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ETHICAL PROVENANCE
Bartha M. Knoppers
Vasiliki Rahimzadeh
Jonathan Lawson
Alexander Bernier
TRACKING ETHICAL PROVENANCE FOR SHARING GENOMIC AND HEALTH RELATED DATA
Notice of Award- September 2023
AIM 1 - Explore normative values and professional norms underlying ethical provenance in the human genomic and health data sharing context
AIM 2 - Develop model data access and sharing agreements by extracting commong clauses used across GA4GH Driver Projects
AIM 3 - Build software that integrates standardized data access agreement clauses to support machine-readable tracking of ethical provenance
4
SELECTION CRITERIA
Eighteen (18) Data Access Agreements were collected from biobanks, research consortia, and research data repositories worldwide.
A representative sample of agreements was selected from amongst those received, chosen according to the following criteria:
Exclusion criterion:
Only outbound data access agreements (DAAs) that enable the transfer of data from a central custodian to a singular third-party recipient were considered. Data contribution agreements or multilateral agreements enabling data exchange were not considered.
Additional contracts will be included in the final version of the study.
METHODS AND OBJECTIVES
The agreements were evaluated for the presence or absence of common elements that determine how data can be reused:
CHOSEN FOR DISCUSSION
CREATION OF SAMPLE CLAUSES
The following considerations guided the drafting of the sample clauses:
INTELLECTUAL PROPERTY
The agreements generally adopted a similar structure:
INTELLECTUAL PROPERTY
Intellectual property clauses generally contain one or more of the following five categories of clauses:
SAMPLE CLAUSE
You understand and acknowledge that the Data may be protected by copyright and other intellectual property rights. Duplication, as reasonably required to carry out Your Research Project with the Data, is nonetheless permitted. Sale of all or part of the Data on any media is not permitted.
You recognise that nothing in this Agreement shall operate to transfer to You any intellectual property rights in or relating to the Data.
You agree not to make intellectual property claims on these Data. You agree not to use intellectual property protection in ways that would prevent or block access to, or use of, any element of these Data, or conclusions drawn directly from these Data.
You can elect to perform further research that would add intellectual and resource capital to these Data and decide to obtain intellectual property rights on these downstream discoveries. In this case, You agree to implement licensing policies that will not obstruct further research and to respect the Fort Lauderdale Principles and the Organisation for Economic Co-operation and Development Guidelines for the Licensing of Genetic Inventions [consider also listing other policies relevant to the local jurisdiction].
PURPOSES OF USE
Describes permissible conditions for research data use.
Informs data users of their general compliance obligations, limits of permissioned data use, and alignment with applicable legislation, ethics approvals, and policies.
Some purpose clauses included obligations to refrain from specific categories of data use. Examples include- performing medical research only or limiting use to non-commercial research.
SAMPLE CLAUSE
You agree to only use the Data shared with you for the approved purposes, in accordance with the conditions established in this Agreement. You further agree to respect restrictions on data use arising from applicable national law, research ethics guidance, contracts, informed consent materials, and institutional policies [include copies of applicable policies or supporting materials in the Appendices].
MONITORING CLAUSES
Monitoring clauses require principal investigators to monitor the use of data that is made by approved researchers at their organization, and to maintain a list of authorised researchers. These authorised researchers were generally required to read, acknowledge, and respect the terms of the agreement.
Monitoring clauses sometimes require principal investigators to commit to the supervision of researchers, or to ensure that researchers undergo training.
Some contracts establish that principal investigators bear legal responsibility personally for the monitoring of researchers. Others require principal investigators to acknowledge this obligation, but only hold the organisation that receives the data legally responsible.
REPORTING CLAUSES
Reporting clauses require data users to provide reports to the data repository regarding the uses made of the data.
SAMPLE CLAUSE
You agree to submit to the Data Provider a report detailing the use made of the Data upon the completion of the approved Research Project, or upon termination of this Agreement, whichever comes first.
You agree to maintain a list detailing all of the members of the Research Team that will have access to the Data, including their name, their qualifications, and their role. You further agree that each member of the Research Team will be required to read the conditions of data use detailed in this Agreement. The Principal Investigator is further required to acknowledge the terms of the Agreement and to monitor the compliance of the Research Team with its terms.
RE-IDENTIFICATION
Re-identification clauses prohibit data users from performing data linkage, data combination, and other acts that could lead to the re-identification of research participants.
There are three principal approaches:
SAMPLE CLAUSE
You agree not to attempt to re-identify Research Participants. You agree not to take any actions that could reasonably be expected to result in the re-identification of Research Participants.
DATA SECURITY
Data security requirements detail the security practices that must be used in handling data and the rights of the data provider to audit those practices.
There are two principal approaches:
SAMPLE CLAUSE
In handling the Data, You agree to implement and to maintain reasonable security measures that are appropriate to protect confidential and non-public information of a sensitive nature. Security measures must include, at minimum, physical, organisational, and technological safeguards.
You agree to allow the Data Provider to audit the security and management documentation to ensure compliance with the terms of this Agreement, upon written request.
DATA DESTRUCTION
Data destruction clauses specify the conditions according to which data must be destroyed, usually upon the conclusion of the research project or the termination of the agreement.
Data destruction clauses differ regarding the conditions that trigger the requirement to destroy data:
Data destruction clauses also differ regarding the consequences of this obligation being triggered:
SAMPLE CLAUSE
You agree to destroy the Data once it is no longer useful for Your Research Project, or upon termination of this Agreement, whichever comes first.
You agree not to retain any copies of the Data, except as required to ensure compliance with: applicable legal requirements; compliance with Data retention; audit requirements; or to preserve study integrity.
AREAS FOR FUTURE DEVELOPMENT
In using these templates to produce contractual agreements, consideration should be given to population-specific clauses, jurisdiction-specific legal requirements, or sensitivities relevant to affected communities or categories of research.
Future meetings of the EP working group will be used to further refine the text of template clauses to create a GA4GH Product.
Additional agreements will be added to the final analysis to improve representativeness (geographies, GA4GH driver projects, jurisdictions, populations, and areas of health research).