Patients’ experience of informed consent can vary widely. Sometimes, it can fall far short of what the process is supposed to be. Susan Krug has the ultra rare disease hypophosphatasia, also known as soft bones. The genetic disease results in an enzyme deficiency that prevents bones from hardening as they should leading to deformities, fractures, the loss of teeth, and other health problems. Susan recently went through the informed consent process as part of a clinical trial in which she is participating. She found the forms were more legalistic than medical in tone, and that her doctor was unable to provide clear answers to her questions.
Susan is currently participating in a late-stage clinical trial. She says she was presented with informed consent documents when she showed up for the first day of her clinical trial, but was told that she could not take them home to review. She said she was essentially presented with the choice of signing the documents on the spot and getting access to the experimental drug in the trial, or not participating. “I felt a little pressure to sign quickly on the trial form,” she says.
She doesn’t think the informed consent process works well. She said four mothers of children in the trial told her they don’t know whether they will have access to the drug once it is FDA approved. They don’t know if they will be compensated for their travel costs. And they don’t know what the potential side effects from the drug are. Even though they wonder about these things, they don’t know who they can to talk for answers.
“’We don’t know what we were signing. We just signed it. For most of them, it was life or death. Either get your kid on this drug or they are going to have respiratory failure.”
An Agreement, Not a Contract
The National Institutes of Health notes that after learning about the risks, benefits, rights, and responsibilities involved in a clinical trial, a patient agrees to participate and signs an informed consent document, it does not signify a legal obligation on the part of the patient. As the document should make clear, patients have the right to leave a trial at any time for any reason and without penalty.