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DAIDS Regulatory Support Center (RSC)
DAIDS Regulatory Support Center (RSC)
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Clinical Research Sites

Summary of Resources
Safety
EAE Manual
DAERS
Paper EAE Reporting
Grading Tables
Training & Resources
Information Distribution
Protocol Registration
Policy and Procedures Manual
DPRS
Registering a Site to a Protocol
Site Deregistration
Training & Resources
Forms
Personnel Information
Protocol Information in DAIDS-ES
DAIDS Record Storage Assessment
DAIDS Financial Disclosure Forms
Informed Consent Process Information

Informed Consent Process Information

DAIDS Memo Regarding Timing of Consent and Re-Consent with Updated IRB/EC/RE-Approved Informed Consent Forms.

August 2018

DAIDS Memo Regarding New DAIDS Requirements:  Informed Consent Process

August 2017

Please see the example Standard Operating Procedures below illustrating requisite information related to the informed consent process.

NIH Human Research Protection Program Standard Operating Procedure/Policy Approval & Implementation: Requirements for Informed Consent (Guidance resource – for use as an example only) 

Version 5.0 - May 2017

Example SOP for Obtaining Informed Consent (Adapted from the Microbicide Trials Network)

Version 1.0 - September 2017

Example SOP for Obtaining Informed Consent in Research Involving Children (Adapted from the Microbicide Trials Network) 

Version 1.0 - September 2017

Please check back for additional information on informed consent coming soon.

Content last reviewed on
November 14, 2017
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DAIDS Regulatory Support Center (RSC)

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