...importance of informed consent in research. Most people have the expectation that they will be treated with respect and as autonomous individuals. They also expect that they have the right to make decisions about what will and will not be done to them and about what personal information they will share with others. However, researchers also are aware that there are circumstances in which obtaining and documenting consent in social and behavioral research may be a complex, and often challenging process. For instance, potential subjects may be fluent in a language but not literate. Researchers may need to deceive research subjects in order obtain scientifically valid data. Asking subjects to sign consent forms linking them to a study about illegal activities could put them at risk of harm. The federal regulations provide sufficient flexibility to address some of these concerns, particularly for research posing no more than minimal risk of harm. For example, the regulations allow waivers of and alterations in the requirements for the consent and documentation processes. Learning Objectives By the end of this module you should be able to: • Distinguish between consent as a process and the documentation of consent. • Recognize the elements of consent. • Determine when waivers are appropriate. • Identify methods for ensuring comprehension of consent. Overview of Informed Consent Federal regulations require researchers to obtain legally effective informed consent from the subject...
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...• Analyze the legal issues related to informed consent and refusal Informed consent is an essential part of the treatment process in psychology. Legally it protects both the psychologist and the individual who will be receiving professional services. According to Pope and Vasquez (2007), informed consent provides the client and the therapist the opportunity to understand his or her legal rights and that they each have an equal vested interest in the treatment process. Pope and Vasquez (2007) also stated that informed consent is a decision making-process that gives the client the... The informed consent is the agreement between two parties to work collaboratively (Pope & Vasquez, 2007). In psychology, the client signs the consent form to allow treatment from the psychologist who may include testing, treatment, and initial psychological assessment. The patients have the right to their information; in terms of benefits, alternative treatments and about the risks. If the patient does not understand what he or she is giving permission to, he or she can allow an authorized decision-maker. The law requires that all persons take reasonable steps to clarify and communicate adequately with their patients about their risks and benefits. The informed consent is basically the understanding and justification of power that should not be abused intentionally or accidentally (Pope & Vasquez, 2007). The informed refusal is when a patient is refusing care; because of legal issues, trust, infectious...
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...My law and ethics understanding and beliefs In 1847 the American Medical Association revolutionized medicine in the United States. Members of this newly formed organization, met in Philadelphia as the first national professional medical organization in the world, dedicated themselves to establishing uniform standards for professional education, training, and conduct. They unanimously adopted the world's first national code of professional ethics in medicine. For more than 160 years since, the AMA's Code of Medical Ethics has been the authoritative ethics guide for practicing physicians. Ethics in Hand are pocket-sized guides to the Code of Medical Ethics for physicians and medical students. The Code articulates the enduring values of medicine as a profession. As a statement of the values to which physicians commit themselves individually and collectively, the Code is a touchstone for medicine as a professional community. It defines medicine’s integrity and the source of the profession’s authority to self-regulate. At the same time, the Code of Medical Ethics is a living document, evolving as changes in medicine and the delivery of health care raise new questions about how the profession's core values apply in physicians' day to day practice. The Code links theory and practice, ethical principles and real world dilemmas in the care of patients. The next time you hear a monotheist tell a non-believer that morals come from the Bible or that moral reasoning cannot provide an...
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...Explain informed consent and confidentiality to the client. Informed consent involves the counselor explaining the benefits and risks of counseling as well as its alternatives. It also allows the counselor permission to record counseling sessions in writing, and via video and auditory means. In an educational institution setting, informed consent allows students to observe counseling sessions. Once these issues are explained to the potential client, the client is asked to sign legal documents that state the client understands and agrees to the services to be provided and their potential dangers. When counseling minors, informed consent must come from a parent. While explaining the pros and cons of counseling to the parent, the counselor must also explain the necessity of confidentiality in the therapeutic relationship with a minor. A confidentiality form is presented during the discussion of confidentiality. In adhering to counseling ethics, the counselor must explain that confidentiality is a promise not to discuss matters that are shared by the client with a third party unless under pre-determined exceptions. The exceptions to confidentiality include reporting information the client reveals to the counselor that suggests he or she is a danger to him or herself or others. For example: If a client talks about killing himself and identifies that he has a plan and the means to execute that plan, it is the counselor's ethical responsibility to inform appropriate...
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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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...an approved protocol must: a) Must occur only when the level of risk changes. b) Occur at least annually. c) Must be conducted by a convened IRB. d) Include copies of all signed consent forms. 161) A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed after the discovery of the adverse event occurrence? a) Report the adverse drug experience to the IRB only if there are several other occurrences. b) Report the adverse drug experience as part of the continuing review report. c) Do not report the adverse drug experience to the IRB since it is a common adverse experience. d) Report the adverse drug experience immediately to the IRB using the forms or the mechanism provided by the institution. 162) How long is an investigator required to keep consent documents, IRB correspondence, and research records? a) As long as the investigator is at that institution b) Until the IRB gives permission for them to be destroyed c) Until the study is closed d) For a minimum of three years after completion of the study 163) Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: a) They are eligible for review using expedited procedures. b) They only involve changes to the consent form. c) The changes must be immediately implemented for the health and well being of the subject. d) The investigator keeps careful records of all changes and includes them in the final...
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...Internal Review Board For The Protection Of Human Subjects In Research North Carolina Central University INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH Request for Review of Research Involving Human Subjects COVER SHEET | | (For Staff Use Only) | | |1. School/Department/Unit:NCCU/Psychology |REQUEST #____________ |Today's Date February 3, 2005 | 2. Name of Principal Investigator (PI) ______________________________________________ Name of Faculty Advisor (FA), if PI is a student__Dr. Les Brinson _________________________________ Telephone Number (PI): 919*530*4526_ Mailing Address (PI): PO Box 19408 Durham, NC 27707 Telephone Number (FA):919*530*5166 Mailing Address(FA): Taylor Ed. Rm 217A Durham, NC 27707 3. PROJECT TITLE: ____________Organizational Communication and Its Relationship With Job Performance and Job Satisfaction _________ 4. PROJECT TYPE: __N__ (Select one: N = New; AR = Annual Renewal; PC = Protocol Change) This is a : _SP__ (Select one: SP = SPECIFIC PROJECT or GP = GRANT PROJECT PROPOSAL) If Grant Project Proposal, list agency and address to which project is being submitted: __________________________________________________________________________________________ ...
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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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...Quiz #5: Client Rights and Counselor Responsibilities 1. Informed consent generally implies that the person: a. does not have the capacity to consent. b. verbally gives consent. c. has been persuaded or coerced to sign the consent form. d. has the capacity to consent and has freely, without undue influence expressed consent. 2. ___________________ to give informed consent means that the client has the ability to make rational decisions. a. Comprehension of information b. Voluntariness c. Capacity d. Willingness 3. Written consent forms should NOT include: a. a discussion of how a managed care system will affect the treatment, if applicable. b. a detailed description of what will occur in therapy and a guarantee that the client will resolve their issues. c. a statement describing the counselor’s theoretical orientation and how this will affect treatment. d. clarification pertaining to fees and charges and procedures for filing for insurance reimbursement. 4. Henry is seeking counseling through his managed care provider. Ethically, he needs to be informed that a diagnosis: a. can become a permanent part of his file. b. of a severe emotional problem will exclude him from getting services. c. is not required if he does not give his approval. d. will in no way influence the course of his treatment. 5. Most ethical codes specify that therapists should: a. be available to their clients even when they are on vacation. b. inform clients that their...
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...US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".) Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.) Which of the following is included in the Nuremberg Code? Voluntary Consent Informed consent is considered an application of which Belmont principle? **** Respect for Persons (Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent) How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. How long is an investigator required to keep consent documents, IRB correspondence & research records? For a minimum of three years after completion of the study. (May be required to keep them longer than 3 years) According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? The study involves no more than minimal risk &...
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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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...constitute intentional deception, (Hertwig & Ortmann, 2008), since this prevents them from inferring the hypothesis being tested for and reduces bias in the study. The approach of deception infringes on one of the most important aspects of research, which has been the source of controversy for a quite sometime, it is participants informed consent. According to the American Pychological Association code of conduct states that it is imparative that the potential research participant be given information about the particulars of the research such as the kind of procedures that may be used and what is expected of them during the course of the research and whether they will be exposed to danger or not. This information gives the participant to make an informed decision whether to participate or not in the research, (American Psychological Association, 2014), the ethical code also emphasizes on the right to privacy of the participant meaning information collected about them will be private and treated as such. A new technique has been advocated by researchers, it is authorized deception, in this technique, the participant is precented with a concent form stating that some of the information provided to...
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...hypothesis of this research is that words heard at normal speed will be easier recalled then those heard at a fast speed. 16. The participant population will consist of undergraduate students currently enrolled in psychology courses at Valdosta State University. Approximately 20 participants will perform the experiment. All participants will be at least eighteen years of age. Students will be asked to voluntarily participate in this experiment. If a participant refuses to participate in the experiment then he or she will not be bothered again. 17. Participants will be asked to read and sign a consent form. The consent form will briefly inform the participants about the experiment, but the details of exactly what is being measured will be kept from them. Each participant will be assigned a number for coding of their data to protect their anonymity. Before and after the informed consent process, participants will be reminded that their participation is voluntary and that at any point in time during their involvement in the experiment, they may decline from further involvement in the experiment. They will again be made aware that if they choose not participate further, they will not be penalized in any way and they will not be bothered further. 18. Participants will not receive any compensation for participating in this experiment. 19. There aren’t any details that are necessarily being withheld from the participants. But since this experiment is being conducted using words...
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...Lesson 3 – Informed Consent, Substitute Decision-Making, and the Family Centered Approach * It should be noted that a choice might properly require only low/ minimal competence, even though its expected risks exceed its expected benefits or it is more generally a high-risk treatment, because all other available alternatives have substantially worse risk/benefit ratios. * Thus, according to the concept of competence endorsed here, a particular individual’s decision-making capacity at a given time may be sufficient for making a decision to refuse a diagnostic procedure when forgoing the procedure does not carry a significant risk, although it would not necessarily be sufficient for refusing a surgical procedure that would correct a life-threatening condition * The greater the risk relative to other alternatives—where risk is a function of the severity of the expected harm and the probability of its occurrence—the greater the level of communication, understanding, and reasoning skills required for competence to make that decision. * It is not always true, however, that if a person is competent to make one decision, then he or she is competent to make another decision so long as it involves equal risk. * Even if the risk is the same, one decision may be more complex, and hence require a higher level of capacity for understanding options and reasoning about consequences. * The evaluation of the patient’s decision-making will seek to assess how well...
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...The Tuskegee Syphilis Experiment was an unforgettable case conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service. The reasoning of the Tuskegee experiment was to study the effects of untreated syphilis in the rural Macon Country on poverty affected African-American males who thought they were receiving free health care from the U.S. government but were actually being injected with syphilis without consent. The research started in 1932, on 600 low-income African American men, out of which 399 who had already contracted syphilis, and 201 who were disease free. To get the participants to begin medical experiments, government funded programs offered free medical care, meals, and free burial services to those who...
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