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Neuroscience Trials of the Future Proceedings of a Workshop (2016) / Chapter Skim
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6 Ethical Considerations
Pages 53-58

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From page 53...
... Petra Kaufmann, director of the Office of Rare Diseases Research and Division of Clinical Innovation at the National Center for Advancing Translational Sciences (NCATS) , began with the admonition that the field has a moral obligation in neuroscience trials to explore change, given the stagnant drug development environment for some disorders.
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From page 54...
... In addition, she suggested that as opposed to parallel systems of data collection in the context of clinical care, research, and regulatory approval, it would be more ethically sound to have better alignment of these data streams in order to maximize the usefulness of those data. This would call for more attention to both data protection and human subjects protection, yet while there appears to be momentum across the field for more data sharing, cultural barriers remain.
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From page 55...
... For studies conducted before this statement was added to the informed consent, the company enlisted the help of data privacy and legal experts to estimate the probability that patients would have agreed to share their data, although in a few cases the informed consent explicitly precluded sharing of information. Ironically, said Rockhold -- although for rare diseases it is especially difficult to de-identify information and thus, these data are frequently not shared -- many rare disease patient groups have indicated support for data sharing.
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From page 56...
... Greg Koski proposed another model, which he called the "Fidelity" model for patient engagement. It allows patients to place their personal health information, genomic information, among others, in a secure personal account, which they control and can invest in ways they choose to support research.
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From page 57...
... Moreover, Chiauzzi noted that people who join PatientsLikeMe have already bought into the social media concept and thus have somewhat different views compared to the general population with regard to privacy. Yet there is still a need to explore privacy in a more nuanced way in terms of conditional and personal factors; thus, PatientsLikeMe is working with research partners to develop measures to assess individual affinity for different aspects of privacy, protection, and data sharing.
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Key Terms

  • data sharing
  • data privacy
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  • clinical trial
  • informed consent

  • subjects protection
  • human subjects
  • rare diseases
  • neuroscience trials
  • awareness tool

  • patient experience
  • trial awareness
  • research partners
  • million patients
  • stagnant drug

  • greg koski
  • structured data
  • personal health
  • qualitative data
  • frank rockhold

  • user agreement
  • validated measures
  • plore privacy
  • trials raises
  • site allows

  • matches patients
  • medication adherence
  • ent perspective
  • allows people
  • moral obligation


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