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) |