A 57-year-old man with amyotrophic lateral sclerosis (ALS) is participating in a clinical trial evaluating a novel therapeutic agent. The patient is accompanied by his wife for the initial session. The research coordinator provides a description of the study and tells the wife he is optimistic that the medication will help patients like her husband. He then shares that more participants are needed for the study to be successful and asks if she would like to enroll as a healthy control. In obtaining consent for the wife's participation, which of the following principles is at risk of being violated by the research coordinator?

Question

A 57-year-old man with amyotrophic lateral sclerosis (ALS) is participating in a clinical trial evaluating a novel therapeutic agent.  The patient is accompanied by his wife for the initial session.  The research coordinator provides a description of the study and tells the wife he is optimistic that the medication will help patients like her husband.  He then shares that more participants are needed for the study to be successful and asks if she would like to enroll as a healthy control.  In obtaining consent for the wife's participation, which of the following principles is at risk of being violated by the research coordinator?

Quizplus · Accepted Answer

11ec160b_3660_fd86_9249_8d9bd1b93545_MD0001_00 Informed consent is a complex medicolegal process that varies slightly across jurisdiction and setting (eg, a clinical versus research setting). Informed consent is generally considered to contain 4 primary elements: disclosure, understanding, voluntariness, and authorization. Disclosure involves providing the patient with information about their medical condition, the proposed medical intervention (eg, experimental drug), and the potential risks and benefits of accepting or declining the proposed intervention. For a consent to be valid, a subject must possess decision-making capacity, and the research coordinator must confirm understanding of the disclosed information. Informed consent must be voluntarily given and be free from any forces of coercion or manipulation. In the described scenario, the research coordinator has suggested to the wife that the experimental medication is likely to help her husband, but that the research study may not be "successful" if more participants don't enroll. This is manipulative and violates the principle of voluntariness because the patient's wife may feel coerced to participate to help her husband. (Choices A and C) The major principles of medical ethics include autonomy, beneficence, nonmaleficence, and justice. Beneficence refers to the ethical imperative for medical interventions to be guided by an intent to do good for a patient. Nonmaleficence refers to the ethical principle of avoiding doing harm to a patient. (Choice B) Confidentiality refers to the ethical principle of protecting the privacy of a patient's health information. Confidentiality is the basis of open and inclusive communication patterns necessary to foster a successful doctor-patient relationship. (Choice D) Veracity refers to the ethical need to communicate truthfully with patients. Educational objective: Informed consent is comprised of 4 major elements: disclosure, understanding, voluntariness, and authorization. For informed consent to be truly voluntary, it must be free from coercion or manipulation. __________ References: Informed consent. (http://www.ncbi.nlm.nih.gov/pubmed/28249147) Informed consent and the capacity for voluntarism. (http://www.ncbi.nlm.nih.gov/pubmed/11986120)

A 57-Year-Old Man with Amyotrophic Lateral Sclerosis (ALS) Is Participating