Anyone who wants to join any medical study must first read and sign a consent form that spells out why the study is being done, what it involves, and how privacy is protected.
The aim is to protect the rights and privacy of participants, provide information about the study, and ensure that each volunteer’s decision is made of their own free will—it’s a process designed to inform you so that you can make the right decision for you, and, if you do decide to take part, then your consent to do so is on record.
“It’s really important that people know their rights,” says Jamie Levey, chief operating officer of the European Huntington’s Disease Network and an HD family member who herself participates in research. “All of this takes a lot of explanation,” she adds, “you want to keep it simple, but that doesn’t necessarily mean shorter.”
Informed consent is essential to prevent the kind of exploitation that has sometimes happened in the past; it’s one way to ensure that the strict ethical research laws and guidelines now in place are closely followed.
There is no single world authority that dictates what an informed consent form must include, each region or nation has different regulations. In the US, each university, hospital or research institute also has its own committee, called an institutional review board (IRB). Each IRB may have its own requirements for what’s included. The exact wording of the informed consent form for Enroll-HD, for example, must be negotiated with dozens of different IRBs in the US alone.
For Enroll-HD, the form is long because the technical terminology is explained in simpler language. It describes the mental and physical exams that are part of the study and emphasizes that participation is voluntary and that anyone can drop out of the study at any time. It also gives you the option to be contacted for future drug trials or other types of studies.