Undertake a Clinical Trial at Your Own Risk

A decade after Jean Burns was diagnosed with Parkinson's disease, she needed a miracle. Even the drugs of last resort had let her down.

Burns, who says she is "often frozen to the floor" by Parkinson's and unable to move her feet, pinned her hopes on an experimental gene therapy study at the National Institutes of Health in Bethesda, Maryland. She knew the treatment would be risky. Surgeons would infuse genes deep into her brain. Only two other patients had gone before her. Burns would be the third.

If it worked, the genes might unlock her muscles and turn back the clock on the progression of her illness. But the purpose of the study is to determine whether the treatment is safe. It will likely be years before researchers test its effectiveness. The informed consent Burns signed offers a litany of potential risks, including a stroke that could plunge her into a vegetative state.

If anything went wrong, she reasoned, she'd be at a world-class research center, where she would be well cared for. Then Burns read the NIH policy...