment
Last Updated: February 16, 2024
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Research Involving Neonates
Last Updated: April 8, 2022
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Research Involving Pregnant Women and Fetuses
Last Updated: April 26, 2024
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Research Involving Prisoners
Last Updated: August 22, 2022
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Research Involving Risk of Suicide
Last Updated: September 14, 2021
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Research Involving Wards of State
Last Updated: August 11, 2016
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Risk Assessment
Last Updated: August 14, 2020
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Secondary Analysis of Public Use Datasets
Last Updated: January 20, 2022
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Short Form Consent Process Instructions for Use
Last Updated: December 13, 2022
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SIRB Site-Control Review Instructions
Last Updated: November 17, 2020
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Sponsor-Investigator Guidelines and Responsibilities
Last Updated: January 6, 2025
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Summary Guidance: Creating and Managing Tissue Banks for Research
Last Updated: September 15, 2013
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Surrogate Consent by a Legally Authorized Representative
Last Updated: February 16, 2024
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The 18 Protected Health Information (PHI) HIPAA Identifiers
Last Updated: March 20, 2013
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Transitioning to the Final Rule
Last Updated: April 6, 2022
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Transplantation of Fetal Tissue
Last Updated: February 26, 2025
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UPDB Consent and Authorization Requirements
Last Updated: October 2, 2019
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Verification from Other Sources
Last Updated: April 30, 2019
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Virtual IRB Meetings
Last Updated: March 16, 2020
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Waiver or Alteration of Consent
Last Updated: July 18, 2024
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Waivers of Consent for Research with Prospective Data Collection
Last Updated: July 18, 2024
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Writing a Review Summary
Last Updated: February 20, 2025
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