Ethical Principles of an Informed Consent - Essay Example

Discuss the ethical principles underlying a particular aspect of informed consent The concept of ethics in nursing though is seen in the same line with the birth of terms as the human rights, it is well accepted that from time immemorial, nursing- the selfless service as one of its multitude colors had ethical obligations also. With the growth of the concept of bioethical standards, the stage is set on, were the healthcare professionals are expected to respect the patient and involve them in the active process of decision making. Thus gone are the days when the patients were as passive observers, and kept out of any clinical decisions as unknowledgeable. Thus now it is widely accepted that every healthcare client as consumer has specific rights and the healthcare providers – the professional are expected to respect the rights. In this nurses as the selfless healthcare professional has an additional duty of supporting and promoting the patients health and also are expected to act as their advocate when necessary. At extreme times when the patient is not in a power of agency, the nurses are expected to do to the patient what he would have done if he is entitled with the power. One such thing that has become a buzz word of ethical standard in both medical practice and research is “Informed Consent”. (Beauchamp &Childress, 1989) Informed consent: Informed consent can be described as an agreement given by the patient for a proposed course of treatment or a research activity, upon receiving clear, understandable information about the ensuing potential benefits and risks. In providing treatment, additionally it is required to explain all treatments available for your health condition, and the risks of receiving no treatment. Informed consent can be regarded even as the epitome of patient’s autonomy. In biomedical ethics, the informed consent is defined as decision obtained from autonomous, competent individual in non coercing way after providing them with the knowledge that they can either accept or reject the proposed course of action. As a annexure a complete informative communication of information is expected, regarding the procedures, that would help them to take individual decisions. It is the fundamental right of the patient to accept and reject the consent after duly obtaining all the information. Now a days the informed consent has been made as a part of law of ethics in many countries as Europe and America. (Faden &Beauchamp, 1986). The key ethical principles governing the informed consent: With the 'Informed Consent' becoming a indispensable moral and legal prerequisite in medical research and treatment it is important to understand the principles guiding it.The four key principles are autonomy, nonmaleficence, beneficence, and justice. The autonomy as the name implies involves the process of allowing the patient or participant to have his own time , respect and opportunity to come up to his own decision. Thus the participants are to be provided with the information nad left to decide on their own. In autonomy great care and caution is to be excised for the vulnerable group as very ill, old , prisoner, children etc. The beneficence on the other hand is the feature that is considered as the moral responsibility of the researcher to care and steps to protect the wellbeing of the patients and participants. Thus they are expected to protect the participant from harm and try to provide maximum benefit, thus benefit has to outweigh the risk. Under the same light comes the concept of non- maleficence that primarily means not to harm . Thus when the ethical question of risk vs. benefit arises there arise the concept of justice. This concept has to be borne in mind while selecting the participants for the study. In selecting participants care is to be exercised in selecting the participants without much bias of race, religion, socioeconomic status and gender. Thus in nutshell it is the duty of the physician / researcher to protect the life, health, privacy, and dignity of the human subject who are involved as participants and the medical research involving human subjects are required to follow the norms of generally accepted scientific principles, that is based on a thorough knowledge of the scientific literature, other relevant sources of information. (World Medical Association Declaration of Helsinki,2002). The Aspects or types of Informed consent: The practice of informed consent historically is found to be rooted to not only to medicine, but also to other fields as moral philosophy, and the law. Now with medicine deeply rooted to law. The informed consent in general has two aspects, the informed consent for medical treatment and informed consent for medical research. The difference being, consent to treatment rooted in case law and consent to research, being based on ethical codes, statutes, and administrative regulations, with the least involvement of courts. (Arnold, 2002) The role of Informed consent in medical treatment: Informed consent in this aspect is the process by which the patient’s freedom, privacy and safety is guaranteed apart from developing the trust and mutual goodwill between the professionals and patients. The informed consent in medical treatment could be characterized in two aspects, one is autonomous authorization of medical intervention, and the other is institutional rules of consent, a legal consent obtained prior to a procedure. In general the informed consent, constitutes of five major elements as voluntarism, that expects a consent without persuasion and inducements: capacity, that defines the patients ability to take a decision, competence being judged according to situations and has its own set of regulations; disclosure that involves the explanation of nature, purpose, risk and chances of the proposed procedure; understanding that demands patient to comprehend the situation, in court the lack of understanding doesn’t stand for a legal issue if proper disclosure of information is proved; finally the decision that deals with the final step of patient’s authorization of the physician to carry out the treatment. (Barer, 1997) Again there are some limitations faced with informed consent, though it leads to better communication between the physician and patient and better quality of care. The major form of the limitation is one where though the purpose of informed consent is to grant autonomy for patients , the purpose not being served with absence of choices to go with for the patient.. The other limitation is that , the informed consent has a cultuirl cross reference in functioning also.. As a result, it may not fit perfectly in the context of certain societies or cultures. The cultural difference is experienced differently in different competitions as Arab, US, UK, and India etc. Even in absence of such differences, delegation of decisions by other members and relatives are seen. (Bayne, 1998) The ethical drive behind concept of patient consent is the need to provide the patient with adequate information about all aspects of their choice. These information’s involves involve the explanation and detailing of benefits and risk of treatment and alternative treatment and also the option and consequence of no treatment. Thus it demands a active participation of professional and participant in obtaining and executing the consent. The health care provider is expected to provide explanation without much medical jargon in a way that does not increase patient’s anxiety. Patients are to be encouraged to ask questions and their understanding should be checked with the explanation of the information to be in a form to suit the patient’s language, level of maturity and competence. The patient should be able to weigh the relevant factors in order to conclude to a balance view and finally make a decision. Thus it operates the ethical drive towards attaining the essential right of patient is informed consent as every individual has the right to receive information about the availability of health services, about one’s own condition and about relevant treatment strategies. (Berg,2001) When, most of times the obtaining of consent is essential there are exceptions as simple and emergency. The simple procedures as blood test and other simple procedures are supposed to be understood by all and doesn’t requires explanation or in emergency – life threatening situation, a situation that requires immediate medical intervention. That would otherwise leads to serious complication or death. Even them consent has to be taken from relatives or care takers. Also these conditions includes conditions that doesn’t need explanation as reflex testing or listening to heartbeat with a stethoscope ,When a patient cannot give informed consent due to unconsciousness or mental disability, The consent is usually informal but in serious medical treatment formally consent. The formal consent involves signing of legal document. Usually for the treatment of sterilizations, hysterectomy, breast cancer, prostate cancer, gynecological cancers, psychosurgery, and electroconvulsive therapy formal, consent has to be taken after implying the effects and alternatives. (Deber etal,, 1996). In nutshell the health care providers has to follows three crucial step of discussing the protocol or future course with the subject, then getting a duly signed form followed by abeyance from performance of onconsented therapy for unconscious patients. (Habiba ,2001) Informed consent for research: The main difference ,between a medical practice and research is that when practice is the intervention that’s solo aim is to provide well being to people, research is entirely different in that it cannot predict a 100% success and it includes activities as testing a hypothesis and the results are never predictable. when discussing the informed consesnt in research activities, three basic things describe the underlying ethical principle , namely the , autonomy, beneficence and justice. While autonomy means participants freedom to accept aor reject or determine their own rights, . Beneficence becomes the work of the health care providers to act and take steps , keeping in mind the best interest of the research subject and Justice on the other hand is basic need of research subject solicitation. (Courtes ,1999) Thus the Informed Consent takes its roots from the main concept, autonomy – that denotes a person’s right to make a free and informed choice about whether to participate, not participate, or withdraw from a research study. Autonomy is based on the fundamental principle of respect for persons, with no binding obligations to participate or being prevented from participating in a research study that involves risk. Thus the informed consent basically is expected to be obtained by the researcher after explaining the potential risk(s) and the participant must be given the freedom to decide freely whether or not to enter the study. In circumstances where the participant is in a condition when patient is not in a position to exercise autonomy diminishes as in the state of the person being unconscious or unable to make decisions or athe subject being a small child then researcher is expected to obtain consent from the next of kin, guardian or health care surrogate. This is a common feature when reserches are carried out in a population of critically ill patient population.( Haddad & Vernarec ,2001) From the above description sit is well understandable that informed consent here stands for the individual’s decision making capacity , that he can apply on provision with choices and unforced by inducement or coercion it is on ethical base that researcher has to inform the participants of the nature and purpose of the research study and also meke them understand the procedures that are to be followed in the research study. Also ethically a researcher is bound to describe any drug or instrument planned to be used and also is expected of him to provide any foreseen discomfort or risk. the ethical principle and also the law demands that it is mandatory for the researcher to inform the subject that they can withdraw from the at any point of time without any consequence. thus the entire principle is based on the mutual trust and faith, that is what the ethical principle about. .. (Kerridge & Lowe, 1997) Thus Informed consent is expected from the study both on r ethical and legal grounds.. The American Nurses Association's Ethical Principles in the Conduct, Dissemination, and Implementation of Nursing Research explains that investigator are expected to respect the participants autonomy decide whether to participate in the research and if yes to what extent and how long.. Legally if not for all the legal body expects the obtaining of consent from the participant atlest for researches involving federal funding . And unlike medical treatment, the written statement is expected from the participant for all researches under the federal guidelines (Code of Federal Regulations), but as exception the written consent is not required only if the when the research activities , involving human subjects falls under any of these categories, reserches that are conducted in established education setting, educational test, or it involves non invasive techniques as survey or interviews, observation, or if it is a research with minimal risk etc.( U.S. National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report, 1978) (American Association of Critical-Care Nurses, 1999) Here the Nurses as health care providers are not expected to cooperate with the researcher if they are concerned about the ethical concerns. They are expected to play a still farther role of bringing ethical concerns to the attention of the participant/ patients orv to others who can assist the patient and review the appropriateness of the research activity. (Helen Aveyard, 2002) When health provider is unable to obtain patient’s consent? From the above study it is quite obvious that any medical treatment or research cannot be carried out without the participants consent orally in some instances and in written format in many instances. With the above mentioned exceptions. If the participant is cognitively not in a position to give consent then it has to be obtained from the relatives or care givers. Without which a heavy legal implication or Battery is to be faced by the healthcare provider. In the absence of any relatives or others, the consent has to b e obtained from the state authority, who can cross check the seriousness with another health provider before giving the consent. (Smith,1994) Role of nurses: Among the professional, usually the nurse’s encounter ethical dilemmas in their practice and often needs some guidance in making relevant patient-care decisions. For them the usual reference is Nursing theory that is believed to be the best source of guidance. The importance of nurses, to definitely obtain prior consent for nursing care procedures is explained and discussed in in various nursing policy documents. Nurses are thus expected to understand the legal and ethical rationale behind the principles of informed consent , first and thaen to effectively apply those principles appropriately to the particular context of nursing care..( Jan Florin etal.,2006). Apart other me,mbers of the medical fraternity, nurses arec also the main group who are at the risk of violating the patients autonomy on daily basis of work so literature stress their need to get consent as regular practice. Thus Informed consent is not alone a set property of surgical or research procedures but is also expected to be obtained prior to nursing care procedures, when ever the whenever patient’s autonomy is under dissection. Nurses are thus expected to d not be mechanistic in decising but should act keeping in mind the needs of individual patients. (Johnstone, 2004) Conclusion: Thus the concept of informed consent is a word in the same vein as autonomy and in the notion and it is a expression of the underlying base that every t individuals have a right to control their medical care and research participation .Thus this principle is found to be binded by both ethical and a legal grounds . Thus the doctrine of informed consent has evolved from with its roots to be the ethical theory and branches as law .. In this for the nurses are expected to act according to legal and ethical rationale that guides the principles of informed consent .and practised accordingly. References: 1. Beauchamp TL, Childress JF. Principles of Biomedical Ethics, Third Edition. New York: Oxford University Press, 1989:1–470. 2. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press, 1986:1–392. 3. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Postgrad Med 2002;48:206-8 4. Arnold T. (2002), The informed consent doctrine, New Jersey Medicine, 99(4): 24-31. 5. Barer D. (1997), Respect for autonomy may conflict with principle of beneficence, BMJ, 315: 254. 6. Bayne R. (1998), Considering patient autonomy, JAMC, 159(8):919-920. 7. Berg JW, Applebaum PS, Lidz CW et al. Informed Consent: Legal Theory and Clinical Practice. Oxford: Oxford University Press, 2001:1–340. 8. Deber R.B., Kraetschmer N. and Irvine J. (1996), What role do patients wish to play in treatment decision making?, Arch Intern Med, 156: 1414-1420. 9. Habiba M.A. (2001), Examining consent within the patient-doctor relationship, Journal of Medical Ethics, 26(3): 183-192. 10. Courtes A. (1999), Sharing decisions with patients: is the information good enough?, BMJ, 318(7179). 11. Haddad A. and Vernarec E. (2001), Ethics in action, RN, 64(5): 25-28. 12. Kerridge I. and Lowe M. (1997), Informed consent and shared decision making, Student BMJ, 5: 275-277. 13. U.S. National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research. Placeof-Publication: Publishername, 1978:1–18 . 14. American Association of Critical-Care Nurses. Standards for acute and critical care nursing practice. 1999. Available www.aacn.org Proposed international guidelines for biomedical research involving human subjects. Geneva, Council for International Organizations of Medical Sciences, 1982. 15. Helen Aveyard BSc MA PhD (2002) The requirement for informed consent prior to nursing care procedures , Journal of Advanced Nursing 37 (3), 243–249. 16. Smith J.A. (1994), Ethical considerations of giving patients choices, Hospital Topics, 72(3): 15-20. 17. Johnstone MJ 2004, Bioethics A nursing perspective 4th edn, Elsevier, Sydney. 18. Jan Florin MSN, RN, Anna Ehrenberg PhD, RN, Margareta Ehnfors PhD, RNT (2006) Patient participation in clinical decision-making in nursing: a comparative study of nurses' and patients' perceptions .Journal of Clinical Nursing 15 (12), 1498–1508. Read More