May 20, 2016: Altered Informed Consent in Pragmatic Clinical Trials

May 20, 2016: Altered Informed Consent in Pragmatic Clinical Trials


Altered Informed Consent in Pragmatic Clinical Trials


Ross McKinney Jr, MD, Trent Center for Bioethics, Humanities, and History of Medicine at Duke University


Informed consent; Minimal risk determination; IRBs; Pragmatic research; Altered informed consent models; PCTs

Key Points

  • The goal of the informed consent process is to enable a good decision on the part of a potential participant. In addition to enabling a good decision, a good informed consent process builds trust.
  • Informed consent is not “one size fits all.” The key is to give the right amount of information to make a good decision using an optimal format for the type of study being proposed. It would be ideal if IRBs were able to construct an informed consent process that optimizes the decision-making process.
  • For many PCTs, altered consent might better match the potential participants’ needs and level of risk. A short oral presentation of the options might be most appropriate for some decisions.

Discussion Themes

What about a model of “incremental” consent, whereby you clearly identify the distinct activities that are incremental (i.e., part of research rather than usual care) and implementing brief consent procedures for each? This means that participants might be asked to provide separate consent for separate activities such as receipt of a specific treatment, contribution of a biospecimen, or use of the EHR for research.

How should we consider the risk of the research versus the risk of the patient's condition of treatment in the totality of risk?

What about the risk to patients in sharing protected health information across covered entities and the need for multiple HIPAA privacy board reviews as well as the impact on research across organizations?

A few emerging innovations are patient-focused, such as the Community-Engaged Network for All Patient-Powered Research Network (CENA PPRN) and the Sage Bionetworks Participant-Centered Consent Toolkit. We ought to do more to engage participants/patients in the advocacy process for sensible approaches to consent.

For More Information

Read more about altered informed consent for PCTs in McKinney et al. (2015) in Clinical Trials:

#InformedConsent; #pctGR
@PCTGrandRounds, @Collaboratory1, @PCORnetwork

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