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.
Adverse Events/Unanticipated Problems Assessment Flowchart
Last Updated: August 23, 2022
Considerations for Pregnancy Testing Prior to Radiation Exposure for Research Purposes
Last Updated: March 4, 2016
IRB Authority: Observation of Consent & Conduct of Research
Last Updated: August 25, 2019
Waivers of Consent for Research with Prospective Data Collection
Last Updated: July 18, 2024
Including Spanish-Speaking Individuals in Research
Last Updated: July 22, 2024
Investigator Responsibilities for Device Studies
Last Updated: February 22, 2023
Investigator Responsibilities for Drug Studies
Last Updated: February 22, 2023
Privacy and Confidentiality
Last Updated: April 5, 2016
Recruitment and Enrollment of Employees in Research
Last Updated: August 24, 2022
Regulatory References – Consent Language for Future Use of Information or Biospecimens
Last Updated: July 16, 2021
Required Documents and Forms for IRB Applications
Last Updated: July 3, 2023
Research Conducted in Elementary and Secondary Schools
Last Updated: September 22, 2020
Research Conducted in Post-Secondary Schools
Last Updated: September 10, 2020
Research Involving Economically or Educationally Disadvantaged Individuals
Last Updated: August 10, 2022
Research Involving Individuals with Decisional Impairment
Last Updated: February 16, 2024
Short Form Consent Process Instructions for Use
Last Updated: December 13, 2022
Sponsor-Investigator Guidelines and Responsibilities
Last Updated: August 7, 2019
Summary Guidance: Creating and Managing Tissue Banks for Research
Last Updated: September 15, 2013