AARHPP

Investigator Guidance Series

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.

Document Tracked Changes Version Date
Adverse Event Flowchart   02.22.2008
Advertisements Tracked Changes 01.30.2012
Assent   03.16.2010
Assessing Risk for Human Participants   01.11.2008
Audio Recordings   02.16.2010
Certificates of Confidentiality   07.14.2010
Children in Research Tracked Changes 02.23.2012
Cognitively-Impaired Individuals (Non-VA)   04.22.2009
Compensation   08.01.2011
Contraceptive Methods   12.09.2011
Data and Safety Monitoring   04.22.2009
Deception and Debriefing   04.10.2008
Devices   N/A
Exempt Research   2.24.2012
Exercise Testing   12.19.2009
Genetic Research   01.05.2012
Guidance for Accessing Protected Health Information - UUHSC   04.19.2011
HIPAA Privacy Rule and Authorization   01.11.2012
HIV Antibody Testing Tracked Changes 03.31.2012
Humanitarian Use Devices (HUD)   03.10.2008
Human Tissue Transfer   01.25.2012
Investigator Qualifications Tracked Changes 03.10.2012
Investigator Responsibilities for Device Studies Tracked Changes 03.10.2012
Investigator Responsibilities for Drug Studies Tracked Changes 03.01.2012
Limited Data Set   01.11.2012
Multimedia Recordings Tracked Changes 02.21.2012
Parental Permission   04.01.2009
Payment Arrangements to Research Personnel   04.24.2009
Placebo Comparators Tracked Changes 02.27.2012
Pregnancy During Research   12.09.2011
Privacy and Confidentiality in Research   05.05.2010
Recruitment and Enrollment of Employees   01.05.2012
Recruitment Methods Tracked Changes 01.30.2012
Reimbursement   08.01.2011
Research Design   05.06.2010
Research Involving Neonates   07.28.2009
Research Involving Prisoners Tracked Changes 04.14.2012
Research Involving Pregnant Women and Fetuses   07.15.2009
Research Involving Students   10.25.2009
Risk Assessment   01.11.2010
Safe Harbor   01.11.2012
Secondary Data - Analysis of Existing Datasets   01.14.2012
Sponsor-Investigator Guidelines and Responsibilities   07.10.2010
Statistical Analysis De-Identification   01.11.2012
Transplantation of Fetal Tissue   01.07.2010
UPDB Consent and Authorization Requirements   02.01.2011
VA Research Involving Cognitively Impaired Individuals   04.22.2009
Video Recordings   02.16.2010
Wards of State Tracked Changes 02.27.2012

Board Member Guidance Series

Document Tracked Changes Version Date
Applicable State Laws   05.26.2009
Equitable Selection of Participants Tracked Version 04.23.2012
Observation of Consent   12.12.2011
Writing a Review Summary   08.2008