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Ethics in research
Ethics in research
Informed consent in clinical setting cit quiz
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Describe the meaning of informed consent, and identify issues relating to it in research on human subjects.
Informed consent is a fundamental ethical requirement for research with human subjects. It is when a subject voluntarily agrees to participate in a research study in which he or she has full understanding of the study before the study begins, (Nieswiadomy, 2014). The informed consent process is where the participant is informed regarding all aspects of the trial, which are important for the participant in making a decision and after studying all aspects of the trial, the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare (Nijhawan et al., 2013). The informed consent process might create several ethical issues if it is not being done properly.
Misunderstandings between the researchers and the participants will result due to communication barriers such as language differences and religious dogma. The individual who
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This is to ensure that the persons concerned are not involved in research which could be harmful for them with regard to a research project. This is because some people in society may not have the capacity to make fully informed decisions.
Beneficence is the act that is done for the benefit of others or a duty to ensure the welfare of the persons concerned. This principal states that the research should do no harm and maximize benefits for participants and minimize risks for participants. Participant must be safe and feel protected by the researcher whenever they sign he consent and agree to participate. Full explanations and information must be detailed to participants. To use easy words and simple language for details so that they will fully understand and to avoid miss understand of the
In response to the question set, I will go into detail of the study, consisting of the background, main hypotheses, as well the aims, procedure and results gathered from the study; explaining the four research methods chosen to investigate, furthering into the three methods actually tested.
...ects of their study before presenting it to an IBR to be certain it does protect the particpants' rights of respect, beneficience, and justice. Research is an important component of medical advancement; but only if it is performed in an ethical way following all requirements and regulations.
In qualitative studies, the researchers are unaware of the interview is likely to untwist. Therefore, informed consent is a must.
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 consent, the patient must be aware and should be able to give a voluntary consent for the treatment and testing without being coerced, even if coercion is very little. Being coerced into giving consent is not voluntary because others people’s opinions account for part of his decision. Prisoners and the poor population are two areas where coercion is found the most when giving consent. Terminally ill patients also give consent in hope of recovering from their illness. Although the possibilities are slim of having a successful recovery, they proceed with the research with the expectation of having a positive outcome. As stated by Raab, “informed consent process flows naturally from the ‘partnership’ between physician and patient” (Raab). Despite the fact that informed consent is supposed to educate the patients, it is now more of an avoidance of liability for physicians (Raab). Although the physician provides adequate information to his patient, how can he ensure that his patient properly ...
Is informed consent always necessary for randomized, controlled trials? The following sentences are different scenarios that answer the question. Informed consent should not be waived unless the treatment is offered inside and outside the trial. Treatment should not involve more than minimal risk compared to alternatives. Genuine clinic must value the treatments the same. No reasonable person should have a preference for one treatment or another (Truog et al. 1999).
To begin, to those who may wonder what informed consent is, it is a legal and ethical prerequisite for clinical research on humans (Bristol, par 2). The purpose of informed consent is to ensure that patient autonomy is respected in decisions about their healthcare (Susilo, 1). Many people say that the term was first used in 1957. There was a malpractice case with Salgo v Leland Stanford Jr. The California Supreme court stated that no patient can submit to a medical intervention without having given “informed consent”. Even though the courts had said this, inf...
Informed Consent Summary What is Informed Consent Osteopathic informed consent is the valid consent obtained in response to a proposed examination or treatment, after appropriate advice and information has been provided by the practitioner. Consent cannot be categorised as informed if treatment is agreed to by the patient without detailing all the information regarding the nature of the treatment, the reasoning for its recommendation and other information they would regard as relevant to their decision, such as inherent risks of the treatment and alternate treatment options.
2. When you ask someone to participate, explain the basic nature of the study. You
Ethics refers to the values and customs of a community at a particular point in time. At present, the term ethics is guided by the moral principles that guide our everyday actions. These moral principles guide the researcher into deciding what is ‘right’ or ‘wrong’. The foundation of medical ethics is governed by two philosophical frameworks that are deontology, and utilitarianism. However ultimately the ethics committees need to balance the risks, and benefits for the participants and the community associated with the particular research proposal. This balance is quite important as the well being of participants is at risk.7
In conclusion, obtaining informed consent is a vital part of respect for the patient and safeguarding of self-determination. The consent to participate in research or treatment should be informed, comprehensible, and free of coercion. There is not a clear black and white answer because no matter what is done to assure informed consent there is always a moment of doubt on the end of the patient as to whether what is going to take place is fully understood and their true wishes honored.
Beneficence is “do no harm” and strives to reduce participant risks and increase benefits. Respect for persons is to treat people with autonomous who can make their own intentional decisions. The final principle Justice, shares a fairness in receipt of the research benefits while also burdening the risks to participants. The three principles are used to clarify challenges in research and give guidelines in behavioral and medical investigations. When obtaining consent from a minor, the form must be signed by a parent or guardian on their behalf.
The article titled “Contemporary Ethical Analyses: A Shortfall in Scientific Knowledge” describes the ethics through the public’s eye. One of the major ethical issues brought up is informed consent.
Sponsor responsibility will be in the selection and preparation of sites. Regulatory documents will be shared electronically. 2. Remote participation: Distances will not be a problem. Study visits and procedures will be done via video conference; data will be recorded by the subjects and transmitted to the site.
Informed consent means that the potential participants are well informed about the research study, the potential risks and benefits of their participation and that it is research, not therapy, that they will participate in.” (Shahnazarian. D,
Ethics in biomedical research keeps health professionals and researchers honest and allows them to have a set of skills to analyze and resolve ethical dilemmas (Mattick, 2006). Ethics also are essential in obtaining a positive relationship with patients and is essential for moral, sociologic, and legal reasons (Hall, 2012). Researchers who participate in unethical and questionable practices are wasting valuable resources and failing the public’s trust. Questionable and unethical research practices have harmed entire populations in the past, such as in World War II, when Jewish people were used against their will for research. Currently, patients have a legal right to consent, and this right protects them from potential harm or unwanted medical attention (Hall, 2012).