Issues of patient consent

Within the ever-changing domain of hospital management practices, patient consent is an important issue, which if adhered to, can reap benefits for the hospital, writes Sheenu Jhawar

In eighteenth century England, a man brought a lawsuit against two doctors who were treating his fractured leg. Instead of continuing to monitor the healing process, which was proceeding without incident, they chose to re-break his leg and put it into an experimental device designed to straighten and lengthen the leg. The treatment was unsuccessful and the patient sued the physicians for malpractice, not just for using an investigational device, but also for doing so without his ’consent’.

In the United States, the concept of informed consent was not the subject of much legal action prior to the twentieth century. However, that changed in the early twentieth century because of a landmark case tried before Justice Benjamin Cardozo.

In this case, a woman had consented to an abdominal examination under anaesthesia, but had not consented to any operation. Inspite of this, the doctor removed a tumor and the patient sued him. Justice Cardozo’s opinion expressed what has become one of the most basic elements in the whole concept of informed consent development, that an individual has the right of bodily self-determination. Thus the concept of ’informed consent’ took shape and was further set in stone with the establishment of the Nuremberg Code 1947.

The tenets of this code have formed the basis for a number of other human rights philosophies developed over the years, among which is the famous Declaration of Helsinki, put forth by the World Medical Association in 1964. These requirements form the basis of the consent procedure as is established in many countries today.

Skeleton of voluntary informed consent include

• Optimum information so the patient can control his or her own body.
  
• The opportunity to weigh the risks of a procedure against the expected benefits.
• Avoidance of unnecessary pain and suffering.

Informed consent was initially developed as a concept to be used on healthcare research participants. However, in view of certain parameters like increasing patient awareness, patient choice, safeguarding against any possible legal implications, it is now generally considered to be an important component of all aspects of health care.

While such consent may be informal in day-to-day medical care, it becomes more important in case of a procedure/surgery being undertaken on the patient.

By being involved in the ‘consent procedure’, the patient not only becomes an active participant in what is happening ‘as a result’ to their bodies, but also gets aware of the various choices involved towards his/her better health outcome.

Ideally these choices, as well as the associated risks and benefits should be formally discussed and documented even during the OPD consultation sessions with the patients. This gives the patient ample time to decide and make a well-informed choice, without the added anxiety that he may feel on the day of the procedure.

This process should include explanation of the proposed decision/ procedure to the patient and presentation of reasonable alternatives to the proposed procedure.

The underlying point to remember is that this information be given in a non-medical lingo, so that the patient does not get intimidated. The patient-doctor relationship and the level of patient understanding play a vital role in this process. As a patient, facing the uncertainty of treatment or the possibility of a procedure can be a daunting task.

The blow can be made mush smoother, if the patient thoroughly understands what is happening to him, in layman terms. The attitude of the doctor, and treatment of the patient as an individual is very important to instill this faith.

Following points need to be remembered

• Explanation of risks and benefits of the proposed procedure as well as of the options. This section should also include probability of associated procedures with the said procedure, for example there might be a possibility of blood transfusion associated with a type of surgery and the patient needs to know this before hand.
• Explanation of risks and benefits associated with ‘no procedure being done’ or leaving the condition as it is. This part often gets neglected but is important in allowing the patient to genuinely weigh his options.
• Evaluation of the patient’s understanding of the risks and benefits involved.
• Taking into cognisance the patient choice.
• Signing and dating the consent form after documenting the entire dialogue with the patient. It is important to remember that the consent be taken by the doctor who will perform the procedure. If that’s not possible, then someone who is ‘capable’ of performing that particular procedure should ideally take the consent. This is to ensure that the patient’s queries and anxieties are answered in the most accurate and correct way possible.

In some cases the patient himself is not able to give consent. This may include the two obvious groups- paediatric patients and the mentally challenged patients, in which case consent is usually taken from the parents/guardians. The third group is that of the accident and emergency patients, where the onus usually lies with the doctor to act in the best interest of the patient and take what is known as the ‘implied consent’ of the patient.

In most other cases, however, it is clear that the patient himself is not competent to make his/her own decisions- patients can be under an unusual amount of stress during illness and can experience anxiety, fear, and depression. In other case, the patient might not be well educated/aware or confident enough to make a choice in his/her best interest. The concept of informed consent, however, still holds good.

As discussed earlier, there are three reasons for taking consent- to inform the patient because it is good practice, to involve the patient since he might already be aware and is interested in making a sound choice, and in the third case, to practice consent as a risk management technique. In this case the third reason stands its stead.

Even if the patient himself cannot make an informed choice, and neither can a surrogate decision maker; it is still important to convey the choices, the risks and benefits involved, and make sure that the patient atleast understands them and signs that understanding in a written format-called the consent form. Within the ever-changing sphere of hospital management practices, the issue of patient consent is also an important one and if adhered to, can provide benefits for the hospital.

The author is clinical auditor, Mid Stafford General Hospital, UK.

Email:sheenujhawar@yahoo.com