What is Informed Consent?
Anyone who wants to join Enroll-HD must first read a consent form that spells out why the study is being done, what it involves, and how privacy is protected. It explains what kinds of personal information will be collected, who will be allowed to see it, and how it is coded so that your identity (your name and other personal information) can’t be connected to the test results or biological data.
The purpose is to protect the rights and privacy of participants, provide information about the study, and also 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 record your consent to do so. “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.”
Almost all medical studies require that participants read and sign an informed consent form of some kind, to prevent the kind of exploitation that sometimes has happened in the past. Informed consent is one way to ensure that strict ethical research guidelines that are now in place are closely followed and that abuses do not occur today.
There is no single international 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 must be negotiated with dozens of different IRBs in the US alone.
For Enroll-HD, the form is long and complex because the technical terminology is explained in simpler language. It describes the mental and physical exams that are part of the study, and explains that participation is voluntary and that anyone can withdraw at any time. It also gives you the option to be contacted for future drug trials or other types of studies.
Your study site coordinator or site investigator can answer any further questions you might have. The goal is for everyone to make an informed decision about whether or not they want to be part of Enroll-HD.