Informed Consent Case Study

This study was approved by the institutional local Ethics Committee. All patients signed an informed consent form and were instructed to bring fresh stools on the same day of urea breath test that was performed within a month after endoscopy. Anti-secretory drugs had to be discontinued at least 10 days and antibiotics for at least one month prior endoscopy and until stool collection for H. pylori antigen detection and urea breath

In this case, the night of January 11, 1983, Nancy Cruzan was driving a car and lost control of her car as she traveled down Elm Road in Jasper County, Missouri. The car overturned, and Nancy Cruzan was discovered lying face down in a ditch without detectable respiratory and cardiac function. Paramedics were able to restore her breathing and heartbeat at the accident site and she was transported to a hospital in an unconscious state. Then neurosurgeon diagnosed her and found that she is having sustained probable cerebral contusions compounded by significant anoxia (lack of oxygen). The Missouri trial court found that permanent brain damage generally results after 6 minutes in an anoxic state and Nancy was in this stage for 12 to 14 minutes.

Explain how and why the concept of informed consent is critical to issues of euthanasia (active and passive) as well as physician-assisted suicide. Informed consent is a process for getting permission before conducting a healthcare intervention on a person, autonomy at its best. In physician assisted suicide we have the informed consent of the patient requesting the help to die. In this instance the patient is the direct cause or their own death, they just require the physician to help them get the medicine needed to end their life, they decide where and when to do it, and they are competent when making this decision. This is important when it comes to the law and the physician possibly being sued. In active euthanasia the physician gives

“Respect for human beings involves giving due scope to peoples capacity to make their own decisions. In the research context, this normally requires that participation be the result of a choice made by the participants” (NHMR, 2007, p.3).  Freegard 2012 (p.60), states that “respecting the rights of others,” includes a responsibility for Health professionals “to let others know about their rights” and that this forms the basis of an informed consent.

Each of these four cases are issues regarding informed consent. Nurses do not consent the patient for procedures. However, they can assure that the patient understands the procedure. They can support and reiterate what the physician is stating. If there is any hesitancy, the nurse needs to document it and relay the information. The nurse is the patient advocate, so as the physician is explaining and describing the procedure, the nurse needs to be present. If the physician is unaware of the level of education, the nurse needs to communicate the level of education to the physician.

When a patient needs to have a medical procedure performed, they must first consent to the procedure. Before accepting or rejecting the treatment, the practitioner is required to give the patient information pertaining to the risks and benefits of the procedure, as well as available alternatives. Additionally, the patient must be mentally competent enough to make an informed decision, and not be manipulated or coerced into a decision.

If you wish to participate in this research study, please sign the form below. Your signature verifies that you agree to participate in the research study for Physical Therapists role in Chronic Diseases. Also, by signing below you are at least 18 years or older.

Informed consent, by definition, requires the administering health care provider to disclose appropriate information to a competent patient, and allow that patient sufficient time to choose, voluntarily, whether to accept or refuse treatment (Appelbaum, 2007). For children, the law upholds an inability to provide their own informed consent as they lack the decisive ability inherent in consent (Appelbaum, 2007). Thereby, for children, a proxy, as determined by the state laws, chooses the course of treatment on their behalf (Appelbaum, 2007). Furthermore, for children of, an undesignated, reasonable age, a consultation about assent, or willingness for acceptance of treatment or care, should follow a guardian’s decision (Appelbaum, 2007). Responsibility

INFORMED CONSENT : Valid consent is impossible. To date, foetal tissue transplants have been handled as any other organ transplants under the UAGA, thus requiring consent of next of kin. The mother cannot give morally legitimate consent, since she initiated the termination of the pregnancy. Elimination of consent, however, would further turn the unborn child into an object; it would be inconsistent with the fact that, biologically, the developing foetus does not interpret the woman’s tissue. The UAGA and the NIH Panel both fail to discern the conflict between normal organ transplants and the function of foetal tissue. In the instance of foetal tissue, the mother is presumed to be the one who gives consent to the use of the tissue for the transplant (or for some other kind of experimentation). Granting to the normal understanding of proxy consent, her role assumes that she is working in the best interest of the unborn child. However, she is also the one who has initiated the final termination of pregnancy. Just quoting the part of the act dealing with informed consent stated in the NewZealand legislation

Informed consent is a process where the physician provides the patient with information so that the patient can make a choice whether to accept or refuse treatment. This concept originates from the patients legal right to direct the type of health care they receive and the physicians ethical duty to involve the patient in the provision of medical care. Children do not have the capacity to give informed consent but their parents must give informed permission for treatment (Pozgar, 2012).

Fundamental to healthcare shared decision-making is the doctrine of informed consent. This shared decision-making is one of the most advocated methodologies in the healthcare treatment decision. Shared decision-making is a method in which the doctor communicates to his patient all the sufficient risk and benefit information on all types of medical treatments and alternative medical treatments. The patient then shares with his doctor all his personal information that might make a particular medical treatment (or a side-effect from it) more (or less) bearable than other medical treatments. Then, the doctor and his patient in tandem use all the information to arrive at a joint decision on the medical treatment. In order to be actively involved in their healthcare treatment decisions, patients must receive sufficient information from their doctors. In this particular role, doctors play the part of teachers or educators for their patients.

As any other clinical research study different ethical issues could arise while conducting my practicum experience. Providing an effective informed consent process is an important ethical aspect that will be thoroughly managed during research design and while recruiting the 150 participants. Respect for potential and enrolled subjects is another topic that will be considered to avoid having ethical problems that will prevent for this to happen. The risk-benefit ratio will also be studied for this to be favorable for the participants.

GCP requires that Investigators receive adequate training on performing the study, including obtaining Informed Consent, and that patients receive adequate information about the study, what is expected, and the risks of participating. A complete description of what is required is also available online at the OHRP website.251 These sections and activities are expanded in special circumstances, such as emergency procedures, and studies with children, captive (e.g. prisoner) populations, mentally incompetent individuals, etc.

There was no informed consent given to the participants to be part of the dataset. It is evidence that Kirkegard and Bjerrekaer’s did not meet the 6 subsections under Part B of informed consent: (1 & 2) elements of informed consent, (3 & 4) of IRB approval of consent procedure, (5) not to preempt federal and local laws, and (6) not to limit physicians’ care.

The inform consent form was a type form that the client needs to sign and dated. I went over the inform consent at the beginning of the session and explain to the client the reason for signing the form. Informing the client that everything that is said between the client and myself would not leave this room and it is confidential. No one has access to this interview, unless otherwise you sign an ROI for me to discuss the information. The main focus/ topic that the client had was being surrounded by co-workers that like to talk about sport and play weird music that he had no interest in. Before client had a different route and the friends /co-workers that he had, they would talk about Big Foot and other topic that the client enjoys talking