Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/10

From Wikisource
Jump to: navigation, search
This page has been validated.


government agencies from other countries, as well as the ethics review board overseeing this study.


  • The sponsor works with business partners in drug development. The sponsor might share your study data with a business partner but only if the business partner signs a contract that requires it to protect your study data in the same way as the sponsor.


  • Study data (which does not identify you) might be published in medical journals or shared with others as part of scientific discussions.


  • To the extent permitted by applicable laws, the sponsor, the ethics review board, Health Canada and/or regulatory agencies in other countries, might review your original health records, which contain information that directly identifies you, to verify the accuracy and completeness of study data collected during the study.


You will have the right to see and copy your personal health information related to the study for as long as the study doctor or research institution holds this information, subject to applicable laws. However, you will not be able to see or copy this information until after the study has been completed.


You may withdraw your permission at any time by providing notice to the study doctor. The study doctor and staff would then no longer use or share your personal health information in connection with the study, unless it is essential to ensure that the study is scientifically reliable. However, the sponsor would still use your study data that was collected before you withdrew your permission. In addition, you would no longer be able to participate in the study.

H3W-EW-S124 (b)
Version: 26-October-2009
Page 10 of 14
Confidential