Informed Consent

If you and your health care provider have discussed the possibility of enrolling in a mesothelioma clinical trial, and you have found a trial for which you meet the eligibility requirements, you will need more detailed information in order to make a decision on whether or not to participate. This involves understanding all aspects of the trial including its risks and benefits, as well as your rights and responsibilities as a patient. The presentation and discussion of these issues is called "informed consent". While all medical procedures and interventions are designed to offer a patient some benefit, many of these measures also carry some risk. Great or small, side-effects or unintended threats to health from any medical intervention must be communicated to a patient in a comprehensive and fully comprehensible manner. As required by the American Medical Association's Code of Medical Ethics, it is every physician's duty to obtain a patient's informed consent prior to the administration of any risk associated therapy.

All medical patients have the right to decide what therapies may be employed to aid them, and only a thorough understanding of a therapy's risks/benefits will allow a patient to provide a physician with truly informed consent.

Informed consent goes beyond your signature on a form, however, and also includes a process that will provide you with ongoing explanations that will help you decide whether to begin or to continue the clinical trial once you have enrolled. Before you make your decision, the investigators conducting the trial will discuss with you:

Purpose of the trial.
Treatment procedures and schedule.
Potential risks and benefits.
Alternatives to trial participation.
Explanation of your rights as a participant.

If you agree to enter the trial, you give your official consent by signing the informed consent document. Once enrolled, the research team will give you frequent updates that may affect your situation, and you will always have an opportunity to ask whatever questions you might have and to address any concerns, therefore, informed consent is an ongoing, interactive process between you and the investigative team.While most people are aware of the fact that formal, patient-signed consent forms are standard procedure prior to many radiological treatments or invasive surgeries, it is less well known that health professionals are also required to obtain informal patient consent for minor laboratory tests or the issuance of pharmaceutical prescriptions. It is in these latter categories that health professionals oftentimes disregard the rules governing informed consent, e.g., a hematology technician drawing blood will rarely, if ever, inform a patient that there exits a miniscule risk of infection from the procedure.

Informed Consent Statutes

Physicians and other health professionals are constantly challenged by the critical task of obtaining a patient's informed consent prior to the delivery of a medical therapy. More than an ethical issue, statutes in all 50 states require that all medical patients be fully apprised of the attendant risks of any significant medical intervention prior to obtaining their informed consent.

While the specific details of informed consent laws vary from one state to another, health professionals in all 50 jurisdictions may be held liable for negligence, battery, and/or medical malpractice if they fail to meet the burden imposed by a state's informed consent law. The overwhelming majority of health care professionals in the U.S. recognize the importance of informed consent, and countless relevant studies have explored novel and improved ways for physicians to ensure that patients fully understand all risks that are attendant to any given medical intervention.

Patient Comprehension Levels will Vary

Medical conditions for which treatment is required are myriad and oftentimes extraordinarily complex. Pharmaceutical, radiological, surgical, and other therapies to treat disease are equally numerous and scientifically sophisticated, and as a result, physicians often face the significant challenge of communicating complex scientific information to the lay person. This challenge can be exponentially greater when a doctor must obtain an informed consent from a patient who, for one reason or another, suffers from diminished mental capacity.

All physicians must make a concerted effort to communicate therapy risks/benefits information to patients who suffer from a mental deficiency. This can be difficult to do, and even more so to quantify the effectiveness of a physician's communications with a patient-what the patient does or does not fully understand can oftentimes be difficult to know. In these and other instances, physicians are encouraged to employ informed consent techniques such as visual and audio aids, questioning patients to test their recall of given medical information, and providing patients with additional written information relevant to their illness and planned medical intervention. Patients who are severely mentally disabled cannot provide doctors with informed consent, and for such individuals, duly appointed guardians will authorize medical therapies in the patient's stead.

To receive a FREE Mesothelioma Web information packet** or to make a request, please fill out the following form :

**For a FREE information packet including treatments, clinical trials, and specialists, please complete the form above or call a Mesothelioma Web coordinator at 1-877-367-6376.

News

Resources

This site complies with the HONcode standard for trustworthy health information: verify here

If you would like to receive a FREE information packet or have questions about mesothelioma, call us at:

Toll-Free 1-877-367-6376