...Informed consent: Dates back to the early part of this century, and centers on the principle of battery. Courts have clearly ruled that most states now have specific informed consent statutes, physicians have a common law duty to ensure that diagnostic, medical, and surgical procedures are authorized by the knowledgeable consent of the patient or his or her legal representative. A physician who fails to obtain his or her patient’s consent to treatment commits a battery. Informed Consent Standards: • This standard requires the physician to disclose to the patient everything that is customary in the profession to disclose under the same or similar circumstances. • In court, plaintiffs in these states must produce an expert witness to testify that the defendant’s actions fell below the standard of customary disclosure. Required Elements: There are five basic elements that must be disclosed to patients in language that a lay individual reasonably can be expected to understand: • The diagnosis, including the disclosure of any reservations the provider has concerning the diagnosis • The nature and purpose of the proposed procedure or treatment • The risks and consequences of the proposed procedure or treatment. This includes only those risks and consequences of which the physician has, or reasonably should have, knowledge. It is not necessary to disclose every potential minor risk or side effect. • Reasonable treatment alternatives. This includes other treatment modalities...
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...| Informed Consent in Emergency Situations | By | | Liz Marotz | 3/1/2016 | | I. Introduction A. Explanation of an Informed Consent B. Type of Informed Consent C. How to use an Informed Consent in Emergency Situations II. Elements of Full informed consent A. Assessment of patient understanding B. The Nature of the decision/Procedure III. Interventions that require Informed Consent A. Cancer Screening test B. Clinical Decision IV. Waive Informed Consent Form A. Reason to waive B. Who gives the approval of waiver V. Conclusion A. Summary Informed consent means that permission is granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits. However, informed consent in an emergency situation can only be presumed rather than obtained when the patient is unconscious or incompetent and no surrogate decision maker is available and the emergency interventions will prevent death or disability. In general, the patient's presence in the hospital ward, ICU or clinic does not represent implied consent to all treatment and procedures. The patient's wishes and values may be quite different from the values of the physician. While the principle of respect for the patient obligates the physician to do their best to include the patient in the health care decisions that affect the patient’s life and body, the principle...
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...Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases may also be further aggravated when a family member or a Legal Authorized Representative (LAR) is not available to decide if the patient should participate in a clinical trial that offers a treatment may increase the of survival more than the current standard of treatment. We must than think of the patient’s best interest at this point. History of Informed Consent Following World War II, the Nazis who performed medical experiments on prisoners of war without obtaining their consent were convicted of murder, but not for their actions of conducting unethical research. Their actions helped bring to life the Nuremberg Code of 1948; the first legal document to enforce the idea that subjects’ participation in clinical research must be voluntary...
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...Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases may also be further aggravated when a family member or a Legal Authorized Representative (LAR) is not available to decide if the patient should participate in a clinical trial that offers a treatment may increase the of survival more than the current standard of treatment. We must than think of the patient’s best interest at this point. History of Informed Consent Following World War II, the Nazis who performed medical experiments on prisoners of war without obtaining their consent were convicted of murder, but not for their actions of conducting unethical research. Their actions helped bring to life the Nuremberg Code of 1948; the first legal document to enforce the idea that subjects’ participation in clinical research must be voluntary...
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...47 D.L.R. (4th) 18, 43 C.C.L.T. 62, awarding the plaintiff damages against the physician for battery and dismissing the action against the hospital. The judgment of the court was delivered by ROBINS J.A.: The question to be decided in this appeal is whether a doctor is liable in law for administering blood transfusions to an unconscious patient in a potentially life-threatening situation when the patient is carrying a card stating that she is a Jehovah's Witness and, as a matter of religious belief, rejects blood transfusions under any circumstances.I In the early afternoon of June 30, 1979, Mrs. Georgette Malette, then age 57, was rushed, unconscious, by ambulance to the Kirkland and District Hospital in Kirkland Lake, Ontario. She had been in an accident. The car in which she was a passenger, driven by her husband, had collided head-on with a truck. Her husband had been killed. She suffered serious injuries. On arrival at the hospital, she was attended by Dr. David L. Shulman, a family physician practising in Kirkland Lake who served two or three shifts a week in the emergency department of the hospital and who was on duty at the time. Dr. Shulman's initial examination of Mrs. Malette showed, among other things, that she had severe head and face injuries and was bleeding profusely. The doctor concluded that she was suffering from incipient shock by reason of blood loss, and ordered that she be given intravenous glucose followed immediately by Ringer's Lactate...
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...medical professional (NHS, 2014). Nurses have to follow the nursing midwifery code, which states nurses should “make sure appropriate informed consent is given and documented before carrying out any action” (NMC,2015). Therefore, prior to any treatment given, the person must give consent for the nurse to carry out the treatment. In order for consent to be valid, it must be voluntary. The person must have come to the decision themselves, with no influence from medical staff, family or friends (Griffith et al, 2013). The consent must be informed, the person must have knowledge and understanding about the what the treatment involves, including risks and benefits or alternative treatments and what will happen if the patient does not have the treatment. For the consent to be valid the person must have mental capacity, meaning they are able to understand the information given and make an informed decision based on the information given to them. Consent can be written, however, signing a form is not valid consent. The person need to have the opportunity to gain knowledge about the treatment, as well as ask a medical professional, with the correct knowledge, any questions they may have involving the treatment. Written consent is normally used where a procedure is invasive, such as surgery or immunisations. A nurse will need to gain written consent from the patient before giving an injection. The nurse will need to explain what the injection is for, why the patient needs it and what...
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...Table of Contents I. Informed Consent A. Patient B. Healthcare Professional C. Consent for others D. Competencies II. Consent Forms A. Emergencies/Non-Emergencies B. Authorization C. End of Life Decisions III. Legal A. Processes B. Malpractices IV. Conclusion V. References The concept of the informed consent is always a subject that is uncertain. An informed consent can be presented as an understanding of the fact and implications. When giving informed consent, the person must have all the facts at the time of consent is needed. Concepts It is extremely important that a patient must be provided all the information needed to give consent and not encouraged or forced by any medical staff member. The patient should also be in right mind before consenting to any procedure. If the patient is under the influence of medication, the consent will have to be given to the next of kin. The physician is responsible for providing all details of the procedure and treatment that will occur to the patient. This conversation should also be noted in the patient’s medical record. The physician has the right to assign another staff member to obtain the informed consent form, but only if the physician has performed the requirements needed. When consent is needed from other family members, the physician is required to provide the family member the details of the treatment. Also, the patient must consent to render his/her voice to...
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...Tuskegee Syphilis Study Dr. Joseph Costa, D.H.Sc, PA-C Health Policy and Management MPH 525 Jessie McCarty April 2013 Table of Contents Chapter Page 1. Tuskegee Syphilis Study 2 2. Tuskegee Basics 3 3. What Went Wrong? 4 Informed Consent 4 Vulnerable Populations 4 Medical Profession Pursued 5 4. Personal Opinion 7 5. Basics of Research 8 Informed Consent 8 Individual Autonomy 9 Beneficence 9 6. Current Policies 11 Policies 11 Exceptions 11 7. Problems with Waving Consent 13 Flexibility 13 Vulnerable Populations 13 Ethical Dilemmas 14 8. Conclusion 16 Chapter 1 Tuskegee Syphilis Study Throughout the years, numerous research studies have taken place. In the United States, on a daily basis thousands of research studies are being conducted. Some of these studies will greatly influence science, while others will make little impact. Historically, some studies have been remembered not for the results, but for ethical dilemmas surrounding the study. The Tuskegee syphilis study is a prime example of a study which made many people aware of the ethical problems surrounding research. The Tuskegee syphilis study made the government begin to analyze how research was performed in the country, and the study opened many eyes to what changes needed to be made. Analyzing the Tuskegee syphilis study allows for one to understand what went wrong with the study and how this study lead to great changes in the world...
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...Profiles * My CEUs * My Reports * Support * Main Menu › VA Human Subjects Protection › Informed Consent Informed Consent Content Author * Diane Paul, M.S., RN National Comprehensive Cancer Network Introduction It is important to understand that informed consent is a process that begins with the recruitment and screening of a subject and the signing of the consent document, continues throughout the subject's involvement in the research, and continues beyond study termination. It includes: * Recruitment efforts encompassing the means of first creating awareness or contact and spanning everything from medical record review to advertisements and other recruitment materials. * Providing specific information and answering questions about the study to subjects in a way that is understandable to them while giving subjects adequate time to consider participation. * Obtaining the voluntary agreement of subjects to take part in the study. While the subject may agree to participate in the study, subjects may withdraw at any time. Part of the ongoing nature of the consent process is verifying the subject's continued interest in participating in the study. * Making plans for the provision of new information to be shared with former subjects, even after the study ends. There is consensus regarding the importance of informed consent. Informed consent is a demonstration of how investigators and those involved in human subjects research show respect to...
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...nurses, emergency room physicians and nurses, theater attendants, medical lab scientists are within the sampling frame. Process The study subjects would be approached to assess their willingness to participate in the study. Using the University of California San Francisco Committee on Human Research consent form for one time research as a template. (32) (See appendix) Those who elect to do so would be given a consent form and the ramifications of filing the forms would be explained in detail. Study Design Information would be elicited with the aid of an interview guide (see appendix 3) designed for this study. The interview would be conducted by Dr. Obieze Nwanna – Nzewunwa with the aid of a note taker and two assistants who would make an audio recording. The recordings and notes would complement each other. The recording would be transcribed, translated and personal identifiers would be removed. After the study the tapes would be destroyed. Analysis The information would be organized, managed and coded using Atlas.ti version 7. The analysis would be performed using grounded theory (33,34) bearing the following codes, sub-codes and themes in mind. This software was chosen because it has a user-friendly interface and is easy to use. It also has functions that allow segmenting, categorizing, annotating, retrieving, and searching within and across documents and categories without fragmenting the original document.(35) THEME CODE SUBCODE 1 Ethical considerations Informed consent Signed...
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...on a business trip. Which of the following is the most appropriate action to take for the investigator? Your answer : The investigator can go ahead and enroll the man without a signed consent. Correct Answer : Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. Comment : The IRB will not provide a waiver of consent under these circumstances and the man should not be excluded from the study simply because his legally authorized representative is temporarily unavailable to sign in person. Verbal approval does not satisfy the FDA requirement at 21 CFR 56.109(c) of signed informed consent document. When obtaining consent from a legally authorized representative (LAR) who is not able to provide signed consent in person, it is acceptable to send the informed consent document to the LAR by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed as noted in the FDA's FAQs. If the LAR agrees, he/she can sign the consent and return the signed document to the clinical investigator by facsimile. Points Earned : 0 Question 2 Question : A general requirement for the informed consent is that no informed...
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...Informed consent Name Course Date Informed consent Informed consent is the procedure of getting permission to take part in a research study or medical procedure founded on access to all vital and easily understandable information about the consequences of participation in terms of benefits and harms (Dolgoff et al, 2009). A healthcare provider may demand informed consent from a patient before providing care or a researcher may request it from a participant before enrolling the individual into a research trial. Informed consent is based on guidelines provided by research and medical ethics. To give informed consent, the person involved must have sufficient reasoning faculties and have all the relevant facts. However, not all individuals may have capacities for informed consent due to impairments to reasoning and judgment such as mental immaturity, severe intellectual disabilities, mental illnesses, high stress levels, being in a coma, Alzheimer’s disease, and severe sleep deprivation. Medical and research actions may be carried out due to lack of informed consent. When a person is considered unable to give informed consent, another person can be authorized to give consent on behalf of that person (Manson & O'Neill, 2007). For instance, legal guardians or parents may give informed consent for young children and the mentally ill. In case a person is given insufficient information to make a reasoned decision, severe ethical issues may arise. In clinical trials...
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...information of how parental consent in the Health Career seems to cause a lot of communication difficulties between the parents, the teens, and the doctors, nurses, etc. I will be using real life examples of situations where communication difficulty occurred, and will be demonstrating some ways we could possibly resolve this issue by using communication models and ideals from our textbook. My main focus is especially on teen abortions and teens that are diagnosed with an STD, and how some states require parental consent and how some states don’t. In many states a minor can consent, and has the capacity to consent or can make his or her own health care decisions, the consent of another person, such as the minor’s parent or guardian, is not needed (Tigges,B.B.2003). This is one of the many reasons why doctors, nurses, etc. have difficulty cooperating with parents and teenagers when there is a required parental consent, or when there isn’t a required parental consent (Griffin-Carlson,M. S.,&Mackin,K.J.2008). Montefiore Medical Center in NYC had a lawsuit in the year of 2012 for “Unauthorized release of private medical information to parent of teen.” Dana Nunez is 17 years old; she goes into the hospital to be treated for genital herpes. The Doctors and Nurses do not need to get Dana’s parents’ permission before treating her, because a minor can consent to health care for sexually transmitted infections in the state of New York. Therefore, Dana Nunez was not informed that she would be getting...
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...throughout the hospital as NABH standards are applicable Vertically as well as Horizontally across the hospital and its various functions. The checklist has 2 components namely: i. Primary: Essentially pertaining to area specific point ii. Secondary: Common requirements for the area This checklist can be used for practical guidance. The assessor should not limit the assessment only to this checklist and can add more points based on their experience and observations. This will help out in updating this checklist and making it more comprehensive in the 2nd version Version 1 Issue Date: 17/05/11 Page 2 of 53 NABH Assessment Checklist CONTENTS Clinical Areas S. No Department/Area Page Number 1. Emergency and Ambulance 5 2. Out Patient Department 6 3. Wards 7 4. Specialized wards 11 5. Palliative Care 12 6. Dialysis Unit 13 7. Intensive Care, Neonatal/ Paediatric ICU and High Dependency Units 14 8. Operation Theatre 17 9. Recovery Room 19 10. Endoscopy 20 11. Rehabilitation 22 12. Imaging: X Ray/ USG/ CT Scan/ MRI 22 13. Nuclear Medicine 24 14. Cardiac Catheterization lab 25 15. Laboratory: Haematology/ Microbiology 16. Blood Bank 27 17. Radiation therapy/Radioactive drugs 28 18. Nutrition 29 19. Research 30 20. Hospital Infection Control 30 Version 1 Biochemistry/ ...
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...Running head: ASSIGNMENT 4 ORGANIZATION OF A HEALTH CARE FACILITY Assignment 4 HSA 515 Organization of a Health Care Facility As a chief operating officer, you are responsible for a 15-bed Emergency Room (ER). You have received many complaints within the last year regarding inadequate patient care, poor ER management, long wait times, and patients being sent away because of lack of space, staff, or physicians to provide appropriate care. Diagnose the root causes of the complaints about the clinic. In a 15-bed Emergency Room (ER), overcrowding of patients is the root cause for inadequate patient care in the ER. The increase in patients throughout the years with limited staff has become an issue for emergency rooms. The increase in patients is created by the increase in the number of aging population with chronic medical conditions and increasing number of uninsured or underinsured patients that go to the emergency room for everyday ailments. Due to the limited number of resources, the emergency room can not maintain an adequate number of physicians, nurses, and support staff to accommodate and care for the number of patients. Overcrowding not only creates long waiting times but also increases risks of medical errors. The physicians are over their capacity which can lead to undue stress and burnout, which in turns leads to poor and inadequate treatment to the patients. Due to the overcrowding, the ER physician will not have...
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