“Every human being of adult years and sound mind
has a right to determine what shall be done with his own body;
and a surgeon who performs an operation without his patient’s consent
commits an assault, for which he is liable in damages”.
Justice Benjamin Cardozo, 19149
The Hippocratic Oath has granted doctors the right to act in their patients' best interests, but this has conflicted the twentieth-century trend that allows people to be in charge of their own health and refuse unneeded medical intervention.8
Withholding thorough information from the patient and providing inappropriate, inadequate consent are important elements of various Medical Consumer litigations. Under the Consumer Protection Act, the patient's right to freedom during treatment has been the subject of several court rulings. Therefore, it is essential that a doctor obtain correct, legitimate consent from his patients. 8
Modern medical practice focuses on informed consent. The conversation between the patient and the healthcare professional leads to the process of informed consent. One of the four key principles of biomedical ethics outlined by Beauchamp and Childress works to defend patients' autonomy.1
Respectful communication is necessary for sharing knowledge, seeking for, and promoting autonomous decision-making. The concept of informed consent enables patients to safeguard themselves against unwarranted procedures. It enables individuals to assume control over their own life.2
An ethical and legal need is to obtain a proper informed consent. The doctor has a moral obligation to uphold patients' human dignity while seeking informed consent.3
The South African Constitution includes the Bill of Rights that affirms the following in section 12 ( 2b ):”Everyone has the right to bodily and psychological integrity, which includes the right to the security in and control over their body4”. National Health Act5, then, states in its section 7(1) that “A health service may not be provided to a user without the user’s informed consent”.
The patients relate to both the distinctive characteristics of the patients (such maturity and education) and how these have been influenced by their socioeconomic background and environment. These people are dealt daily by the clinicians. occasionally there may be communication hurdles that cause misconceptions, or the patient could not remember the medical treatment, etc. Given this situation, it is important to realise that informed consent is a myth and that doctors should instead use their knowledge to make decisions and act in patients' best interests.22
Studies conducted to gauge patients' comprehension of the informed consent procedure have typically reached the conclusion that it is exceedingly challenging to gauge patients' understanding.8,10,22
These challenges came up as well in this study when trying to figure out how to gauge acceptable understanding. It is difficult to assess the idea of informed consent comprehension.
Despite the general lack of comprehension of the informed consent process, one conclusion emerged when the level of understanding of the process was correlated with patient characteristics. Patients with more formal education generally performed better in clinical trials.10,22,26
This study also found similar result on the meaning attached to signing of consent form for operation. The more educated a patient, the more likely he/she was to link informed consent to the understanding of the procedure (P=0.0006). In fact, all patients having a diploma or a degree made the said connection.
In the same vein, a review of studies on informed consent by Sugarman and McCrory supported these findings. After analysis of 99 articles, covering a wide range of aspects of informed consent, they concluded that there was lower understanding of information on informed consent among older persons and those with fewer years of education42. Verastegui also made the same observation.24
In contrast, this study did not find a correlation between understanding of informed consent process and age (P=0.287).
Moreover, contrary to findings in this study, Minnies et al. in Cape Town, had a higher percentage of patients with adequate understanding. Seventy five percent of the sample had a high level of understanding of informed consent process in a vaccine trial.22 Despite the fact that the context of the study was different, these findings are likely explained by the observation made earlier. The fact that researchers spent a lot of money in the training of field workers whose job is to explain the trial to patients until they understand it well enough to participate.
This is why their suggestion that patients with a minimum of grade 7 be considered for research studies in order to reach an adequate level of understanding of the process of informed consent is not applicable in clinical practice. It is not feasible in clinical environment where every patient has to give consent for whatever procedure he/she has to undergo to have a required minimum education level.
Ideally, the patient-physician relationship should be like research subject-investigator because patients need as much information and understanding as the research subjects do before signing the consent form. Informed consent should not be different in clinical practice and research trials.43
This study has found that contrary to other studies, the education level did not determine the ability for patients to recall the risks associated with the procedures (P= 0.672) or the indication of the procedure. The most likely assumption for this situation is that healthcare workers did not systematically mention the risks of the operation and other elements of a valid consent to patients.
Clegg-Lamptey and Hodasi support this assumption. They observed that a possible explanation for poor patients understanding could be that consenting medical staff had less communication skills, did not have the proper knowledge or experience or did not make time to speak properly to patients.15
Berman et al. made similar findings. They stated that few guidelines existed describing what surgeons should discuss. Younger and private surgeons discussed complications more often than older surgeons and those in academic practice.16
This is in line with findings of this study where only 13% of patients could recall risks related to the procedure.
Shenker et al. noticed in USA that they were no guidelines for practitioners determining pre- operative requirements of a valid truly informed consent. Hence, the emphasis on the statement that informed consent is ethically required of healthcare practitioners in their relationship with all patients, and should not be viewed as a luxury.44 This is why Straus et al. stressed that informed consent is a process requiring a dialogue. Through this communication, physicians have a responsibility to ensure that their patients know even the regulations related to the consent process.30
Concerning the quality of information given to patients, this study found that patients who had the consent process explained by the doctor had a higher chance of having the information checked (P=0.014).Which shows that the consenting healthcare worker had an important role to play. Minnies et al. as mentioned earlier, made similar findings. Experienced nurses obtained higher percentage of understanding among research subjects than those with less experience.22
Worsening the situation of lack of understanding was the fact that consent forms were only in English in a hospital where 75% of patients got their procedure further explained in their mother tongue. This was a huge drawback from the patient’s perspective. Besides, the form is not clearly understandable from a nonprofessional standpoint.
Hill et al. went even further on mentioning difficulties in translating medical terminologies into lay and local languages. They wondered how someone would understand an ethical concept that he or she hardly uses in everyday life to communicate46. It is obvious that concepts like “risks” “benefits”, “random” were not easily understood22.
Another criteria is that most of the times patients and relatives blindly sign the consent form without reading it. An analysis of consent forms used in public or private hospitals in South Africa and patients‟ interpretation could be a subject of another research study.
Discussing the impact of language barriers on informed consent, Hersnt et al. in USA, found that even in a hospital with onsite interpreters‟ service, vulnerable patients, those with limited English proficiency, had in their file poor documentation to prove that informed consent was properly obtained prior to procedures. Yet, this was why this service has been made available in the first place.
Furthermore, it is important to consider the workload in public hospital as one of the contributing factors to lack of interaction between surgeons and patients. This is exactly what Humayn et al. have found: ”Poor adherence to the principle of informed consent on the part of doctors in public hospitals in Pakistan.”12
However, when Danish molecular scientists from a private biopharmaceutical business and molecular biologists from a university research unit compared ethical considerations, they came to similar conclusions. When on the job, molecular biologists at university research units did not often discuss ethical issues, whereas molecular scientists at private biopharmaceutical companies made ethical evaluation a top priority out of concern for the interests of customers and investors. This demonstrates that the gap between the commercial and public sectors still exists even with an acceptable workload.
In a case that Lupton described, the English courts had ruled that failing to provide the patient with sufficient information about an operation constituted negligence in and of itself. Therefore, it would be challenging to avoid allegations of carelessness if a doctor failed to provide sufficient information at the time of gaining consent. 18
Given this context, it is presumed that patients' lack of knowledge of the informed consent process is a result of doctors' reduced attempts to give them the information they require. It emphasises how important it is for patients to properly comprehend the informed consent procedure.