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63]

Original Article

Audit of informed consent document for major surgical

procedures at a tertiary care hospital
ABSTRACT
Background: Consent is being regarded as the cornerstone of a doctor patient relationship. No patient can be forced,
directly or indirectly, to accept treatment which it may refuse, even if it is painless, beneficial to him and without any
risk including the fact that refusal may have life threatening consequences. Lack of an informed consent is an area
that can win legal suits for the patient even when the claim for any negligence is weak.
Aim: To review the informed consent documents in cases of major surgical procedures conforming the accepted
principles of informed consent and to prepare a checklist for help in future audit of informed consent documents.
Methods: Authors compiled a list of desirable and essential content areas in informed consent document based
on commonly accepted professional standards. Informed consent forms of planned major surgical procedures for
department of surgery, obstetrics and gynecology and orthopedics were included. 100 informed consent forms,
selected randomly by computer at medical records department, for each department were studied for 23 attributes.
Descriptive statistics and exploratory data analysis techniques were used to analyze the data.
Result: The consent documents lacked a third of essential elements in totality for all the departments [08/ 23] while
few partially.
Conclusion: There is ample room for training of treating registered medical practitioner on how an informed consent
should be documented so as to be safe ethically as well as legally. Consent is never a defense in an allegation of
medical negligence.

Keywords: Audit, checklist, consent, informed, obstetrics and gynecology, surgery

INTRODUCTION
Consent being regarded as the cornerstone of a doctor–patient
relationship, no patient can be forced, directly or indirectly,
to accept treatment which it may refuse, even if it is painless,
beneficial, without any risk, or even life threatening.[1]
As per Section 13 of Indian Contracts Act, 1872, when two
or more persons agree upon the same thing in the same
sense, they are said to consent. The implications of Indian
Penal Code [IPC] Section 87 are that only a person equal to
or above 18 years of age can give a legally valid consent for
any procedure that includes risk to life.[2] Another Section 89
IPC empowers the guardian of an infant under 12 years or a
mentally ill person of any age, to consent to the infliction of
Dhara Goswami,
Swapnil Sudhirkumar Agarwal1,
Smruti B Vaishnav2, Lavlesh Kumar3,
Krishnadutt Harishankar Chavali4
MBBS Student, Departments of 1Forensic Medicine and
Toxicology and 2Obstetrics and Gynaecology, Pramukhswami
Medical College and Shri Krishna Hospital, Karamsad,
3
Department of Forensic Medicine and Toxicology, SBKS Medical
College and Research Institute and Dhiraj Hospital, Vadodara,
Gujarat, 4Department of Forensic Medicine and Toxicology, All
India Institute of Medical Sciences, Raipur, Chhattisgarh, India
Address for correspondence: Dr. Swapnil Sudhirkumar Agarwal,
Department of Forensic Medicine and Toxicology, Pramukhswami
Medical College and Shri Krishna Hospital,
Karamsad, Gujarat, India.
E‑mail: swapnilagarwal@yahoo.in
Submission: 15-10-2018, Revision: 21-01-2019,
Acceptance: 26-01-2019, Published Online: 11-02-2020

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DOI:
How to cite this article: Goswami D, Agarwal SS, Vaishnav SB,
10.4103/jms.jms_69_18 Kumar L, Chavali KH. Audit of informed consent document for major surgical
procedures at a tertiary care hospital. J Med Soc 2019;33:91-6.

© 2020 Journal of Medical Society | Published by Wolters Kluwer ‑ Medknow 91

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Goswami, et al.: Audit of informed consent document for major surgical procedures
harm to the infant or the mentally ill person, provided it is
done in good faith and is done for his benefit.
Persons above the age of 12 years are considered to be capable
of giving consent under Section 88 IPC. This section differs
from Section 87 in two particulars – (1) under it any harm
except death may be inflicted and (2) the age of the person
consenting is not mentioned (but under Section 90, the age
of the consenting party must be at least being 12 years).[2]
Lack of an informed consent is an area that can win legal suits
for the patient even when the claim for any negligence is weak.
Thus, better understanding of the informed consent process not
only protects but also advances the interests of both patient
and doctor.[3] It is, therefore, imperative that consents taken are
legally valid covering all the components of an informed consent.
In case, consent is not obtained that will give rise to cause
of action for seeking the remedy criminally for making any
invasive procedure without consent of patient amounting to
assault with criminal force under Section 350 IPC and can also
seek a civil remedy for compensation for the injury occurred
to the patient in accordance with Law of Torts. If a doctor
fails to obtain a legally valid consent, then even without any
damage occurring, the patient has a right to sue the doctor
for the injury on his personal or private rights.[4]
The National Consumer Disputes Redressal Commission
(NCDRC) awarded compensation of Rs. 1 Lac with interest
at 15% together with cost of Rs. 1000/‑ where the patient
underwent an operation for acute appendicitis under spinal
anesthesia which lasted for 11 h (usually takes about 4 h).
A second operation, in the name of re‑exploration, was done
after a week without consent of the patient. Consent for
re‑exploration was not signed by patient, had name of the
anesthetist only, and not associated with any surgical record.[5]
In another case, prescribed format was used to obtain
patient’s signature with no endorsement as to consent
written on the form; instead written portion interpolated
subsequently to accommodate space available above the
signature, giving rise to bona fide and legitimate doubt about
authenticity and genuineness of consent.[6]
The NCDRC stated that concept of “informed consent”
postulates that all information are to be explained to the
patient and/or guardian in easily comprehensible nonmedical
terms, preferably in local language about: (1) diagnosis,
(2) nature of treatment, (3) risks involved, (4) prospects
of success, (5) prognosis if procedure is not performed,
and (6) alternative methods of treatment. The given case
had signature in consent form obtained 2 days after surgery,
92 Journal of Medical Society / Volume 33 / Issue 2 / May-August 2019
procedure to be performed was neither mentioned in clearly
understandable terms nor explained to the patient or guardian
in simple local language, many columns were left blank, name
of the doctor was not filled up, and signature of husband of
patient was obtained in the column meant for witness. There
was no consent for blood transfusion and anesthesia. On this
basis, partly filled up consent form cannot be construed as
informed consent and constituted deficiency in service.[7]
NCDRC has held that with no specific mention about name of
surgery, the type of anesthesia, and signatures being taken
in a mechanical fashion much in advance on the date of
scheduled surgery, such consent forms cannot be considered
“informed consents.”[8]
Supreme court has held “deficiency in service” where consent
was given for excision biopsy while surgeon removed the
entire tumor with patient becoming paraplegic on grounds
that consent for excision biopsy cannot be taken as implied
consent, much less informed consent for surgery of the
tumor.[9]
NCDRC has held “deficiency in service” for not obtaining
consent of a conscious and mentally alert patient where it
was obtained from the grandson. Form also did not document
the rationale for performing surgery and associated risks
involved being communicated to the patient.[10]
No negligence was held by the NCDRC in a case, where
consent was given for laparoscopic procedure explicitly
authorizing the doctor to carry out any additional procedure
in case of emergency. The doctor had done conventional/open
cholecystectomy as he encountered dense adhesions in the
gallbladder abandoning laparoscopic procedure.[11] Consent
for hysterectomy where there was no name of the surgeon
along with not even the name of patient to be operated has
been held “not to be valid consent.”[12]
These are few examples where legally invalid consent invited
trouble to attending medical practitioner(s). Hence, this
study was undertaken at a teaching tertiary care center with
intention to peruse the informed consent documents (ICDs)
for their legal validity taken for elective major surgical
procedures. Major surgical procedure is defined as any
operation: (1) within or upon the contents of the abdominal,
pelvic, cranial, or thoracic cavities or (2) which, given the
locality, condition of patient, level of difficulty, or length of
time to perform, constitutes a hazard to life or function of
an organ or tissue. Major surgery usually requires general
anesthesia and a period of hospitalization of varying
length (often a week).[13] The objectives were to review
the ICDs in cases of planned major surgical procedures
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Goswami, et al.: Audit of informed consent document for major surgical procedures

conforming the accepted principles of informed consent and IBM) (Trial version 14). Descriptive statistics and exploratory
to prepare a checklist for help in the future audit of ICDs. data analysis techniques were used to analyze the data.

MATERIAL AND METHODS RESULTS

The current study was started after due approval from the
Institutional Ethics Committee with source of data being the
Medical Records Department. A checklist was prepared before
the start of study forming the “case report form” of the study.
A list of desirable and essential content areas in informed
consent based on commonly accepted professional standards,
additional elements relevant to shared decision‑making, and
suggestions from a surgeon ethicist were included in the
study. A preliminary checklist was prepared, tested on ten
cases, and based on the results; components of the checklist
were improved to be used for the study. The final checklist
was filled depending on the presence or absence of particular
component(s) of a legally valid consent.
One hundred informed consent forms of the departments of
surgery, obstetrics, and gynecology (OBG) and orthopedics
each, selected randomly by computer, were studied.
Emergency procedures for these departments as well as
consent for anesthesia were excluded from the study.
The data gathered were entered in MS Excel Worksheet and
analyzed using SPSS (Statistical Package for Social Sciences by
Twenty‑three attributes were studied from the files for
informed consent form [as per Table 1] with results found
depicted in Tables 2‑5.
All three departments did not mention experience of
operating surgeon for the given procedure, name of the
practitioner who shall be actually doing the procedure,
date of the procedure (except in 4 cases of OBG), optional
treatment/procedure(s), time required for the procedure,
presence of any third party/assistants during the procedure,
and information with regard to filming/televising the
procedure for educational purpose.
Surgery consent forms lacked date when consent was
obtained, name of the patient in the consent form, explanation
of benefits of procedure and likelihood of additional surgery,
possible risks, and known complications of planned procedure.
Benefits of procedure were found in all orthopedic consents,
which also had explanations for possible risks and known
complications of the procedure and likelihood of revision
surgery.

Table 1: Informed consent preliminary checklist (case report form)

Department: ___________________Case number: ______________
Content Yes No Not applicable
Patient’s name
Date, when consent taken
Proposed procedure
Date of procedure
Benefits of procedure
Optional treatment/procedure (s)
Experience of operating surgeon with regard to procedure being performed
Possible risks and known complications of the planned procedure
Time required for the procedure
Name of practitioner who shall be performing the procedure
Any third party/assistants to be present during the procedure
Information with regard to filming/televising the procedure for educational purpose
Disposal of any tissue or part to be removed during the procedure
Likelihood of additional surgery
Likelihood of revision surgery
Assurance or guarantee of success of the planned procedure
Opportunity to ask questions
Signature of the patient/LAR
Thumb impression of the patient/LAR
In case of thumb impression, signature of a third party as witness
Signature of the practitioner who has taken consent with name and designation
Exonerating clause for doctor, nurse, hospital, etc.
Reflected shared decision‑making

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Goswami, et al.: Audit of informed consent document for major surgical procedures

In OBG, there was only one case where there was no
witness evidence for illiterate patient. In orthopedics, there
were two cases where there were no signatures/left thumb
impression (LTI) of either the patient/legally acceptable
representative (LAR), while in surgery, there was one case
where there was no signature/LTI of either the patient/LAR
and one case of illiterate patient with no signature of
witness (only patient’s LTI).
None of the departments had included exonerating clause for
doctor, nurse, hospital, etc., or given assurance or guarantee
of success of the planned procedure.
This is based on the review of the ICD, which appeared to be
mostly mechanical with most of the matter already typed and
incomplete information. It is subjective in nature.
DISCUSSION
In a study, content analysis of hospital informed consent
forms for procedures undertaken was conducted for
evidence of the basic elements of informed consent and
items that might enhance patient–physician interaction
reflecting shared decision‑making. The content of most
forms did not meet accepted standards of informed consent
or patient–physician interactions.[14] In our study, except for
seven attributes as stated in results, most of the attributes
were found to be fulfilled.
In another study, questionnaires sent to 196 psychologists
in private practice revealed that content of the forms dealt
primarily with issues regarding fees and not with information
that satisfies the requirements of informed consent with
average readability for the consent forms returned as
“difficult.”[15] This was not the case in our study as content
was easily readable and comprehensible (in whatever was
written).
In a survey undertaken with 10% of all US hospitals to
determine the content of informed consent forms and
their ability to be understood by individuals with differing
reading comprehension levels, it was found that majority of
procedural forms were complex and not easily understood
by an average patient. Majority did not list specific benefits
or potential complications of the planned procedure.[16] In
our study, consent forms were easy to read and comprehend,
but specific benefits were mentioned by the department of
orthopedics only in totality.

Table 2: Preliminaries
An interview, based on structured questionnaire, on
Attribute in consent form OBG Ortho Surgery 106 patients over the age of 18 years who had undergone
Patient’s name 93 100 71
elective or emergency surgery revealed that, in 8.5%
Date, when consent taken 74 86 39
cases, no consent was obtained, 38% actually understood
Experience of operating surgeon with regard 0 0 0
to procedure being performed the information, 66% were informed about the type of
Name of practitioner who shall be 0 0 0 anesthesia, none was given any hint about complications
performing the procedure of anesthesia, and only 11% actually signed the consent
Signature of the practitioner who has 88 94 85
taken consent with name and designation
forms themselves.[17] In our study, barring few exceptions,
n: 100 for all the three specialties; hence % are not provided. OBG: Obstetrics and
all the forms had relevant signatures/LTIs of the patients or
gynecology; Ortho: Orthopedics their LARs.

Table 3: Procedure/surgery/treatment specific particulars

Attribute in consent form OBG Ortho Surgery
Proposed procedure 75 74 85
Date of procedure 4 0 0
Benefits of procedure 8 100 26
Optional treatment/procedure(s) 0 0 0
Possible risks and known complications of the planned procedure 36 99 30
Time required for the procedure 0 0 0
Any third party/assistants to be present during the procedure 0 0 0
Information with regard to filming/televising the procedure for educational purpose 14 0 0
Disposal of any tissue or part to be removed during the procedure 24 4 7
Likelihood of additional surgery 37 2 13
Likelihood of revision surgery 1 95 0
Assurance or guarantee of success of the planned procedure 0 0 0
Opportunity to ask questions 0 0 0
Exonerating clause for doctor, nurse, hospital etc. 0 0 0
n: 100 for all the three specialties; hence % are not provided. OBG: Obstetrics and Gynecology; Ortho: Orthopedics

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Goswami, et al.: Audit of informed consent document for major surgical procedures
Table 4: Acknowledgment from patient/legally acceptable
representative
Attribute in consent form OBG Ortho
Signature of the patient/LAR 89 86
Thumb impression of the patient/LAR 11 12
In case of thumb impression, 10 12
signature of a third party as witness
n: 100 for all the three specialties; hence % are not provided. OBG: Obstetrics and
Gynecology; Ortho: Orthopedics, LAR: Legally acceptable representative
Table 5: Overall impression
Attribute in consent form OBG Ortho
Reflected shared decision‑making 0 0
n: 100 for all the three specialties; hence % are not provided. OBG: Obstetrics and
Gynecology; Ortho: Orthopedics
An audit of consent form completion was conducted
with an educational intervention followed by re‑audit
to reassess compliance where 37 forms were analyzed.
Re‑audit demonstrated an improvement in documentation
of benefits (91%–100%) and additional procedures (0%–7.5%).
Additional areas for improvement such as offering a copy of
the consent form to the patient and confirmation of consent
if a delay occurred between consenting and the procedure
were identified.[18] In our study, none of the department
mentioned who actually shall be doing the procedure and
the date of procedure.
In a consent audit on 100 adult participants undergoing
major procedure on elective basis under general anesthesia,
99% participants could state the correct name and site of the
procedure, 92% could state the mode of anesthesia, while only
39% received an information leaflet regarding the operation,
of which 80% claimed this could enhance their understanding
of the procedure. About 70% could recall the potential surgical
risks. Most essential items were completed in the consent
forms. Nearly 24% forms involved witnesses. About 6% of
consent documents had illegible surgeon’s handwriting.[19]
In our study, there was no issue of illegible handwriting of
person who had taken consent. Declaration of possible risks
and complications was present in one‑third cases of OBG and
surgery while in 99% cases of orthopedics.
A retrospective study done on the medical notes of 54 patients
undergoing three types of elective gynecological surgery over
a 7‑month period assessed for the presence of consent forms,
the legibility of the doctor’s name, and his/her suitability and
the extent to which risks of the operations were documented.
All contained signed NHS (National Health Services) consent
forms with signatures of doctors and patients. All identified
doctors were assessed suitable to take consent with only two
names not clearly legible. The documentation of risks was
found to be incomplete.[20] This was not the case in our study.
Journal of Medical Society / Volume 33 / Issue 2 / May-August 2019
A prospective audit of 76 patients undergoing elective
orthopedic surgery assessing how effectively patients are
Surgery consented at a busy teaching hospital demonstrated that
97 patients were often given incomplete information about
2 their management. Despite this, patients themselves felt that
1
the level of information given to them was appropriate and
allowed them to make an informed decision.[21] Our study did
not reflect shared decision‑making, as important elements to
be known before informed consent can be given were lacking.
Surgery CONCLUSION
0
The concept of “informed consent” has gained importance
due to suits brought by patients who allege that they did not
understand the nature of medical procedure to which they
gave consent.[22] A well‑explained and documented informed
consent not only protects the physician from exposure to
liability but also increases the patient’s autonomy in decisions
concerning health and encourages compliance with treatment.
The present study served as an audit of ICD for planned
major surgeries in departments of surgery, orthopedics, and
OBG. Lacunae found have been intimated to improve upon
them, taking care to maintain privacy and confidentiality of
stakeholders with an educational intervention planned for
medical practitioners. After using the checklist for 300 cases, the
lacunae were identified and a new checklist developed which can
be used to audit ICDs by institutes. It is in process for copyright
following which it shall be published too for everybody’s use.
Acknowledgment
Acknowledgment is due to Prof. (Dr.) Dinesh Kumar, Professor
Community Medicine, for his immense help in analysis of
the data.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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