Ethical Requirement for an Informed Consent

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It has been an accepted practice in hospitals and medical clinics that sick patients will be treated by doctors based on the symptoms being manifested If the sickness is just common colds, the doctor will examine the throat possibly for tonsillitis and then medicines will be prescribed. In instances that the doctor cannot identify the ailment, laboratory analysis of sputum, urine, and blood will be required. This is being done to narrow down the possibility of an ailment that the doctor has in mind but not yet certain. Normally, the doctor will not explain in detail the reasons for the laboratory analysis and why you have to spend extra money.

When the laboratory analysis is completed and the doctor has the result, he will just read it and then he will tell you what is the ailment about. Unless you inquire further, no detailed explanation to prove his findings will be done and if the doctor heed to the request, the explanation is done in a manner that layman cannot fully grasp and with a sense of time pressure as if telling the patient that the doctor got so many things to do and the patient should better stop asking questions and have to go.

Analyzing the scenario that was presented, the doctor is legally liable for his actions due to the fact that he ordered the conduct of sample collection and laboratory analysis without the informed consent of the patient.

The patient has the right to informed consent and asks for the reason as to the need for laboratory analysis. The right to informed consent is explicitly guaranteed by the Fourteenth Amendment of the U.S. Constitution which says “ No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property,…” (krusch.com, “The Fourteenth…). Informed consent is related to provision for life, liberty and property. Informed consent is a voluntary decision by a competent and independent individual that is devoid of coercion to accept or reject some proposed action made by a medical practitioner with the end in view of giving a solution to his/her (patient) medical problems.

In our case, the patient was given no choice as the doctor ordered the laboratory analysis without proper consultation from the patient as to the wisdom of doing it. Under the informed consent consideration, the patient has the right to be informed of the proposed treatment or care and give the consent or approval to the health care professional before any treatment or activity can begin. (Sakellari, Abstract).

The patient’s right to choose the treatment or care alternative to be given to him or her is termed as “autonomy” (Patient’s autonomy, 2^nd par.). With informed consent, and definition of autonomy, respect for patient’s autonomy should always be a prime consideration. In the lights of informed consent and autonomy, it is safe to assume that ethical requirements exist and should be completely satisfied to come up with a wise decision. It is also safe to theorize that satisfying the ethical requirement of informed consent is not a sufficient measure to protect patient’s autonomy. This paper aims to justify this theory.

The most important ethical requirement for getting informed consent is the full comprehension of the patient regarding the details of the proposed action to cure his ailment. The right of the patient to be involved in deciding what measure or actions is best for his health must be respected by the health professionals. The latter must ensure that people are not treated with measures contrary to their will and desire (Sakellari, Abstract).

The author continued by saying that contemporary standards in bioethics tend to offer respect for patients being treated by health professionals. This according to the author increases also in the same dimension the self-respect of health professionals as well. As a human being and as a consumer of health-related services every health care patient has their specific rights in relation to the delivery of health care services.

Sakellari stressed that health care professionals in their role as providers of services related to patients’ care should respect those rights. The President’s Commission for the study of Ethical Problems in Biomedical and Behavioral Research urges nurses as health care professionals to consider their duty to promote and support the health of the clients and to act as advocates for patient’s rights. A nurse according to Sakellari should do to his patients what should be done to himself under the same situation of losing the power of agency.

Patients’ autonomy and informed consent are among the contemporary bioethical standards that should be given emphasis according to Sakellari. This view of Sakellari is supported by the article from emedicinehealth.com, entitled “Informed Consent”.

Among other things related to informed consent and autonomy, the website stressed the following: “Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo such treatment or test. This process of understanding the risks and benefits of treatment is known as informed consent. It is based on the moral and legal premise of patient autonomy: You as the patient have the right to make decisions about your own health and medical conditions” (1^st par.) The patient must give voluntary informed consent as regard treatment and all medical tests procedures associated with the treatment. The website added that the legal term for failing to get informed consent prior to performing the test on the patient is called “battery or a form of assault” (2^nd par.).

The website added that for many types of activities like a physical exam with the doctor, the patient’s willingness to undergo such an exam is considered as implied consent. For other evasive tests which by nature will involve significant risks, the patient will be asked to sign an explicit or written consent.

The website exposed that there are cases where informed consent is not needed before any activity related to curing of the ailment or injury is needed and this is in cases of emergencies. In these cases wherein the patient has no capacity to decide what treatment to be done, medical care is done immediately to prevent serious and irreversible health conditions. Another scenario according to the website is in cases where incompetence to decide is being exhibited by the guardian or someone who brought the injured to the hospital. The medical care has to be done in the absence of informed consent to prevent serious irreversible damages to vital organs.

The website reported that there are four considerations for informed consent and they are as follows:

“You must have the capacity (or ability) to make the decision.
The medical provider must disclose information on the treatment, test, or procedure in the question, including the expected benefits and risks, and the likelihood (or probability) that the benefits and risks will occur.
You must comprehend the relevant information.
You must voluntarily grant consent, without coercion or duress” (Components of Informed Consent, 1^st par.)

Based on these considerations, the patient must be in the right frame of mind during the time that the pros and cons of the treatments (disclosure under medical terms) of health care proposal is being discussed. The right frame of mind would suggest that one should not be drowsy or sleepy or under the influence of spirit or drug. Moreover, the patient should not be emotionally depressed during the deliberation. If the health care professional notice this mental condition on the patient or his representative, the deliberation should be called off and postpone until such time that emotions and depressed feeling are gone. This is to ensure that thorough understanding of disclosure or the alternatives and the gains and possible losses are well taken before the decision is made.

For routine tests like blood tests, the website reported that consent, in this case, is implied. However, for invasive tests or alternatives where significant risk is involved, the patient should be given a written consent form and explanation in the patient’s native language is required. According to the website, the following components should be well explained and must be included in the written consent agreement. In cases that they will not be offered, the patient must insist the doctor the wisdom of providing them:

“An explanation of the medical condition that warrants the test, procedure, or treatment
An explanation of the purpose and benefits of the proposed test, procedure, or treatment
An explanation or description of the proposed test, procedure, or treatment, including possible complications or adverse events
A description of alternative treatments, procedures, or tests, if any, and their relative benefits and risks
A discussion of the consequences of not accepting the test, procedure, or treatment” (Documentation of Consent, 3^rd par.)

The consent form, stressed by the website should be signed and dated by the attending physician and the patient who must ask for a copy of the document. The informed consent and autonomy in a setting of a hospital and a test subject who is still young and appointed the parents as signatory follow the same procedure as was discussed in the previous case setting. The major ethical consideration in getting informed consent should always be the ability and capacity of the individual to understand the disclosure of the physician in charge of the project.

A perfect model of informed consent solicitation can be observed in the practice of hospitals notably St. Jude’s Research Hospital in the USA. The website stjude.org advices that “Informed consent is an interactive process between you, your child, and the medical team (What is informed consent, 1^st par.). The hospital provided the following steps to follow in order to get genuine informed consent from patients. You will be briefed on the following:

The purposes and description of the study
The procedures to be performed (you will be told about any procedures or medicines that are investigational)
The expected length of the study
The benefits and any possible risks or discomforts
The alternative treatments that are possible
The hospital’s respect for your privacy
Whom to contact for answers to questions
The voluntary nature of participating in a study (What is informed consent? 1^st par.)

The website further revealed that the doctors of St. Jude involved in the study will obtain permission from both parents and guardian for the child’s participation in the research. The procedure of the study will be explained as well to the children aged 7 years or older in a language style they will fully comprehend and they will be encouraged for queries to ensure they fully understand. After conference with the doctor the child will be asked for the acceptance of his part in the research study.

It doesn’t stop there, reported by the website, informed consent will be a continuous process. The parents and child can ask questions before, during and after the study and their concerns will be promptly addressed. It can be noticed that the procedure is really geared for the mutual understanding of both parties and transparency is very evident. This practice will result to a genuine informed consent as both parties trust each other.

The country of Canada approach the ethical issues on informed consent and autonomy as the US did with few additional requirements. The Health Canada advises the following:

“ Information letters and consent forms must be presented on institutional / departmental letterhead.
The level of language used should be appropriate to the age and comprehension / reading level of the subject population, generally at approximately a grade 6 – 8 reading level:
- Avoid the use of legalistic phrases.
- Volumes, weights, etc. should be expressed in meaningful scales as well as scientific measurements (e.g., blood draws in numbers of teaspoonfuls or proportion of a Canadian Blood Services donation)” (General Points, 1^st par.)

The website further advised that in cases where parent or guardian consent is needed, the form should explicitly imply the need and the name of the minor and guardian capacity should be recorded. If an assent (or non-concurrence) is to be sought from a minor, the form should appropriately reflect it and it should be expressed explicitly in the form. Furthermore, the assent should be written in age-related language.

According to the website, the other information required are the following: General information as to name and address of the researcher and that of the invited, what will participant do, the risks and benefits, compensation and expenses, who will access the information generated from the research, the degree of confidentiality of the result so as not the expose the identity of participants, and contact information of the investigators. Furthermore, as reported by the website, a prohibition statement in the consent form is needed to the effect as follows:

“It should not be stated to the participant that a Research Ethics Board has approved the study, since this may appear to offer a guarantee of safety. In fact, approval means only that the Committee considers the risks to fall within a scale of risks which a reasonable participant may be invited to accept, and that the risk-to-benefit (or risk-to-knowledge) ratio of the study appears favourable.
No clause or language should be used to excuse or appear to excuse investigators or other persons or institutions involved from liability for their negligence or other fault”. (Consent Form Don’ts, 1^st par.)

Solicitation of informed consent by biomedical companies in developing countries in order to test their new products on human volunteers reveal a very disturbing trend. In a situation of a poor country where people are practically without access to medical treatment and health care, the only hope to be treated is to volunteer as research subject. Klip and Moreno claimed that in this scenario, the subjects have no power to question the treatment alternatives nor the issue of autonomy (Critical review if informed consent, Abstract). Most of the volunteer subjects were illiterate and don’t know how to read and write.

Differences in culture mean also great differences and wide discrepancy in access to power. The authors claimed that in this situation, the full understanding of the choices is ignored and the subjects were encouraged to sign as many as 8 pages documents the content of which are completely not understandable as the majority cannot read and write. The verbal explanation of those in charge as to benefit and risks was likewise questionable as most of the volunteers cannot understand English.

Nevertheless, the research companies were able to obtain the informed consent. In this case, the patient’s autonomy was also violated as they were offered no choice Analyzing the procedure done to get the informed consent, definitely, the action of the new medicine was explained but surely, the side-effects were neglected.

According to the authors, the biomedical researchers intentionally did not tackle the issue of side-effects of the drug as it may cause failure to get the informed consent. It could have been much better if a knowledgeable person was chosen to represent them so that the resulting informed consent will be really genuine. In addition, appointing a knowledgeable representative will not result to ignoring the people’s autonomy as a group. This is a living proof that not all informed consent can guarantee the autonomy of the patient.

The issue of clear comprehension of a patient as to his choices of medical intervention is very important for informed consent acquisition. Two researchers conducted a study with the aim of knowing whether the informed consent of elderly people confined in the hospital are really genuine. Auerswald et al. reported that out of 173 subjects suffering from delirium, 33 or 19% had no documents attesting that informed consent was issued by them to the hospital and doctor in charge (The Informed Consent Process, Abstract). Furthermore, the authors discovered that there were no assessments of competency and capacity to decide made.

Cognitive capacity assessments were done in 7 or 4% of the cases. Discussion of potential risks associated with the treatments being done were made to surrogates in 61 or 35% of the cases. Only 47% of the cases use surrogates despite the fact that cognition capability of the patients is very low. The author continue by saying that despite of the fact that patients are suffering from delirium, 4% of the them were claimed by surrogates with normal mental status. This only proves that what really happen is different from the theory as far as ethical informed consent is concerned.

The ethical concept of religiously implementing the treatment to patients according to plan including the fine tuning as situation demand for it is also an important concern. Dickens and Cook emphasize the importance of exercising appropriate skills in implementing procedures according to plan and informing the patient of the choices they have to implement. They remind health care practitioners that aside from ethical considerations, legal liability is also upon them in cases of negligence. Lastly, the authors reminded health professionals that informed consent is a continues process and not only an event or a signed form.

It is now an accepted fact that informed consent can only be classified as genuine if the patient and the health care professional were both successful in communicating with each other the risks and benefits that a particular plan of medical care can give.

A lasting informed consent is one that is based on a concrete foundation of trust. Mutual trust is needed before an informed consent can be arrived at. The patient will opt for an assent if he is not certain of the expertise the medical care practitioner can give. Common sense will tell us that a patient will lose more in the agreement than the medical care specialist if in the process something happen to his health. Untoward incidents happen and in the medical field, it is termed as negligence. This is the reason for the mounting cases of negligence and medical malpractice in our courts.

A written informed consent duly signed by the patient and the physician is a potent legal document which can withstand the rigors of legal battle. Documented informed consent also serve as guard to both parties that their responsibilities should not be neglected.

Informed consent as was learned from this research paper is a continuing process and does not end in both parties affixing their dated signatures. Affixing the signature is just the start of a grinding and challenging activities bothparties will implement in their search for victory against sickness and abnormalities. Offering yourself or your beloved son or daughter as guinea pigs for the sake of science is a great sacrifice. Mankind should be thankful to these courageous young and adult men and women who sacrificed themselves for the sake of relieving pain, sickness and miseries of terminally ill and hopeless patients. They barely sacrificed their future and their defense is only a piece of paper of informed consent.

It is now a common knowledge that not all signed informed consent documents were offered under the ideal circumstance as discussed in this paper. Still a number of unethical health care professionals abound as in the case of biomedical researchers recruiting volunteers willing toundergo testin g with their newly discovered drug out of ignorance of its side effects and arduous need for medical cure. There are still a number of health care professionals who perform their job just for the purpose of doing it ignoring the reality that people got only one dear life. Destroy a portion of that life by one’s negligence will ruin everything.

Careful study of the healthcare care proposal not letting blind corners to exist will mean honor for you as a health care professional and everlasting praise from the patient as he is absolutely right in signing the informed consent. In the end, you will get more endorsement from satisfied customers as you do your job of life saving with passion. If only 99% of all signed informed consent were real and achieved with full understanding that the benefit outscore the risks, and both parties know their responsibilities, then we can conclude that it will guarantee protection of patient autonomy.

Works Cited

Auerswald, K., Carpentier, P., and Inouye, S. “The Informed Consent Process in Older Patients Who Developed Delirium: A Critical Epidemiologic Study”. The American Journal of Medicine, November 1977, 103(5), pp.410-418.

Dickens, B and Cook, R. “Dimensions of informed consent to treatment”. International Journal of Gynecology and Obstetrics. 2004. 85(3), pp.309-314.

emedicinehealth. “Informed Consent”. 2008. Web.

Klip, D and Munoz, M. “Critical review of informed consent and autonomy in the context of biomedical research in developing countries”. Paper presented at VIII Annual Symposium on Biomedicine, Ethics and Society: “Rethinking Informed Consent: The limits of autonomy”, Sandhamn. 2006.

krusch. “The Fourteenth Amendment: First Amendment ll?”. 2008. Web.

Sakellari, E. “Patient’s autonomy and informed consent”. ICUS NURS Journal. 2003. Issue 13, pp.1-9.

stjude. “ What is Informed Consent?” 2008. Web.

hc-se. “Requirement: Informed Consent Documents”. Science and Research. 2007. Web.

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Ethical Requirement for an Informed Consent

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