Informed consent and Role of Physician & Nurse

The right of people (including ‘mature minors’ and the very old) to make informed decision and formally consent or refuse to consent to treatment in health care contexts is now widely recognized as a basic ethical and legal precondition to conscientious medical practice’ and the conscientious provision of nursing care (Dicken & cook, 2004).


Of all the patients’ rights which might be claimed in a given health care context, however, none is perhaps more challenging to power, authority and sometimes the integrity of attending health professionals than the patient’s right to make informed choices about his/her care and treatment. The doctrine of informed consent, although having a profound ethical dimension, is essentially a legal doctrine developed partially out of recognition of patient’s right to self-determination and partially out of the nurse’s or other health professionals duty to give the patient information about proposed treatment so as to provide him or her with the opportunity of making an “informed” or “rational” choice as to whether to undergo the treatment (Beauchamp & Childress, 2001).

 In distinguishing the differences between a legal and moral approach to informed consent, Faden and Beauchamp (1986) explain that  legal law’s approach to informed consent ‘springs from pragmatic theory’, which focuses more on a physician/ nurses duty to disclose information to patients and not to injure them. By the contrast, moral philosophy’s approach to informed consent springs from a right to make an autonomous choice’. Similarly, the moral demand to respect autonomy is clearly the prime motivator of the health professional’s duty to disclose information, and the moral principle of non-maleficence is the prime motivator of the health professional’s duty not to harm or injure patients. Informed consent is: “The process of agreeing to take part in a study based on access to all relevant and easily digestible information about what participation means, in particular, in terms of harms and benefits.” (Parahoo, 2006).In this paper informed consent and ethical principlism, elements of an informed and valid consent and role of  physicians and mainly nurses in getting valid consent will critically discussed.

Informed consent also rests heavily on moral principles or ethical principlism both for its content and justification as an action guide. The principle of respect for person is the most important moral principle to justify getting the informed consent. The respect for Person has at least two ethical considerations.  The first is that the client/ patient who are undergoing elective treatment or surgery be treated as an autonomous being—a person who makes decisions or deliberates for her/himself about personal goals and then acts upon them. The autonomy which demands respects for patients as self- determining choosers, and justifies allowing them the option of accepting risks. The second is that those persons who are not able to make and carry out decisions for themselves, such as children or very older people or those who have a certain kind of mental disorder must be protected from coercion by others and from activities that harm them.  How much to protect them is related to the risk of harm and likelihood of benefit to them.  In medical treatment or, nursing intervention respect for person’ demands that participants enter into a medical or nursing care program voluntarily and with good information about the treatment goals. Another moral principle related to informed consent is beneficence which demands the maximization of patient wellbeing via consent processes (Johnstone, 2009).

In addition, justice and non-maleficence are an essential principles related to informed consent. The justice- which demands fairness and that, patients not be unduly or intolerably burdened by consent processes. The moral principle non-maleficence- which demands the protection of patients from battery, assault, trespass, exploitation and other harms that may result from inadequate or inappropriate consent processes (including the inadequate or inappropriate disclosure of information). Despite of autonomy is one of the important moral principles to getting consent however it should be noted that while autonomy is a value underlying the doctrine of informed consent it is not the value, nor an absolute value. As Faden and Beauchamp (1986) point out, at best autonomy is only a prima-face value, and to regard it as having overriding value would be both historically and culturally odd. This is not to say that autonomy does not have a significant place in a moral approach to informed consent. It merely means that it does not have a sole place, and can be justly restricted by other competing moral principles.

In addition, justification of informed consent especially for research purpose is associated with consequentialism.  The Consequentialist reasons are grounded in the conviction that the action with the best overall expected consequences is, generally, the action we ought to take. The primary consequentialist reason for adopting a principle of informed consent, then, is that doing so has the best expected consequences compared with alternatives. This view can be supported by a number of contentions, including the following:

   A) Obtaining subjects’ informed consent to participation tends to increase their   Adherence to the protocol, and hence the quality of the research and purposed treatment.

B) Since investigators are not always able to identify the risks their research or may pose to subjects, a process of informed consent provides the benefit of an additional layer of risk review tailored to the interests of the individual subject.

C) Affirming a principle of informed consent is likely to foster public trust of the research community; without such trust the research enterprise could not flourish.

This could be argued from both utilitarian and deontological perspectives. The utilitarian approach could be based on non-maleficence; society expects and trust health care professionals to be truthful and to respect individual persons to maintain good client/ professional relationship. Trust between the client and the professional is essential. Similarly, from deontological perspective, based on respect for personhood, people are entitled to practice autonomy. To be able to make rational decisions knowledge or information is an essential component. In legal basis of informed consent is not, in itself, a criminal offense it could result in a charge of criminal assault or a suit of negligence.  

When we discuss about an informed and valid consent, its components are standards of that consent is either informed or valid or not. It is generally recognized within medical or bioethics that disclosure, comprehension, voluntariness, competence, and consent itself from the analytical components concepts of informed consent (Faden & Beauchamp, 1986). Morally speaking, consent should be regarded fully informed; it must satisfy number of criteria, including those relating to information aspect and those relating to the giving consent itself. Beauchamp and Childress (2001) argues that for consent to be informed, there must be a disclosure of all relevant information (including benefits and risks) and patient must fully understand (comprehend) both the information which has been given and the implications of giving consent.  Pedroni and Pimple (2001) centered that three different standards for disclosing information have evolved in legal and bioethical contexts:

1) A professional practice standard, which requires disclosure only of the information that professionals typically provide;

2) A reasonable person standard, which requires disclosure of the information that a thoughtful layperson would consider relevant to such a decision; and

3) A subjective standard, which requires disclosure of the information considered to      be material to the decision by the specific person who must make

In addition, if one goal of informed consent is to ensure that patients have sufficient information to be able to determine which decision about their medical or nursing care compliance is most compatible with their individual interests and values, then a subjective standard of disclosure would seem to be the most appropriate. However, it is impossible for health professionals to know in advance what information each potential subject of a given care will take to be relevant. In practice, the best way to facilitate informed consent may be to design consent forms and other informational materials to satisfy a reasonable person standard, supplemented by conversations intended to elicit and answer any questions that are not otherwise addressed (Pedroni & Pimple, 2001). Secondly, the consent must be voluntarily given (i.e. the patient must be free of coercion or manipulation), and lastly the patient must be competent to consent (i.e. both rational and prudent). Even this requirement; however seems too very strong, virtually every decision is controlled to some extent to others. So if the concept of voluntariness is ever it have any application in real world, it will have to consist in substantially non-controlled decisions and actions rather than complete freedom.

Beauchamp and Faden (1986) point out “control is external through influences…. But not all influences are controlling.” The three controlling are identified and suggested, first of all, coercion is external always fully controlling and thus it is incompatible with informed consent, secondly, persuasion is never controlling and is always compatible with informed consent and finally, manipulation is double standard it helps client to change the attitude and other psychological and emotional components of a person through information therefore it is sometimes be compatible with informed consent sometimes not. It is most important that, informed consent is based upon the premise that a patient has the legal right to make his or her own decisions on medical treatment. The law presumes that an adult is competent to make a treatment choice, i.e., has the mental capacity to consent to or refuse treatment. However, minors generally do not have the legal right to consent. The issue of competency is, however, controversial and complicated. This is because there is no substantial agreement on the characteristics of a competent person, or on how competency should be measured. Nor is there any legal test of competency that commands general acceptance’ (Gert et al 1997). Decision Making Capacity addition to having adequate information, understanding, and freedom from controlling influences, informed consent requires that potential subjects have the capacity to make a decision about participation. That is, they must have the ability to determine whether participation or non-participation is most consistent with their authentic preferences, goals and values. As a precondition of decision making capacity, persons giving consent must have reasonably stable preferences, goals and values with which they genuinely identify, suggesting that a certain level of maturity is necessary (Pedroni & Pimple, 2001).

By the contrast, obtaining informed consent is depends on different situation. Some Exceptions to the obligation to obtain an informed consent include the following (Princeton insurance, 2009).

1.    Emergency—the patient presents with a life-threatening injury or illness requiring immediate attention and is unable to communicate and there is no time to obtain consent from another appropriate person. Only care that is medically necessary to remedy the emergency situation is permitted.

2.    Waiver by Patient—the patient may expressly waive the right to be informed of the risks and alternatives to treatment. A patient’s waiver of informed consent is treatment-specific; informed consent must be obtained for other proposed treatments or procedures.

3.    Therapeutic Privilege—disclosure of all known risks of treatment believed to cause the patient the risk of significant harm (typically psychological). The patient should be evaluated by a provider not otherwise involved in his/her care before invoking this exception. Permission from the patient to discuss the information with his or her family should be sought.

In clinical care or community setting the heart of nursing is the patient. We have discussed so many issues about informed consent so far. In this context nurses have much to contribute to the informed consent/decision making debate. It is also clear that nurses play a great role as an advocator for patients. Further, it is clear that the nursing profession needs too much greater attention to doctrine of informed consent and its moral implications for nurses- not least the duties it imposes on nurses to obtain patients informed consent to nursing care and nursing procedures, and the issues it raises concerning nursing paternalism (Johnstone, 2009).  It is perhaps important to emphasize that, although the doctrine of informed consent has traditionally been discussed primarily in regard to medical care and treatment, the underlying moral principles and values and moral requirements of this doctrine are apply equally to other kind of health profession including nursing care and procedures. This is because nursing is not so different or less exempt than any other health care professionals from the moral standards governing consent procedures, including the demands to (Adopted from Johnstone, 2009)

·         Disclose all relevant information necessary for an informed decision about purposed nursing cares and procedures.

·         To ensure the patient properly understand the information and implication of giving consent

·         Ensure that the consent is patients’ rational choice (nurses don not coerce or manipulate the patient into giving consent).

·         To ensure that patient is competent to make informed choice and if not, that the surrogate decision-making on the patients’ behalf.

The issue in patient nurse relationship during informed consent should be based on paternalistic unlike medical paternalism. However these issues both stand as fertile ground for further debate!

                   Conclusion

Informed consent is in modern medical and nursing profession is an essential component when delivering a care to a patient. Giving proper information to the patients about their medical and nursing care is health care professional’s legal and moral obligation. It is nurses’ duty to provide proper and adequate information to the patient about intervening treatment and other medical procedures. Morally providing information to the patient is beneficence and non-maleficence and treating a patient with fairness. However, certain type of  information should not be disclosed in particular situation like emergency situation, wavier by patient and therapeutic privilege. The main reason for informed consent is to treat patient is as a sovereign body and respect his right of self-determination and partially out of the nurse’s or other health professionals duty to give the patient information about proposed treatment so as to provide him or her with the opportunity of making an “informed” or “rational” choice as to whether to undergo the treatment. In a clinical setting nurse should establish a good therapeutic relation based on honesty which is only effective when there is assertiveness between patient and nurses.

                                          Work cited

1.    Beauchamp, T., L & Childress, j (2001) Principle of biomedical ethics (5^th Ed.). Oxford University press, New York

2.    Dicken, B & Cook, R (2004) Ethical and legal issues in reproductive health: dimensions of informed consent to treatment. International Journal of Gynecology and Obstetrics, vol. 85 No.3, pp. 309-14.

3.    Faden, R. R & Beauchamp, T., L (1986) A history and theory of informed consent. Oxford University Press, New York

4.    Gert, B., Culver, C & Clouser, K., D (1997) Bioethics: a return to fundamentals. Oxford University Press, New York

5.    Johnstone, M-j (2009) Bioethics: a nursing Perspective (5^th ed.) Churchill Livingstone, Elsevier

6.    Parahoo, K (2006) Nursing research: principles, process and issues (2nd edition), Basingstoke: Palgrave Macmillan.

7.    Pedroni, J.A., & Pimple, K.D. (2001). A brief introduction to informed consent in research with human subjects. Retrieved June 27, 2007, from poynter.indiana.edu/sas/res/ic.pdf.

8.    Princeton insurance (2005) Reducing risk: informed consent (revised in 2005). A Publication on HealthCare Risk Management from Princeton Insurance from http//www.pinsco.com/downloads/...risk/NJ.Informed.Consent.June05.pdf