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Table 2 Common elements of clinical guidelines and position statements

From: Health care providers and direct-to-consumer access and advertising of genetic testing in the United States

Guideline

 

Recommend involvement of HCP

Informed consent

Provide or refer to HCP for pre- and/or post-test counseling

Communicate results in clear and/or culturally appropriate manner

Provide or require clinical evidence for recommended intervention

Provide user-friendly materials for DTC services

Address or disclose privacy and data storage policies

Disclose or require scientific evidence on which test is based (covering analytical and clinical validity, clinical utility)

Establish or require laboratory quality standards

Disclose laboratory accreditation

Increase regulation of DTC testing

Unbiased advertising and claims

Public and/or provider education

North America

American College of Medical Genetics (ACMG) [140]

2008

X

X

X

X

  

X

X

 

X

   
 

American College of Obstetricians and Gynecologists (ACOG) [141]

2008

X

X

X

   

X

      
 

American Medical Association (AMA) [138]

2008

X

X

X

          
 

American College of Clinical Pharmacology (ACCP) [136]

2009

X1

 

X

    

X

     
 

American Society of Clinical Oncology (ASCO) [137]

2010

X

X

X

   

X

X

  

X

 

X

 

American Society of Human Genetics (ASHG) [134]

2007

 

X

  

X

 

X

X

 

X

X

 

X

 

National Society of Genetic Counselors (NSGC) [135]

2007

X

X

 

X

 

X

X

  

X

   
 

Canadian College of Medical Geneticists (CCMG) [143]

2011

X

X

    

X

X

 

X

 

X

 

Europe

European Society of Human Genetics (ESHG) [133]

2010

X1

X

X

 

X

 

X

X

X

 

X

X

X

 

Human Genetics Commission [139]

2010

X2

X

 

X

X

X

X

X

X

 

X

X

 

Asia

Human Genetics Society of Australasia (HGSA) [142]

2007

      

X

   

X

 

X

  1. 1Should also seek guidance from a genetics professional. 2For test interpretation.