Shortcomings of the Concept of Consent - Essay Example

Running Head: Consent Consent of the of the Consent It is a phrase and quite possibly it is a justification not in favour of civil or criminal liability. Those who utilize this protection are quarrelling that they should not be supposed liable for a tort or a crime, since the conduct in question were taken with the claimant or "victim's" consent and authorization. Negligible needs have been recognized about the contentment of consent information offered to possible research participants. For example, the consent report must notify topics: That the events are part of investigate or conduct, About risks and reimbursement to the person's participation or no contribution that they have the right to extract without punishment at any time. For consent to treatment, alternative treatments and their risks and benefits are to be mentioned. Review The presence of an institution wide review body for research (also called institutional, ethics or human subject protection review board) and guidelines of its composition and functions are mandated. Treatment review occurs only when treatment is new, controversial or bordering on the experimental. Ethics and credential committees perform such reviews. Other licensing or regulatory bodies that require adherence to similar guidelines govern organizations not receiving funds from the Canadian or American federal governments. Individual researchers who do not receive government funding and who do not belong to an organization are not required to adhere to such regulations. However, adherence to the guidelines is recommended for good practice, research and citizenship and to avoid legal liability. When organizations or groups without ethical review boards propose research, a university, hospital, licensing or professional organization, or another institution does reviews. Psychologists performing research or working within provincial or state agencies may need to follow additional guidelines. Individual researchers and practitioners are required to follow consent guidelines in lock step. Thus, consent information is usually given through a typed document with a set order of information. Unfortunately, these documents are often long and complex and require a college education in order to be understood by the participant. In addition, the order in which information is presented can make comprehension difficult for the participant. The complexity of informed consent documents prompts many to return to old complaints about the intrusion of ethics review bodies into research or treatment and the impracticality of consent. In order to improve the consent process, empirical studies of the efficiency and value of current methods are necessary. Instead of spawning such research, complaints have led to a lessening of consent requirements. For example, an exempt-from-ethics-review status for research designated as no risk has been introduced other jurisdictions simply maintain existing general guidelines. Coal of Consent The cause for this requirement of accomplishment comprise: a partial view of consent, bewilderment over what constitutes "informing," the techniques of achieving consent, the lack of a comprehensive theoretical base for consent, and reluctance by researchers. The imaginary view that individuals have the right to make assessment for themselves forms the root for well-versed consent. Nevertheless, this philosophy was included into consent guidelines only after frequent subject and patient mistreatment. Changes in consent processes have often been reason by political view rather than empirical study of informed consent. As a result, many researchers and practitioners view consent as a necessary burden rather than a useful adjunct to good research or practice. At the same time, current consent methods are perceived as optimal, even in the face of contrary evidence. Just as past guidelines, new requirements for ensuring scientific integrity have been established without empirical study. While some rules have been stated in a negative manner forbidding certain behaviours, rules stated in a positive manner often are open to interpretation. In addition there is no ethical decision making model for researchers or practitioners to use in resolving issues not covered by existing rules. However, individual IRBs may encourage investigators to seek advice from their IRB. Similarly, there are no provisions within existing regulations for educating researchers or practitioners to apply consent rules. The addition of treatment ethics to psychological or medical curricula is limited (The Canadian Federation for the Humanities. A recent exception is the U.S. requirement that all trainees receiving federal scholarships be educated in research ethics. PURPOSES OF THE PRESENT PAPER The present paper discusses shortcomings of the concept of consent and presents a framework, Informing for Consent, for overcoming these shortcomings and fulfilling the philosophical, legal and theoretical requirements of consent. This framework can also form a background for the empirical study of consent. An important topic of research is the efficiency and efficacy of methods to operationally individual autonomy and self-determination. In addition, this paper presents methodologies available to researchers and practitioners for informing subjects or patients. Conceptual Difficulties With Consent The lack of integration between the concepts of competence (also termed capacity or capability) and informed consent is a major conceptual difficulty with consent. In order to have informed consent, at least three criteria must be fulfilled: demonstrated competence for decision making, voluntaries, and understanding. Competence and Consent The phrase "decision making" is often confusing because it refers both to the "decision made" and the process that is used to make that decision. Decision making competence includes the ability to follow a reasonable process, weigh the consequence of alternative action (including inaction or refusal), and make the preference known. Within research or treatment, decision making competence is the ability to decide whether or not to participate in research or treatment, to continue or withdraw even after it has begun, and to make these choices known through oral or written statements, gestures, or through the actions of a parent or of a guardian. Reasonableness of the decision making process is judged according to the process a reasonable individual would. Voluntaries, Being Informed and Consent In order to consent, voluntaries or freedom from any implied or actual coercion is required. The person must be informed, which means that the person fully understands participation in research or treatment. The understanding of a reasonable person is the standard used to judge informed consent. Lack of Criteria For Decision Making, Understanding or Proxy Appointment Despite requirements for consent, there are no widely accepted, empirically established criteria for determining: (a) The quality of the participant's decision-making process, (b) The adequacy of the participant understands, (c) The reasonableness of the participant's choice, or (d) The appointment of a proxy decision maker if the participant is deemed incompetent. The lack of criteria has potential serious consequences for the subject or patient, researcher practitioner, the courts and policymakers, and for our understanding of the development and deterioration of competence to self-consent. When subjects or patients assent to participation, the reasonableness of their choice, their level of understanding and the decision making process used is rarely questioned. Similarly, if the person later withdraws their assent, these decisions are not analysed. If, however, the person does not assent to the prescribed treatment, the person's competence may be questioned. Other than in obvious instances of very young children, people who are comatose or severely mentally retarded or ill, this occurs despite the fact that the reliability of determining total or partial incompetence is poor. Thus a person's autonomy and self-determination may be denied and their right to adequate protections removed. At the same time, our understanding of the reasonableness of choices, levels of comprehension of consent information and the quality of decision-making processes are severely limited. This is particularly true for older children, elderly people, and persons with mental illness or mental retardation. The researcher/practitioner too is faced with a series of ethical dilemmas surrounding the use of a flawed concept. Finally, courts and policymakers may make inaccurate decisions based on flawed information. Chinese medicine It is based on the belief that the body will fight off and recover from illnesses when the body is in balance in terms of Yin Yang and the Qi. Despite a long history of practices, Chinese doctors in each generation guarded their knowledge as family secrets. Little of the knowledge was shared in public for peer reviews until the government of the Peoples Republic of China established modern research and education systems for the discipline. Many westerners considered Chinese medicine unscientific and some even equated it with Voodoo magic. However, recent academic researches in China may help to add some scientific insights on why some treatments are effective. Herbs are used heavily in Chinese medicine. Each prescription is a cocktail of many herbs tailored to the individual patient. The herbs are simmered in water over several hours to reduce to a cup of concentrated herbal tea. The doctor usually designs a remedy using one or two main ingredients that target the illness. And then the doctor adds many other ingredients to adjust the formula to the patient's Yin Yang conditions. Sometimes, ingredients are needed to cancel out toxicity or side effects of the main ingredients. Some herbs require the use of other ingredients, as catalyst or else the brew will be ineffective. The latter steps require great experience and knowledge, and make the difference between a good Chinese herbal doctor and an amateur. Unlike western medications, the balance and interaction of all the ingredients are more important than the effect of individual ingredients. Due to the emphasis on achieving equilibrium of Yin Yang in the patient's body for it to heal itself, Chinese medicine is believed to be more suitable for treating chronic illnesses than medical emergency. Methodological Difficulties In addition to the weak relationship between competence and consent, there are a number of methodological difficulties with the current concept of consent. These difficulties include the use of minimal standards for the content of information to be presented and the no empirically established methods of presentation of that information. Although the President's Commission recognized some of these difficulties, the regulations went forward without modification today and remain essentially the same today. Very often subjects or participants do not fully understand either what they are assenting or dissenting. Since that time, individual studies have consistently shown not only a lack of understanding, but also misunderstanding of consent information). The lack of understanding is greater for people who read and comprehend information at levels lower than at which the information is presented, who can not process information rapidly, who process information better in ways other than reading, or who have difficulty remembering things. Despite the evidence for lack of understanding by patients and subjects, consent documents remain complex. Using that which a reasonable person would understand as the standard for consent implies that we know what a reasonable person would understand in a given context. Use of a reasonable person standard implies that there are some normative data against which to compare; however, some, including this author, argue that the standard should be complete understanding for each individual regardless of the norm especially for decisions that may involve high risk and low benefit for the individual participant. (This also was the original intent of the President's Commission but reaction from researchers and practitioners was too great). Furthermore, this standard assumes that there is a way to determine the understanding of the potential participant. In order to make such a determination, a standardized method would be required, including established criteria for understanding and that if an individual does not attain those criteria, an informal or formal proxy would be. At present, there are no normative data for what a reasonable person understands in various consent situations (e.g., high versus low risk with high versus low individual benefit); neither methodology for collecting that information; nor criteria for what constitute poor understanding so that a proxy can be appointed. Reason behind picking this article: The main reason behind picking this article is the working and authenticity behind this article more than this article is so compiled and according to the current scenario that is faced by both the physicians as well as the patients. In addition, the article in which information is presented make comprehension easy for the participant, this article is too a bit different in nature. Use of a reasonable person standard implies that there are some normative data against which to compare; however, some, including this article, argue that the standard should be complete understanding for each individual regardless of the norm especially for decisions that may involve high risk and low benefit for the individual participant. How It Relates To Tcm: As we discussed earlier that despite a long history of practices, Chinese doctors in each generation guarded their knowledge as family secrets. Little of the knowledge was shared in public for peer reviews until the government of the Peoples Republic of China established modern research and education systems for the discipline, that is the reason why the outflow of knowledge is very less now the question arises that what is role that consent is performing in rising the outflow of knowledge This the answer for that occurrence of an association open reassess body for research and strategy of its work and functions are authorized. Treatment review occurs only when conduct is new, notorious or adjacent on the experimental. Ethics and credential committees perform such reviews. Personal researchers who do not obtain government funding and who do not belong to an organization are not required to adhere to such regulations. However, adherence to the guidelines is recommended for good practice, research and citizenship and to avoid legal liability. When organizations or groups without ethical review boards propose research, a university, hospital, licensing or professional organization, or another institution does reviews. Psychologists performing research or working within provincial or state agencies may need to follow additional guidelines. Individual researchers and practitioners are required to follow consent guidelines in lock step. Thus, consent information is usually given through a typed document with a set order of information. Unfortunately, these documents are often long and complex and require a college education in order to be understood by the participant. In addition, the order in which information is presented can make comprehension difficult for the participant. The complexity of informed consent documents prompts many to return to old complaints about the intrusion of ethics review bodies into research or treatment and the impracticality of consent. In order to improve the consent process, empirical studies of the efficiency and value of current methods are necessary. Instead of spawning such research, complaints have led to a lessening of consent requirements. Primary & secondary references: The primary references I have mentioned in this paper are more likely is the choice for any writer working on the paper like this why Because these are more then authentic and quite close to the topic, while the secondary references are too very helpful and authentic but they are less applicable then the primary references. References Primary references Ilgen, D. R., & Bell, B. S. (2001). Conducting industrial and organizational psychological research: Review of research in work organizations. Ethics and Behavior, 11, 395-412. Informed Consent: Legal Theory and Clinical Practice by Jessica W. Berg, Paul S. Appelbaum, Lisa S. Parker, and Charles W. Lidz, Oxford University Press, 2001 Atkinson, J. (2006) Private and Public Protection: Civil Mental Health Legislation, Edinburgh, Dunedin Academic Press Druml C., Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive, Curr Opin Crit Care. 2004 Dec;10(6):570-3. Dunn LB, Nowrangi MA, Palmer BW, Jeste DV, & Saks ER, Assessing decisional capacity for clinical research or treatment: A review of instruments. Am J Psychiatry, 163(8):1323-1334. Fisher, JA., Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Secondary references Trials Industry, Kennedy Institute of Ethics Journal. 2006; 16(3): 251-268. Holmes-Rovner M, Wills CE., Improving informed consent: insights from behavioral decision research, Med Care. 2002 Sep;40 (9 Suppl):V30-8. Solomon RC., Ethical issues in medical malpractice, Emerg Med Clin North Am. 2006 Aug;24(3):733-47. Wang CE, Huch MH., Protecting human research subjects: an international perspective, Nurs Sci Q. 2000 Oct; American Psychological Association. (2001). Ethical principles of psychologists and code of conduct. Monitor on Psychology, 33, 77-89. American Psychological Association, Committee for the Protection of Human Participants in Research. (1992). ; Ethical Principles. American Psychologist, 47, 1597-1611. Bala, N., & Cruickshank, D. (1986). Children and the charter of rights. In B.Landau (Ed.). Children's rights: The practice of family law. Toronto: Carswell. Barrios, B., & Hartmann, D. (1988). Fears and anxieties. In E.Mash and L.Terdal (Eds.). Behavioral assessment of childhood disorder! (2nd ed.). New York: The Guilford Press. Belter, R., & Grisso, T. (1984). Children's recognition of rights violations in counseling. Professional Psychology Research and Practice, 15, 899-910. Brewer, T., & Faitak, M. T. (1989). Ethical guidelines for the inpatient psychiatric care of children. Professional Psychology Research and Practice, 20, 142-147. Ferguson, D. (1990). Ingredients for comprehensive consent to health care legislation. Health Law in Canada, 12, 7-32. Grisso, T., & Vierling, I. (1978). Minors' consent to treatment: A developmental perspective. Professional Psychology, 9, 412-437. Hart, S. (1991). From property to person status: Historical perspective on children's rights. American Psychologist, 46, 53-59. Rozovsky, L.E., & Rozovsky, F.A. (1990). The Canadian law of consent to treatment. Toronto: Butterworths. Weithorn, L., & Campbell, S. (1982). The competency of children and adolescents to make informed treatment decisions. Child Development, 53, 1589-1598. Weithorn, L. (1983). Involving children in decisions affecting their own welfare. In G.B.Melton, G.P.Koocher, & M. J.Saks (Eds.), Children's competence to consent. New York: Plenum. Read More