Should Participants Ability To Give Informed Consent

In their article, “The Concept of Informed Consent,” Faden and Beauchamp give two varying definitions of informed consent, namely sense one and sense two. Sense one is defined as autonomous authorization, meaning that the patient or subject agrees and then gives authority to move forward with a proposal (Vaughn 191). The authors give four conditions that have to be met for informed consent to be recognized: the patient has to understand the information presented to her, there should be no manipulation or coercion, and she has to intentionally give her authorization (Vaughn 191). Faden and Beauchamp also note that the fourth condition, where the patient gives her authorization, is pivotal in this sense since it differentiates autonomous authorization

Informed consent is the basis for all legal and moral aspects of a patient’s autonomy. Implied consent is when you and your physician interact in which the consent is assumed, such as in a physical exam by your doctor. Written consent is a more extensive form in which it mostly applies when there is testing or experiments involved over a period of time. The long process is making sure the patient properly understands the risk and benefits that could possible happen during and after the treatment. As a physician, he must respect the patient’s autonomy. For a patient to be an autonomous agent, he must have legitimate moral values. The patient has all the rights to his medical health and conditions that arise. When considering informed

The Doctor and Patient relationship aspect of Medicine has changed drastically in the last twenty years. It has evolved from paternalism (the doctor makes the decision for the patient) to shared decision making where the patient is considered an equal partner in his/her own health related decisions. Informed consent is the cornerstone for this view. When a patient or a research subject makes an autonomous decision after understanding, the risks and benefits involved with the decision is Informed consent. Complete Informed consent covers the following components: competency, disclosure, comprehension and voluntary. Competency refers to the requirement for the individual to be of legal age and be mentally competent to understand the process.

As per Beal & Lewis, 2014 Informed consent is a process of education and the correct education is a key to the ability to provide consent.

Interestingly, IRBs are set up mainly to confirm that a clinical trial is ethical and that the process will not harm patients. Whether or not the clinical trial is constructed properly or not is commented upon, but may not be a major focus of the review. For this reason, many institutions also require a concurrent review by an institutional “Office of Clinical Research” and a regular meeting of supervising clinicians during the

The informed consent should indicate the participant has read, and understands the details of the study. A statement regarding the maintenance of privacy, confidentiality, and right to decline to participate is included on the consent form, and discussed with each participant prior to the beginning of any interviews. One copy of the consent form is provided to the participant for their records, with the original signed copy is maintained by the researcher in safe

The need by a medic or a physician to inform his or her patient of the required facts concerning a surgical procedure, or any procedure at that is always critical. Informed consent follows the principle that a physician has the duty to disclose all the relevant information to the patient, prior to treatment or services. Informed consent is obtained so that the patient is able to make a reasonable decision based on the facts presented. Along with the proposed course of treatment, the physician also offers alternatives to the patient (Hall & Bobinski, 2014).

As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases

If informed consent is not collected, how well the patients know if they are getting the treatment in the trial that best suits their wishes? The author states “If the

Informed consent is the current guiding principle for the ethical conduct in medical research and originated after the 1947 Nuremberg Code and the 1964 Declaration of Helsinki (Nguyen et al., 2015). The purpose of the informed consent process is to provide potential research subjects information about the nature of the clinical trial, the risks, benefits, underlying procedures, and alternative treatments (Bloswick & Skowron, 2015). The research team must provide the patient with sufficient information so the participant can fully make an informed, uncoerced choice about whether to begin or continue participation in a clinical trial. This process is an ongoing exchange between the subject and the research team throughout the research study.

This type of consent is then “apparent where patients can control the amount of information they receive, and what they allow to be done” (6). However, while this type of consent does seem ideal, one has to question whether or not what the physician might see as irrelevant or ‘too much’ information, the patient might disagree. The patient and physician could potentially view things differently in terms of what would be helpful information, and if the patient was not told of a factor, how could they fully give their informed genuine consent? The physician and patient must ensure that they have a positive and effective dialogue to achieve O’Neil’s concept of genuine consent.

A primary protection of the rights of clinical research subjects revolves around the concept respect for persons and the provision of informed consent (Belmont Report, 1979). Legal and ethical policies and guidelines enforce that research participants give informed consent prior to voluntary enrollment in a research study (Code of Federal Regulations,1999). However, the informed consent process presents some major challenges for study participants and

Informed consent is required for the principle of autonomy for all treatments, including exams, injections, surgery, medication and radiation, to name a few. It is found in the Health Care (consent) and Care Facility (Admission) Act part 2. Informed consent may be expressed or implied and is based on a reasonableness standard. The elements of informed consent are that the consent must be voluntary (ie. not coerced, forced, or made unconsciously), it must be made by a patient who is mentally capable of consent (adult or mature minor, not suffering from inebriation or mental incapacity), and it must be informed. A patient is mentally capable to consent and can understand the nature of the treatment, understand its intended effects and alternatives,

As a researcher, I believe patient information leaflets (PILs) are essential in facilitating informed consent because they serve as an integral of keeping the participant fully informed (2). PILs that I make will contain relevant information about the research trial presented in language understandable

That said, a key question which also should be stressed is how to limit participants from withdrawing once obtaining consent. I suggest a way to easily prevent scrutinizing the validity of the data is by first, ensuring that all volunteers, healthy or patient, are completely committed in participating, and if patients request to withdraw, a valid reason is obligatory. An introduction of a penalty should be considered to patients or subjects who provide an inadequate excuse. Secondly, screening out a defined population who have a language barrier. This will allow investigators to ensure thorough evaluation of the information sheet by hiring professionals to translate or even provide a separate informed consent in an understood language for patients