August 19, 2016: Privacy and Confidentiality in Pragmatic Clinical Trials

August 19, 2016: Privacy and Confidentiality in Pragmatic Clinical Trials


Privacy and Confidentiality in Pragmatic Clinical Trials


Alan Rubel, PhD, JD, School of Library and Information Studies, University of Wisconsin-Madison


Privacy; Pragmatic clinical trials: Human subjects protection; Research ethics; Personal health information; Data access; Data security

Key Points

  • The definitions of privacy are varied and include notions of having control over your information; limiting how others are able to access your information; and respecting contextual norms regarding the flow of personal information.
  • Research participants consistently express concerns about the privacy of their health information—yet there are problems with traditional protections. While the current framework provides important protections, it is not tailored to address all research uses of data and instead may create disincentives to use.
  • The Fair Information Practice Principles (FIPPs) provide guidance on the collection, use, and protection of personal information. In the context of health information, these principles support a framework that ensures open and transparent data collection, specifies the purpose for the collection, limits and minimizes the data and its use, gives individuals control, provides for the integrity and quality of the data, safeguards its security, ensures oversight and accountability, and provides remedies for breaches.
  • Modified approaches to consent and engagement may be a better way to ensure appropriate, justifiable uses of health information. Alternative mechanisms for respecting privacy and autonomy include an opt-out option, broad or individual notification, and the use of patient advisory councils and community consultation.

Discussion Themes

De-identified data may have limited utility in pragmatic clinical trials, and even de-identified data may not be sufficiently protective of privacy.

How do we balance the need for privacy with the data needs of a successful learning healthcare system?

For More Information

Read more about privacy and confidentiality in PCTs in the publication by McGraw et al. (2015):

Read about a public-private collaborative that’s created a common framework based on FIPPs:

#FIPPS, #pctGR
@PCTGrandRounds, @Collaboratory1, @PCORnetwork

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