A recent review (Grady, C. NEJM 2015; 372: 855-62) stresses some of the emerging challenges of informed consent, particularly in the research setting.

Key points:

• “Research participants have deficits in their understanding of study information, particularly of research methods such as randomization.”
• “Reasonable people disagree about the adequacy of the information presented on the consent forms.”

Trends Which Challenge Current Informed Consent Process:

1. Learning Health Systems. “Should informed consent for these activities be more similar to research informed consent or clinical informed consent?” “Is it ethically acceptable for a patient or research participant to provide consent for an unspecified or broad range of activities?”
2. Adoption of Complex Technologies, like genetic sequencing. “How should information be presented [with]..complex information, substantial uncertainty…incidental findings, and implications for blood relatives?”
3. Consent for Future Use of Clinical Data or Biologic Specimens. “How specific does the information provided in the consent process need to be regarding future uses of data or specimens?”
4. Demographic Changes/Diminished Capacity in Elderly. “Older age, diminished mental capacity, and dementia per se do not indicate that a person is incapable of consenting…there is a need for respectful and efficient tools and processes for assessing capacity.”

Bottomline: In order to treat patients in a respectful manner, continued efforts at addressing these questions are needed to promote informed choices of patients while advancing medical science and clinical care.

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