A recent review (Grady, C. NEJM 2015; 372: 855-62) stresses some of the emerging challenges of informed consent, particularly in the research setting.
- “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:
- 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?”
- Adoption of Complex Technologies, like genetic sequencing. “How should information be presented [with]..complex information, substantial uncertainty…incidental findings, and implications for blood relatives?”
- 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?”
- 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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