Introduction:
Bangladesh is a densely populated country where every citizen has the right to receive medical treatment. In view, policy-breaking issues on infringement of the right to surgical informed consent is a major problem. Herein, negligent disclosure on treatment, where the surgeons have not entrusted for any bodily surgery of the patients at public general hospitals and private nursing homes because they have been unable to fill up the Surgical Consent Form for their error-prone. By that, it bears a tormented and harmful impact on the patient’s life. But at present, there is a shortage of doctors, and there is a lack of complete treatment. Again, it is seen that the doctor asks the patient to fill the consent form for surgery, but both of them have to suffer in making the right decision as there is no proper policy in that form.[1] Because of the healthcare system in Bangladesh, a few disputes have been arising from the breaches of the contractual surgical policy that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign or contract the informed consent form.[2]
Besides, an important issue is that, when it comes to informed consent, patients are actively contracting with their surgeons about their physical surgery through medical bonds. But the patients must have reasonable information if they are to play a vital role in making decisions that reflect their involved appraisals and preferences, and the surgeons play a key role as advisors in this process.
Similarly, the policy implies what the government does not intend to do and reinforces the principles required for accomplishing sustainable goals. Despite this, there are no defined regulations or procedures regarding surgical consent between surgeon and patient. Only a few sections of the penal code, 1860 represent the matter. Also, few sections have much controversy regarding the permission procedure of surgical consent. As a result, both doctor and patient have been violating rules regarding surgical informed consent for their mutual understanding.[3]
Legal Terms and Policy Breaking Issues:
Again, where a surgeon is handcuffed and sent to jail custody for punishments under Section 304 of Bangladesh Penal Code,1860 on the death of a postoperative patient with consent, what is the valid reason and policy in this regard?
In that instance, surgery can be conducted without the guardian’s consent to preserve the patient’s life, and no action should be taken against the doctor if the patient dies. If the patient dies after the operation with the consent letter, many surgeons are either on bail or in jail custody as an accused under section 304. Consequently, it is a breach of law and a breakdown of contractual policy.[4]
Whereas Section 88 and Section 89 provide a defense to doctors or surgeons, but Section 304 of Penal Code, 1860 enunciated that punishment for culpable homicide not amounting to murder; it becomes a contrary part of the due sections.
Similarly, despite the exemption, no effective action has been taken to prevent the doctors from being charged under Section 88 and Section 89 of the Bangladesh Penal Code,1860. On the other hand, in the same state, a doctor is accused of the law-making procedure on culpability under Section 304 is in force and no sympathy has been expressed for the surgeons in prisons. The decision to repeal Section 304 of the Act should be included in the forthcoming policy – for the benefit of the state, the people, and the doctors.[5]
Also, Section 304-A states that causing death by negligence, if a person kills someone by acting recklessly or negligently and it is not culpable homicide, that person will be punished.[6] Besides, where the surgeon begins the operation, he takes the consent of the patients. At this situation, if the doctor cannot save the patient’s life by performing the procedure properly, not because of negligence, the surgeon is also regarded as convicted and sent to prison for their faulty work. Because of this, they are extremely underestimated.
Informed Consent Form (ICF):
The Informed Consent Form must contain information to allow the subject to make informed decisions about participation in clinical investigation. The process is two segments, Patient information sheet provides information regarding a Consent certificate, it is used to document consent and will be signed if the volunteer agrees to participate in a trial. Above all, individual decisions to participate must be voluntary and free from coercion or undue influence.
Reasons to take Informed Consent:
Informed consent: Ethical and legal obligation in a clinical trial, it is a mandatory process for clinical trials, there are various aspects of trial such as purpose, benefits and potential risks, alternatives of given procedure or intervention.
Before undergoing any therapy, a patient has the right to obtain all necessary information. Volunteers will receive all trial information via IC. The informed consent method protects human volunteers in clinical trials. This ensures that participants have all the information they need to make an informed decision about participating in a study.
Proper informed consent provides freedom to potential subjects to say no without feeling guilty or fearing repercussions.
Basically, informed consent involves:
- Disclosure of Information
- Adequate comprehension, and
III. Voluntary decision to participate
Failure to Secure Informed Consent- Necessary Elements of Proof:
Developed into something like negligence theory, with the duty of providers to obtain informed consent and reasonable patient standard are four elements. Firstly, Patient facts were not disclosed by healthcare professionals. Secondly, the patient agreed to treatment without knowing why. Thirdly, knowledgeable patients would not have consented in identical situations. Finally, the treatment in question produced a little damage.
Recommendations:
To the point, several inversions to the requirement for informed consent are included. Firstly, Informed Consent is an ethical commitment that surgeons must fulfill in patient-surgeon relationships with a moral responsibility to identify the best treatments for each patient. Then, a discussion with patients of the hoped-for benefits and the potential risks. By that, the patient must be compatible to make a voluntary decision about whether to go through the procedure or intervention as to the surgery.
Secondly, before receiving any therapy, a patient has the right to obtain all necessary information and ask questions. Therefore, Participation must be voluntary and free of compulsion or improper influence.
Thirdly, Trial-related information can be provided in oral and written form, and it must be in understandable language to mean, the information presented to potential subjects is in a language and at consistency, the subjects can understand scientific terminology and medical terms.
The consent process may not include exculpatory language through which a subject is made to waive or appear to waive any of his or her legal rights or to release or appear to release the investigator, the sponsor, the institution, or its agents from liability for negligence.[7]
Surgery Related Case Laws:
In some cases, even when no doctor-patient relationship exists, courts impose duties on doctors. In the words of the Supreme Court “every doctor, at the governmental hospital or elsewhere, has a professional obligation to extend his services with due expertise for protecting life”[8] and even if death results from a physician’s or surgeon’s error of judgment or mistake, the physician or surgeon will not be held responsible.
In the same way, under section 105 of the Evidence Act, 1872, the burden of proof is on the accused to prove his defense under this section.[9] In discharging his burden, the accused should prove that the patient on whom he operated knows the risk he was running in consenting to the operation by a kabiraj, uneducated in the practice of surgery. “Merely because the operation did not succeed, the doctor cannot be said to be negligent” and the appeal of the doctor was allowed.[10]
Conclusion:
A policy is that circumferences what a government is going to do and what it can achieve for the society as a whole regarding the policymaking. Though the policies and laws are interrelated with any legislation, the two terms are used for different purposes. However, Informed consent can be violated, for example, failure to give informed consent occurs when a surgeon gives the patient a written and oral consent form but fails to explain the medical ethical conditions or legal jargon the form refers to, or the risk of complexity or death from a mode.
Provided that, the patient breaches informed consent, then a medical professional fails to obtain informed consent from their patient, and subsequent care results in injury, damage, or harm, there may be grounds to bring a swear to something for medical negligence. Thus, the government bodies reconsideration that the policy of contractual surgery must be reformatted, and related to non-dynamic policies should be formulated from a healthy and humane point of view, not in a crisis. In other words, policies are only documents and not laws, but these policies can lead to new laws.
Writer: Osman Goni Emon, LL.B (Hon’s), 3rd Year, Department of Law, Daffodil International University.
Endnote:
[1] Gabay, G., Bokek-Cohen, ‘Y. Infringement of the right to surgical informed consent: negligent disclosure and its impact on patient trust in surgeons at public general hospitals – the voice of the patient’ (2019) BMC Med Ethics 20, 77 <https://doi.org/10.1186/s12910-019-0407-5> accessed 18 November 2021
[2] ibid
[3] The penal code, 1860
[4] ibid, Sec. 304
[5] ibid, Sec. 88 & Sec. 89
[6] ibid, Sec. 304A
[7] Exculpatory Language in Informed Consent Documents: Examples of Acceptable and Unacceptable Language (OPRR Letter, 1996),<https://www.hhs.gov/ohrp/regulations-and-policy/guidance/exculpatory-language-in-informed-consent-documents/index.html> accessed 11 November 2021
[8] Parmanand Kataria vs. Union of India [1989] AIR SC 2039
[9] The Evidence Act, 1872
[10] Dr. (Smt) Kumud Garg v. Raja Bhatia [2004] CPJ [369]