Informed Consent and Vulnerable Populations

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Informed consent is a legal doctrine or condition where a person has given permission based upon an approval and understanding of the facts and the resultant effects of such an action. In this case, the person involved needs to have all the relevant facts, be of sane mind, without mental impairment and of sound judgment at the time of consenting. Vulnerable populations refer to those populations that legitimately cannot be able to competently understand information and make valid or reasoned conclusions. These populations include people with mental disorders, children, and elderly, medically or chemically dependent, and drug abusers. It also includes those in institutions that bounds them and are not free to make decisions without coercion or undue influence and research with children or incapacitated people, that puts them in danger and offers no direct benefit to them must secure the consent of their parents or surrogates. Atkinson, J. (2006).

In medical terms, informed consent is the communication process that involves the patient and the doctor that results in the patient’s willfully agreeing to undergo particular medical intervention. The physician should disclose and humbly inform the patient matters concerning the patient’s health such as the patient’s diagnoses, the nature and reason of a recommended treatment or modus operandi. The patient or the person concerned should be made to understand with no ambiguity, the benefits and the risks associated with the proposed treatment, procedure, action and cost associated with such an operation. Should also understand whether there exists alternative, and the extents to which those alternatives can be compared to the proposed treatment. The risks and benefits of the alternative treatment procedure compared to the recommended treatment and the associated benefits or risks of not taking or taking that treatment procedure. Dunn LB, Nowrangi MA, Palmer BW, Jeste DV, & Saks ER.

In informed consent, the patient should be given a chance to ask all questions that concerns his or her health. This will the patient to draw out a better understanding about the treatment and its procedure, so as to make sound and informed decisions whether to accept or refuse a particular procedure or treatment. A patient’s competency is very important as it means that the patient can understand and explain the options, their implications on his or her health, and hence be able to give a logical reason why he or she has decided on a particular alternative instead of the others. This process is based on ethical and regal bases of patient independence. It gives the patient autonomy to make decisions about his or her health and medical conditions. There are four necessary components to an informed consent.

They are:-

The patient must be capable of making sound decisions
The physician or the doctor must clearly explain all the details concerning the treatment, tests, or procedures to be carried out, including benefits and risks associated with such an operation.
The patient must comprehend and acknowledge understanding of the relevant information and
The patient must voluntary and willfully give consent. That is without undue influence. Atkinson, J. (2006).

However there are certain circumstances where the concept of informed consent can be altered. These conditions include;-

An emergency case where medical attention is required immediately to save life or to prevent irreversible harm.
In circumstances where the patient is incompetent and cannot make sound decisions and hence cannot give permission.

In case of incompetent where the patient is a child or an incompetent adult, surrogate consent either from a guardian or a parent is necessary. The parent is only allowed to consent only if it is in the best interest of the child. Substitutes on the other hand may only consent on a treatment procedure that is of benefit to the patient. Fisher, JA.2006.

Patients in most cases have problems understanding the nature of their illness and how to manage that illness.The doctor has a duty to ensure that the patient understands all the concepts and hence able to make a valid conclusions. Patients on the other hand require honest and up-to-date information about their illness its possible outcomes, risks and benefits of various interferences. They also require to be helped to recognize and to choose their favorite treatment. In uncertain conditions, they require full and honest interpretations, with no omissions and disgusting remarks and an advice clearly supported by the best possible confirmation. Holmes-Rovner M, Wills CE.(2002).

Most physician and doctors however dislike the concept of informed consent and view it just like a mandatory legal procedure forced on them by the Consumer Protection Act. They argue that use of informed consent raise suspicion and suspect. Patients mistrust doctors who give several alternatives and tell the patient to choose one. Patients have total confidence in their doctors and hence expect them to take responsibility and not pass them to the patients. Most patients fail to understand most of the medical advices and hence assume doctors are capable of choosing the best treatment for them. Physicians also argue that informed consent wear down doctor and patient relationship in that being open and honest makes the patient nervous, unenthusiastic and upset especially in cases of lethal diseases. Holmes-Rovner M, Wills CE.(2002).

However the case, informed consent remains a good legal practice as nobody has authority over somebody’s body. Doctors and physicians should therefore have sympathy and be sensitive to the disturbing needs of the patient seeking consultation as Dr Franz put it “Even if a physician takes pains to use appropriate language, he may still lack empathy if he is not acutely sensitive to the emotional needs of the patient seeking consultation. Distraught by anxiety, fear and perhaps suspicion, the patient hears the sounds but not the meaning of words”. Physicians and doctors therefore should see it as their responsibility to guide a patient in understanding the condition of his or her medical condition and the best alternative to deal with the situation Solomon RC. (2006).

References

Atkinson, J. (2006) Private and Public Protection: Civil Mental Health Legislation, Edinburgh, Dunedin Academic Press.

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 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;40 (9 Suppl):V30-8.

Solomon RC., Ethical issues in medical malpractice, Emerg Med Clin North Am. 2006;24(3):733-47.

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Informed Consent and Vulnerable Populations

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