...Informed Consent 1 Running Head: HUMAN SUBJECTS Human Subject’s Comprehension of Informed Consent Informed Consent 2 Statement of the Problem A primary protection of the rights of clinical research subjects revolves around the concept respect for persons and the provision of informed consent (Belmont Report, 1979). Legal and ethical policies and guidelines enforce that research participants give informed consent prior to voluntary enrollment in a research study (Code of Federal Regulations,1999). However, the informed consent process presents some major challenges for study participants and research staff. Several papers have addressed problems with the current process. Brady (2003) identifies the following issues: subject’s hesitation to ask detailed questions, variable presentation of the content, and difficulty verifying the subject’s comprehension. Also, a survey performed by Center Watch in 2002 found that 14% of subjects did not read the consent before signing it and a high percentage of volunteers admitted to not fully understanding the risks and not knowing what questions to ask. The concept of “therapeutic misconception” (Joffe, Cook, Cleary, Clark, & Weeks, 2001) in research is another problem that has received much attention in both legal and bioethics literature. It is important that potential subjects are aware that...
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...participants outweighs the good of the research” and “Informed consent/ deception”. Protecting research participants from harm calls for ensuring their rights and mental/ physical health is not violated or adversely affected by the research. If conducting research on illegal drug use, a researcher, cannot tell participants, that their disclosure of drug use or illegal drug sales is completely confidential. Knowing the information provided can harm the respondent or subject the researcher to criminal prosecution, should he or she withholds information subpoenaed as part of a litigation. To protect respondents and, themselves the researcher may want to reconsider conducting research that exposes criminal activity. The researcher may also opt to continue unethically with the research because they feel the harm to respondents outweighs the data garnered from the research conducted This could lead to sanctions by the IRB, so to ethically continue with the research, respondents need to inform their responses may not be confidential....
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...made about the strengths and weaknesses of the different parts, as well as of the whole, Burns (2000). Reflection follows on from this by encouraging the analysis of clinical practice, this in turn, helps the healthcare professional to develop his/her knowledge and to acquire a deeper level of understanding about the complexities of nursing practice. Boud et al (1985) suggests that this type of learning contributes to the development of clinical competence. The critical incident is taken from my recent clinical practice within the Endoscopy Unit. I will be reflecting upon and critically analysing gaining informed consent prior to the patient’s emergency Endoscopy and when to act within patient’s best interests. My rational for the chosen clinical incident is because of the impact it had on me. I realised I was not fully informed on the process of obtaining 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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...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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...Doctrine of Informed Consent ME1231_Jesarela_Module3_Lab1.doc October 3, 2015 Shepard Valley Out-Patient Surgery Clinic. 46873 East Revenue Lane 45263 Patient Must Be Awake, Alert and Oriented When Signing Date: _____________ Time: ____________ Consent of the surgery 1. The purpose of this form is to verify that you have received this information and have given your consent to the surgery or special procedure recommended to you. It’s the obligation of the surgeons to provide you with the information you need in order to decide whether to consent to the surgery or special procedure that your surgeons have recommended. You should read this form carefully and ask questions of your surgeons so that you understand the operation or procedure before you decide whether or not to give your consent. 2. The type of procedure to be performed: ________________________________ 3. Type of anesthesia: ________________________________________________ 4. Name of the surgeons who will be performing the surgery:_____________________________________________________ 5. All operations and procedures carry the risk of unsuccessful results, complications, injury or even death, from both known and unforeseen causes, and no warranty or guarantee is made as to result or cure. You have the right to be informed of: ▪ The nature of the operation or procedure, including other care, treatment or medications; ▪ Potential benefits, risks...
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...Confidentiality and Informed Consent Claudia Lewis PSY/305 6/29/15 Dr. Daniel Williams Jr, PsyD, MSW Confidentiality and Informed Consent Introduction Dear client this paper is to inform you, of your right to confidentiality, and further more explain the process of informed consent. In the world of Psychology and counseling, confidentiality and informed consent has been the cornerstone to our practices (University of Phoenix, 1994). This paper will help you to understand how the things you say during the counseling sessions may have legal implications against you; by first explaining the decision of Tarasoff v. the board of Regents of the University of California, followed by how it relates to the therapist-client relationship in regards to confidentiality; then finally explaining the process of informed consent and refusal. Tarasoff v. Board of Regents of the University of California Decision According to University of Phoenix Confidentiality after Tarasoff (1994), the Tarasoff v. board of regents of the University of California case was heard before the California Supreme court, when Tatiana Tarasoff, a student at The University of California was killed by a fellow student. Her parents sued the University of California, the Police and the Therapist (University of Phoenix, 1994). The parents claim was that neither the School, Police or the Therapist warned them of the intentions of this fellow school mate to kill their daughter, Tatiana Tarasoff, as the fellow...
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...Confidentiality and Informed Consent Raul Delgado PSY/305 December 16, 2015 Gina Craft, MS, MA Confidentiality and Informed Consent Informed consent is usually a practice between a patient and his provider, it is a permission established prior to a procedure after gaining knowledge of the risks that are going to be involved with in the procedure. Although implications could occur with the informed consent, these including; “1) medical emergencies, where there is immediate danger to life and the delay that would be necessary to obtain consent might be harmful; 2) incompetency, where die patient is unable to give a legally valid consent; 3) therapeutic privilege, where there is discretion to withhold information which might have a detrimental effect on patient health if disclosed; 4) waiver, where die patient can waive his or her right to be informed, to make the treatment decision, or both; and 5) mentally ill and dangerous, where mentally ill patients who are imminently in danger of harming themselves or others may be involuntarily committed and treated” (Faden & Beauchamp, 1986; Sprung & Winick, 1989; Alberta Mental Health Act, 1990) Confidentiality holds similar characteristics to an informed consent. Just as informed consent, confidentiality could also be between a physician and his or her patient, anything the patient may reveal is usually upheld in confidentiality unless permission is permitted by the patient to send his or her information to a third party...
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...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 this family member. If the patient is unconscious, the courts may be brought in or it is the physician’s decision to proceed if the patient’s life is in danger. Competencies The patient or appropriate surrogate must be competent or have decision-making capacity, that is, be capable of understanding the consequences...
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...The informed consent is a written document in which a person, whether client or participants in a research study, agrees with the course of treatment (for counseling) or to participate (in case of study) after having received specific and enough information on the procedures that would be subject to. The area of psychology that I will consider for this discussion is research. Informed consent in research involves many factors. Informed consent should be provided to participants prior the study takes place. This document should provide sufficient and clear information of the study: duration, any possible risks or discomforts participants may suffer, and if participants will be or not compensated (amount must be specified). Additionally, informed...
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...Information Sheet Purpose of the Study: As part of the requirements for MSc in Marketing Practice at Letterkenny Institute of Technology, I have to carry out a research study. The study is concerned with Internet Marketing and its use within SMEs in Sligo, Ireland. What will the study involve? The study will involve collecting data through questionnaire, online focus group and one to one interviews. Why have you been asked to take part? You have been asked to be a respondent because you match criteria relating to the research study and your insights would be most valuable. Do you have to take part? You do not have to take part. This information sheet is to inform you of what the research intends to evaluate. Your information will be used anonymously in order to complete the dissertation. Participants can withdraw from the research at any time before, during or after the commencement of data collection. All information collected will be treated in the strictest of confidence. Will your participation in the study be kept confidential? Yes. Any extracts from what you say that are quoted in the thesis will be entirely anonymous. What will happen to the information which you give? The data will be kept confidential for the duration of the study. On completion of the thesis, they may be retained for a further six months and then destroyed. What will happen to the results? The results will be presented in the dissertation. They will be seen by my supervisor...
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...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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...The words “informed consent” gives an understanding to what it is. As a professional it is our duty to inform the individuals we are serving of what is happening and what could happen. First, we must understand the why. Informed consent is an important concept that can be seen when looking back through history. It is a safe guard that protects both the professional and the individual that is receiving the service or treatment. Second, we have to understand the “what” and the “who”. When presenting the information that needs consent we have to fully understand what the information is that we are trying to communicate to the individual. So that we can explain in away the individual can understand. The individual must be given the full...
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...The decision of Tarasoff v. the Board of Regents of the University of California was that, for the first time imposed a liability on a therapist for failing to protect a potential victim, when therapist Dr. Moore had a client, Prosenjit Poddar that confided in him that he intended to kill a woman, he did not name the woman, but none the less he claimed he was going to kill her when she got back from her vacation, even though Dr. Moore called his supervisor and the campus police, he was still sued by The Tarasoff family when Poddar did indeed end up killing her after campus police let him go two months prior because he appeared to be rational and promised he would not harm her (Kagle J, Kopels S. P.1 1994). The therapist – client relationship is that of a confidential manner. The therapist is to keep anything the client says under strict confidentiality however; this article argues that this is not the case because social workers have never really been able to offer their clients unlimited confidentiality because in recent years the demand for accountability has increased as well as greater access to information in records, mandated child abuse reporting and expanding court involvement in professional decision making (Kagle J, Kopels S. P.1 1994). Now more than ever therapists are faced with their obligation to protect their client’s privacy as well as the duty to protect third parties from harm. Especially when dealing with potentially violent clients who are court ordered...
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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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