“A research network funded with millions by the Affordable Care Act will begin conducting vast studies next year to compare standard medical treatments. But what about the 100 million patients in the network — do they have a choice in the matter?
Will researchers get permission from each of those patients? And if patients are told about the studies, what, exactly, will they be told? These questions have bioethicists, scientists and health care officials debating how to bring the question of patient informed consent into the 21st century.
Obamacare is best known for extending health coverage to more Americans. But the health care law has many provisions aimed at improving health care outcomes and safety while lowering costs. One element is “comparative effectiveness” research: not just finding out whether a drug or treatment is safe and effective but comparing drugs head to head to find out which is better, for everyone or certain populations.
And with electronic medical records and vast pools of data, some of these studies have the potential to make lightning-fast, dramatic discoveries. But informed consent issues have the potential to slow such studies and make them too expensive.”