While you are in nursing school, you are taught the three basic ethical principles that are involved when providing patient care; respect, beneficence, and justice. These three basic ethical principles should always be considered when conducting research studies involving any human subjects. Even further consideration should be taken when conducting research studies involving specific vulnerable populations, such as the mentally-disabled. Respect Respect involves autonomy, or freedom from external control or influence; independence. The Belmont Report (1978) states that “An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give …show more content…
Who should bear the risk of a research study, who is equal and who is not, and who should receive its benefits? We, as nurses, should always be fair and without bias when distributing the risks and benefits to any patient during a research study. It may be challenging to do this when dealing with patients that are mentally-disabled. It can be difficult when deciding who will be given an opportunity to participate in the research study and who will be excluded. The mentally-disabled could be selected simply because of their mental disability and because they can be easily manipulated. On the other hand, they may not be selected to participate in the study because of their mental disability. The Belmont Report (1979) states that there are formulations to fairly distribute the burden and benefits of a research study, “These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort,(4) to each person according to societal contribution, and (5) to each person according to merit.” Overall, participants should not be selected or excluded from a research study based off the fact that they have a mentally disability, unless justified by the research study …show more content…
Informed consent is a process, not just a form that needs to be signed by the participant. Participants should always be given all information, including possible risks and benefits, when participating in the research study. They should also know that participation is voluntary. This information will help them make informed decisions and decide whether or not they want participate in the research study. Special considerations are required when obtaining informed consent from a patient that is mentally-disabled, as they may not be able to fully comprehend the information they are being given. It is up to the nurse and/or medical professionals to assess and determine if the patient is capable of giving informed consent and able to comprehend all information and education given. Participants that are mentally-disabled may not be capable of giving informed consent and therefore the patient would need some type of legally authorized person. It would be the responsibility of the nurse and/or other medical professional doing the research to provide an appropriate explanation, seek the individual's assent, consider the preferences and best interests, and obtain appropriate permission from a legally authorized person or patient, if
Besides, if a person lacks mental capacity to give valid consent, nurses caring for such a person should be involved in assessing the treatment to be administered. However, they must be “aware of the legislation regarding mental capacity, ensuring that people who lack capacity remain at the centre of decision making and are fully safeguarded.”6 The Mental Capacity Act (2005) offers assistance regarding ‘capacity’. The Act applies to all aged 16 and above and to those with learning disability, dementia, brain injury, autism and mental health issues.
Obtaining an informed consent is a vital part of current health care. This document lists out several key pieces of information for both the patient, Provider, and the ancillary staff that also access the document during the procedure process. However, obtaining informed consent has not always been the practice norm and in research, informed consent carries different specifications.
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
Insofar as informed consent has been expounded, two main principles of bioethics have emerged as paramount; autonomy and non-maleficence. Although seemingly clear, the boundary of both respecting a person’s autonomy and doing no harm becomes blurred when the patients have disabilities that remove their ability to reason and justify soundly (e.g. total brain injuries or severe stroke patients). Although the participants in the proposed study will be fully-abled as per the exclusion criteria, understanding why cognitively impaired participants cannot give ‘informed’ consent further elaborates on higher-order-thinking required in the informed consent process. Without such a process, patients whom elect to become participants may not understand that this research is a separate entity to their regular treatment regime, and essentially will have become coerced into consenting due to a lack of clarification (Kerridge, Lowe, & Stewart, 2009; Rigg, 2012a; Rigg, 2012b).
This care study is about a service user with Cerebral Palsy and Dysphasia. This assignment will give a brief description of her background history, her condition and care needs. In order to maintain the confidentiality of the service user, I will refer to her as Daisy Chain and any personal information will be changed accordingly and not be used in conjunction with anything else other than this study. I obtained consent from the service user, her family and the adult day centre where she attends. Together we all arrived and agreed with the name Daisy Chain to use in place of her real name, as once again to maintain her confidentiality. (Anderson, 2010) Anderson (2010, p.53) wrote that “Consent covers more than simply gaining
In an article by “Vulnerable individuals represent a broad and vaguely defined group of people. Participants can be said to be vulnerable to the extent that their ability to give informed consent may be affected by physical, mental or emotional responses to their situation” (Nordentoft & Kappel, p. 369). When planning a research project, a researcher or IRB should consider the vulnerable participant as there is often diminished capacity to participate in their care thereby bringing into question the validity of understanding informed consent and the ability to withdraw from participation at any time. The Institutional Review Board (IRB) serves to protect vulnerable populations such as children, prisoners, pregnant women, and the physically
Review Ethics boards should be considerate of the patient’s they are using to conduct their research by first having them fill out an agreement to participate in the research. This idea is reinforced by a field researcher who had to get the patients to sign permission slips before interviewing them and the research wouldn’t reveal their identity. The field researcher found this was an effective way to make the patients whom the experiment is being conducted on comfortable and willing to participate. It allows the patients to have a say on whether they are willing to have specific research done on them whether related to psychological reasons such as asking questions or to have biological research
Respect for human dignity includes two rights; the right to self-determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients’ rights.
The court of appeal held patients should not be viewed incapable of understanding medical matters, society has change capable adults are able to make autonomous decisions to determine their future. Likewise therapeutic privilege should not be abused in deciding what and how much to tell patients we need to ensure we support patients in their choices. Nurses more than ever need to ensure the duty we owe our patients is fully met the NMC Code Professional Conduct (2015) now specifies a duty of candour to patients. This encourages an open and honest relationship in all matters therefore when patients ask specific questions nurses have a duty to answer within their scope of experience. Following Montgomery (2014) nurses are required to consider what the average patient would want to know about treatment and the material risk, what a reasonable person in a given situation would want to know about any risks involved in treatment or should know. The nurse is required to provide enough information for the patient what significance to give these risks in light of their own values beliefs and desire to determine their own future this can only work if patient and nurse work in close partnership. This goes in hand with NMC code (2015) standard 2 to listen to people respond to concerns
In the world of medicine, consent is an ethical and a legal agreement between patient and their health care provider; to participate in but not limited to research trials or to obtain medical or surgical interventions. Consent generally is expressed or implied. Express consent can be an oral declaration or it can be provided by printed document. (informed consent). Nevertheless, consent is not an independent entity. It does not function on its own. It works in conjunction with capacity. Spike 2017, stated informed consent is the single most important concept for understanding decision-making capacity. This is measured by a patient’s ability to understand, retain, process and re-communicate the information provided by the medical professionals.
Studies investigating the capacity of patients with mild-to-moderate cognitive impairment to give consent or those analyzing the decision-making of surrogates of AD patients with dementia often present conflicting results. The ethical principle of autonomy clearly recognizes each person’s right to make informed decisions with respect to participation in research. However, taking into account the nature of the disease, (which affects cognitive processing in a critical way) and its progression towards dementia there are justified concerns about the capacity of these patients to give informed consent in an AD research context. Thus, there is a need to equilibrate the protection of vulnerable adults with their right to choose to participate in such research. It is debatable whether patients with mild to moderate impairment are capable of giving informed consent. For instance, while some studies assessing the consent-giving capacities of mildly cognitively impaired AD patients conclude that they do not have these capacities (Kim et al., 2001), others seem to show that the reverse is true and a proportion of patients with mild and moderate AD are perfectly capable of making informed decisions (Karlawish et al. 2002).
Informed consent is an integral part of the medical process, but what is it? How can the principles of Informed Consent conflict with each other or with patient care? It is important to examine Informed Consent very carefully and explore how the principles of Beneficence and Patient Autonomy work with each other for the best interests of the patients, even if the patient is refusing some treatment that is important in the standard of care. However, it may be possible that Informed consent and these elements work against one another, and conflict with the best interests of the patient.
Informed consent is a formal agreement that a patient/member signs to give permission for a medical procedure or program after an explanation of risks and benefits are given to the patient/member (Merriam-Webster.com, 2015). Another definition for informed consent is, “tenet requiring that competent patients, who are free to consent, be sufficiently informed and be the principal decision makers in their own care” (Brannigan, 2001).
57). This exchange of information should be administered at a 5th grade comprehension level. The subject should be willing to participate in the study with no reward offered for participation. The informed consent process begins with participant selection and ends with a signed document of agreement.
There are five principles to ethical nursing. The first principle, nonmaleficence, or do no harm, it is directly tied to a nurse's duty to protect the patient's safety. This principle dictates that we do not cause injury to our patients. A way that harm can occur to patients is through communication failures. These failures can be intentional or as a result of electronic or human error. Failing to convey accurate information, giving wrong messages, and breaking down of equipment, can cause harm to patients. Some of these communication problems may certainly occur whether a patient is at a neighborhood clinic or 500 miles away, but distance and high reliance on electronic technology make close examination of communication and ethical