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A Guide to Understanding Informed Consent

The informed consent process provides you with ongoing explanations that will help you make educated decisions.

If you and your physician have found a clinical trial that is of interest to you and for which you are eligible (that is", default", you meet requirements such as type and stage of cancer, age, treatment history, overall health, and others), you will need information in order to make a decision about whether to participate in the trial. Making a decision about participating in a research study involves understanding the potential risks and benefits as well as your rights and responsibilities. The presentation and discussion of these important issues are part of the process called informed consent. This guide will tell you what to expect during the informed consent process, explain its importance to clinical research participants, and describe how it fits into a larger system that protects the welfare of people who take part in clinical trials.

A Definition of Informed Consent

You may already have experience with signing consent forms for other kinds of medical procedures, such as surgery, or for cancer treatments such as radiation or chemotherapy. However, informed consent for a clinical trial involves much more than just reading and signing a piece of paper. Rather, it involves two essential parts: a document and a process.

The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains your rights as a participant. It is designed to begin the informed consent process, which consists of conversations between you and the research team. If you then decide to enter the trial, you give your official consent by signing the document. You can keep a copy and use it as an information resource throughout the course of the trial.

The informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Researchers and health professionals know that a written document alone may not ensure that you fully understand what participation means. Therefore, before you make your decision, the research team will discuss with you the trial’s purpose, procedures, risks and potential benefits, and your rights as a participant. If you decide to participate, the team will continue to update you on any new information that may affect your situation. Before, during, and even after the trial, you will have the opportunity to ask questions and raise concerns. Thus, informed consent is an ongoing, interactive process, rather than a one-time information session.

Myth and Reality

Before you start exploring this section of the site, you may find it helpful to confront some of the most common misperceptions about informed consent and clinical trials. Even if these do not represent your thinking about informed consent, they can serve as a helpful reminder of what the process is really about before you go through it.

Myth: Informed consent is designed primarily to protect the legal interests of the research team.

Reality: The purpose of the process is to protect you and other participants by providing access to information that can help you make an informed choice. It also is designed to make you aware of your rights as a participant.

Myth: The most important part of this process is signing the informed consent document.

Reality: Actually, the heart of this process is your ongoing interaction and discussions with the research team and other medical personnel–before, during, and after the trial. The document is designed to get this conversation started.

Myth: My doctor knows best; he or she can tell me whether or not I should consent to participate.

Reality: Your doctor is likely to be a valuable source of advice and information, but only you can make this decision. No one–not even medical experts–can predict whether a treatment, screening, prevention, or supportive care method under evaluation in a trial will prove successful. The informed consent process is designed to help you weigh all of the information and make the right choice for you or your child.

Myth: Once I sign the consent form, I have to enroll and stay enrolled in the trial.

Reality: That's not true. Even after you sign the form, you are free to change your mind and decide not to participate. You also have the right to leave a clinical trial at any time for any reason, without forfeiting access to other treatment.

Myth: Medical personnel are busy, so I can't really expect them to keep me informed as the trial progresses or listen to my questions.

Reality: The research team has a duty to keep you informed, make sure that you understand the information they provide, and answer your questions. If you ever feel that you are not getting what you need, do not hesitate to speak up. You will be given the name and phone number of a key contact person who can answer your questions throughout the course of the trial. Keep in mind that people like you are making this research possible through their willingness to participate.

BY National Cancer Institute


What happens if the prospective participant in a clinical trial is not an adult, but a child or teenager? What, if anything, should be done to educate the young person about the trial and ensure that he or she is given a say in whether or not to participate?

At one time, it was assumed that young people lacked the ability to consent to participation in clinical research. Instead, parents or guardians went through the informed consent process on their behalf and gave what was known as "proxy consent."

Over the past couple of decades, medical and legal experts have given much thought to the special issues surrounding children's participation in clinical trials. In the eyes of the law, children under 18 are not adults; therefore, legal permission for their participation must be given by parents or guardians after going through the informed consent process on their behalf.

However, many people involved in treating young people believe that the child or adolescent should play a role in the decision to enter a research study. The American Academy of Pediatrics calls this "empower [ing] children to the extent of their capacity" and talks about this shift in thinking in "Informed Consent, Parental Permission, and Assent in Pediatric Practice." The National Commission for Protection of Human Subjects of Biomedical and Behavioral Research established age 7 as a reasonable minimum age for involving children in some kind of assent process. It is felt that most children this age can understand information tailored for their knowledge and developmental level.

Health care providers want young people to know that they have a say in what happens to them and that their questions and input are valued. Encouraging their involvement in decision-making is done out of respect for their rights as individuals and the desire to give them a sense of ownership in what happens during the trial. Even though children cannot "consent," because true consent implies full understanding, they are now routinely asked whether they agree (assent) or do not agree (dissent) to participate. Their parents or guardians are no longer asked to give "proxy consent" but instead give "informed permission."

Parents reviewing written information about a clinical trial for their child can interact with the research team and learn how the study will work, its objectives, the possible benefits and risks of participating, and the child's rights and responsibilities. In this way, they can make a fully informed decision about whether or not to give "informed permission" for their child's participation in the clinical trial.

2001-2010 National Alliance against Mandated Mental Health Screening & Psychiatric Drugging of Children. All rights reserved.

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