Your information is powerful! Your involvement in clinical research studies such as Enroll-HD will help us better understand HD, help improve the standard of care for HD patients, and – critically – accelerate the development of effective treatments for HD.

By taking part in these types of studies, you will find out more about HD and become familiar with some of the types of assessments commonly used in clinical trials. By participating in Enroll-HD you can also choose to be invited to join other HD research studies and new drug trials that are happening near where you live.

Many people involved in medical research report that it makes them feel empowered, a feeling that in doing something to fight back they regain some control over their disease.

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.

Contact your nearest study site and speak to the staff there, they will be able to answer your questions.

To get as many scientists as possible working on HD, CHDI makes research study data available to verified researchers all over the world while protecting the privacy of study participants.

When you join a study, your name is not entered into the study database. Instead, your information is associated with an identifier that is unique to you. Only a very limited number of people can see your name, including the people at the clinical site you visit and a small number of designated study personnel that monitor the quality of the data collected. Blood samples are protected in a similar manner as they are transferred to the storage repository.

Data collected within a study are entered into a database that includes only study information explicitly consented to on the informed consent form. Further, before any study dataset is shared with researchers, several factors that could be used to identify participants—such as birth date, site name, and visit date—are removed. A statistical team then looks at the remaining information—such as CAG-repeat length and sex—and calculates the risk of identification to ensure that it is extremely low.

Any researcher who wants to use study data or biosamples must first sign a legal agreement where they assure in law to not use the data or biosamples to re-identify any participants.

Data and biosamples are distributed in strict adherence to international data protection laws (General Data Protection Regulation, GDPR in the EU and UK, and Health Insurance Portability and Accountability Act, HIPAA in the US) and researchers are required to use and store the data in a secure and confidential manner.

CHDI aims to make HD research study data available to verified researchers and scientists all over the world; more researchers working with these data and biosamples increase the chance that exciting breakthroughs will be made.

To access study data or biosamples, a researcher must be verified as working at a recognized research organization. They are further required to sign specific legal agreements assuring they will follow lawful and ethical standards of research and keep all information confidential. See ‘How is my privacy protected’ above for further information on data privacy.

Not everybody uses these terms in the same way, but a clinical trial usually tests either a new drug or other therapy/intervention (e.g., exercise) to see if it is safe and/or whether it can improve symptoms or slow disease progression. Usually, a clinical trial is set up so that some participants get the experimental drug, others get an inactive form (placebo), and both groups are monitored over time to see which does better. Individuals are typically randomized to be in one of these groups, and the study is blinded, meaning neither the researchers nor the participants know who received what (active drug or placebo).

Observational studies like Enroll-HD aren’t designed to test treatments; they observe people over time in normal settings and under their normal clinical care routine. Observational studies take lots of measurements relating to the disease, lifestyle factors, current clinical care, and so on. Observational HD studies provide us with very helpful information on how the disease changes in individuals over time and may give us new insights into HD, such as how certain factors may affect when symptoms appear or how fast the disease progresses.

When you sign up for Enroll-HD, you can choose to be contacted by your local site staff if a suitable trial starts up near you that is looking for participants like you.

You can also search for all current research opportunities in the US on the HD Trialfinder or on Clinicaltrials.gov.