Revision Date: 2023.12.21
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Definitions
Coercion - the practice of persuading someone to do something using force or threats
Governance - In the context of biomedical research, we define the processes of governance to include the freedoms, constraints, and incentives that determine how two or more parties manage the ingress, storage, analysis, and egress of data, tools, methods, and knowledge amongst themselves and with others. (Mangravite, et al., 2020)
Undue influence - refers to influencing a person's will through psychological pressure or taking advantage of an existing relationship
Acronyms
DCC - Data coordination center
FAIR- Findability, Accessibility, Interoperability, and Reusability
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Ethical conduct of research involves the application of established professional norms and ethical standards in the performance of all activities related to scientific research. Research misconducts throughout the 20th century have highlighted the need to codify the tenets of research ethics into important documents including the Nuremberg Code (1945), the Declaration of Helsinki (1964), and the Belmont Report (1979). Each of these documents provides a global foundation of basic ethical principles expected to underlie the conduct of biomedical and behavioral research involving human subjects. While a Sage-specific summary will never replace these existing documents, some key guiding principles are identified below.
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Research conducted using “big data” or “big health data” (i.e., complex datasets of increasingly diverse data including -omics and phenotypic data from a combination of sources) can lead to group harm. Examples of group harms can include: (1) health–related algorithms produced through machine learning techniques on a homogeneous (i.e., non-diverse) data set have been found to place underserved populations at risk of biases leading to the receipt of inadequate medical care; (2) conduct of research without unambiguous consent of the individuals or the group as a whole and draw conclusions in a manner that is harmful to populations (e.g., the Havasupai case).
Justice:
Issues of Justice in the research environment are expansive. The historical approach to justice through the 20th century mainly concerns the equitable selection of subjects and the distribution of the risks and benefits of participating in research. Modern social discourse further includes community perception and trust, community involvement in the research enterprise, and heightened focus on representation in research with the downstream impact of progressinghealthcare standards. Sage Governance seeks to consider these concerns by evaluating factors of representation in research for participants, researchers, and institution types.
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Standard | Relevant for | Brief description |
HIPAA Regulations | Healthcare plans, clearinghouse, and providers and anyone processing patient data on their behalf | Privacy rules = Use and disclosure of patient data Security rules = Administrative and technical security standards |
EU GDPR | Organization collecting or processing data from the EU | rules governing the collection, transfer, storage, processing, use, and deletion of personal data |
US State data privacy regulations | Organization collecting or processing personal data | expansion of federal privacy regulations relevant for cyber security and medical/health data data minimization opt-in consent participant rights |
Common Rule | Organizations conducting human subjects research | federal regulations providing baseline protections for human subjects involved in biomedical and behavioral research IRB oversight informed consent requirements |
Country-specific privacy laws | Organizations sharing data collected outside the US or EU |
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The Belmont Report (1979) https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Declaration of Helsinki (1964) https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Mangravite, Lara M., Avery Sen, John T. Wilbanks, and Sage Bionetworks Team. Mechanisms to Govern Responsible Sharing of Open Data: A Progress Report. Manubot, 2020. https://github.com/Sage-Bionetworks/governanceGreenPaper/tree/3c2a648b892d8c672a3043c4bacda65505947921
Nuremberg Code (1947) https://en.wikipedia.org/wiki/Nuremberg_Code#cite_ref-ushmm_6-1
Wilkinson, M., Dumontier, M., Aalbersberg, I. et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data 3, 160018 (2016). https://doi.org/10.1038/sdata.2016.18
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