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The following documents are required for a Data Access Request submission:
Under the Brain-CODE Governance Policy, all data access requests for data stored in Brain-CODE must be approved or exempted from review by the External Requester’s local IRB/REC/REB. Approved study protocols should explicitly mention using the specific data set the External Requester is seeking access via Brain-CODE. If the Brain-CODE data set being requested is being used in addition to an existing IRB/REC/REB-approved study, External Requesters are asked to complete an IRB/REC/REB amendment explicitly mentioning use of said data set. For support on preparing such an amendment, please contact governance@braincode.ca. |
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Prior to review by the DAC and the ISC, the Informatics Team, which manages the Brain-CODE platform, will review the request and contact the External Researcher if there are any concerns or questions about the application. If upon review of the Data Access Request, the decision is made to deny the request, the Informatics Team at OBI will explain the decision to the External Researcher. The External Researcher who has requested access to the data can email governance@braincode.ca to request further information about why the request was denied and appeal the decision. |
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Each Brain-CODE user signs a Platform Terms of Use Agreement that binds them to appropriate use of the data, including a prohibition to attempt to attribute, link, connect, or associate any data with any natural person. In addition to a Terms of Use Agreement, every researcher that applies via the Controlled Access Mechanism will be required to sign a legally binding Data Use Agreement with the Ontario Brain Institute. As part of the Zone 3 Data Use Agreement, they are agreeing to only access the specific data requested and to only use the data for the specific purposes outlined in the agreement, the REB-approved application, and the Data Access Request. The agreement binds researchers to keep all data strictly confidential and to notify OBI in writing of any data breaches or unauthorized access. Researchers agree to provide OBI with annual updates on the data use and data access. The agreement explicitly states that attempt to re-identify individuals from the data is strictly forbidden and under no circumstances is contact with individuals permitted. |
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While each consent form may have minor changes to the standard consent form language based on local Research Ethics Board (REB) and institutional requirements, the original consent language will be very similar to the following. OBI has a robust process for tracking consent and approval for third-party data sharing which is adhered to at all times. The Brain-CODE Standard Consent Language is currently as follows:
Which data will be collected and why? These data are being collected as part of an Ontario collaborative study on [ID Program], and will be used in conjunction with data collected from persons with the same and different conditions. This will allow researchers to study the causes of the disorder, improve diagnoses, and develop treatments and interventions. In addition to the data that will be collected from [study intervention], we will also be collecting your health card number and other demographic information like [insert details]. Your encrypted health card number or [other data we collect in this study] may be used to link with data stored in independent databases, such as OHIP, or other databases in a secure environment. By providing consent to this study, you are agreeing that the data collected during this study will be stored electronically in a database developed and maintained by the Ontario Brain Institute (OBI). This database is known as Brain-CODE, and it will be stored in reputable facilities with high level security protocols. Brain-CODE will allow researchers to use the data collected in these collaborative studies to perform research and learn more about how [disease] affects the brain. What will happen to my data? Brain-CODE is an open-access database. This means that researchers and organizations outside this study can request access to data that have been stripped of information that can identify you.Your health card number will be encrypted upon entry into Brain-CODE and will remain encrypted at all times. How will my information be kept confidential? We wish to assure you that your privacy is very important to us. When you join the study, you will be given an ID number. Researchers will use this ID number to organize your data, instead of your name or other information that can identify you directly. Any data collected for study purposes that could potentially identify you will be stored in a highly secure manner and never be released or disclosed in a form that could identify you. We will use tools that remove identifying information using the most advanced tools available to minimize the risk of identifying you from the information we collect or release. This process will be applied to all data, including any new data that have been linked through other databases, such as OHIP. [Organization] and OBI have entered into legal agreements to protect your data, and to set out the purposes for which these data will be collected, used, stored and disclosed. Steps have been taken to make sure your data are safe and the risk of identifying you is minimized. The OBI will continue to monitor these safeguards as new technologies evolve in order to limit any new risks to privacy. Who will have access to my information, and what will they see? Data collected through this study and stored in Brain-CODE will be available to researchers in this study. A current list of these researchers and organizations can be found at: [Email governance@braincode.ca for the program specific link]. Data from this study that have had identifying information removed using the most advanced tools available may be shared with local, national and international researchers and organizations that are not part of this study. This open approach is being used by researchers internationally to better understand disease. Access to data by outside researchers or organizations will require a detailed plan for the use of the data, and approval from a Research Ethics Board, as described in OBI’s Data Sharing Policy http://www.braininstitute.ca/Brain-CODE-governance . These researchers or organizations will be required to enter into an agreement with OBI that clearly states the safeguards that will be in place to protect those data, and the purposes for which these data may be collected, used, stored and disclosed. OBI may take some of your data, combine them with data from many other people, and make them available to enhance the public’s awareness of research. We will use tools to remove identifying information from these combined data sets, making the risk of identifying you minimal. If I decide later on that I no longer want to be part of this study, what happens? You can withdraw from the study at any point. No new data will be collected or linked to other data from that point on. Upon your request, any data that have not been processed to remove identifying information will be destroyed. However, we are not able to remove any data that have already been analyzed, processed to remove identifying information or linked with other data for placement in Brain-CODE. To withdraw from the study, contact [Site PI; email; phone]. If you have any questions, please ask [appropriate person at site]. Further information about Brain-CODE is available at http://www.braininstitute.ca/Brain-CODE-governance . Any of the information in this letter can be sent to you by mail, upon your request. |
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Platform Terms of Use Agreement I have requested a license to use Brain-CODE (the “License”). Brain-CODE (as the same exists from time to time, including any upgrades, replacements, or supplements thereof, “Brain-Code”) is an informatics platform that permits the storage, access and analysis of data (any information or data on Brain-CODE from time to time, is referred to herein as “Data”). I hereby agree to abide by the following terms:
OBI”) in association with applying for a Brain-CODE account, the License, or otherwise, are accurate.
Permitted Purpose”) and not for any other purpose, including without limitation any commercial purpose, without the prior written consent of OBI.
Informatics Governance Policy as the same may be amended from time to time. The Informatics Governance Policy can be found at http://www.braininstitute.ca/brain-code .
“We would like to acknowledge the individuals and organizations that have made data [and analysis] used for this research available including [ID program name/Data producer name], the Ontario Brain Institute, the Brain-CODE platform, the Government of Ontario, as well as [independent collaborator names].” 10. I will immediately provide written notice to OBI upon gaining knowledge of the occurrence of any of the following: (i) unauthorized use of, or access to, Brain-CODE and/or the Data and (ii) abnormalities in the Data or evidence that certain Data is incorrect.
19. My obligations under this Agreement with respect to access to Brain-CODE continue for the entire period over which I have access to Brain-CODE. The following sections of this Agreement survive termination: 2,3, 4, 5, 6, 7, 8, 9, 11, 14, 15, 19, 20, 21, 22 20. No amendment to or modification of this Agreement will be binding unless in writing and signed by OBI. 21. This Agreement is governed by the laws of the Province of Ontario and the federal laws of Canada applicable therein. If for any reason a court of competent jurisdiction finds any provision, or portion thereof, to be unenforceable, the remainder of this Agreement shall continue in full force and effect. 22. The undersigned is hereby put on notice that the confidentiality and the terms of use of data are extremely important to OBI and any breaches of this Platform Terms of Use Agreement will be vigorously prosecuted. 23. It is my express wish that this Agreement and any related documents be drawn up and executed in English. Il est la volonté expresse des parties que cette convention et tous les documents s’y rattachant soient redigés et signés en anglais. |
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DATA USE AGREEMENT
without limiting the more expansive definition of the term Data used in this Agreement, all of the data described in the Data Access Request shall be considered “Data” for the purposes of this Agreement);
https://braininstitute.ca/research-data-sharing/brain-code ;
10. External Researcher shall be granted a license to use Brain-CODE (the "License"), wherein any rights to access Brain-CODE and the Data are non-transferable and not exclusive. Obligations under this Agreement with respect to access to Brain-CODE and Data continue irrespective of whether the License has been granted or terminated, and for greater certainty External Researcher agrees that OBI may revoke the License or access to Data at any time, at the sole discretion of OBI; It is my express wish that this Agreement and any related documents be drawn up and executed in English. Il est la volonté expresse des parties que cette convention et tous les documents s'y rattachant soient redigés et signés en anglais. |
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