Whether you’re looking for new ways to treat your condition or want to contribute to medical research, a clinical trial may be the right choice. But before you join one, you must understand the entire process.
This involves understanding what informed consent is. This article will help you do just that.
What is Informed Consent?
Informed consent is a collaborative decision-making process that requires healthcare professionals and patients to evaluate options based on the patient’s unique preferences, priorities and best interests. It demonstrates respect for the patient and builds trust and confidence in medical professionals. It also helps reduce unnecessary legal claims based on incorrect assumptions about appropriate medical care.
In medical practice, informed consent is used for many different procedures, including signing up for clinical trials. These include treatments using high-risk medications, tests inside the body, and childbirth interventions. Clinical trials and other research studies that involve people are also required to obtain informed consent from the participants.
This process can be difficult. For example, if a person has dementia or another medical condition that affects their ability to comprehend information, they may be unable to give informed consent. In these situations, a legally authorized representative or parent can provide support on their behalf.
Even when a patient has the mental capacity to give informed consent, it is still possible that they will refuse treatment because of fear or misunderstanding. This is why healthcare professionals need to take the time to explain each option carefully. Visual aids like infographics and videos can help them communicate complex topics in an easy-to-understand way. The process of obtaining informed consent should also be documented.
Why is Informed Consent Important?
When doctors and patients communicate well about the risks involved in medical procedures, it helps create trust and reduces risk for both parties. Good communication also minimizes the likelihood of medical malpractice lawsuits arising from misunderstandings and miscommunication.
Clinical trials allow physicians to study new medications or treatments on a larger group of people, which could help improve the overall quality of health care and treatment options for future patients. Informed consent is a vital component of medical research, as it shows respect for the individual’s right to personal autonomy and allows them to make a choice that is best for their specific situation.
Informed consent consists of a discussion process and written documents to ensure that a participant understands the research and has been made aware of what is being tested, including any potential discomforts or risks. The Food and Drug Administration requires informed consent for all clinical studies that involve human subjects. This includes a written information sheet or a verbal explanation from the researcher and a signed document to verify comprehension of the study.
This concept of informed consent can take time to achieve. When patients cannot make decisions, family members, guardians or conservators (as determined by state law) can act as surrogate decision-makers to provide informed consent.
What Are the Benefits of Participating in a Clinical Trial?
Participation in a clinical trial allows participants to be first in line for new treatments for their medical condition before they become widely available. They also have access to expert medical, often multidisciplinary, care at leading healthcare facilities and are monitored closely by a dedicated team of doctors and nurses. This can include extra tests and appointments, as well as longer stays at the hospital for a device trial (like a neurostimulator), depending on the specifics of their study.
In addition, there may be additional financial compensation for their participation. If the study tests a new drug, participants will be assigned randomly to receive the experimental treatment or a placebo. The participant’s regular healthcare team will be alerted that they are participating in a trial so they can immediately monitor their health status and provide appropriate treatment if needed.
Another benefit of participating in a clinical trial is the knowledge that they are contributing to medical research and helping others with their condition in the future, especially those who cannot be supported by current medicines or treatments. This can be particularly reassuring for people who have rare diseases. Participants also feel that being part of a research project allows them to play a more active role in their health care, and some find it exciting to know they could be among the first to benefit from a potentially life-saving treatment.
What Are the Risks of Participating in a Clinical Trial?
While every step is taken to keep patients safe, clinical trials involve some risks. For example, the experimental treatment may have side effects that are different from or worse than those of the standard treatment. Also, the new approach may need to be revised. Moreover, your personal information may be used for research purposes without your knowledge.
In addition, there could be a financial cost to you if you participate in the study. However, in most cases, you do not have to pay extra for the treatments under study; your health insurance will cover them. Also, you will usually be compensated for the time and travel involved in your participation.
Many people participate in clinical trials to contribute to medical research and advance treatments for diseases like cancer. Others feel they are playing a more active role in their healthcare. Still, it is important to understand what you are signing up for and be confident in the information you are being given. Your doctor is a great resource and can help you learn more about a trial, including whether it is appropriate. You can also ask for more information from a research coordinator or a nurse. You can also seek information from patient advocacy groups and the US Food & Drug Administration.