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Table 2 Selected examples of consent form language on publication, data sharing, and data ownership

From: Patient consent to publication and data sharing in industry and NIH-funded clinical trials

Sponsor indicated a commitment to publish

 “When the results of this study are published, no data will be listed by name or ID number.” (CAMP trial, publicly funded)

 “When the results of this study are made public, the doctors will not use your name or let anyone know about you personally.” (OAT 1 trial, publicly funded)

Sponsor did not indicate a commitment to publish

 “The Study Team may also use my information to prepare reports or publications about the study.” (DUR001–104 trial, industry-funded)

 “If any publication or presentations result from this study, you will not be identified by name.” (ROMICAT 2 trial, publicly funded)

Sponsor indicated a commitment to share

 “The National Heart, Lung, Blood Institute (NHLBI) requires that the data collected during a research study is made available to qualified investigators and non-study researchers.” (HF Action trial, publicly funded)

 “Data collected from you and other participants in this study will be shared with other doctors in the research field, but no names of patients will be used.” (CP-AI-005, industry-funded)

Sponsor indicated de-identified data may be shared

 “Other researchers who are approved through standard, approved agreements may be permitted to analyze the data without your personal identifying information.” (COAG trial, publicly funded)

 “Study data may be published or shared with other researchers, but the identity and medical information of each study participant will remain strictly confidential.” (TBM100C 2302 trial, industry-funded)

Explicit statement of data or biological sample ownership - Sponsor

 “Data collected and recorded on study forms are the property of Corus Pharma, Inc.” (CP-AI-006 trial, industry-funded)

 “All research samples will become property of the NHLBI after conclusion of the BMT CTN Protocol #0102 study” (BMT-CTN-0102 trial, publicly funded)