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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.

Adverse Events/Unanticipated Problems Assessment Flowchart

Last Updated: 2022-08-23

Advertisements

Last Updated: 2020-09-09

Applicable State Laws

Last Updated: 2022-07-14

Assent

Last Updated: 2019-10-14

Basic Physiological Research

Last Updated: 2019-09-19

Biopsies for Research Purposes

Last Updated: 2021-05-26

Certificates of Confidentiality

Last Updated: 2019-05-16

Compensation of Research Subjects

Last Updated: 2021-04-13

Concise Summary

Last Updated: 2022-02-03

Consent During the COVID-19 Public Health Emergency

Last Updated: 2020-09-22

Considerations for Pregnancy Testing Prior to Radiation Exposure for Research Purposes

Last Updated: 2016-03-01

Deception and Debriefing

Last Updated: 2012-06-25

Elements of a Data Monitoring Plan

Last Updated: 2022-09-29

Elements of a Safety Monitoring Plan

Last Updated: 2022-09-29

Equitable Selection of Participants

Last Updated: 2019-08-26

Exempt Research

Last Updated: 2023-03-06

Exercise Testing in Research

Last Updated: 2016-05-26

Expedited Category 8(a) Decision Chart

Last Updated: 2022-03-21

Expedited Category 9 Decision Chart

Last Updated: 2020-11-20

Expedited Review of Research

Last Updated: 2023-02-21

Gender Inclusive Language in Research

Last Updated: 2019-08-01

Genetic Research

Last Updated: 2021-02-02

Help Sheet for Exemption Umbrella Protocol Applications

Last Updated: 2014-03-21

HIPAA Privacy Rule and Authorization

Last Updated: 2019-10-21

Human Tissue Transfer

Last Updated: 2022-08-09

Including Spanish-Speaking Individuals in Research

Last Updated: 2023-11-15

IND Exemption Criteria

Last Updated: 2019-08-14

International Research

Last Updated: 2022-08-22

Investigator Responsibilities for Device Studies

Last Updated: 2023-02-22

Investigator Responsibilities for Drug Studies

Last Updated: 2022-02-22

Investigators and Key Study Personnel

Last Updated: 2022-07-08

IRB Authority: Observation of Consent & Conduct of Research

Last Updated: 2019-08-25

Mandatory Reporting

Last Updated: 2021-01-20

Multimedia Recordings

Last Updated: 2019-10-17

Parental Permission

Last Updated: 2019-03-27

Payment Arrangements to Research Personnel

Last Updated: 2009-04-24

Placebo Comparators

Last Updated: 2020-09-04

Pregnancy During Research Participation

Last Updated: 2021-04-28

Privacy and Confidentiality

Last Updated: 2016-04-05

Recruitment and Enrollment of Employees in Research

Last Updated: 2022-08-24

Recruitment Methods

Last Updated: 2020-09-04

Regulatory References – Consent Language for Future Use of Information or Biospecimens

Last Updated: 2021-07-16

Required Documents and Forms for IRB Applications

Last Updated: 2023-07-03

Research Conducted in Elementary and Secondary Schools

Last Updated: 2020-09-22

Research Conducted in Post-Secondary Schools

Last Updated: 2020-09-10

Research Design

Last Updated: 2020-09-10

Research Involving Children

Last Updated: 2022-02-02

Research Involving Economically or Educationally Disadvantaged Individuals

Last Updated: 2022-08-10

Research Involving Individuals with Decisional Impairment

Last Updated: 2019-08-30

Research Involving Neonates

Last Updated: 2022-04-08

Research Involving Pregnant Women and Fetuses

Last Updated: 2022-04-11

Research Involving Prisoners

Last Updated: 2022-08-22

Research Involving Risk of Suicide

Last Updated: 2021-09-14

Research Involving Wards of State

Last Updated: 2016-08-11

Risk Assessment

Last Updated: 2020-08-14

Secondary Analysis of Public Use Datasets

Last Updated: 2022-01-20

Short Form Consent Process Instructions for Use

Last Updated: 2022-12-13

SIRB Site-Control Review Instructions

Last Updated: 2020-11-17

Sponsor-Investigator Guidelines and Responsibilities

Last Updated: 2019-08-07

Summary Guidance: Creating and Managing Tissue Banks for Research

Last Updated: 2013-09-15

The 18 Protected Health Information (PHI) HIPAA Identifiers

Last Updated: 2013-03-20

Transitioning to the Final Rule

Last Updated: 2022-04-06

Transplantation of Fetal Tissue

Last Updated: 2012-06-25

UPDB Consent and Authorization Requirements

Last Updated: 2019-10-02

Verification from Other Sources

Last Updated: 2019-04-30

Virtual IRB Meetings

Last Updated: 2020-03-16

Waiver or Alteration of Consent

Last Updated: 2022-04-05

Waivers of Consent for Research with Prospective Data Collection

Last Updated: 2019-08-01

Writing a Review Summary

Last Updated: 2020-07-15