TABLE 1.
DUKE UNIVERSITY | |||
---|---|---|---|
Title of original study | Genetics and Pharmacogenetics of Epilepsy (“Epilepsy”) | ||
Subjects | 975 adults with epilepsy | ||
Recontact for additional research described in consent form? | Yes | ||
Options offered in consent form concerning recontact? | No | ||
Consent form disclosures about results | Participants will not receive research results, but will be offered “incidental findings” | ||
Consent form options about results | None | ||
Method of recontact | Letter, then phone call | ||
Individual results provided during recontact? | No | ||
UNIVERSITY OF NORTH CAROLINA-CHAPEL HILL | |||
Title of original study | Gene Modifiers in Cystic Fibrosis (“CF”) | Environmental Polymorphisms Registry (“Biobank”) | |
Subjects | 1,306 adults and children with CF | 15,000 adult “healthy volunteers” | |
Recontact for additional research described in consent form? | No | Yes | |
Options offered in consent form concerning recontact? | No | No | |
Consent form disclosures about results | Participants may receive results of “potential clinical consequence” | Participants will not receive results; may or may not receive results in follow-up studies | |
Consent form options about results | Participants can opt to receive results of “potential clinical consequence” | None | |
Method of recontact | In person, in the clinic | Letter | |
Individual results provided during recontact? | No, but told they have one of two genetic variants that may affect severity of CF | No, but told they have one of two genetic variants under study and there is no known relationship between these variants and any disease in people who do not have CF | |
SEATTLE CHILDREN’S | |||
Title of original study | Autism Genetic Resource Exchange (“AGRE”)* | Study of Autism Genetics Exploration (“SAGE”)* | SEARCH for Diabetes in Youth (“Diabetes”) |
Subjects | 1,163 families with >1 child with autism | 1,000 children (with autism or suspected ASD) and their parents | 3,474 children with diabetes |
Recontact for additional research described in consent form? | No | Yes | Yes |
Options offered in consent form concerning recontact? | Yes | No, because recontact was part of the study design | Yes |
Consent form disclosures about results | Participants will not receive results | Parents will be told if child has gene variation being studied. No other results given | Results may be given to diabetes provider |
Consent form options about results | Option for return of specific test results (Fragile X testing and chromosomal analysis) | None | Participants can opt for their provider to receive results |
Method of recontact | Phone call | Letter, then phone call | Letter |
Individual results provided during recontact? | No | Yes, told that CNV was identified and referred to medical genetics clinic | Yes, preliminary results |
SAGE and AGRE were combined in this analysis as the “Autism” studies; see Methods section for more details.