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Int J Health Policy Manag 2015, 4(1), 1318

doi 10.15171/ijhpm.2014.104

Original Article
Adherence to informed consent standards in Shiraz hospitals:
matrons perspective
Alireza Mohsenian Sisakht1, Najme Karamzade Ziarati1, Farideh Kouchak2, Mehrdad Askarian3,*
Abstract
Background: Informed consent is an important part of the patients rights and hospitals are assigned to obtain
informed consent before any diagnostic or therapeutic procedures. Obtaining an informed consent enables patients to
accept or reject their care or treatments and prevent future contentions among patients and medical staff.
Methods: This survey was carried out during 2011-2. We assessed adherence of 33 Shiraz hospitals (governmental and
non-governmental) to informed consent standards defined by Joint Commission International (JCI) Accreditation,
USA. The questionnaire was designed using the Delphi method and then filled out by hospital matrons. We calculated
valid percent frequency for each part of the questionnaire and compared these frequencies in governmental and nongovernmental hospitals using analytical statistics.
Results: Considering 63% of the hospitals that filled out the questionnaire, no statistically significant difference was
observed between the governmental and non-governmental hospitals in adherence to informed consent standards.
Conclusion: This study shows a relatively acceptable adherence to standards about informed consent in Shiraz
hospitals but the implementation seems not to be as satisfactory.
Keywords: Informed Consent, Shiraz Hospitals, Standards
Copyright: 2015 by Kerman University of Medical Sciences
Citation: Mohsenian Sisakht A, Karamzade Ziarati N, Kouchak F, Askarian M. Adherence to informed consent standards
in Shiraz hospitals: matrons perspective. Int J Health Policy Manag 2015; 4: 1318. doi:10.15171/ijhpm.2014.104

Article History:
Received: 4 June 2014
Accepted: 20 October 2014
ePublished: 26 October 2014

*Correspondence to:
Mehrdad Askarian
Email: askariam@sums.ac.ir

Key Messages
Implications for policy makers
Hospital managers in Shiraz should develop measures and protocols in order to enhance their patients knowledge about informed
consent standards.
Policy-makers at the Shiraz University of Medical Sciences should pay more attention to evaluation hospitals about informed
consent standards, in order to enhance the quality of healthcare services and their patients satisfaction.
Implications for public
Patients should be aware of their right to take enough information about any decision for their disease, to decide to accept or reject it.

Introduction
Informed consent, an important part of the patients rights,
is a free and revocable agreement between patients and
medical staff about medical processes and involves the nature
of procedures including therapeutic or diagnostic ones,
risks and benefits and alternative procedures (1). Obtaining
an informed consent enables the physician to diagnose the
patients disease while observing his/her rights. In addition,
the patient becomes able to accept or reject their offered care
or treatments (2). Indeed obtaining informed consent is a
way for patient participation in his/her care process (3). An
informed consent that is taken in an appropriate way prevents
future contentions among patients and medical staff (2).
In Iranian patients bill of rights, two out of 10 items are about
informed consent which shows its importance (4). Hospitals
Full list of authors affiliations is available at the end of the article.

are assigned to obtain informed consent before any diagnostic

or therapeutic procedures (5).
According to a study in Tehran University of Medical Sciences
(TUMS) on measurement of university hospitals standards
defined by the World Health Organization (WHO), the least
adherence was found to be in the field of patient and family
rights (which included obtaining informed consent) by 47.5%
(6). Another study also conducted in Tehran showed that Iran
health ministry standard considers just six options out of the
15 standards defined by the WHO in the field of informed
consent. These studies show the need to pay more attention
to this important field of medical ethics (7).
Research in other countries has shown that despite the legal
coercion to obtain an informed consent in an appropriate way,
what actually happens cannot fulfill legal and professional

Mohsenian Sisakht et al.

requirements and the content of most of them did not meet

accepted standards. It seems that systematic education of
medical staff is needed to improve the process of obtaining
informed consent (1,8).
Taking a signature on the bottom of an informed consent
form is not enough to say that this important part of medical
ethics is applied in the hospital. Informing the patient about
risks, benefits and costs and freedom to accept or reject
the procedures is a part of patients rights and should be
considered in the process of obtaining informed consent (9).
Joint Commission International (JCI) defined hospital
standards in different issues including patient and family
rights. A part of patient and family rights is informed
consent which indicates that minimum standards should be
considered in hospitals (5). These standards include the route
of obtaining informed consent, informing the patients, and
defining the procedures which need informed consent and
recording (5).
We designed this study to understand the adherence of Shiraz
hospitals to these important standards, and to estimate the
differences between governmental and non-governmental
hospitals, as well as general versus specialized hospitals in
Shiraz, from matrons perspective. In this way, the defects in
some parts of informed consent standards become evident
and we are able to know whether any defects exist in the some
policies, in informed consent taking standards, in defining the
procedures that need taking informed consent, in standards
of informing patients or in other standards.
Methods
In this study which was carried out during 20112 in Shiraz
(with about a million and a half inhabitants), we surveyed 33
hospitals (all of Shiraz hospitals), including governmental,
non-governmental, general and specialized ones, to evaluate
their adherence to informed consent standards defined
by Patient and Family Rights section of JCI Standards for
Hospitals (5).
The questionnaire had been developed according to those
standards determined in the JCI guideline. We translated
the questions then after Iranianizing and Islamizing them,
we used the Delphi method by participation of 18 specialists
including community medicine specialists, residents of
community medicine, PhDs in medical management and
both governmental and non-governmental hospital matrons.
Considering cultural differences between countries, we
adjusted some standards related questions such as standards
in blood products transfusion, who can sign the consent form
instead the patient, etc. according our culture because of
differences from the global view in our Islamic view of blood
transfusion and also the persons allowed to give consent
instead of the patient. We used the Delphi method to evaluate
our questionnaire in different dimensions such as scientific
and cultural ones.
According to Skulmoski et al. the Delphi method is an iterative
process used to collect and distill the judgments of experts using
a series of questionnaires interspersed with feedback (10).
The first step of the Delphi method is to design a questionnaire
which can be done by literature review, experience and pilot
14

study (10). In this step, as mentioned before, we used the JCI

standards after applying some changes to make the questions
answerable according to our culture. Then the questionnaire
had to be surveyed and accredited by an expert team,
comments had to be considered and the new questionnaire
given out to them again. Comments of an expert team had
to be applied in the final questionnaire (10). After applying
the comments by the above-mentioned specialist group, the
questionnaire was prepared to be used and we distributed
them among the matrons of 33 Shiraz hospitals, and we
also explained to them the importance and privacy of their
answers face to face.
To assess the reliability of the questionnaire, we calculated
Cronbachs alpha in a pilot study (= 0.909), which meant the
questionnaire was reliable.
The questions included clear definition of informed consent
process, staff training, obtaining informed consent according
the policies, informing patients about their health status,
listing procedures and treatments in need of specified consent,
collaboration of related physicians and staff in preparing the
mentioned list, defining the process for obtaining consent
from others (non-patient), justifiability of obtaining consent
from others, clarifying the individuals other than the patient
who gave consent in the patients record, informing patient
and their family about the scope of a general consent and
when it is used by the hospital, defining how a general consent
is documented in patients record, informing patients enough
about plan and responsible persons before obtaining consent,
informing patients enough about risk and benefits of plan
before obtaining consent, informing patients enough about
possible alternatives before obtaining consent, informing
patients enough about consequences of refusing treatment
before obtaining consent, informing patients enough about
likelihood of successful treatment before obtaining consent,
obtaining consent before surgery, invasive procedure,
anesthesia, using blood products and high risk procedures,
clarifying the identity of the person who informed patients
for above procedures in patients record, documenting the
consent in patient record (5).
The choices of each question were based on 4-pointed
options, including: complete adherence, partial adherence,
no adherence, and I do not know. But to calculate the
score better we assumed complete adherence and partial
adherence and also no adherence and do not know, as
equivalent options.
We included all Shiraz hospitals while the exclusion criterion
was lack of hospital cooperation. That means 12 hospitals
(including governmental and non-governmental and also
specialized and general ones) were excluded from this study.
In the end, 21 hospitals returned the questionnaires (63.6%
response rate). Information regarding the hospitals is listed
in Table 1.
To increase the validity of the results, we preferred matrons
answering the questions, because the hospital matron is a
very senior nurse, and he/she has authority and knowledge
regarding the hospital policies. We asked them to attach
documents about some of the questions, if there were any.
Five out of the 21 hospitals (23.8%) that participated in the

International Journal of Health Policy and Management, 2015, 4(1), 1318

Mohsenian Sisakht et al.

Table 1. Characteristics of Shiraz hospitals
Hospital

Type

Specialty

Namazi
G
General
Shahid Faghihi
G
General
Ghotb-e-Din
G
Burns
Alavi
NG
General
Ordibehesht
NG
General
Markazi
NG
General
Shahr
NG
General
Dena
NG
General
Farahmand Far
NG
General
Dr. Mir
NG
General
Al-Zahra
G
Cardiology
Kousar
NG
Cardiology
Shooshtari
G
Obstetrics
Dastgheib
G
Pediatric
Rajaee
G
Trauma
Amir
G
Oncology
Zeinabie
G
Obstetrics and gynecology
Chamran
G
Orthopedic neurosurgery
Hafez
G
General
Ebn-e-Sina
G
Psychiatry
Ali Asghar
G
General
G= governmental; NG= non-governmental

study attached the documents. These documents were about

admission sheets, release sheets, and also some procedures
such as lumbar puncture, double lumen insertion, etc. Each
hospital had its own style in preparing these forms, but their
contents were the same in all of hospitals in each form. In
each form, the patients identity data was written first, then
after explanation of the process, the patients or their care
givers were requested to sign the form.
We compared the results of governmental vs. nongovernmental and general vs. specialized hospitals about
adherence to informed consent standards.
Statistical analysis
To understand the adherence to standards, we calculated the
percent frequency for each part of the questionnaire and the
difference of these frequencies between governmental vs.
non-governmental and general vs. specialized hospitals were
compared.
Results
Table 2 shows informed consent standards in rows
and adherence to informed consent standards in both
governmental and non-governmental hospitals in columns.
We also calculated total scores of adherence of governmental
and non-governmental hospitals to these standards which are
presented in the last row.
Non-governmental hospitals had stricter adherence in almost
all aspects of informed consent standards. As we can see in
the 9th standard: Clarifying the individuals, other than the
patient, who will give the consent in the patients record,
adherence in both governmental and non-governmental
hospitals were 100%, but in the 11th and 17th (5th part)
standards: Defining how a general consent is documented
in patients record and, Obtaining consent before high risk

procedures, governmental hospitals were better.

Another comparison can be made between general and
specialized hospitals as presented in Table 3.
In this part, data shows that specialized hospitals have
stricter adherence in almost all aspects of informed consent
standards. As we can see in the 9th standard: Clarifying the
individuals, other than the patient, who will give the consent
in the patients record, adherence in both specialized and
general hospitals were 100%, but in the 1st, 8th, 17th (2nd and 4th
part) standards, general hospitals were better.
Although the perfect score is a complete adherence (100%) to
all options of the standards, we assumed >75% as acceptable
adherence, 75% and >25% as partially acceptable and <25%
as non-acceptable.
By assuming the above scoring system, 73.9% of the total
of governmental and non-governmental hospitals applied
acceptable standards and 26.1% partially acceptable. In
comparison between general and specialized hospitals, the
latter performed better and 73.9% of them applied acceptable
standards and 26.1% partially acceptable. General hospitals
were not as good and 43.5% of them applied acceptable
standards and 56.5% partially acceptable. None of the
hospitals was found to be non-acceptable.
Discussion
Our data shows a relatively acceptable adherence to informed
consent standards in governmental, non-governmental and
specialized hospitals but the condition is not as acceptable in
general ones. These acceptable results can be affected by the
method of collecting data.
The data in this article was obtained from the hospitals
matrons, so poor adherence to obtaining informed consent
standardsas shown in other studies in Iran (6,7)may be
hidden. Also this may happen more in non-governmental
hospitals than governmental ones. For example, Amini and
colleagues study in Tehran, in which the patients, rather than
the matrons, filled out the questionnaires, 31.2% of patients
had complete information about their health status (11). But
in our study in which the questionnaires were filled out by
hospital matrons, informing patients about their health status
was implemented in governmental hospitals by 72.7% and in
non-governmental hospitals by 90%.
The findings of Amini et al. and our study are summarized
in Table 4. The Amini et al. study also shows that 11.8% of
patients have information about their treatment plan (11),
while in our study, informing patients enough about the plan
was applied in governmental hospitals by 78.6% and in nongovernmental hospitals by 100%.
The patients awareness about the likelihood of a successful
therapeutic plan was 33.3% in Amini et al.s study (11) versus
78.6% and 85.7% in governmental and non-governmental
hospitals in our study.
Patients information about possible alternatives in Amini
et al.s study was 21.5 % (12) while informing patients about
possible alternatives in our study was 64.3% in governmental
hospitals and 100% in non-governmental.
As we can see, in all of the above issues, from the patients
viewpoint, it seems, the information they receive was not

International Journal of Health Policy and Management, 2015, 4(1), 1318

15

Mohsenian Sisakht et al.

Table 2. Adherence to informed consent standards by governmental and non-governmental hospitals in Shiraz

Adherence to standards
Standards

No adherence to standards

Governmental
hospitals
n= 13 (%)

Nongovernmental
hospitals
n= 8 (%)

Governmental
hospitals
n= 13 (%)

Nongovernmental
hospitals
n= 8 (%)

Clear definition of informed consent process in hospital policies

11 (84.6)

8 (100.0)

2 (15.4)

0 (0.0)

Staff training in implementing the policies

10 (76.9)

8 (100.0)

3 (23.1)

0 (0.0)

Obtaining informed consent according the policies

12 (92.3)

8 (100.0)

1 (7.7)

0 (0.0)

Informing patients about their health status

10 (76.9)

7 (87.5)

3 (23.1)

1 (12.5)

Listing procedures and treatments need specified consent

7 (53.8)

6 (75.0)

6 (46.2)

2 (25.0)

Collaboration of related physicians and staffs in preparing mentioned list

8 (61.5)

6 (75.0)

5 (38.5)

2 (25.0)

Defining process for obtaining consent from others (non-patient)

10 (76.9)

7 (87.5)

3 (23.1)

1 (12.5)

Justifiability of obtaining consent from others

11 (84.6)

8 (100.0)

2 (15.4)

0 (0.0)

Clarifying in the patients record, individuals, other than patient, and

obtained consent

13 (100.0)

8 (100.0)

0 (0.0)

0 (0.0)

10

Informing patient and their family about the scope of a general consent
and when used by the hospital

6 (46.2)

6 (75.0)

7 (53.8)

2 (25.0)

11

Defining how a general consent is documented in patients record

10 (76.9)

6 (75.0)

3 (23.1)

2 (25.0)

12

Informing enough patients about plan and responsible persons before

obtaining consent

10 (76.9)

8 (100.0)

3 (23.1)

0 (0.0)

13

Informing enough patients about risk and benefits of plan, before

obtaining consent

10 (76.9)

8 (100.0)

3 (23.1)

0 (0.0)

14

Informing enough patients about possible alternatives, before obtaining

consent

8 (61.5)

8 (100.0)

5 (38.5)

0 (0.0)

15

Informing enough patients about consequences of refusing treatment

before obtaining consent

11 (84.6)

8 (100.0)

2 (15.4)

0 (0.0)

16

Informing enough patients about likelihood of successful treatment

before obtaining consent

10 (76.9)

7 (87.5)

3 (23.1)

1 (12.5)

17

Obtaining consent before:

Surgery

12 (92.3)

7 (87.5)

1 (7.7)

1 (12.5)

Invasive procedure

10 (76.9)

7 (87.5)

3 (23.1)

1 (12.5)

Anesthesia

7 (53.8)

7 (87.5)

6 (46.2)

1 (12.5)

Using blood products

4 (30.8)

5 (62.5)

9 (69.2)

3 (37.5)

High risk procedures

10 (76.9)

6 (75.0)

3 (23.1)

2 (25.0)

18

Clarifying the identity of who informed patients for above procedures

in patients record

10 (76.9)

8 (100.0)

3 (23.1)

0 (0.0)

19

Documenting the consent in patient record by signature or record of

verbal consent

10 (76.9)

7 (87.5)

3 (23.1)

Total scores

220 (73.6)

164 (89.1)

79 (26.4)

satisfactory but in the matrons opinions, the information

they gave to patients was enough. Also in Sheikhtaheri et al.
study in Kashan, it seems, the patients were not satisfied with
the information they received before their operations (12).
Presumably, these support the idea of underestimating the
problems of informed consent standards.
Another assumption is that the data which medical staff think
should be given to a patient differ from what the patient wants
to hear, so we can see a gap between what is satisfactory for
obtaining an informed consent according to medical staff and
what is satisfactory for giving an informed consent according
to a patient.
It is noteworthy that informed consent is an important issue
that addressing this issue from a different perspective such
as matrons, patients, clinicians, etc. gives different results.
For example, Ogundiran and colleagues study in Nigeria
16

1 (12.5)
20 (10.9)

has surveyed surgeons opinion around informed consent

standards and their results shows that surgeons in Nigeria
have enough knowledge about this important issue but their
adherence to these standards in practice is lesser than their
knowledge (13). For another example we can look the Taylor
and Kelner study; they have studied physicians perspective
about the informed consent regulations. They have surveyed
170 oncologists from eight countries. This study shows that
physicians regarded informed consent regulations, a way for
decrease effective doctor-patient communication and they
also assumed the informed consent regulation as having a
negative impact on their patient care (14).
Another point revealed in both Tables 2 and 3 is that the score
for application of the determined standards in hospitals is less
than their existence. That means despite relatively appropriate
determination of (i.e. adherence to) informed consent in

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Mohsenian Sisakht et al.

Table 3. Adherence to informed consent standards by general and specialized hospitals in Shiraz
Standards

Adherence to standards
General
Specialized
n= 11 (%)
n= 10 (%)

10 (90.9)

9 (90.0)

1 (9.1)

1 (10.0)

Clear definition of informed consent process in hospital policies

No adherence to standards
General
Specialized
n= 11 (%)
n= 10 (%)

Staff training in implementing the policies

8 (72.7)

10 (100.0)

3 (27.3)

0 (0.0)

Obtaining informed consent according the policies

10 (90.9)

10 (100.0)

1 (9.1)

0 (0.0)

Informing patients about their health status

8 (72.7)

9 (90.0)

3 (27.3)

1 (10.0)

Listing procedures and treatments need specified consent

6 (54.5)

7 (70.0)

5 (45.5)

3 (30.0)

Collaboration of related physicians and staffs in preparing mentioned list

7 (63.6)

7 (70.0)

4 (36.4)

3 (30.0)

Defining process for obtaining consent from others (non-patient)

8 (72.7)

9 (90.0)

3 (27.3)

1 (10.0)

Justifiability of obtaining consent from others

10 (90.9)

9 (90.0)

1 (9.1)

1 (10.0)

11 (100.0)

10 (100.0)

0 (0.0)

0 (0.0)

5 (45.5)

7 (70.0)

6 (54.5)

3 (30.0)

6 (54.5)

10 (100.0)

5 (45.5)

0 (0.0)

9 (81.8)

9 (90.0)

2 (18.2)

1 (10.0)

9 (81.8)

9 (90.0)

2 (18.2)

1 (10.0)

8 (72.7)

8 (80.0)

3 (27.3)

2 (20.0)

9 (81.8)

10 (100.0)

2 (18.2)

0 (0.0)

7 (63.6)

10 (100.0)

4 (36.4)

0 (0.0)

Surgery

10 (90.9)

10 (100.0)

1 (9.1)

0 (0.0)

Invasive procedure

10 (90.9)

7 (70.0)

1 (9.1)

3 (30.0)

Anesthesia

7 (63.6)

7 (70.0)

4 (36.4)

3 (30.0)

Using blood products

6 (54.5)

3 (30.0)

5 (45.5)

7 (70.0)

High risk procedures

8 (72.7)

8 (80.0)

3 (27.3)

2 (20.0)

9 (81.8)

9 (90.0)

2 (18.2)

1 (10.0)

8 (72.7)

9 (90.0)

3 (27.3)

1 (10.0)

9
10
11
12
13
14
15
16
17

18
19

Clarifying in the patients record, individuals, other than patient, obtained

consent
Informing patient and their family about the scope of a general consent
and when used by the hospital
Defining how a general consent is documented in patients record
Informing enough patients about plan and responsible persons before
obtaining consent
Informing enough patients about risk and benefits of plan, before obtaining
consent
Informing enough patients about possible alternatives, before obtaining
consent
Informing enough patients about Consequences of refusing treatment
before obtaining consent
Informing enough patients about likelihood of successful treatment before
obtaining consent

Obtaining consent before:

Clarifying the identity of who informed patients for above procedures in

patients record
Documenting the consent in patient record by signature or record of verbal
consent

Table 4. Comparison of the same issues from two viewpoints: patients and matrons
Options

Amini et al. study (Questionnaire filled by patients)

Patients information about their health status

31.2%

Informing patients about their health status

Patients information about therapeutic plan

Our study (Questionnaire filled by matrons)

Governmental
Non-governmental
72.7%

90.0%

78.6%

100.0%.

78.6%

85.7%

64.3%

100.0%

11.8%

Informing patients about therapeutic plan

Patients awareness about success likelihood

33.3%

Informing patients about success likelihood

Patients information about alternatives

21.5%

Informing patients about alternatives

hospital policies, implementation is not satisfactory.

Conclusion
This study shows a relatively acceptable adherence to standards
about informed consent in Shiraz hospitals but according
the other studies in Iran, the standards are not applied in a
correct way in hospitals and patients are not satisfied. Also, in

the present study, the rate of implementing standards is low.

That means, despite relatively appropriate determination of
informed consent in hospital policies, implementation is not
satisfactory.
To upgrade the standards, collaboration of a team including
those who determine the policies, talk with patients and
inform them is needed.

International Journal of Health Policy and Management, 2015, 4(1), 1318

17

Mohsenian Sisakht et al.

Ethical issues

6.

The study was approved by the ethic committee of Shiraz University of Medical
Sciences (SUMS).

Competing interests

The authors declare that they have no competing interests.

7.

Authors contributions

Authors contributed to the publication of this article as follows: study concept

and design (AMS, NKZ, FK, and MA); analysis and interpretation of data (AMS,
NKZ, and FK ); drafting of manuscript (AMS and NKZ); critical revision of the
manuscript (AMS, NKZ, FK, and MA).

Authors affiliations

Student Research Committee, Shiraz University of Medical Sciences,

Shiraz, Iran. 2Department of Community Medicine, Golestan University of
Medical Sciences, Gorgan, Iran. 3Department of Community Medicine, Shiraz
Nephrourology Research Center, Shiraz University of Medical Sciences, Shiraz,
Iran.

8.

9.

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