Informed Consent Law
Informed Consent Law covers the legal aspect regarding an individual's right to be informed of and consent to a procedure or treatment suggested by a physician or professional. This written authorization can limit professional liability issues for the individual providing the service.
Prior to signing this agreement, ethics dictate that the physician providing or performing the treatment and/or procedure should discuss with the patient the patient's diagnosis; the purpose of the treatment or procedure; the risks involved; alternative treatments; and the risks and benefits of refusing treatment. The patient can then make an informed decision to accept or refuse the treatment or procedure. In the event that the patient is incapacitated to the point of not being able to make an informed decision, a family member, as authorized by law, can replace the patient.
Informed consent is used not only in the medical sector but in any other sector where an individual's wellbeing and/or health are at stake. When accepting to undergo experimental treatments or clinical trials an individual has the right to be informed of all the risks involved and consent to the latter.
Some states have statutes that are designated as the Patient's Bill of Rights. It ensures that the patient is treated fairly by the health care system and that the system is under the obligation to meet the patient's requirements. It gives the patient the right to address any issues they may have and it encourages the active role of staying healthy or getting healthy by patients.
Know Your Rights!
Informed Consent Law - US
- American Cancer Society - Patient's Bill of Rights
Here you will find a summary of the Consumer Bill of Rights and Responsibilities that was adopted by the US Advisory Commission on Consumer Protection and Quality in the Health Care Industry in 1998. It is also known as the Patient's Bill of Rights.
- American Medical Association - Informed Consent - Patient Physician Relationship
Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention.
- CFR - Title 45 Public Welfare
Except as provided in paragraph (b) of this section, this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the federal government outside the United States.
- Federal Tort Claims Act (FTCA)
Federal Tort Claims Act (FTCA) cases are varied. Those cases handled by section litigators include traditional problems in tort law, such as medical malpractice and other personal injury litigation, as well as seminal issues arising in areas as diverse as regulatory agency activities, wild animal attacks in national parks, and professional malpractice. The section also handles litigation brought by persons who contracted AIDS allegedly due to government negligence in the course of blood transfusions or other medical procedures. Section attorneys protect the United States from exposure to excessive liability, and from second-guessing of governmental policy decisions through tort litigation.
- Informed Consent - Definition
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and future consequences of an action. In order to give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts at the time consent is given.
- Medicine Plus - Patient Rights
As a patient, you have certain rights. Some are guaranteed by federal law, such as the right to get a copy of your medical records, and the right to keep them private. Many states have additional laws protecting patients, and healthcare facilities often have a patient bill of rights. An important patient right is informed consent. This means that if you need a treatment, your health care provider should give you the information you need to make a decision.
- Waiver of Informed Consent for Research in Emergency Situations
The current state of emergency medicine and research has resulted in the application of standard treatments that often have not been scientifically evaluated for safety and effectiveness and may render unsatisfactory outcomes. Given the insufficiency of standard treatment alternatives, it is appropriate, in certain situations and with special safeguards, to provide experimental treatments without obtaining the informed consent of the subject. However, in order to protect the rights and welfare of the subjects, several conditions must be met.
Organizations Related to Informed Consent Law
- Agency for Healthcare Research and Quality (AHRQ)
The Agency for Healthcare Research and Quality's (AHRQ) mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As 1 of 12 agencies within the Department of Health and Human Services, AHRQ supports research that helps people make more informed decisions and improves the quality of health care services. AHRQ was formerly known as the Agency for Health Care Policy and Research.
- HHS - Office for Civil Rights
Federal civil rights laws and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, together protect your fundamental rights of nondiscrimination and privacy.
- Office for Human Research Protections (OHRP)
It is essential that consent forms be written in plain language that research subjects can understand. In addition, the consent form should not contain any exculpatory language. That is, subjects should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence.
Publications Related to Informed Consent Law
- Guide to Understanding Informed Consent for Research - National Cancer Institute
If you and your physician have found a clinical trial that is of interest to you and for which you are eligible (that is, 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.
- Informed Consent - Ethics and the Law
As a matter of both ethics and the law, adult patients - who have no cognitive impairments - should be centrally involved as decision-makers during their medical care. In ethics, the well-established principle of "respect for persons" that supports this perspective. Because no one is usually better suited than adults themselves to appreciate what a diagnosis and treatment means for their lives, patients should ordinarily be respected as "experts" about the medical treatment that is desirable to them.
- Informed Consent - University of Washington School of Medicine
Opportunities to "consent" a patient abound on the wards. The aim of this section is to provide you with the tools required for the "basic minimum" as well as providing a more complete picture of the ideal informed consent process. You will find that the particular circumstances (e.g. the patient's needs or the procedure) will determine whether a basic or complete informed consent process is necessary.
- Informed Consent in Psychotherapy and Counseling - Standards and Guidelines
Here are some resources including forms, standards, guidelines and references that may be helpful in thinking through the process of informed consent.
Articles on HG.org Related to Informed Consent Law
- What Are the Risks Involved with Medical Tourism?Medical tourism occurs when a person from one country researches and travels to another for healthcare procedures that are usually cheaper or higher quality than the home nation. However, there are certain risks involved depending on the country and procedure sought such as injury or illness from recovery times.
- Surgery Abroad: Legal Uncertainty When Things Go WrongTraveling to another country is fraught with dangers and could lead to illness, healthcare complications and injury through botched surgical procedures. Before initiating the travel to receive such surgery or treatment, it is important to consult with a legal representative to determine if there are other concerns or specific uncertainty that may reach a resolution through a lawyer.
- Common Dental Negligence LawsuitsCommon forms of negligence usually lead to litigation claims against the dentist or the practice when the patient suffers injury during his or her treatment at the clinic. Knowing which common negligence claims affect citizens throughout the country may provide additional details and ways of obtaining compensation when suffering from similar circumstances.
- Dental Malpractice Lawsuit: Elements to EstablishThe four elements of any malpractice suit have a connection to dental malpractice lawsuits as well, and they must exist for the claim to have any chance of success. For a patient that has suffered an injury or complication through a dental visit, it is important to seek professional legal advice before attempting to pursue compensation.
- How to Enforce a Court Order Against a Foreign Medical Provider?It is when medical tourism and treatment in other countries causes injury that the patient may need to try to have a court enforce an order or judgment upon a foreign medical provider or physician. Before this is even possible, it is imperative that the person involves knows the foreign laws that affect the case and how they work into the court system.
- Dental Implants and Nerve Damage - Is It Malpractice?Experts have explained that dental implants are often the last resort in attempting to correct mouth and tooth complications that may harm the remaining teeth and gums inside. When the dental implant or medication lead to nerve damage and severe problems, it is important to investigate if these instances are part of malpractice or errors in judgment.
- Contraceptives Crossing the Border and the Legal HurdlesIt is when contraceptives become purchasable over the counter that crossing the borders of the country could lead to legal complications in selling and giving these items to others. The legal hurdles the nation may face in loss of sales or difficulty in maintaining laws when a person crosses the border could cause other impacts to business and the legal system.
- Link between Antibiotics and Dental Standard of CareTo treat various issues inside the mouth as well as to prevent the possible infections that occur, a dentist may prescribe antibiotics. This is considered a standard of care in usual circumstances, but there are other methods used that prevent problems that are more often put to use which may manage and intervene before antibiotics become the best option.
- The Definition of Medical TourismThe travel of a person from the United States to another area of the world for a medical procedure that is less costly or may provide better benefits than found in the American states is medical tourism. The act itself is not illegal, but the travel and healthcare obtained could lead to complications and several issues outside and inside the country.
- Dental Implants Resulting in Dental Malpractice ClaimsThere is a need for dental implants for various individuals throughout the country, but there are many incidents out of the twenty percent of dental prostheses needed by all United States citizens that cause issues. Out of the few of the fifteen to twenty percent annually needing the implants, dental malpractice claims arise through injury to the patient.
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