IRB, Office of Research Development COOK COUNTY BUREAU OF HEALTH SERVICES
Office of Research Development

      
Thursday, Jul 29, 2010
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DECISION TREE III: When Waivers or Variations in the Consent Process May Be Allowed
 

Use of Waivers or Variations Requires Prior IRB Approval


 
     DOES THIS STUDY ENTAIL MORE THAN MINIMAL RISK? 

    YES OR NO                                                        YES OR NO                                                             NO

IS DOCUMENTATION OF CONSENT SAFE?
 
 
 
 
 
 
 
 

               NO                               YES

IS PRIOR DOCUMENTED CONSENT PRACTICABLE? 

 YES                                                                             NO
 

IS FULLY DOCUMENTED CONSENT PRACTICABLE?
 
 

  YES                   NO

Prior Consent Not Practicable

Example:
Health services studies where subjects' knowledge of the study may invalidate the research 

IF:
A waiver or alteration will not adversely affect the rights and welfare of the subjects;

AND

Whenever possible, subjects will be provided with additional pertinent information after they have participated in the study.

Not Safe

Example:
Subjects are users of illegal drugs
 

IF:
There may be a significant risk to the subject from linking a consent document to him/her

    Fully Documented Consent Not Practicable

Examples:
Subject does not understand English;  or
All contact will take place over the telephone.
 

IF:
An IRB-approved summary of the verbal presentation will be used; 

AND 

An independent witness to the oral presentation signs the summary;

AND

Copies of the signed summary and short form are provided to subject and witness, with short form in language understandable to subject 

Full Consent Process Without Documentation Permitted Full Documented Informed Consent Process Short Form Consent Process Permitted Waiver of Consent  Process Permitted
Decision Tree I:  Level of Review, Based on Study Design
Decision Tree II:  Level of Review, Based on Subject Population
Decision Tree IV:  Consent Process Required:  Persons Not Able to Consent to Research
Decision Tree V:  Type of Review and Consent for Research Involving Human Biological Specimens

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