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
- Electronic Records and Patient SafetyGuidelines have been put in place for healthcare professionals and staff in medical facilities that require that standards are followed closely. These guidelines are to provide proper treatment and avoid medical malpractice as much as possible. One standard is to provide safety of medical records and privacy. A physician may be held liable for breaching a patient’s confidentiality.
- Can a Doctor Give Someone Else My Medical Records Without My Permission?Individuals are provided with a number of privacy rights, especially concerning their healthcare records. These rights are pursuant to the Health Insurance Portability and Accountability Act (HIPAA) as well as state laws. However, there are a number of situations in which medical records may legally be shared with others.
- Am I Entitled to My Medical Records?Generally, patients are entitled to a copy of their medical records as provided under state and federal law. However, they must usually follow a specific procedure, and there may be exceptions to access.
- Medical Malpractice and Lack of Informed ConsentEvery day across America, millions of medical procedures take place without incidence. In fact, for the most part, the United States is one of the safest places in the world to have a medical procedure done. However, once in a while, something goes wrong.
- Understanding Informed ConsentAnyone who has ever been to a doctor has probably seen a form relating to informed consent. But what is informed consent? What happens if you are asked to consent to something that you do not understand and are later injured?
- What is HIPAA and What Does it Mean to Me?The Health Insurance Portability and Accountability Act (HIPAA) is a set of statutes designed to improve the efficiency and effectiveness of the US health care system. Much of it pertains to privacy issues related to your health records and what doctors and insurance companies can share with one another and with others. This is, to many, the most important part of HIPAA and creates a number of new rights for patients and new obligations for those in the medical profession.
- Who Should I Choose as My Health Care Agents?Your health care agents make health care decisions on your behalf if you are unable to provide informed consent at the time and have not already done so.
- When a Health Care Power of Attorney WorksYou need a health care power of attorney. So does your mom, dad, spouse, aunt, uncle, brother, sister, and child (age 18 or older.)
- Informed Consent Sparks Heated DebateThis past January, the Connecticut State Board of Health and Board of Chiropractic Examiners held a series of public hearings on whether there is a need to mandate that chiropractors warn their patients of the risk of stroke prior to performing certain spinal manipulations.
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