What is the right to refuse medical treatment?
A patient may refuse treatment that the healthcare provider deems to be an act of beneficence out of the principle of autonomy. In the United States, the right to refuse treatment is protected by 42 CFR § 482.13.
How should the nurse explain the meaning of ethics to patients?
The nurse is asked to explain the meaning of ethics to a patient. The nurse should correctly state, "Ethics is a system of standards that refer to ideas and actions in terms of being (Select all that apply)
What are the ethical principles of patient care?
any food requested and in as large a quantity as desired. 1.considerate and respectful care from all care providers. The individual rights of patients are an important ethical theme in health care.
What do nurses avoid in ethical practice?
In ethical practice, nurses avoid allowing personal judgments to bias their treatment of patients. 88 What is the term for the beliefs held by the individual about what matters? Values are ideals and beliefs held by an individual or group; values act as a standard to guide one's behavior.
What are the ethical issues of randomized clinical trials?
RCTs are a very useful method in environmental health research but they also raise a variety of ethical issues, ranging from obtaining informed consent, to minimizing risks, to protecting privacy and confidentiality (Resnik et al 2005).
Is a no treatment control group ethical?
Most people accept the use of placebo controls in trials for conditions with no effective treatment. However, PCTs raise ethical concerns when a proven effective treatment exists, since randomizing subjects to a placebo exposes them to the potential harms of non-treatment.
Is using placebo for patient treatment ethical Why or why not?
Placebo use, however, is criticized as being unethical for two reasons. First, placebos are supposedly ineffective (or less effective than “real” treatments), so the ethical requirement of beneficence (and “relative” nonmaleficence) renders their use unethical.
What is the purpose of randomizing participants in a randomized controlled trial?
Randomization helps prevent bias. Bias occurs when a trial's results are affected by human choices or other factors not related to the treatment being tested.
What is no treatment control?
a control group whose members are not exposed to any experimental manipulation or intervention, thus serving as a neutral comparison for study groups receiving the treatment under investigation.
When is a control group unethical?
In this way, having been in the control group in the short term serves to improve the school in the long run. But isn't it unethical to deprive schools or children of effective methods? If the methods were so proven and so widely used that not to use them would truly deprive students, then this would be unethical.
Why is placebo not ethical?
A common argument against placebo is that its use is unnecessary, and therefore unethical, when “proven effective therapy” exists, in which case any new treatment should be tested against this existing treatment.
Is placebo trial ethical?
The World Medical Association has reaffirmed its view that in general it is ethically unacceptable to conduct placebo controlled trials if a proven therapy is available for the condition under investigation.
Why are placebo clinical trials unethical?
Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit.
Why is it important to randomize treatments?
Randomization as a method of experimental control has been extensively used in human clinical trials and other biological experiments. It prevents the selection bias and insures against the accidental bias. It produces the comparable groups and eliminates the source of bias in treatment assignments.
What are the advantages and disadvantages of Randomised control trials?
Randomisation minimises allocation bias and selection bias. Blinding minimises performance bias....Disadvantages of randomised control trial study designPower calculation might demand vast samples size, which require more resources from the investigators.Validity requires multiple sites, which will be difficult to manage.More items...•
How do you randomize patients in clinical trials?
The easiest method is simple randomization. If you assign subjects into two groups A and B, you assign subjects to each group purely randomly for every assignment. Even though this is the most basic way, if the total number of samples is small, sample numbers are likely to be assigned unequally.
What are the ethical obligations of a clinical trial?
A well-designed clinical trial should answer important public health questions without impairing the welfare of participants. Ethical obligations to trial participants and to science and medicine pertain to all stages of a clinical trial: design, conduct, and reporting results.
What is the ethical dilemma of physicians and health care workers?
One area of ethical dilemma of physicians and health care workers can be attributed to the conflicting roles of helping the patient and gaining scientific knowledge , as stated by Schafer (1982)
What is clinical decision?
Clinical decisions for treatment that are based on weak or anecdotal evidence, opinion, or dogma, without the evidence of rigorous scientific support, raise their own ethical questions. It is not easy to distinguish between clinical research and clinical practice.
What is the role of a physician in medical research?
By contrast, in his modern role of scientific investigator, the physician engaged in medical research or experimentation has a commitment to promote the acquisition of scientific knowledge. When properly set, designed, and conducted, a clinical trial is an ethically appropriate way to acquire new knowledge.
Which funding sources require responsible conduct of research training?
Many funding sources, including the US NIH and NSF, require responsible conduct of research training for all students, trainees, fellows, scholars, and faculty utilizing their funds to conduct research.
Is there an expectation of death or disability as a result of a trial?
There is no expectation for death or disability as a result of the trial. The degree of risk for the patient should not exceed the humanitarian importance of the problem to be solved. The subjects should be protected against even a remote possibility of death or injury.
Do clinical investigators need to be trained in ethics?
All clinical investigators should have training in research ethics. The US NIH website has resources for training in the areas of scientific integrity, data, publication, peer review, mentor/trainee relationships, collaboration, human and animal subjects, and conflict of interest. Many funding sources, including the US NIH and NSF, ...
What is nonrandomized treatment allocation?
Treatment allocation in a clinical trial can be randomized or nonrandomized. Nonrandomized schemes, such as investigator-selected treatment assignments, are susceptible to large biases. Even nonrandomized schemes that are systematic, such as alternating treatments, are susceptible to discovery and could lead to bias. Obviously, to reduce biases, we prefer randomized schemes. Credibility requires that the allocation process be non-discoverable. The investigator should not know what the treatment will be assigned until the patient has been determined as eligible. Even using envelopes with the treatment assignment sealed inside is prone to discovery.
How does randomization work?
In some early clinical trials, randomization was performed by constructing two balanced groups of patients and then randomly assigning the two groups to the two treatment groups. This is not always practical as most trials do not have all the patients recruited on day one of the studies. Most clinical trials today invoke a procedure in which individual patients, upon entering the study, are randomized to treatment.#N#Randomization is effective in reducing bias because it guarantees that treatment assignment will not be based on the patient's prognostic factors. Thus, investigators cannot favor one treatment group over another by assigning patients with better prognoses to it, either knowingly or unknowingly. Procedure selection bias has been documented to have a very strong effect on outcome variables.#N#Another benefit of randomization which might not be as obvious is that it typically prevents confounding of the treatment effects with other prognostic variables. Some of these factors may or may not be known. The investigator usually does not have a complete picture of all the potential prognostic variables, but randomization tends to balance the treatment groups with respect to the prognostic variables.#N#Some researchers argue against randomization because it is possible to conduct statistical analysis, e.g., analysis of covariance (ANCOVA), that adjusts for the prognostic variables. It always is best, however, to prevent a problem rather than adjust for it later. In addition, ANCOVA does not necessarily resolve the problem satisfactorily because the investigator may be unaware of certain prognostic variables and because it assumes a specific statistical model that may not be correct.#N#Although randomization provides great benefit in clinical trials, there are certain methodological problems and biases that it cannot prevent. One example where randomization has little, if any, the impact is external validity in a trial that has imposed very restrictive eligibility criteria. Another example occurs with respect to assessment bias, which treatment masking and other design features can minimize. For instance, when a patient is asked "how do you feel?" or "how bad is your pain?" to describe their condition the measurement bias is introduced.
What is the term for a constrained randomization?
Another type of constrained randomization is called stratified randomization. Stratified randomization refers to the situation in which strata are constructed based on values of prognostic variables and a randomization scheme is performed separately within each stratum. For example, suppose that there are two prognostic variables, age and gender, such that four strata are constructed:
What is adaptive randomization?
Adaptive randomization refers to any scheme in which the probability of treatment assignment changes according to assigned treatments of patients already in the trial. Although permuted blocks can be considered as such a scheme, adaptive randomization is a more general concept in which treatment assignment probabilities are adjusted.
What is the most common form of randomization?
The most popular form of randomization is simple randomization. In this situation, a patient is assigned a treatment without any regard for previous assignments. This is similar to flipping a coin - the same chance regardless of what happened in the previous coin flip.
What is minimization in randomization?
Minimization is another, rather complicated type of adaptive randomization. Minimization schemes construct measures of imbalance for each treatment when an eligible patient is ready for randomization. The patient is assigned to the treatment which yields the lowest imbalance score. If the imbalance scores are all equal, then that patient is randomly assigned a treatment. This type of adaptive randomization imposes tight control of balance, but it is more labor-intensive to implement because the imbalance scores must be calculated with each new patient. Some researchers have developed web-based applications and automated 24-hour telephone services that solicit information about the stratifiers and a computer algorithm uses the data to determine the randomization