when a subject agrees to participate in a study based on disclosure of personal information.

The process during which a subject learns all the details of a particular clinical trial such as study design, risks, benefits, etc. that would effect their decision to participate.  Patients who agree to participate in a study are asked to sign and date an informed consent form, which describes this information about the study, after all their questions are answered.  Signing the informed consent form confirms the patient's willingly volunteers to participate.

the procedure whereby the nature of the experiment is explained to participants before it begins and their consent to participate in the experiment is obtained

A process by which a participant voluntarily confirms his or her willingness to participate in a particular clinical study, after having been informed of all aspects of the study relevant to the participant's decision to participate, including known and potential risks and benefits. Informed consent is documented by means of a written, signed and dated informed consent form.

Consent that is granted only after one understands all that the consent permits or prohibits and the implications and possible effects of granting that consent. Appropriate translation services need to be provided for persons to be truly "informed" when more than one language is involved.

The process in which a person is given all the relevant information about a health care decision and voluntarily agrees to it. The concept is based upon the principle that a physician has a duty to disclose information that allows the patient to be an informed participant in his or her own treatment. It is not clear how genomic technologies will affect the informed consent process.

Written consent which has been given after information has been received and understood by a person.

The process by which a patient receives a written explanation of the risks and benefits to a medical treatment involving research, so they can make an informed decision on whether or not to participate. If a patient chooses to participate, they will indicate in writing that they understand and agree to the information provided. The written document used in this process is called a consenting document. The consenting document has been reviewed and approved by an Institutional Review Board or human use committee to ensure that it accurately reflects what the research protocol states will be done and is understandable to the average lay-person. A person must be at least 18 years of age before they can provide informed consent.

a legal term referring to the disclosure and consideration of all relevant facts available on which to base an intelligent decision and consent to a particular medical treatment.

The process of reaching an agreement based on a full disclosure and full understanding of what will take place. Informed consent has components of disclosure, comprehension, competence and voluntary response. Informed consent often refers to the process by which one makes decisions regarding medical procedures including the decision to donate the organs of a loved one. BACK TO THE TOP

agreement to undergo a medical procedure after the technique, its risks, and its possible complications have been explained

Informed consent correlates to signing forms that legally allow the surgery to proceed. Informed consent assumes that the patient has read about, been educated and understands all of the events, risks and complications that could take place as a result of surgery.

Permission to do something which is given with complete knowledge of all relevant facts, such as the risks involved or any available alternatives.

Means that: 1. The parent has been fully informed of all information relevant to the activity for which consent is sought, in his or her primary language or other mode of communication. 2. The parent understands and agrees in writing to the carrying out of the activity for which his or her consent is sought, an the consent describes the activity and lists the records (if any) which will be released and to whom; and 3. The parent understands that the granting of consent is voluntary on the part of the parent and may be revoked at any time.

Written consent that is freely given after information has been received and understood.

The principle of informed consent rests on the idea that human research subjects should be able to agree to participate, or to not participate in research in the light of comprehensive information about the nature and purpose of the research. It is based on the assumption that individuals have a right to know what is happening to them.

a patient's written consent to a surgical or medical procedure or other course of treatment, given after the health care worker has informed the patient about the potential benefits, risks, and alternatives involved

An ethical principle in research, in which participants have a right to be informed, before participating, of what they will be asked to do. [Go to source

A procedural step, conducted before an experiment begins, in which the research participants are asked to give their agreement to participate, based on full information about what the experiment will involve.

a consent that is obtained after a full disclosure of the facts and risks involved; sometimes an allegation in medical negligence cases

(See also consent) The data subject has been informed that Partners, in order to ensure that they are working with the same person, may share personal information such as name, address and date of birth without the data subject signing an explicit consent form.

A legal standard that requires a patient to be fully informed about the potential risks factors and benefits of treatments such as chemotherapy, radiotherapy and surgical procedures before undergoing such therapy or surgery. Once patients are aware of the procedure(s), they sign a form giving medical staff permission to proceed.

a person’s agreement to allow something to be done to him or her (such as surgery) that is based on a full disclosure of facts needed to make that decision and the competence to understand.

The agreement to do something or to allow something to happen, such as a surgical operation, but only after all the relevant facts are known. In contracts, informed consent occurs only after both parties fully disclose everything known that is of significance to the agreement.

Type of protection available to people who consider entering a drug trial. Before entering the trial, participants must sign a consent form that contains an explanation of (a) why the research is being done, (b) what researchers want to accomplish, (c) what will be done during the trial and for how long, (d) what risks are in the trial, (e) what benefits can be expected from the trial, (f) what other treatments are available, and (g) the participant's right to leave the trial at any time. See also CLINICAL TRIAL.

the subject of an experiemtn or medical procedure must be able to understand the risks involved and give permission for it to proceed, knowing these risks

Agreement to take part in a clinical trial, or to take a test, after a full written or verbal explanation of the trial including the risks and benefits of taking part, has been provided by the researchers.

A process in which people are given full information about a study, which allows them to make a knowledgeable decision about whether to participate. go to glossary index

A written agreement by the program participants to voluntarily participate in an evaluation or study after having been advised of the purpose of the study, the type of the information being collected, and how information will be used.

The agreement of a person (or his or her legally authorized representative) to submit to any medical procedure, in full knowledge of all procedures and requirements as well as possible risks and benefits entailed.

An administrative and legal device by which approval to proceed based on known or predicted consequences is obtained and recorded from a patient or from a volunteer for medical research, and thus avoiding an accusation for what otherwise might be an assault. Just what 'informed' means can be the subject of much legal and ethical wrangling. One modern interpretation is that it means as much as the person giving the consent demonstrates that he or she wants to know (although most physicians, ethics committees, institutional review boards and courts underpin this with a minimum everyone should be told about the procedure being consented to).

An individual willingly agrees to participate in an activity after first being advised of the risks and benefits.

The knowing, legally effective consent of any individual or the individual's legally authorized representative. (In the state of Florida at the time of printing, an individual's legally authorized representative may not give consent for the individual to be a human subject in research study, except under certain limited circumstances. Contact the IRB office for more information.) Such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.

A procedure by which people freely choose to participate in a study only after they are told about the activities they will perform.

Agreement of a person being studied, based on the person’s knowledge about the goals, methods, benefits, and risks of the study. Informed consent is given with the understanding that the person can change his or her mind about the study at any time.

The agreement of a person to serve as a research participant or to enter therapy after being told the possible outcomes, both benefits and risks.

An individual's agreement to allow something to transpire subsequent to the individual having been informed of associated risks involved and alternatives.

Potential subjects are informed in language appropriate for their level of understanding about all features of the research that may affect their willingness to participate; their questions should be answered; and they should be free to choose to participate or not, and to discontinue participation at any time.

Agreeing to a medical procedure after careful evaluation of the potential risks and benefits and making an informed decision.

The process of learning key facts about a clinical trial before participating, including: Why the study is being done What is to be accomplished What will be done and for how long What risks are involved What benefits can be expected What other treatments are available Whether the subject may quit the trial at any time

Having enough information and understanding to make a decision about your own health care. This may apply to tests, treatment, or other aspects of health care.

The process of making decisions about medical care that are based on open, honest communication between the health care provider and the patient and/or the patient's family members.

the consent must be consensual, freely given, informed, and specific to both the treatment and the caregiver.

The permission granted by a participant in a research study after they have received comprehensive information about the study or where certain tests are to be performed.

Information to the participant that describes the study and indicates where to direct any questions or concerns.

Informed consent is a legal term referring to the right of individuals to make informed medical treatment decisions. Under State law, informed consent typically includes the right to be told of one's medical condition and prognosis, the risks and benefits associated with a recommended procedure or course of treatment, and the risks and benefits of other available treatment options, including the option of refusing treatment. When a person becomes mentally incapacitated, his or her right to give or withhold informed consent typically passes to the person's legal representative, usually an agent or attorney-in-fact under a durable power of attorney, a court-appointed guardian, or a close family member.

the agreement of a patient to participate in a clinical trial about which they have a full understanding. Patients must sign an informed consent form in order to be accepted on to a trial but maintain the right to leave the trial at any point

The written signature and dated voluntary confirmation of patient or subject as to willingness to participate in a clinical trial after full disclosure of information on the trial, benefits, potential risks, and rights and responsibilities.

Permission that is given by a person with mental capacity after receiving full disclosure of options.

A process in which a patient gives written consent (agreement) to undergo a medical procedure after having been provided with information about the nature of the procedure, risks, potential benefits, alternatives, and so on by his or her doctor.

information given to a usability test subject prior to the test that explains in general terms what is about to happen and makes clear that continued participation is voluntary

Disclosure of a certain amount of information to the patient about the proposed treatment and the attainment of the patient's consent, which must be competent, understanding, and voluntary.

An agreement signed by all volunteers participating in a clinical research study, indicating their understanding of: (1) why the research is being done; (2) what researchers hope to learn; (3) what will be done during the trial, and for how long; (4) what risks are involved; (5) what, if any, benefits can be expected from the trial; (6) what other interventions are available; and (7) the participants right to leave the trial at any time. (See protocol.)

A person's agreement to allow something to happen (such as surgery) that is based on a full disclosure of facts needed to make the decision intelligently.

consent by a patient to undergo a medical or surgical treatment or to participate in an experiment after the patient understands the risks involved

a disclosure document of agreement between the participant and the Principal investigator

an autonomous authorization by an individual regarding a medical intervention or involvement in biomedical research

a shared decision between you and your patient

legally required procedure to ensure that a patient knows about the potential risks and benefits of a treatment before it is started.

A process (oral, written, or both) in which complete information regarding participation in a specific research protocol is presented to the subject or the subject's legally authorized representative in understandable language. Such consent shall be sough under circumstances which provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and with no undue influence. No informed consent may include language which the subject or the representative is made to waive any of the subject's legal rights or release the investigator, sponsor, institution or its agents from liability for negligence. In almost all instances, informed consent must be documented by use of a written consent form which has been approved by the Institutional Review Board (IRB) and signed by the subject or the subject's legally authorized representative.

A contractual agreement between a patient and a physician, whereby the patient gives permission to undergo a certain procedure based on as clear an understanding of the issue as is possible. This understanding should be based on education and explanation.

This is the process by which a patient and or his family learn about all of the aspects of a medical treatment and its benefits and risks before agreeing to be treated. It is a very important part of any medical procedure. Treatment cannot begin until informed consent has been obtained.

Every doctor (or other medical practitioner) has a duty to inform the patient of any and all risks and considerations of the available options and treatments so that the patient may be able to give an informed written consent to a procedure before the doctor or medical practitioner can administer the treatment. Violation of this duty gives the patient a medical malpractice cause of action.

The process and paperwork done to inform a research subject about the study, and to gain consent for their participation.

The process of providing all relevant information about the trial's purpose, risks, benefits, alternatives and procedures to a potential participant, who then, consistent with his or her own interests and circumstances, makes an informed decision about whether to participate.

The process in which a person learns key facts about a clinical trial or research study and then agrees voluntarily to take part or decides against it. This process includes signing a form that describes the benefits and risks that may occur if the person decides to take part.

The process of learning key facts about a clinical trial before participating (see clinical trials)

when appropriate information is provided in order to enable patients to make decisions which reflect their own values. Health professionals subscribe to the values of non-directive counselling and informed consent, in order that patients can make decisions which are best for them, on the basis of full and balanced information. Relevant information might include: the purpose, risk, and benefits of testing; the reasons why the patient might participate in or decline testing; any available alternative procedures, interventions and treatment; decisions which may have to be made after receiving test results.

The process by which sufficient information is provided by the healthcare team in understandable language about proposed treatment in order for the patient to make decisions about treatment and care.

A term used to describe the responsibility of doctors or researchers to ensure that patients or people being researched have an understanding of the relevant facts regarding their care or participation in research. We can also say that consumers have a right to practice informed consent when they buy particular foods. Informed consent relies on our having access to reliable, truthful, and complete information.

The voluntary, informed agreement of an adult with decision making capacity to participate in a research study, based on an understanding of the study, its possible benefits and risks, the alternatives and their possible benefits and risks, and other information provided by the investigator and other members of the research team. Informed consent is obtained through a process of interaction between the potential subject and members of the research team. This process may include discussions, questions and answers, and review of a written document called an informed consent form. See also INFORMED PERMISSION.

the legally effective permission of a human participant or a participant's legally authorized representative (e.g., parent or legal guardian of a minor child).

A document that outlines an entire procedure or research study. It describes the procedure or study, including possible risks and benefits. Signing the informed consent means you understand and agree to the procedure or participation in the study.

The process by which the patient or parent/legal guardian gains understanding about the potential risks and benefits of the treatment plan and legally agrees to accept those risks.

A process in which a patient is given all available information necessary to understand the risks and benefits of proposed treatments. He or she can then give or withhold informed consent.

Informed consent requires test takers to give their consent before being tested; it is legally and ethically required. Test takers are to be told what the purposes of the test are, who will have access to the scores, and how the results will be used.

The verification of a person's willingness to volunteer in a research project. The verification is requested only after the person has received complete, objective information about the research, including its objectives, potential benefits, risks and inconveniences, alternative therapies that may be available (if applicable), and the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.

The process by which a patient gains an understanding of what will be involved in receiving a medical treatment or procedure, including why it is being done, its risks, and other alternatives, before agreeing to treatment.

Informed consent is informing the participants of the potential risks that may be involved and having them voluntarily agreeing to participate. Sometimes a signed document is used for this purpose.

the necessary written consent of the ESA staff member who is requested to act as a test subject of an experiment or whose personal image is requested for use for commercial purposes.

A term used to describe the obligation of physicians or researchers to allow patients or subjects to be active participants in decision regarding their care or participation in research.

agreement or permission required to be given by a resident or their representative before a treatment or procedure involving risks is undertaken. The resident or their representative must not only be informed of the risks, but must understand them for the consent to be valid.

A written or verbal agreement from a person who agrees to take part in the project or evaluation. Informed consent involves giving clear information about what will happen to the person BEFORE they make the decision to participate.

The person giving consent receives information necessary to make a decision about their care, including information about the consequences of any treatments or services (e.g. risks and benefits, as well as many alternative treatments and their right to refuse treatment).

A statement for the patient to sign and date that explains in language understood by the patient all relevant informa­tion related to the proposed treatment. It should include alternatives and consequences of no treatment at all. This docurnent is given to the patient to sign and date after the proposed treatement is dis­cussed with the doctor who will do the procedure.

The knowing, legally effective consent of any individual or the individual's legally authorized representative. Such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. Informed consent must be sought under circumstances that minimize the possibility of coercion of undue influence and must include the eight basic information elements described in the regulations (see below). Information must be presented in language understandable to the subject or the subject's legally authorized representative.

the absolute legal right to choose or refuse medical treatments that have been explained to you by your doctor. This includes the right to refuse the use of blood once your healthcare provider has explained the risks, benefits and alternatives. It also protects the physician from liability since the document is your sworn statement that you are aware of the risks of refusing possible life saving treatment. See Medical Director or Proxy.

The situation where a competent person, in possession of all the relevant facts, has agreed to participate in a research study.

Hospital form, signed by the patient, which documents an understanding of medical procedures.

For certain medical procedures, doctors are required to have patients sign an informed consent form, stating that the patient has been informed of the medical procedure, allows the procedure to be performed, and is aware of any alternatives to the procedure and risks involved.

Agreement to take part in a study that is given voluntarily and based on an understanding of the risks and benefits of the work.

informed consent is a process all potential study participants must go through. This process includes learning the key facts about the study before deciding whether or not to participate in the study.

Following disclosure of the risks and options, the permission given by a person with mental capacity prior to receiving medical treatment.

An agreement obtained voluntarily from a patient for the performance of specific medical, surgical or research procedures after the material risks and benefits of these procedures and their alternatives have been fully explained in nontechnical terms.

The name given to the process during which a person weighs the known and possible risks and benefits of a trial, then agrees voluntarily to participate. When someone agrees to be in a trial, they sign an agreement called an Informed Consent Form.

The process in which a person learns the key facts abut a Clinical Trial and then agrees voluntarily to take part or decides against participation. This process includes signing the Informed Consent Form that describes the Benefits and Risks that may occur if the person decides to take part.

A process by which the researcher explains all potential risks and benefits of a clinical trial to potentially willing and eligible participants. The Institutional Review Board (IRB) must approve the informed consent and all potential participants must sign the form in advance of starting the clinical trial.

The client's granting of permission to the professional agency to use specific intervention procedures, including diagnosis, treatment, follow-up, and research. This permission must be based on full disclosure of the facts needed to make the decision intelligently. Informed consent must be based on knowledge of the risks and alternatives.

any consent in which the party (buyer or seller) clearly understands what he or she is signing and why; it is obtained when the agent makes his or her explanation commensurate with the education and understanding of the party.

A legal concept requiring full disclosure to the patient of the nature and consequences of proposed medical tests and treatments and obtaining the patient's consent. Informed consent requires disclosure of the diagnosis, potential risks and benefits of the proposed medical treatment or procedure, and the benefits and limitations of available treatment alternatives.

refers to the requirement that a patient or resident be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course.

The complete and open discussion of all procedures, benefits, risks, and expectations of a clinical trial between clinical investigators and potential patients. The FDA requires all patients to sign an informed consent form before participating in a trial.

The voluntary verification of a patient's willingness to participate in a clinical trial, along with the documentation thereof. This verification is requested only after complete, objective information has been given about the trial, including an explanation of the study's objectives, potential benefits, risks and inconveniences, alternative therapies available.

The legal and ethical requirement that no significant medical procedure can be performed until the competent patient has been informed of the nature of the procedure, risks and alternatives, as well as the prognosis if the procedure is not done. The patient must freely and voluntarily agree to have the procedure done.

the process of deciding whether or not to join a clinical trial, after learning enough information to make a responsible decision about participating. All trial participants must provide written agreement before entering a study.

The process of learning the key facts, risks and benefits about a clinical trial in order to decide whether or not to participate. It is also a continuing process of education to the participant throughout the life of the trial.

the process in which a person learns the facts about a clinical trial (research) and voluntarily agrees to take part by signing a consent form that describes the possible risks and benefits of the treatment.

The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.

A process in which the risks, benefits, and requirements of a research study are explained to people invited to take part in the study. Before entering the study a participant should sign an informed consent form, which should contain in writing the benefits, risks and basic structure of the study.

Consent of the patient who has received sufficient information to have surgery, receive medication, or participate in a clinical study.

The agreement of a person (or his or her legally authorized representative) to serve as a research subject, with full knowledge of all anticipated risks and benefits of the experiment.

In-formd Kon-sent] The process where a patient learns about all the aspects of a medical treatment or clinical trial before agreeing to participate. This process should include a detailed explanation of the potential risks and benefits of all standard medical procedures and treatments.

Consent given voluntarily, by a competent  person, able to fully understand the benefits  and potential risks of their decision.

An individual's deliberate, voluntary decision to participate in research, based on the researcher's description of what will be required during such participation.

Agreeing to take part in a clinical trial, or have a particular treatment, with a full understanding of the benefits and drawbacks.

The process of educating a potential clinical trials participant so he or she can make an educated decision as to whether to join a clinical trial. All patients must be informed of their rights as a participant, the safety hazards they might face, the study aims, and what is to be expected of him or her. Patients must sign an informed consent form to attest that they have received this information.

Consent is informed consent when notice is given, prior to the collection of the personal information, regarding who is collecting the information, who will have access to it, what are the intended uses of the information, and whether the disclosure of such information by the client is voluntary or required in order to obtain the offered services.

A process in which the risks, benefits, and requirements of a trial are explained to people thinking of joining the trial. Before entering the trial a participant should sign an Informed Consent Form, which should contain in writing everything that was explained in person about the trial. The form should state: a) why the trial is being done and what it hopes to prove, b) what will be done to you during the trial and how long the trial is, c) the risks and benefits of the trial, d) other treatments available for your condition, and e) that you have the right to leave the trial at any time. Informed consent exists to make sure that anyone thinking of joining a trial makes a decision based on complete information and that no one is pressured into joining.

means that unless you have been found incapable, people who treat you must give you enough information about the treatment, its good point and bad points, that you can make an educated decision about whether you will allow the treatment, before you are treated. If you have been given enough information to make a good decision, you can give what is legally called informed consent.

A medico-legal doctrine that holds providers responsible for ensuring health service users or patients understand the risks and benefits of a procedure or medicine before it is administered.

Agreement by the participants in an evaluation of the use of their names and/or confidential information supplied by them in specified ways, for stated purposes, and in light of possible consequences prior to the collection and/or release of this information in evaluation reports.

The process by which a person learns about and understands the purpose and aspects of a clinical trial before voluntarily deciding whether or not to participate.

The principle of informed consent means that patients have the right to be fully informed about a trial before agreeing to participate in that trial. The patient receives complete trial information, including treatment specifics, potential risks, benefits and side effects. The patient must sign an "informed consent form" before he or she is allowed to participate. If the protocol changes during the trial, the informed consent process is repeated.

A person's agreement to allow something to happen after the person has been informed of all the risks involved and the alternatives.

Person's agreement to allow something to happen, such as a medical procedure, that is based on full disclosure of the facts necessary to make an intelligent decision.

A parent's written permission to assess their child, provide services for the child, or to place the child in special education.

a way to protect people entering a drug trial. Each participant in a clinical trial in the U.S. must sign a consent form that explains the purpose of the trial, the results expected, the mechanics of the trial, potential risks, a list of other treatments that are available. There is also a statement telling the participant that (s)he can leave the clinical trial at any time.

A document that, when signed by a patient, acknowledges he/she has been informed of the risks and benefits of a medical procedure and has had the opportunity to ask questions with all questions having been answered.

A required process that informs research participants of details about the treatments and tests they may receive and the possible benefits and risks associated with these treatments and tests. A consent form must be signed before starting in a clinical trial and again if any changes are made to the protocol during the trial.

Before enrolling in a clinical trial, patients or healthy subjects must be informed, in language that they can understand, of the possible risks and benefits associated with their participation. People who decide to participate must first sign an informed consent form signifying their knowledge and agreement to participate.

An uncoerced, cognizant choice. The issue of informed consent arises in medicine and medical research with some frequency. In particular, in order to give informed consent to procedures they are to undergo, patients ought to: a) know the relevant medical facts of their case, b) know the risks of the procedure, c) know what alternatives are possible, d) feel free to withhold consent. [See Case Studies related to Informed Consent

The process by which a volunteer for a clinical trial agrees to participate after being fully informed regarding purposes of the trial, risks and benefits associated with participation in the trial, and whether volunteers will be randomized to receive treatment or placebo.

Voluntary acknowledgment of the purpose, procedures and specific risks of an activity in which one intends to engage.

Permission given by an individual to proceed with a specific test or procedure, with an understanding of the risks, benefits, limitations, and potential implications of the procedure itself and its results

The process through which people learn all of the information they need to make an informed decision about joining a clinical trial. Informed consent documents must explain the risks of the study, alternatives to the study, and how research-related injuries will be addressed.

the process of obtaining a patient's permission for a procedure after the patient and doctor have discussed the risks, benefits, and alternatives of the procedure and the patient understands them.

The voluntary consent given by a patient to participate in a trial. The patient must be informed of the trial's purpose, treatment, benefits and risks of participation, and the schedule of required procedures.

A patient's right to know the risks and benefits of a medical procedure.

an agreement signed by prospective volunteers for a clinical research trial that indicates their understanding of (1) why the research is being done, (2) what researchers want to accomplish, (3) what will be done during the trial and for how long, (4) what risks are involved, (5) what, if any, benefits can be expected from the trial, (6) what other interventions are available, and (7) the participant's right to leave the trial at any time.

A discussion of the procedures, risks, and benefits of a clinical trial between the investigator and the patient. All patients must sign the informed consent form before participating in a trial.

The principle that potential subjects are given adequate and accurate information about a study before they are asked to agree to participate, and that they do in fact agree (consent) to participate. In giving informed consent, subjects many not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.

A participant's written agreement (signed and dated) to be in a clinical study after fully discussing complete and important information about the clinical study with the researchers (investigator and study coordinator)

Form a document disclosing the risks, benefits, and alternatives to a procedure. In Situ a Latin term meaning "in place" or not removed.

The patient agrees to a certain medical intervention based on his or her evaluation of all relevant information about the procedure, alternatives, and the competence of the treating team.

The process in which a patient learns about and understands the purpose of a clinical trial and then agrees to participate (or not). This process includes a document defining what a patient must know about the potential benefits and risks of therapy before being able to undergo it knowledgeably. Informed consent is required by regulated studies. A patient who signs an informed consent form and enters a clinical trial is still free to leave the trial at any time and can receive other available medical care.

The process in which a person learns key facts about a clinical trial and voluntarily agrees to take part in it by signing a consent form describing the potential risks and benefits of treatment.

Permission to proceed given by a patient after being fully informed of the purposes and potential consequences of a medical procedure.

the agreement between concerned parties about the data-gathering process and/or the disclosure, reporting, and/or use of data, information, and/or results from a teacher's assessment and evaluation. See Confidentiality, Consent, Reporting.

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.

The ethical practice of obtaining consent to undergo a medical procedure or participate in a medical study while respecting individual choice and protecting an individual from harm.

A process in which a person learns key facts about a clinical trial or genetic testing before deciding whether or not to take part in it. Informed consent includes information about the possible risks, benefits, and limits of the trial or genetic testing. It goes on through the entire trial or genetic testing process. A process of information exchange between a clinician and an individual or their legal proxy designed to facilitate autonomous, informed decision making. The informed consent process for genetic testing should include an explanation of the medical and psychosocial risks, benefits, limitations, and potential implications of genetic analysis, a discussion of privacy, confidentiality, the documentation and handling of genetic test results, as well as options for managing the hereditary disease risk.

A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. Informed consent also refers to the process of information exchange between researcher and participant prior to participation in research. The information to be conveyed to the participant is factual information, including an assessment of the risks of participation, eight specific elements required by Federal regulations, a description of the procedures that will be performed, and the persons responsible. The information conveyed by the participant to the researcher is an indication of his or her comprehension of the process, the voluntary nature of participation, and understanding of his or her rights, including the right to withdraw. The informed consent form is a written document, signed by participants in research studies prior to commencement of the study. The form is presented to and signed by the participant, who should have a chance to ask questions regarding the research prior to the commencement of the study.

The medical and ethical principle that a patient should only consent to treatment after he/she fully understands the treatment or procedure, his/her rights and all of the medical options.

The permission given by a person before surgery or other kinds of treatment. The patient, or a parent or guardian, must understand the potential risks and benefits of the treatment and legally agree to accept those risks.

The process by which a person receives an explanation of the risks and benefits to a medical treatment or research study and agrees to participate and indicates in writing that he or she understands and agrees to the information provided. A person can provide informed consent at the age of 18.

A legal term that refers to a person's consent to a proposed medical intervention after being provided information deemed relevant to that decision. The information that is legally required include: diagnosis, nature and purpose of proposed intervention, risks and consequences of proposed treatment, probability that the treatment will be successful, feasible treatment alternatives, and prognosis if the treatment is not given.

A process in which a person is given important facts about a medical procedure or treatment, a clinical trial, or genetic testing before deciding whether or not to participate. It also includes informing the patient when there is new information that may affect his or her decision to continue. Informed consent includes information about the possible risks, benefits, and limits of the procedure, treatment, trial, or genetic testing.

a process of obtaining consent from a patient which ensures that the person fully understands the nature and implications of the test before giving his or her agreement to it.

The legal standard that states that a patient must know certain risks and benefits regarding therapy before agreeing to take it.

The documented agreement by a patient to a treatment, examination, or procedure after the patient receives the material facts about the nature, consequences, and risks of the proposed treatment, examination, or procedure and the alternatives to it. Referenced by 610.010 - Offender Consent for Health Care

A decision based on knowledge of advantages and disadvantages and implications of choosing a particular course of action.

Process of informing a patient about the potential risks and benefits of participation in a trial. No patient may be enrolled in a trial without his i.c. The process includes discussion with the physician-investigator and also with a research nurse or coordinator. If the patient agrees to participate, an i.c. document outlining in plain language what treatment the trial is testing, the risks and benefits of participation, and the alternatives to participation, is signed by the patient and is witnessed by a disinterested person.

The voluntary agreement obtained from a subject (or the subject's legally authorized representative) to participate in research or related activity, before participating in that activity. The consent must permit the individual (or legally authorized representative) to exercise free power of choice without undue inducement or any element or deceit, fraud, force, duress, or other form of coercion or constraint.

A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic or preventive procedure.

An agreement signed by the human subject, and/or a parent/guardian, stating that the proposed research and any possible risks have been explained and understood prior to participation in an experiment.

Informed consent is a process by which a person learns the details about a clinical trial and agrees to participate. The scientist explains the purpose of the trial, expected benefits and known risks, and what is expected of the patient-participant. The scientist also answers any questions. If the patient agrees to participate in the trial, she or he signs an informed consent document acknowledging that the trial was explained and is understood.

The right to have information explained to you so that you fully understand and agree to the nature of the proposed treatment.

Process of explanation to the patient of all risks and complications of a procedure or treatment before it is done. Informed consents are signed by the patient, a parent of a minor child, or a legal representative.

An ongoing process in which potential candidates for research studies or clinical trials learn about the study's key facts, including the purpose of the study, potential risks and benefits, and other treatment alternatives. The purpose of informed consent is to enable candidates to make the most appropriate decisions about beginning or continuing to participate in the study or trial, or pursuing other options.

Permission obtained from a patient to perform a specific test or procedure. Informed Consent is required before performing most invasive procedures and before admitting a patient to a research study. The document must be written in the language understood by the patient and at least one witness. Included in the document are clear, rational statements that describe the procedure or test, the risk to the patient, the expected benefits to the patient, the natural anticipated consequences of not allowing the test or procedure, and the alternative procedures or diagnostic aids that are available. Also required is a statement that care will not be withheld if the patient does not consent; Informed Consent is voluntary. By law, Informed Consent must be obtained more than a given number of hours or days before certain procedures are performed and must always be obtained when the patient is fully competent. The physician is responsible for giving the patient this information.

Informed Consent refers to the signing of forms which legally allow a surgery to proceed, and assumes that the patient has read about and understands the events, risks, and complications that can occur as a result of surgery.

A process during which the patient learns the key facts about HIV testing--including what will occur during HIV testing and counseling and the purpose and benefits of HIV testing--before deciding whether to allow testing to proceed.

Except in the case of an emergency, a doctor must obtain a patient's agreement (informed consent) to any course of treatment. Doctors are required to tell the patient anything that would substantially affect the patient's decision. Such information typically includes the nature and purpose of the treatment, its risks and consequences and alternative courses of treatment.

Agreement by participants for the use of personal information, supplied by them in specified ways, for stated purposes, by the evaluation EHR/NSF Evaluation Handbook, Chapter Seven: GlossarySource web site

for consent to be informed and valid: The client must be legally competent, that is, able to understand the nature and consequences of the proposed use/disclosure of the information (if not, see below, Substitute Consent); It must be freely given; It must be informed - that is, sufficient information must be provided to allow the individual to make a reasoned decision; It must be specific - that is, the purpose the information will be used for must be clear.

A process in which a person learns key facts about a clinical trial or medical procedure, including potential risks and benefits, before deciding whether or not to participate in a study. Informed consent continues throughout the trial.

an ethical requirement of social scientific research which specifies that research subjects will be informed as to the nature of the research about to be conducted, their anticipated role in it, and the uses to which the data they provide will be put.

Refers to requirements that health care providers and researchers explain the purposes, risks, benefits, confidentiality protections, and other relevant aspects of medical care, a specific procedure, or participation in medical research. Informed consent is also required for the authorization of release or disclosure of individually identifiable health care information under HIPAA.

A process in which the risks, benefits, and requirements of a trial are explained to volunteers. Before entering the trial, participants must sign an informed consent form, which should include a plain-language description of the benefits, risks, and basic structure of the trial.

The process by which a patient learns about all aspects of a medical treatment or a clinical trial before agreeing to participate in it. Of course, a patient may decline the treatment or may decline to participate in the clinical trial. This process includes a detailed explanation of the potential benefits and risks of all procedures and treatments.

A document which gives a detailed description of the aims and methods used in a research study, including insurance cover safeguarding participants. It must be supplemented with an interview with a senior doctor who, after having clarified all aspects relating to the study, obtains the volunteer's consent to participation through signing the consent form.

To consent to something after being given full or adequate disclosure.

a legal document that explains a course of treatment, the risks, benefits, and possible alternatives; the process by which patients agree to treatment.

The process by which an individual willingly and voluntarily agrees to participate in an activity after first understanding the risks and benefits or participation vs. non-participation in an activity or research study. In a genetic study, potential participants should be appraised of the study goals, risks, benefits, alternative to participation, disclosure policies, and financial and time commitments involved in study participation. The informed consent process should be documents, typically with a signed consent form approved by an Institutional Review Board. Special considerations apply to vulnerable populations (i.e., minors, mentally handicapped individuals). [Source: NHBLI/NCBI Glossary

Person's voluntary agreement, based upon adequate knowledge and understanding, to participate in research or undergo a medical procedure. In giving informed consent, human subject may not waive legal rights or release or appear to release an investigator or sponsor from liability for negligence. Go to 21 CFR 50.20 and 50.25.

An agreement to do something or to allow something to happen, made with complete knowledge of all relevant facts, such as the risks involved or any available alternatives. For example, a patient may give informed consent to medical treatment only after the healthcare professional has disclosed all possible risks involved in accepting or rejecting the treatment. A healthcare provider or facility may be held responsible for an injury caused by an undisclosed risk. In another context, a person accused of committing a crime cannot give up his constitutional rights--for example, to remain silent or to talk with an attorney--unless and until he has been informed of those rights, usually via the well-known Miranda warnings.

Consent given by a patient after learning about and understanding fully the purpose and other aspects of a clinical trial or procedure.

Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of an action. The individual needs to be in possession of all of his faculties, such as not being mentally retarded or mentally ill and without an impairment of judgment at the time of consenting. Such impairments might include illness, intoxication, drunkenness, using drugs, insufficient sleep, and other health problems.

Informed Consent is the third episode of the third season of House and the forty-ninth episode overall.