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document
To share or not to share : a randomized trial of consent for data sharing in genome research . PURPOSE Despite growing concerns toward maintaining participants ' privacy , individual investigators collecting tissue and other biological specimens for genomic analysis are encouraged to obtain informed consent for broad data sharing . Our purpose was to assess the effect on research enrollment and data sharing decisions of three different consent types ( traditional , binary , or tiered ) with varying levels of control and choices regarding data sharing . METHODS A single-blinded , randomized controlled trial was conducted with 323 eligible adult participants being recruited into one of six genome studies at Baylor College of Medicine in Houston , Texas , between January 2008 and August 2009 . Participants were randomly assigned to one of three experimental consent documents ( traditional , n = 110 ; binary , n = 103 ; and tiered , n = 110 ) . Debriefing in follow-up visits provided participants a detailed review of all consent types and the chance to change data sharing choices or decline genome study participation . RESULTS Before debriefing , 83.9 % of participants chose public data release . After debriefing , 53.1 % chose public data release , 33.1 % chose restricted ( controlled access database ) release , and 13.7 % opted out of data sharing . Only one participant declined genome study participation due to data sharing concerns . CONCLUSION Our findings indicate that most participants are willing to publicly release their genomic data ; however , a significant portion prefers restricted release . These results suggest discordance between existing data sharing policies and participants ' judgments and desires .
51012
Intervention_Educational
consent for data sharing
51013
Intervention_Educational
informed consent
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Intervention_Control
controlled
51015
Intervention_Educational
experimental consent documents
51016
Intervention_Educational
data sharing .
51017
Outcome_Other
consent for data sharing
51018
Outcome_Other
public data release
51019
Outcome_Other
restricted ( controlled access database ) release
51020
Outcome_Other
opted out of data sharing
51021
Outcome_Other
data sharing concerns
51022
Outcome_Other
publicly release
51023
Outcome_Other
restricted release
51024
Participant_Condition
genome research
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Participant_Sample-size
323
51026
Participant_Age
adult
51027
Participant_Sample-size
110