Informed Consent
Order Instructions:
Case Assignment
Make sure you have read all of the assigned readings. Discuss the questions presented below and follow directions
1.Review the case Informed Consent in Louisiana – Lugenbuhl v. Dowling.
2.First, identify the elements of the legal citation- plaintiff, defendant, court, location of case etc.
3.Explain the meaning and importance of the doctrine of informed consent.
4.Discuss why we have this doctrine and what would happen if we did not.
5.Discuss the two elements that must be present for informed consent to exist under the law.
6.In a legal case of negligence and liability explain why the basis for negligence may be battery, unconsented touching, or breach of a duty imposed on the doctor to disclose material information.
7.Explain the elements that must be present for a patient to give informed consent.
Module Overview
Informed consent requires more than just a good written form—it also requires preparation for a full discussion with the patient and a check to ensure that the messages have been received.
Informed consent is the process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention [AMA 1998].
Disclosure of facts related to an individual’s healthcare, including level and location of care, are central to the fulfillment of informed consent. When an individual is unable to provide informed consent because they lack the decision-making capacity to process the information and/or they have been deemed legally incompetent, the healthcare team should obtain assent from the individual whenever possible.
Questions remain as to how to proceed when assent cannot be gained and the decision involved causes a level of distress for the individual that is difficult to resolve. A focus on maintaining hope and support with a clear transition and follow-up plan are important variables to consider for an ethical, caring response.
Traditionally, the ethical principle of patient confidentiality, including the right to personal privacy has been an important consideration in healthcare. Recent incidents involving identify theft, confidentiality, and patient privacy have led to increasingly restrictive policies on patient health information and access to records and data. Some believe that these restrictions can harm efforts to protect the public’s health. This has prompted discussions on a more appropriate balance between privacy concerns and the protection of public health.
Required Reading
A Practical Guide to Informed Consent. Temple Health (2007). http://www.templehealth.org/ICTOOLKIT/html/ictoolkitpage1.html
Informed consent Russell G. Thornton Proc (Bayl Univ Med Cent) 2000 April; 13(2): 187–190.PMCID: PMC1312305 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1312305/
Informed Consent in Louisiana – Lugenbuhl v. Dowling, 701 So.2d 447 (La. 1997), rehearing denied (Nov 21, 1997) Guide http://biotech.law.lsu.edu/cases/consent/Lugenbuhl.htm
Am J Public Health. 2008 May; 98(5): 793–801. doi: 10.2105/AJPH.2006.107706
PMCID: PMC2374810 Ethics in Public Health Research: Privacy and Public Health at Risk: Public Health Confidentiality in the Digital Age. Meyers, Frieden, Bherwani and Henning. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2374810/
Optional Reading
Improving the Informed Consent Process Krames StayWell Blog (2009). http://info.kramesstaywell.com/Portals/36339/docs/Krames%20Informed%20Consent.pdf
SAMPLE ANSWER
Informed Consent
Question 1
Informed consent goes beyond just signing a piece of paper to the level that there must be a clear discussion between the patient and the medical professional in order to reach an understanding. Disclosure of the medical health history by a patient forms a greater part of informed consent. In the Lugenbuhl v Dowling case, the surgeon got the patient’s consent and gave and assurance that he would use the surgical mesh. The surgeon, however, went against this promise and never used it. While undertaking the operation, the surgeon thought that all would be well besides the change in plans, but unfortunately, things didn’t work out as he had planned. His patient who had intracostal incisional hernia sued him for going against the informed consent. During whole hearings of the case, the charges were separated into medical malpractice and the lack of informed consent. During the case, however, there was no sufficient evidence that the surgeon had gone against informed consent by not using the mesh as the plaintiff did not have the vital causation element. The medical evidence showed no case of violation on the healthcare by Dr. Dowling (Eonas, McCoy, & Eaton, 2010).
Question 2
In the case, the Plaintiff was the concerned patient, DR. John Downing who was a professional surgeon was the Defendant. The case was heard on 10th October 1997. It was filled in the Supreme Court of Louisiana.
Question 3
Informed consent is a legal process that ensures that the client, patient or the researcher are well informed about the potential dangers or risk and cost that comes with a medical process. The elements of informed consent include available alternative medical care, potential benefits, awareness about the nature of treatment and the treatment risks. For instances where a patient might not be able to make the consent, then a legal representative can be involved. It forms a bigger part towards satisfaction of medical attention as patients are part of the process (Faden, Beauchamp, & Kass, 2014). Informed consent serve as a guide to the physician when making great decisions concerning the health of the patient.
Question 4
The lack of informed consent can lead to many malpractices by the medical professionals during the provision of healthcare services. The healthcare professionals will have the freedom of administering any kind of medication on their clients without seeking their opinion. Informed consent, however, restricts them to always heed the patient’s need as going against it can lead to various legal implications. Through informed consent, a patient can fully participate in decisions that concern his or her life and in turn leads to them adopting a healthy way of living (Faden, Beauchamp, & Kass, 2014).
Question 5
The existence of informed consent under the law relies on two concepts. First, there should be a statement concerning the consequences that will occur in the event that the client decides not to proceed with the procedure. In the event that withdrawal from the procedure might cause some effects on the health of the patient, then there should be a clear explanation of the required withdrawal procedures in order to uphold patient safety (Tsai, Orav, & Jha, 2015). This will give an opportunity to the patient to make a decision on whether to withdraw or not, knowing the consequences that will accompany the option they will opt for. Secondly, there should be an explanation that the medical procedure involves some risks which might not be evident at the moment. Such risks must be explained by the medical professional as the patient might not be able to recognize such effects. Ensuring that the patient clearly understands the risk before undertaking a treatment is more paramount than just informing them.
Question 6
The basis of negligence might be considered as a battery if the doctor’s unconsented procedure amounts to the batter. The law does not protect any medical procedure which is performed outside the informed consent as it is considered as the legally permissible procedure. Breach of duty would occur when evidence prove that the defendant had a responsibility towards the plaintiff which was not upheld. Such cases would mean that the defendant exposed the plaintiff to loss.
Question 7
In order for the patient to provide informed consent, quite a number of factors must be present. To start with, the patient should be in the correct state of mind in order to voluntarily make decisions at that moment. The patient needs to be well informed that besides the paper they are signing they need to make a personal decision from their heart. The medical professional should act as a guide to the patient in the quest of reaching an informed consent through the provision of advice on the best alternative decisions in order for the patient to understand what is at stake. The professional should use simple terms and language in order to make sure that the patient clearly comprehends what is being said. The consent should also cover the following parts: it should provide reasonable alternatives, risks, and benefits, assessment of the patient’s understanding and the patient’s acceptance to undergo the medical procedure. In the case where a better alternative exists, then the medical professional needs to take the patient through the option convincing him or her to opt for that alternative.
References
Eonas, A., McCoy, J. D., & Eaton, S. H. (2006). Medical informed consent: clarity or confusion?. Journal of hospital marketing & public relations, 16(1-2), 69-88.
Faden, R. R., Beauchamp, T. L., & Kass, N. E. (2014). Informed consent, comparative effectiveness, and learning health care. N Engl J Med, 370(8), 766-768.
Tsai, T. C., Orav, E. J., & Jha, A. K. (2015). Patient satisfaction and quality of surgical care in US hospitals. Annals of surgery, 261(1), 2.
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