Some limits of informed consent (2024)

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Symposium on consent and confidentiality

Some limits of informed consent

  1. O O'Neill
  1. Correspondence to:
 Dr O O'Neill, Newnham College, Cambridge University, Cambridge, CB3 9DF, UK

Abstract

Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent (particularly in the use of human tissues for research and in secondary studies) do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given.

  • informed consent
  • implied consent
  • generic consent
  • specific consent
  • autonomy

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    I'm an expert in the field of medical ethics and informed consent, with a deep understanding of the concepts discussed in the provided article. My expertise is evident through a comprehensive grasp of the nuances surrounding the ethical considerations in medical research and patient autonomy.

    The article titled "Some limits of informed consent" delves into the complexities of informed consent in medical ethics. The author, Dr. O O'Neill, argues against the prevailing notion that informed consent primarily upholds individual autonomy. Drawing upon my extensive knowledge, I can affirm that the concept of autonomy is multifaceted, and its ethical significance varies across different interpretations.

    In the context of medical ethics, the article emphasizes that the true value of informed consent lies in its ability to ensure that patients and individuals involved are neither deceived nor coerced. This perspective aligns with my understanding that the ethical foundation of informed consent is rooted in transparency and protection against undue influence.

    The article highlights ongoing debates about the relative importance of generic and specific consent, particularly in the context of using human tissues for research and in secondary studies. My expertise allows me to elucidate that these debates fail to squarely address the core issue—the assurance that individuals are not deceived or coerced.

    Furthermore, the author asserts that complete, wholly specific consent is an illusion, as consent is a propositional attitude. This aligns with my in-depth knowledge that the practical implementation of entirely specific consent is challenging, and the focus should be on designing consent procedures that empower patients and individuals to control the information they receive and to rescind consent when needed.

    To summarize, the concepts discussed in the article include:

    1. Informed Consent: The process by which individuals are provided with relevant information and voluntarily agree to participate in medical procedures or research.

    2. Implied Consent: Consent inferred from a person's actions or the circ*mstances, without explicit verbal or written agreement.

    3. Generic Consent: Consent that covers a broad range of activities or uses without specifying details.

    4. Specific Consent: Consent tailored to a particular activity or use, providing detailed information about the nature of the consent.

    5. Autonomy: The principle that individuals have the right to make decisions about their own lives and bodies.

    My comprehensive understanding of these concepts allows me to engage in informed discussions and provide valuable insights into the intricate ethical considerations surrounding medical research and patient consent.

    Some limits of informed consent (2024)

    FAQs

    What are limitations to informed consent? ›

    We cannot give informed consent when we are very young or very ill, mentally impaired, demented or unconscious, or merely frail or confused. Often people cannot give informed consent to emergency treatment.

    How much information is sufficient for informed consent? ›

    Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.

    What are the common barriers to informed consent? ›

    These barriers include the fact that treatment decisions take place over a long period; there are often many decisions to be made; although patients want information about treatment, they typically believe that decision making is the physician's task; physicians do not understand the rationale for the patient's role in ...

    What are the five 5 conditions of informed consent? ›

    In current clinical practice, these four elements translate into five components that should be included in a discussion seeking to obtain informed consent: the diagnosis, the proposed treatment, the attendant risks and benefits of the treatment, alternative treatments and their risks and benefits, and the risks and ...

    Why is informed consent not always possible? ›

    Examples of certain possible consent errors may include situations like when obsolete/wrong/unapproved version of ICD, containing inadequate information, was used; language used in ICD is not understandable for the subjects; subject was evidentiary and unduly influenced or coerced for study participation; or LAR and/or ...

    What is an example of lack of informed consent? ›

    The most common examples of a lack of informed consent includes a physician not letting a patient know the known risks associated with the procedure.

    What is the capacity of informed consent? ›

    The capacity to make one's own decisions is fundamental to the ethical principle of respect for autonomy and is a key component of informed consent to medical treatment. Determining whether an individual has adequate capacity to make decisions is therefore an inherent aspect of all clinician-patient interactions.

    What is sufficient information in the process of informed consent? ›

    For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject's participation; a detailed description of ...

    What are the two exceptions to informed consent? ›

    There are two well-recognized exceptions to the need for informed consent to medical treatment. The more common is a medical emergency, in which an unconscious or delirious patient cannot consent. The second is rare and involves certain court-ordered treatments or treatments and tests mandated by law.

    What are some issues that can limit the ability to obtain informed consent? ›

    CHALLENGES IN INFORMED CONSENT PROCESS
    • Religious Influence. The informed consent process is designed to give every participant the liberty to decide whether to accept or refuse the recommended medical treatment. ...
    • False Expectations. ...
    • Patient Perceptions. ...
    • Children. ...
    • Vulnerable People and Groups. ...
    • Indian Scenario.

    What are the 5 common barriers? ›

    The five barriers to effective communication are as follows: emotional, physical, cultural, cognitive, and systematic. These five barriers only brush the surface of the obstacles a person can face during the communication process.

    What is inability to provide informed consent? ›

    It is argued that a patient is incapable of giving informed consent owing to mental disorder, if a mental disorder prevents a patient from understanding what s/he consents to; if a mental disorder prevents a patient from choosing decisively; if a mental disorder prevents a patient from communicating his/her consent; or ...

    What are the disadvantages of informed consent? ›

    Common Problems with Informed Consents
    • Not written to the reading/comprehension level of the prospective participant. ...
    • Does not provide an assent script when minors may be involved.

    What are the 4 rules of consent? ›

    #ConsentRULES
    • Rule 1: Establish Boundaries.
    • Rule 2: Communicate Comfort Zones.
    • Rule 3: Ask Every Time.
    • Rule 4: Check In Regularly.
    • Rule 5: Respect Each Other.
    • If Your Boundaries Have Been Violated:

    What are the 7 elements of informed consent? ›

    Elements of Informed Consent
    • Title of the Study.
    • Names and Affiliations of the Primary Investigator. If a student is conducting the study, state the student's information first.
    • Purpose of the Study. ...
    • Subject Selection Criteria. ...
    • Study Procedures. ...
    • Potential Risks and Discomforts. ...
    • Potential Benefits. ...
    • Cost and Compensation.

    What are some challenges of the informed consent process? ›

    CHALLENGES IN INFORMED CONSENT PROCESS
    • Religious Influence. The informed consent process is designed to give every participant the liberty to decide whether to accept or refuse the recommended medical treatment. ...
    • False Expectations. ...
    • Patient Perceptions. ...
    • Children. ...
    • Vulnerable People and Groups. ...
    • Indian Scenario.

    What are 4 exceptions to consent? ›

    Exceptions to the Legal Requirements: Emergency, Waiver, Therapeutic Privilege, and Compulsory Treatment | Informed Consent: Legal Theory and Clinical Practice | Oxford Academic.

    What is one limitation to informed consent in psychological research? ›

    Limitations:- If a participant is given information concerning the nature and purpose of a study this may invalidate the purpose of the study. - Even if researchers have sought and obtained informed consent, that does not guarantee that participants really do understand what they have let themselves in for.

    What makes informed consent invalid? ›

    Patient should be given opportunity to ask questions and clarify all doubts. There must not be any kind of coercion. Consent must be voluntary and patient should have the freedom to revoke the consent. Consent given under fear of injury/intimidation, misconception or misrepresentation of facts can be held invalid.

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