You can fight HD, support our families and help search for a cure. Help us.
Research into Huntington disease is vital to the development of effective treatments and a cure for this debilitating disease. The Huntington Society of Canada is aware of the importance of research and has as part of its mission to “further research to slow and prevent Huntington disease”. We do this through the funding and support of key individuals who are doing work in the HD field, as well as working jointly with other groups, such as the Huntington Study Group and HighQ.
Before you consider participating in research there are a number of things for you to think about:
• Why do I want to participate in research?
• What types of research will be conducted?
• How do I contact those who are doing research?
• How do they take care of my best interests and minimize risk to my family and me?
• Once I start participating how long do I have to continue?
Let’s look at these questions one at a time.
Choosing to Participate
At the 2006 HSC Conference, we conducted a survey to ask people about their views of research and why they did, and did not participate. The results of this survey showed that for those who participate in research the main reason they do so is that it is important to them that they be a part of finding a cure. As well, they have an interest in research and knowing more about HD. For those who did not participate the main reason was that they were afraid and did not know much about the research process and how they could help.
For each person who participates in research it is an important personal decision, but one that should be based on accurate information. This freedom of choice is built into how researchers conduct their work, and you should never be pressured to participate, and always feel free to ask questions.
Types of Research
Research is generally divided in to two categories: basic and applied research. Basic research is when a researcher has a particular idea or interest that he/she will investigate without a particular application in mind. This type of research can be very valuable to improving knowledge about diseases or chemical responses, for example.
Applied research is when a researcher has a particular application for the information that will be learned from the investigation. Clinical research or trials are a common form of research in Huntington disease. In these studies, volunteers are involved in assisting investigators to verify clinical process, medications, procedure, etc.
Many different types of people can participate in research: those with HD, those at risk, and families. This will depend on the type of research that is being conducted at any given time, by each researcher. Essentially, not every person is appropriate for every research study. There are often specific criteria that you will need to meet: age, gender, risk status, etc. Just because you may not be a candidate for one study, it does not mean that you will not be appropriate for other studies. Because research can happen in many different ways, interviews, analysis of blood and other specimens, taking a new drug or trying a new method of treatment, each research study will be different. For example, in Canada there are researchers who are looking at:
• Effects of Coenzyme Q10,
• The PHAROS Project looking at the natural history and experience of those at risk who do not know their status; and
• COHORT a long term observational study of those with HD.
Who is doing HD research in Canada?
There are many researchers who are doing investigations in Canada, which may or may not be appropriate for you. If you are interested in participating in clinical research, talk with the Huntington Society of Canada National office or a local Resource Centre Director, or member of your care team (genetics, neurology, psychiatry, social work) to see if there is some way that you can participate.
Protecting Research Participants
Historically, research has not always been stringently regulated resulting in many people being hurt or participating without their knowledge. This is no longer the case. Before any research can be conducted it must meet specific guidelines that ensure that individuals who participate in the research studies have all the information about the study, the risks and benefits to them, and have provided their consent.
In order for any researcher to get approval to do research, they must adhere to ethical standards that are set out internationally. In Canada, the federal government sets the minimum standard in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm). In this statement it outlines the principles that researchers must build into the research application:
Respect for human dignity
Respect for free and informed consent
Respect for vulnerable persons
Respect for privacy and confidentiality
Respect for justice and inclusiveness
Balancing harm and benefits
Essentially, these principles when put into practice will mean that the research that you are participating in will treat you with respect, keep you aware of all important information so that you can decide if you want to join, keep all information about you private and confidential, it will be fair and include a variety of people (gender, ethnicity, etc. where appropriate), the risks that you will be exposed to will be minimized, and that there will be the most benefit possible. While there still may be some risk, you will be informed of this and will be able to make your personal decision with the information that the researchers provide to you.
To ensure that this happens and is followed, each investigator must include approval from an “Office of Research Ethics”, with the institution that they are connected with, e.g.: university, hospital, etc. Those that are funding the research also require that the research be followed ethically.
Clinical Trials in Canada
Additionally, there are special precautions that are taken when researchers conduct clinical trials with drugs in Canada. In Canada, drugs are authorized for sale once they have successfully gone through an extensive drug review process. This process falls under the mandate of Heath Canada’s Health Products and Food Branch (HPFB). This branch is responsible for the approval process for pharmaceutical drugs, vitamins, vaccines and medical devices from pre-clinical trials to post market surveillance, inspection and investigation. Throughout the process, the safety and well being of Canadians is the paramount concern.
The intent of a clinical trial is to research and gather information on drug’s dose, effectiveness and safety in humans. Trials are undertaken with informed and consenting human subjects according to good clinical practices and ethical guidelines. This provides a controlled environment where the procedures for drug administration and the evaluation of the results are closely monitored.
Essentially, the government, offices of research ethics, and researchers themselves work very hard to protect the people who volunteer to participate in research. All avenues, from ethical reviews to the well being of individuals, are kept in mind. Should there be any adverse effects of participation, the research can be stopped immediately. As well, if at any time an individual decided that they can no longer participate, they can voluntarily withdraw.
Each research study is designated to continue for different amounts of time: long (up to years) or short (days). You can withdraw from research studies at any time as your life circumstances change. People who have participated in research in the past say only you can decide if this is the right decision for you, but the value that you may be adding to the knowledge of HD can be invaluable.
Trials are undertaken with informed and consenting volunteers, and are conducted according to procedures. The evaluation and results are closely and carefully monitored.
Everything is done to protect the people who volunteer to participate in research. The well-being of the individual is considered paramount. In the unlikely event of an adverse reaction or if a concern is expressed, the participant can withdraw at any time.