Volume 8 No 1 2020 V2.indd


International Journal of Integrated Health Sciences 1

and good communication aimed at to get the 
best treatment results for patients. IC can be 
defined as the consent given by the patient 
and or his family to the doctor based on an 
explanation of the medical actions to be taken 
against the doctor and the risks associated 
by it.2 IC is a method for sharing information 
between the doctor and the patient so it must 
occur collaboratively (cooperation) that 
both between doctors and patients and their 
families to get the best choice for the patient 
treatment.3

The patient-doctor relationship will be 
well established if each part understands 
the role itself and functions concerning IC. A 

Relationship between the Quality of Informed Consent at Surgical 
Procedure in Terms of Ethics and Medicolegal with Satisfaction of 
Patient Health Service in dr. Zainoel Abidin Hospital

 Abstract 
 
 Objective: To determine the relationship between the quality of informed 

consent in terms of ethics and medicolegal with patient health service 
satisfaction at the dr. Zainoel Abidin Hospital (ZAH) Banda Aceh.

 Methods: This study is an observational analytic with a cross-sectional 
method. Subject selection through a total sampling method. This study 
involved patients who were treated at dr. Zainoel Abidin Hospital (ZAH) 
Banda Aceh and a total of patients were 100 (52 men and 48 women) 
who met the inclusion criteria carried out on 16 December 2019 to 31 
December 2019.

 Results: As many as 90% of respondents rated informed consent 
made at ZAH as good quality and 85% expressed the satisfaction with 
health services at ZAH. An ethical and medicolegal review of informed 
consent emphasizes the basic principles of bioethics. As many as 84% of 
respondents stated that their autonomy rights had been fulfilled, 92.50% 
thought that the doctor had done beneficence, nonmaleficence, and justice 
well in the process of informed consent and 92.33% of respondents rated 
the three elements of informed consent as being well implemented. 
Based on the results of the chi-square statistical test showed a significant 
relationship between the quality of informed consent in terms of ethics 
and medicolegal with patient health service satisfaction under the value 
of p=0.001 (p≤0.05).

 Conclusion: Good quality of informed consent in terms of ethics and 
medicolegal has an important role in increasing patient satisfaction with 
health services at the dr. Zainoel Abidin Hospital of Banda Aceh.

                 Keywords: Ethics, informed consent, medicolegal, satisfaction

Received:
January 12, 2020

Accepted:
March 30, 2020

Correspondence: 
Taufik Suryadi,
Department of Forensic Medicine and Medicolegal, 
Faculty of Medicine, Universitas Syiah Kuala/ Zainoel 
Abidin Hospital Banda Aceh, Indonesia, 
e-mail: taufik.suryadi.ts@gmail.com, taufiksuryadi@
unsyiah.ac.id

Original Article

Taufik Suryadi,1 Putra Safana,2 Dedy Syahrizal3

1Department of Forensic Medicine and Medicolegal, Faculty of Medicine,  Universitas Syiah Kuala/Zainoel Abidin  
  Hospital Banda Aceh, Indonesia
2Medical Student Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia
3Department of Biochemistry, Faculty of Medicine, Universitas Syiah Kuala, Banda Aceh, Indonesia

Introduction

Informed consent (IC) consists of two words, 
namely informed which means that it has 
received an explanation or information, 
and consent means approval or giving 
permission.1 IC is an embodiment of the 
patient-doctor relationship based on trust 

pISSN: 2302-1381; 
eISSN: 2338-4506; 
http://doi.org/10.15850/
ijihs.v8n1.2000
IJIHS. 2020;8(1):1–7



2 International Journal of Integrated Health Sciences 

doctor understands how to provide adequate 
information that can be accepted by patients. 
The doctor should provide information 
using language that is understood easily by 
patients. The doctor must also understand 
the sociocultural and emotional aspects of the 
patient.4 The IC process does not only to get 
the patient’s signature but rather respects the 
patient’s right to autonomy.5 IC while viewing 
through ethical principles is included in the 
basic rules of bioethics autonomy and when 
it views in the context of patient rights, IC is 
included in the right to self-determination.6 

The quality of informed consent in terms 
of ethics can be assessed from the fulfillment 
of four basic principles of bioethics, that are 
beneficence, nonmaleficence, justice, and 
autonomy. Beneficence contains how the 
doctor will make informed consent which 
gives attention, friendliness, compassion, and 
empathy to patients. Nonmaleficence means 
that doctors try to minimize harm to patients 
with not to force it to frighten, and do not 
lie to patients in making decisions.  Justice 
is genuinely done by doctors in conveying 
information and every patient is given an 
informed consent process before medical 
treatment. Autonomy is a right that is owned 
by the patient, namely how the patient 
gets information, giving choices, privacy, 
confidentiality and the right to give consent.6,7,8

Based on medicolegal, IC is a legal concept 
that guarantees the patients have the right to 
know about the risks, benefits and alternative 
therapies to be taken,7 also if included in the 
approval of civil medical actions which if not 
implemented can be categorized as violating 
the law.2,8 Quality of informed consent 
in terms of medicolegal can be assessed 
from fulfillment based on three aspects, 
namely, the approver must be competent 
that is aged 21 years or more (threshold 
element), the giver of explanation and the 
contents of the explanation (information 
element), and approval (consent element). 
This concentration element consists of two 
parts, namely, voluntariness (freedom) and 
authorization (authority).8 The fundamental 
problem is that there are still many findings in 
the field about the informed consent process 
that have not been implemented properly so 
that it has the potential to be a problem of 
ethical and medicolegal violations. The ethical 
aspects related to IC focus on autonomy, trust, 
self-determination, personal integrity, and 
non-dominance. While the medicolegal aspect 
is protection, prevention of deviant behavior 

and procedures that are not essential. IC is 
still often become a cause of conflicts between 
doctors and patients.6,7,8 

From previous study reported that poor 
communication is the highest cause of patient 
complaints with prevalence in Jakarta 66,3%.3 
In Indonesia, obstacles in conducting ICs, 
including explanation problems which the 
patient does not understand. The results of the 
study of patient safety management team for 
hospital services obtained information that 
giving of informed consent in various health 
service institutions only asks patients to sign 
an informed consent sheet so that it affects 
the knowledge of patients and families.9,10 The 
main of purpose this study was to determine 
the relationship between the quality of 
informed consent in terms of ethics and 
medicolegal at surgical procedures with the 
satisfaction of patient health services in Dr. 
Zainoel Abidin hospital (ZAH) of  Banda Aceh. 

Methods

This research is an observational analytic with 
a cross-sectional method. Subject selection 
through a total sampling method. This study 
involved patients who were treated at the 
Dr. Zainoel Abidin hospital of  Banda Aceh 
numbered 100 people (52 men and 48 women) 
who met the inclusion criteria carried out on 
December 16, 2019, to December 31, 2019. 
This study has conducted ethical clearance and 
has been approved by the ethics committee of 
the health research, the Faculty of Medicine, 
Syiah Kula University / Zainoel Abidin Hospital 
No. 333/EA/FK-RSUDZA / 2019.

Inclusion criteria in this study include (1) 
male and female patients over the age of 21 
years, (2) patients who have had surgery, (3) 
patients who have given informed consent 
before the treatment, (4) patients who 
can read and write and communicate well. 
Exclusion criteria: (1) patients suffering from 
mental disorders.

The data taken is the primary data. 
Primary data were obtained from the results 
of filling out the informed consent quality 
questionnaire to determine the quality of 
the informed consent in terms of ethical and 
medicolegal aspects, and also the satisfaction 
of patient to health services obtained from the 
results of filling out the questionnaire that had 
been tested for validity. The questionnaire 
used in this study was made by the research 
team and has been validated with a validity 
value> 0.361 and reliability 0.871.

Relationship between the Quality of Informed Consent at Surgical Procedure in Terms of Ethics and 
Medicolegal with Satisfaction of Patient Health Service in dr. Zainoel Abidin Hospital



International Journal of Integrated Health Sciences 3

Taufik Suryadi, Putra Safana, et al.

Results

The study was conducted on patients treated 
in Raudhah rooms of ZAH as many as 100 
respondents, with characteristics based on age 
and gender presented in table 1. The average 
value of participant age was 51.52 (SD 15.51), 
50.50 median, 47 modus, 21 minimum, and 83 
maximum.

Table 1 shows that based on gender, most 
respondents are male with 52 respondents 
(52%) and based on age group, most 
respondents aged between 56 to 65 years are 
26 respondents (26%), although the mode of 
age of respondents is not from these group 
but from the age group of 46–55 years that is 
47 years old respondents are 7 respondents 
(7%). In terms of age, all respondents have the 
right to give consent which is 21 years or older 
so that the threshold element is fulfilled 100%. 
All participants stated that the doctor who 
explained was the doctor who took the surgery, 
from this statement it could be concluded that 
there was fairness in treating respondents in 
the IC process (justice fulfilled 100%). The 
description of the quality of informed consent 
in terms of ethics and medicolegal is shown in 
table 2:

Table 2 shows that the basic rules of 
bioethics have been implemented well. As 
many as 84%   of respondents stated that 
their autonomy rights had been fulfilled and 
on average 92.50% thought that the doctor 
had done beneficence, nonmaleficence, and 
justice well in the informed consent process. 
Medicolegal obtained an average of 92.33% 

Table 1 Characteristics of Respondents

Characteristics
Frequency of 
Respondents

(n=100)  %

Age
      21–25 years 8 8 
      26–35 years 14 14 
      36–45 years 12 12 
      46–55 years 20 20 
      56–65 years 26 26 
      >65 years 20 20
Gender
      Man 52 52
      Women 48 48

Table 2 The Description of the Quality of 
   Informed Consent in Terms of 
   Ethics and Medicolegal

Rated Aspect Assessment

Fulfill (%) (%)

Ethics
      Beneficence 93 (93) 7 (7)
      Non maleficence 93 (93) 7 (7)
      Justice 100 (100) 0
      Autonomy 84 (84) 16 (16)

      Average 92,50 (92,50)
7,50 

(7,50)
Medicolegal
      Threshold 
      element 100 (100) 0

       Information     
       element 93(93) 7 (7)

      Consent element 84 (84) 16 (16)

      Average 92,33 (92,33)
7,67 

(7,67)

IC Quality

       Ethics and 
       medicolegal 90 (90) 10 (10)

of respondents rated the three elements of 
informed consent as fulfilling the medicolegal 
rules. Accumulatively, the assessment of 
ethical and medicolegal aspects is carried 
out simultaneously, the fulfillment of the 
basic ethical principles of beneficence and 
nonmaleficence is assessed when the doctor 
provides information (information element), 
while the autonomy rules are assessed 
together with the consent element. From the 
tabulation obtained data about the quality 
of informed consent in the hospital room 
ZAH cumulatively percent shows that of 
100 respondents regarding the quality of 
informed consent, 90 respondents rated good 
(met the ethical and medicolegal rules) and 
10 respondents rated not good.

The level of patient satisfaction with 
health services in ZAH was assessed based 
on 5 aspects, there are tangibles, reliability, 
responsiveness, assurance, and empathy. 
Obtained an overview of the level of 
satisfaction of health services from each 
respondent as listed in Table 3.



4 International Journal of Integrated Health Sciences 

Table 3 shows that from 100 respondents, 
most respondents expressed satisfaction 
with the reality (tangibles) and empathy in 
providing health services as much as 96 and 
95 percent. From the tabulation obtained data 
about patient satisfaction with health services 
in the hospital room of ZAH cumulatively 
based on statistical calculations showed 
that out of 100 respondents, 85 respondents 
rated satisfaction with services in ZAH and 15 
respondents rated dissatisfaction in service at 
ZAH. In this study to assess the relationship 
between the quality of informed consent in 
terms of ethical and medicolegal aspects with 
the satisfaction of health services, the Chi-
Square statistical test is used in Table 4.

In this study, the Chi square test was used 
to determine the relationship or effect of two 
nominal variables and to measure the strength 
of the relationship between these variables. 
Based on Table 4 it can be explained that 
the results of the chi-square statistical test 
showed a significant relationship between the 
quality of informed consent in terms of ethics 
and medicolegal with patient health service 
satisfaction with a value of p=0.001 (p≤0.05).

Discussion

IC must make the patient understand in the 

context of receiving information before the 
patient gives consent for medical treatment 
against them, this can be achieved if there 
is effective doctor-patient communication.3 
Patient satisfaction is also related to the quality 
of IC. Patient satisfaction is always the main 
target of health services. Quality treatment 
results are indicators of the quality of health 
services.5 Discussing patient satisfaction with 
health care, especially in surgical procedures 
and its relation to IC quality is not easy, because 
it is difficult to determine how the patient’s 
understanding of surgical procedures.1 
Determination of patient satisfaction with 
health services is also not easy to achieve 
because of many factors that influence it, 
including socioeconomic, knowledge, culture, 
health status, doctor-patient relationship, staff 
performance, number of facilities, and medical 
records system.5

Regarding surgery, two principles of 
medical ethics are related closely, namely the 
principle of autonomy and non-maleficence. A 
patient must get full information before getting 
surgery and enough data must be submitted 
by the doctor to the patient so that ethical and 
medicolegal aspects can be accomplished. 2 
The principle of autonomy means the doctor’s 
moral principle to always respect the patient’s 
rights, especially in this case is the right to 

Table 3 Overview of Patient Satisfaction with Service Quality based on the Five 
   Dimensions of Service Quality

Service Satisfaction Satisfied  % Not Satisfied  %
Tangibles 96 96 4 4 
Reliability 81 81 19 19 
Responsiveness 86 86 14 14 
Assurance 92 92 8 8 
Emphaty 95 95 5 5 
Over all of service satisfaction 85 85 15 15 

Table 4 The Relationship between the Quality of Informed Consent in Terms of Ethical and  
   Medicolegal Aspects with the Satisfaction of Health Services

     Health Service Satisfaction

Satisfied Not Satisfied (n=100) p-value

The Quality of Informed Consent
Good 81 9 90 0,001*
Not Good 4 6 10

Relationship between the Quality of Informed Consent at Surgical Procedure in Terms of Ethics and 
Medicolegal with Satisfaction of Patient Health Service in dr. Zainoel Abidin Hospital



International Journal of Integrated Health Sciences 5

determine what can be done to him (the 
right to self-determination), which is then 
developed in the doctrine of informed consent. 
The principle of non-maleficence is the moral 
principle of the doctor not to take actions that 
will worsen the patient’s condition (primum 
non nocere, above all, do no harm).8

The results of this study conducted at the 
Raudhah ward (surgery ward) of ZAH in 100 
respondents found a relationship between 
the quality of informed consent in terms of 
ethics and medicolegal with patient health 
service satisfaction. This is in line with a 
study conducted by Jhonson et al, in which 
result there was a significance relationship 
between giving informed consent and the 
level of satisfaction on the day of surgical 
procedure (p=0,02).11 The results of this study 
were also supported by Sari’s study showed 
that there was a relationship between giving 
informed consent before surgery and patient 
satisfaction.12 When viewed specifically, the 
quality of Informed consent at ZAH most of the 
respondents rated good for both the giver of 
explanation, the contents of the explanation, 
and the giver of approval. Judging from the 
results of this study it was found that the 
doctors at ZAH had given good informed 
consent judged from ethical and medicolegal 
aspects.

During the interview with the respondent, 
the respondent also stated that the doctor who 
gave the IC was patient enough to wait for the 
patient’s answer, allow to asking questions, 
and when giving consent there was no 
pressure and force. Thus the nonmaleficence 
code of ethics has also been implemented 
well which means that the doctor has tried to 
minimize losses to the patient due to decision 
making without coercion, fear or deception 
from the doctor. However, there are 7% of 
respondents who stated that there was a 
compulsion but not from a doctor but from 
a patient’s family who wanted an immediate 
operation even though the patient himself did 
not want to. This research is different from 
research conducted by Aldossari et al.,5 who 
found that 8.3% of respondents felt pressured 
by medical staff in decision making.

From an ethical perspective, in this study, 
there were still 16% of respondents who had 
not been accommodated in their autonomy 
rights. This shows that respondents and the 
Indonesian people, in general, are still not 
strong in autonomy because it is common 
knowledge that Indonesia is still communal, 
that is, everything is left to the family and 
not yet entirely dependent on independent 

decisions. The right of autonomy that has 
not yet been fulfilled is privacy (freedom of 
choice) because it still depends on the family 
of 14% and the right to give consent of 2%. 
From the aspect of Justice, doctors have done 
well both when giving information and when 
getting patient approval, all done fairly.

IC is a process that shows effective 
communication between doctors and patients 
and the meeting of thoughts about what will 
and what will not be done to patients. IC viewed 
from the legal aspect is not as an agreement 
between two parties, but rather towards 
unilateral agreement on services offered 
by other parties. Viewed from civil law, the 
relationship between health care providers 
and health service recipients is a contractual 
relationship. From this relationship, a bind 
of agreement between the two parties arises 
and rights and obligations emerge from each 
side. What is the right of the first side will 
become an obligation for the other side, and 
vice versa.7,8,13

In medicolegal, IC has 3 elements, namely 
threshold elements, information elements, and 
consent elements. The threshold element, ie 
the consent giver must be competent. By law a 
person is considered competent (competent) 
is when an adult, conscious and in a mental 
state that is not under control. An adult is 
defined as an age that has reached 21 years 
or has ever been married.13,14 Information 
elements, consisting of two parts, namely 
disclosure and understanding. In this study, 
doctors have provided adequate information 
(93%), but there are also 7% inadequate that 
is related not given information about the 
benefits of the actions taken (5%) and doctors 
do not introduce themselves when giving 
IC (2%). Understanding based on adequate 
understanding brings consequences to medical 
personnel to provide information (disclosure) 
in such a way that the patient can reach an 
adequate understanding. Many experts say 
that if this element is not done then the doctor 
is considered to have neglected to carry out 
his duty to provide adequate information.7,8,13 
Consent elements also consist of two parts, 
namely, voluntariness (freedom, freedom) 
and authorization (approval). Volunteering 
requires no deception, misrepresentation 
or coercion. Patients must also be free from 
“pressure” by medical personnel who behave 
as if to be “left” if they do not agree to the offer. 
Many experts still argue that carrying out “not 
excessive” persuasion can still be morally 
justified.8,13

The description of patient health service 

Taufik Suryadi, Putra Safana, et al.



6 International Journal of Integrated Health Sciences 

satisfaction shows that of 100 respondents, 85 
respondents rated satisfaction with the service 
and 15 respondents rated dissatisfaction. 
Following the research objective of knowing 
the level of satisfaction of Raudhah inpatients 
with services, the following discussion will 
be carried out the results of research on 
patient satisfaction in evaluating the quality 
of health services by applying the concept 
of “RATER” that is reliability, assurance 
(guarantee), reality (tangibles), empathy and 
responsibility.14 According to Muninjaya14 
which states that satisfaction is defined as the 
recipient’s service response to the suitability 
of the customer’s interest level with real 
performance can be felt after the service user 
receives the service. 

The suitability of IC quality with patient 
satisfaction with health services is reflected 
in what is delivered to the patient at the time 
of providing information following what the 
patient feels after the surgical procedure is 
performed.6,7,8 This conformity is described: 
reliability criteria reflected by attitude the 
hospital staff who able to handles patient care 
issues precisely and professionally and who 
arrive on time to the room when the patient 
needs it, this is in accordance with the ethical 
principles of beneficence and non-maleficence. 
Hospital staff informs clearly them of the things 
that must be followed in treatment (autonomy 
and beneficence). Hospital staff notifies clearly 
about matters that are prohibited in treatment 
(autonomy and nonmaleficence).7,8 Assurance 
criteria reflected by attitude the hospital 
staff who pays attention to complaints the 
patient feel, who can answer questions about 
the treatment actions given, who honest in 
providing information about the situation and 
who always gives greetings and smiles when 
meeting to the patient, this is in accordance 
with beneficence and autonomy. Tangibles 
criteria reflected by attitude the hospital 
staff who always maintains neatness and 
appearance (beneficence). Emphaty criteria 
reflected by attitude the hospital staff who 
gives information about all treatments that 
will be carried out (autonomy-beneficence), 
who attentives and provides moral support 
for the patients (beneficence), services 

provided by hospital staff do not look at rank 
/ status but are based on patients conditions 
(justice-autonomy), Responsiveness criteria 
reflected by attitude the hospital staff who are 
are willing to offer assistance to the patient 
when patient experience difficulties even 
without being asked (beneficence and non-
maleficence).6,7,8,13

The results of the study on the level of 
patient satisfaction with health services in the 
Raudhah Room of ZAH showed that expressed 
satisfaction generally with the health services. 
Chi-Square statistical test results obtained 
p-value 0.001 in this study showed that 
there was a significant relationship between 
the quality of informed consent of surgical 
procedures in terms of ethics and medicolegal 
with patient health service satisfaction in 
ZAH (p<0.05). This shows that the quality 
of informed consent at ZAH which has been 
good also contributed to the level of patient 
satisfaction. The results of the study are 
supported by Hallock et al.1 study which 
states there was a significant association 
between satisfaction and knowledge of 
informed consent. According to Sari’s study, 
that the patient’s health condition includes 
the diagnosis of the course of the disease, the 
process of medical treatment, and the results 
of services. Indicators of health services 
chosen by patients are priority measures 
of the quality of health services, tend to be 
the main source of the formation of patient 
satisfaction.12

This study shows that there is a relationship 
between the basic rules of bioethics applied 
to the IC process with patient satisfaction 
criteria. Good quality IC in terms of ethics 
and medicolegal have an important role in 
increasing patient satisfaction with health 
services at the Dr. Zainoel Abidin Hospital of 
Banda Aceh. A limitation of this study is that 
data collection is limited to respondents in the 
operating theater at the time of the study, so the 
results of the study may not reflect all patients 
who had undergone previous operations. It 
might also not be relevant to the experience 
of patients in other rooms. But in general, this 
study is very useful for the development of 
hospital service systems in the future.

Relationship between the Quality of Informed Consent at Surgical Procedure in Terms of Ethics and 
Medicolegal with Satisfaction of Patient Health Service in dr. Zainoel Abidin Hospital

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