Critical Review on Informed Consent

This study aims to determine the implementation of informed consent at the Sitti Khadijah I Muhammadiyah Mother and Child Hospital Makassar. This study was conducted using normative research methods. The results of this study concluded that informed consent had been carried out and used the form in accordance with the juridical review, but the filling had not appropriately done, and at the time of implementation there were still a few deficiencies.

inpatient and outpatient services, which often involve medical treatment to patients covering a variety of cases, which requires prior informed consent. The available forms and their implementation are the main reasons for the authors to examine the thesis entitled "Legal Analysis of Regulation of Minister of Health Number 290/MENKES/PER/III/2008 concerning Informed Consent at RSIA Sitti Khadijah I Muhammadiyah Makassar". This study aims to determine the implementation of informed consent at RSIA Sitti Khadijah I Muhammadiyah Makassar.

2) RESEARCH METHODS 2.1. Types and Nature of Research
The type of this research was normative legal research which was a legal research that studies written law from various aspects of theory, history, philosophy, comparison, structure, composition, scope, and material of general explanation consistency, and article by article. The type of research used to answer the problem and elaborate on the subjects that had been prepared in this study was a descriptive type, with an applied normative approach (applied law research) that was a legal research applying normative legal provisions directly to any particular legal event that occurs in society . 1

Population and Sample a. Population
All doctors who work at RSIA Sitti Khadijah I Muhammadiyah Makassar and patients who receive both elective and emergency cesarean section. b. Sample Doctors who are in charge of Emergency Services, Delivery Room Services, and Inpatient Services and patients treated in Emergency Services, Delivery Room Services, and Inpatient Services.

Data Collection
Data collection techniques are techniques for collecting data from one or several data sources that are determined. In a study, there are at least three types of data collection techniques, including: the study of documents or library materials, examinations or observations, and interviews (Soerjono Soekanto, 2006: 21). To obtain complete and relevant data, the data collection techniques used by the author were as follows: a. Field Study Data collection techniques in the field study were carried out through interviews. Interview is a way to obtain data by doing question and answer directly with the primary data source. b. Literature Review Literature study is a data collection technique using several literary books, legislations, documents and other written sources to obtain material related to the problem under study.

Processing and Data Analysis
The step taken after obtaining the data is to analyze the data. Data analysis has an important position in research to achieve research objectives. In terms of analyzing data, the authors used an interactive analysis model in the form of a cycle consisting of three main components, including: a. Data Reduction It was a process of selecting, focusing and simplifying the data. This process continued until the end of the research report. b. Data Display Presentation of data in the form of a description of a narrative that allowed conclusions to be made. Presentation of the data must refer to the formulation of the problem, so that the answers could be obtained from the problem under study. c. Conclusion Drawing Final conclusions would not occur until the data collection process ended, so it needed to be verified in order to be accountable. The informed consent form that was provided at RSIA Sitti Khadijah I Muhammadiyah Makassar took the form of a standard agreement whose form and contents had been determined by the Indonesian Medical Council (KKI), but there were slight differences in the witness section. The informed consent form used at RSIA Sitti Khadijah I Muhammadiyah Makassar was not uniform in the witness section, there were several forms that were still signed by 1 witness (only from the hospital) and there were also 2 witnesses (the hospital and the patient) which should be based on KKI. This was done to facilitate the filling and maintain compliance with the standards of an informed consent, so that it could be a strong evidence when a dispute arised.

3) RESULTS and DISCUSSION
The informed consent form available at RSIA Sitti Khadijah I Muhammadiyah Makassar contained: a. Header containing the hospital logo and name, form sheet code, patient identity (medical record number, name, date of birth, gender, age, and ward), statement of approval or rejection of medical action. b. Provision of information containing the name of the doctor implementing the action, the information provider, and the recipient of the information/approver. c. The type of information containing the diagnosis, the basis of the diagnosis, medical actions, indications of action, procedures, goals, risks, complications, prognosis, alternatives and risks, etc. d. Signatures showing that have given and received the information e. The identity signing the agreement or rejection containing the name, age, gender and address f. Description of time and place g. The name and signature of the patient who made the consent h. The witness's name and signature 3) Implementation of Informed Consent at RSIA Sitti Khadijah I Muhammadiyah Makassar Before the doctor performing medical treatment, the doctor is obliged to provide information about the type of illness suffered by the patient and the medical action to be taken to save the life of the patient and the risks that may arise from the medical action to the patient and his family. 2 Permanent procedures for taking medical actions that are permanent and binding are the patient's consent to take medical treatment. Acceptance from these patients is filled in the form of informed consent. This informed consent form has generally been prepared in such a way that the doctor/hospital and the patient only needs to fill in the column provided for this after explaining verbally to the patient or the patient's family. 3 Because informed consent is an agreement to take medical action, the existence of an informed consent is very important for those who make a health service agreement, so it can be seen that the existence of an informed consent is very important and necessary in the hospital. The problem is whether the contents of the informed consent form have met the legal requirements for the agreement .1 According to Guwandi, Informed Consent states at least 4 components contained, including: a. Patients must have the capacity or ability to make decisions; b. Doctor must provide information about the actions to be taken, testing, or procedures, including benefits and risks that may occur; c. Patients must understand the information provided; d. Patients must voluntarily give their permission without coercion or pressure. To every patient who would undergo medical treatment at RSIA Sitti Khadijah I Muhammadiyah Makassar, informed consent was given by the doctor. After an agreement was made, an informed consent form would be offered, both the approval and rejection forms in the form of a standard form in the following format: 1) Header of approval or rejection statement of medical action; When a medical action would be taken, the patient/family who was entitled to give consent was carried out Informed Consent. The informed consent form in RSIA Sitti Khadijah I Muhammadiyah Makassar was in the form of a standard agreement form that had been determined by the Indonesian Medical Council (KKI) consisting of 2 forms, including: a. Approval form of informed consent; and b. Rejection form of informed consent. These forms were used after the patient who had the right to sign consent was given a detailed explanation of the diagnosis of the disease, the actions to be taken, the risks that may occur and the prognosis after the medical treatment. The hospital and medical personnel who will perform medical treatment will respect any decision from the patient or family to determine whether to agree or refuse to take medical action. After an agreement is made, the patient/family will be offered a form according to the agreement that is the rejection form or approval form of the medical action. The identity of the patient who signed the medical action agreement consisting of name, age/gender, and address. The identity of the party that signed the medical action agreement must be complete, bearing in mind that if a dispute occurs later in the day it is clear who is responsible for the approval or rejection of the medical action. The identity that has been filled in by the patient on the Informed Consent form at RSIA Sitti Khadijah I Muhammadiyah Makassar is considered quite complete. 2) A statement explaining that the patient has understood and comprehended the explanation given by the doctor; consisting of: 2 a. 3) Status of signatories to approval for medical treatment; including from the patient himself, wife, husband, child, father/mother. The parties of the patients who are entitled to sign the approval or rejection of medical actions can be given by the patient or family as regulated in the Explanation of Law Number 29 of 2004 concerning Medical Practices article 45 section (1). Patients who are entitled to sign the medical agreement consist of: the patient himself, wife, husband, biological children, biological father/mother, or siblings. In fact, as the format of the signatory status in the Informed Consent form provided at the RSIA Sitti Khadijah I Muhammadiyah Makassar only provided a choice: on me/(empty column) me. Therefore, to adjust to the explanation of the Law, information should be added that in addition to the patient who is entitled to give a statement only the wife, husband, biological children, biological father/mother, or siblings. 4) The identity of the patient to be taken for medical treatment, consisting of name, age/sex, address, place of care ie room or ward, class and medical record number. The filling of the complete patient identity including the place of care, the medical record number is an absolute requirement for approval of medical treatment. This is to avoid mistakes that might occur if the patient's identity is not written in detail. Some cases of medical action errors occur due to the lack of detail of the identity of the patient concerned, so that medical action is carried out on different patients. This can be fatal. The format for filling in the patient's identity in the informed consent form that has been provided at RSIA Sitti Khadijah I Muhammadiyah Makassar is quite complete and detailed and it is expected that there will be no wrong target for medical treatment. 5) A statement stating that the signatory of the informed consent is made with full awareness and not under duress. It is an absolute requirement that the decision to reject or approve medical treatment is done voluntarily and not under duress. This is based on Article 1321 of the Civil Code that: "There is no valid agreement if the agreement was obtained by force or fraud". The hospital or doctor functions as a health servant according to their duties and obligations. The doctor will try all actions based on scientific and ethical medical practices. The doctor will try to explain in detail the medical action plan that will be done and the magnitude of the benefits for the patient, but the decision maker whether a medical action will be done or not to the patient is the full right of the patient or the family. Thus, all these decisions are an agreement between the doctor and the patient made in a voluntary and without coercion. If the rule is violated, then the Informed Consent has been done is not valid. The Informed Consent Form available at RSIA Sitti Khadijah I Muhammadiyah Makassar has fulfilled the requirements under Article 1321 of the Civil Code. 6) The name and signature of the doctor who provided the informed consent explanation. The name and signature of the doctor who provided the Informed Consent explanation is very important because if there is a dispute against the patient, it will easily provide confirmation of the case. It is better if the doctor's full name is written clearly and completely in the Informed Consent form, so there is no difficulty if confirmation is needed. 7) The name and signature of the patient who approved the medical action. The name and signature of the patient who approved the medical action is very important because if a dispute occurs later, it will easily provide confirmation of the case. The full name should be clearly stated on the Informed Consent form. The party giving the signature on the Informed Consent form is the party who, based on the explanation of Law Number 29 of 2004 Article 45 section (3), has the right to give approval for medical treatment. 2) In the form provided, it is necessary to mention who is entitled to become a witness. Witnesses, including nurses or other paramedics from the hospital, are needed to strengthen testimony in court in case of a dispute with the patient. It is also needed to make uniformity of the forms because there are some that only require the signature of 1 witness and there are also 2 witnesses. RSIA Sitti Khadijah I Muhammadiyah Makassar is a teaching hospital for obstetrics and gynecology. These fields are supported by personnel in the field of health, among others, there are obstetricians with the status of clinic educator doctors who assist general practitioners who are undergoing specialist education (residents), nonspecialist doctors, clinical educators, general practitioners, nurses, midwives, and other personnel health. The ones who implement medical procedures in this field are specialist doctors and residents. This is based on the Indonesian Medical Council Decree which issues a Doctor Registration Certificate (STR) and is strengthened by the decision of the Obstetrics and Gynecology Specialist Association that every general practitioner who is studying in Obstetrics and Gynecology has competence in the field of The Science of Obstetrics and Gynecology including carrying out all the specialist actions under the guidance/approval of the doctor of Obstetrics and Gynecology Consultants. In order to assess the implementation of informed consent at RSIA Sitti Khadijah I Muhammadiyah Makassar, the authors have conducted research from 2 May 2019 to 2 June 2019. The research was conducted by taking 50 samples of cases of the implementation of informed consent in that range of time. The author reviews the implementation of informed consent by: a. Looking for patients who will be taken medical treatment; b. Check and analyze the informed consent form that has just been implemented. c. Interviewing doctors who provide explanations of the informed consent d. Analyzing the implementation of the informed consent both forms that have been filled and the doctor's understanding of the informed consent that has been done In a predetermined range of time, the authors examined the implementation of the informed consent that that has been done by: a. Examining the informed consent form that has been filled, then analyzing based on the applicable law whether all parts that should have been filled out and carried out by the doctor and the patient were completely filled out. b. The researchers conducted interviews with physicians who filled the informed consent with guidance on the sequence of questions that have been made by the researchers. c. Analysis of the filling of Informed Consent at RSIA Sitti Khadijah I Muhammadiyah Makassar Based on the research on filling out the informed consent form that has been carried out, the results obtained are: 1) Patient identity The patient identity written down on the form consisted of the medical record number, the patient's name, gender, date of birth, age, and patient care room. From the examination of 50 informed consent forms that had been obtained, 50 (100%) forms had been completely filled out. Thus, in the event of a dispute with the patient in the future, the doctor and hospital can prove that the patient who has taken the medical action is the right patient. 2) Provision of Information In the column for providing information, there was the name of the doctor carrying out the action, the name of the information provider, and the name of the information recipient/the /approver. From the examination of 50 informed consent forms that had been carried out, it was obtained: a. 10 forms (20%) did not provide the full name of the doctor implementing the action b. 41 forms (82%) did not provide the full name of the person providing the information c. 27 forms (54%) did not fill in the clear name of the information recipient/the approver d. 1 form (2%) error in filling out the name of the information recipient/the approver e. 2 forms (4%) without an information provider's signature f. 48 forms (96%) contained the signature of a specialist doctor in the information provider column, whereas it is known that the person providing the information is a resident if the patient is a patient from a clinical teaching specialist doctor, and an UGD general practitioner, nurse, or midwife if the patient is a patient from a specialist doctor non clinical educator. g. 50 forms (100%) provided the signature of the patient receiving the information approver Although this was a negligence (culpa), it would weaken the position of the doctor/hospital in the event of a dispute in the future, where the evidence in the form of the informed consent form became less strong due to the unclear identity of the signed informed consent from the patient. 3) Filling in the type of information provided In the column for information provision, there is a diagnosis, rationale of the diagnosis, medical action indication of action, procedures, goals, risks, complications, prognosis, and alternatives & risks. From the examination of