|Year : 2019 | Volume
| Issue : 4 | Page : 288-292
Assessing the legal nature of informed consent and attitude of patients attending outpatient departments of a dental hospital in Bengaluru City: A cross-sectional study
Yashashwini N Simha1, N Vanishree2, Deepa Bullappa2, Keerthi Prasad2, L Ramesh2
1 Department of Prosthodontics, KLE Vishwanath Katti Institute of Dental Sciences, Belgaum, Karnataka, India
2 Department of Public Health Dentistry, Bangalore Institute of Dental Sciences, Bengaluru, Karnataka, India
|Date of Submission||08-Feb-2019|
|Date of Decision||05-Mar-2019|
|Date of Acceptance||10-Oct-2019|
|Date of Web Publication||12-Dec-2019|
Dr. Deepa Bullappa
Department of Public Health Dentistry, Bangalore Institute of Dental Sciences, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Informed consent is an ethical and legal requirement for research involving human participants. Aim: This study aimed to assess the patients' awareness of legal nature and attitude regarding the importance of the consent process. Materials and Methods: A descriptive, cross-sectional questionnaire survey was undertaken. Data were collected from the patients who seek care in the Outpatient Department of the Dental College, Bengaluru, for 3 months from June 2014 to August 2014. The data analysis was done using the statistical software SPSS version 14 to generate descriptive statistics. Results: Out of 376 (100%) participants, majority (103 [27.4%]) belonged to the age group of 21–30 years. With regard to the scores, 163 (74.4%) males had a score range of 7–12 as compared to females (117 [74.4%]). Conclusion: Informed consent process is intended to protect patients and to promote an enlightened ethics in patient–dentist relationship. Our study showed that many patients had limited knowledge of the legal implications of signing or not signing consent forms and did not recognize written consent as primarily serving their interest.
Keywords: Attitude, awareness, dental hospital, informed consent, legal
|How to cite this article:|
Simha YN, Vanishree N, Bullappa D, Prasad K, Ramesh L. Assessing the legal nature of informed consent and attitude of patients attending outpatient departments of a dental hospital in Bengaluru City: A cross-sectional study. J Indian Assoc Public Health Dent 2019;17:288-92
|How to cite this URL:|
Simha YN, Vanishree N, Bullappa D, Prasad K, Ramesh L. Assessing the legal nature of informed consent and attitude of patients attending outpatient departments of a dental hospital in Bengaluru City: A cross-sectional study. J Indian Assoc Public Health Dent [serial online] 2019 [cited 2020 Nov 24];17:288-92. Available from: https://www.jiaphd.org/text.asp?2019/17/4/288/272780
| Introduction|| |
Informed consent is an autonomous action by a subject or patient that authorizes a professional either to involve the subject in research or to initiate a medical plan for the patient. It is the fundamental mechanism whereby the physician informs the patient about the options for the diagnosis and treatment of the patient's illness. It is not just a form to be signed as a hospital formality, but a process, which ensures respect for persons through the provision of thoughtful consent for an option to decide on the best possible treatment in disease processes.
Recently, a number of high-profile cases reported in the media have drawn attention to patients' concerns about consent to treatment. The law relating to consent in this country remains in the professional domain, judged by what a responsible body of medical opinion would tell people about their treatment. Theoretical principles suggest that when a person is legally competent, his/her consent to treatment is valid when it is based on information, understanding, and noncoercion. Before starting any treatment, a person should be informed about what is wrong; about possible treatment options, including no treatment; what each entails; and a consideration of the risks and benefits.
Much has been written in the medical literature on why informed consent is so important and what it is in theory and in practice. However, there is a limited discussion on this issue in the dental literature within India, despite the importance of this subject to dental providers. In dentistry, as in other branches of medicine, patients have trusted their providers to do what is clinically best for them. Discussions between dentists and their patients on treatment are more in the nature of a few notes for the dentist's records than a written account of a negotiated clinical plan with the options explained for the patient. This situation may not concern patients unduly, as they may feel that the potential hazards of dental treatment are few.
Dentists' obligation to obtain patients' consent to treatment is based on ethical principles, legal requirements, and professional policies. Any treatment or investigation performed without consent can result in legal action for damages and even criminal proceedings. The dentist may be found guilty of serious professional misconduct by the professional registration body.
At present, the level of information given to obtain informed consent can vary widely between individual dentists. This situation is changing. Patients are demanding better and more information about their health care. Some have taken legal action when they have concluded that their clinicians have failed to provide sufficient information about the outcomes of selected treatments.
Although there has been some research on patients' retention of information after the consultation when consent is obtained, we do not know much about patients' knowledge and understanding of the consent process and the role of the consent form.
Misinformed consent or consent given without proper understanding of what is involved is of little legal value; this implies that the patients are able to understand, retain, and recall the information given to them prior to signing the consent form and they wish to be fully informed. Hence, the present study was undertaken with an objective of determining the patients' awareness of legal nature and attitude regarding the importance of the consent process.
| Materials and Methods|| |
A descriptive questionnaire survey was undertaken with an aim to assess the legal nature of informed consent and attitude of patients attending outpatient departments of a dental college in Bengaluru city. Permission to conduct the study was obtained from the principal of the dental college where the study was conducted. The study proposal was the institution. Implied consent was obtained from the patients who were presently attending the outpatient department by disclosing that the data collected were for research purpose. Patients who agreed to participate in the survey were assured of confidentiality. A specially prepared and pretested format, exclusively designed for recording all the relevant data pertaining to general information, was used.
The study was decided prior to be completed with the duration of 3 months keeping a view to cover five samples per day in the lunch break time. Hence, approximately, 400 samples were decided earlier, but due to the time constraint and holidays, 376 samples were achieved.
A pilot study was carried out on 10% of the desired population in order to check the feasibility and relevance of the prepared format. This population was not included in the main study. The format was designed in English and Kannada languages and with respect to few questions, certain modifications were done based on the observations marked during the administration of format while doing pilot study. The questionnaire was tested for its validity and reliability from the subject experts before the main study. Additions and modifications of the questions were considered. Kappa score was found to 0.78 to check the intraexaminer reliability. The questionnaire was then administered to every patient attending the outpatient department of the institution. Piloting of the questionnaire was performed at the outset which helped to check the feasibility and relevance of the questionnaire.
Data were collected from the patients who seek care in the Outpatient Department of the Dental College, Bengaluru, for 3 months from June 2014 to August 2014. Patients in the age group of 18–65 years who gave informed consent to participate were included.
The questionnaires were distributed to 376 patients who were willing to participate in the survey. The patients were explained about the questionnaire before they answered the questions.
The questionnaire was categorized into two components: one component measuring awareness scores and the other measuring understanding components, awareness scores ranging from 1-5 were categorised as 1, 6-10 as 2, 11-15 scores as 3 and 16-20 scores as 4. Similarly, understanding scores were categorized as scores ranging from 1 to 6 as 1, 7–12 as 2, 13–18 as 3, and 19–24 as 4 understanding scores.
SPSS (Statistical Package For Social Sciences) version 20. [IBM SPASS statistics (IBM corp. Armonk, NY, USA released 2011)] was used to perform the statistical analysis.
| Results|| |
Out of 376 (100%) participants, 334 (88.8%) knew about consent form and 320 (85.1%) felt that informed consent is necessary [Table 1]. Majority of the participants were males (219 [58.2%]) followed by females (157 [41.8%]) [Table 2]. Out of the 376 (100%) participants, majority belonged to the age group of 21–30 years (103 [27.4%]) followed by 41–50 years (76 [20.2%]); 31–40 years (66 [18.1%]); 10–20 and 51–60 years (44 [11.7%]); and 61–70 years (41 [10.9%]). Age and awareness scores showed that the age groups of 10 to 20 yrs and 61 to 70 yrs had higher scores ranging from 6 to 10-29 (65.9%) and 22 (53.6%) respectively [Table 3]. Majority of the males [163 (74.4%)] were in category 2 when gender and understanding scores were considered [Table 4]. Similarly, age and understanding scores showed that the age group of 10 to 20 yrs and 61 to 70 yrs had higher scores ranging from 1 to 6-19 (43.1%) and 18 (43.9%) respectively [Table 5].
|Table 1: Distribution of the study participants based on the responses to the questionnaire|
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|Table 2: Distribution of the study participants based on gender and awareness scores|
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|Table 3: Distribution of the study participants based on age and awareness scores|
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|Table 4: Distribution of the study participants based on gender and understanding scores|
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|Table 5: Distribution of the study participants based on age and understanding scores|
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Most of the study participants (294 [78.2%]) opted 18 years as the legal age to give informed consent followed by 12 years which was opted by 67 (17.8%) participants and 5 years by 15 (4%) participants, whereas 200 (53.2%) respondents did not know about for what informed consents are recorded following which 109 (29%) participants responded to protect the doctor and 67 (17.8%) responded to protect the patient.
| Discussion|| |
Informed consent is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial, the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare.
Conventionally, informed consent is thought to be in terms of the documents signed and dated by participants, setting forth the purpose, benefits, risks, and other study information necessary to allow the participants to make an informed and voluntary decision to participate in the clinical study. In reality, informed consent is the process that applies to each communication to participants, commencing with the subject recruitment material and the initial telephone screening of potential subjects through the conclusion of the study. It also describes the obligation of the investigator to inform the subject about the personal benefits and risk an individual faces in the study.
In the background of this lack of patients' awareness, consent to medical intervention remains an ethical and legal responsibility of the physician. For consent to be fully informed, the physician has to address five areas, namely the nature, purpose, risks, and benefits of and availability of alternatives to the proposed procedure. The Supreme Court of India has also given the following guidelines on informed consent: a doctor must seek and secure the consent of the patient before starting treatment. The consent so obtained should be real and valid. The information should include the nature and procedure of the treatment and its purpose, benefits and effect, alternative treatment if any available, an outline of the substantial risks, and the adverse consequences of refusing treatment.
The Supreme Court judgment emphasized the need for specificity of consent. Consent given only for a diagnostic procedure cannot be considered as consent for a therapeutic procedure. Consent given for a specific procedure will not be valid for conducting another procedure. However, there can be a common consent for diagnostic and operative procedures where they are contemplated. Consent can also be sought for a particular surgical procedure that also explicitly covers additional or further procedures that may become necessary during the course of surgery. The nature and extent of information to be furnished by the doctor to the patient to secure the consent should be acceptable as normal and proper by a body of Doctors skilled and experienced in the particular field.
Most dental treatments involve “implied consent.” For example, the patient opens his/her mouth for examination and allows a procedure to be done. However, implied consent may not provide sufficient protection for the dentist against legal action. Expressed consent is obtained from a patient for a specific procedure and should be obtained for all procedures that are not routine and carry a material risk. Oral consent is one form of expressed consent and is normally adequate for routine treatment such as fillings and prophylaxis. However, it should be witnessed and properly documented in the patient's record. Apart from this oral discussion, written consent should be obtained for any proposed therapy and the information provided should include the risks and benefits of the treatment and also possible alternative therapies. Even verbal consent if obtained properly, is valid. However, later, the patient may deny having been given information either because he/she would have genuinely forgotten or because he/she would have a grievance and wish to strengthen a legal case against the dentist. Hence, when the patient cannot give consent, it is always advisable to take the signature of the family member along with a third party witness signature. Written consent is advisable as it may decrease liability from miscommunication.
Several studies have shown that written information has beneficial effects. Patients who were given written information have better understanding and postoperative recall of information.
In the present study, 88.8% of respondents knew about informed consent, which was an important finding of our study, the reason of which was that the study setting was in a dental college situated in Bengaluru city where majority of the people are educated. Interestingly, 53.2% of the respondents did not know about what does the informed consent is actually for and what are its components, which was similar with the studies conducted by Singh et al. and Ahmed et al.
Nearly 73.4% of the study participants were aware about Consumer Protection Act (COPRA); however, still, 26.6% did not know about COPRA. It is time we take essential steps in educating this group of population so that they enjoy their basic rights at the fullest.
Similarly, on categorizing males and females, 74.4% comprised of males who had understanding scores ranging from 7 to 12, and the distribution was similar in case of females.
Our study showed that many patients have limited knowledge of the legal implications of signing or not signing consent forms and do not recognize written consent as primarily serving their interest. Limitations of the present study are that it is a cross-sectional study and cannot follow up the changes in concepts about informed consent on the patients. A qualitative study design should have been followed up. A more standardized questionnaire should have been used.
| Conclusion|| |
Informed consent process is intended to protect patients and to promote an enlightened ethics in patient–dentist relationship. Our study showed that many patients had limited knowledge of the legal implications of signing or not signing consent forms and did not recognize written consent as primarily serving their interest. Patients have limitations in understanding clinical information also. This calls for an intense public health education program for the population with media support over a long period of time for outcome measures.
Financial support and sponsorship
Conflicts of interest
This is an Indian Council of Medical Research-approved project (Short Term Studentship – STS) with reference id-2014-03770.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]