|Year : 2021 | Volume
| Issue : 1 | Page : 16-21
Assessment of knowledge and attitude toward informed consent and assent for biomedical research involving children among health-care professionals in Belagavi city: A questionnaire study
Vidyavathi H Patil, Shivayogi M Hugar, Niraj S Gokhale, Shweta Kajjari, Nivedita Saxena, Pooja K Dialani
Department of Pediatric and Preventive Dentistry, KAHER's KLE VK Institute of Dental Sciences, Belagavi, Karnataka, India
|Date of Submission||01-Jan-2021|
|Date of Decision||02-Mar-2021|
|Date of Acceptance||03-Apr-2021|
|Date of Web Publication||22-Apr-2021|
Dr. Vidyavathi H Patil
Department of Pediatric and Preventive Dentistry, KAHER's KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Most of the nations have proposed research regulations to protect the rights and welfare of the research participants. Among such regulations are the informed consent and assent. In the present world, informed consent and assent is the cornerstone in health practice. Aims and Objectives: To compare and evaluate the knowledge and attitude toward informed consent and assent for biomedical research involving children among health-care professionals in Belagavi city. Materials and Methods: A cross-sectional questionnaire study was conducted among 300 house surgeons divided into four groups of Medical, Dental, Nursing, and Ayurveda faculty of Belagavi city. A self-administered multiple choice questions were used to evaluate the knowledge and a five-point Likert scale was used to asses attitude regarding informed consent and assent for research involving children. Statistical analysis was done using SPSS version 20. Results: There was statistically significant difference in mean knowledge and attitude among all four groups (P < 0.05), and there was no significant correlation between knowledge and attitude as a whole in each group of professionals (P > 0.05). Conclusion: Emphasis on additional training is the need of the hour for all the faculty participants and also incorporation of study material regarding informed consent and assent for research involving children by the policy makers.
Keywords: Assent, informed consent, research
|How to cite this article:|
Patil VH, Hugar SM, Gokhale NS, Kajjari S, Saxena N, Dialani PK. Assessment of knowledge and attitude toward informed consent and assent for biomedical research involving children among health-care professionals in Belagavi city: A questionnaire study. J Indian Soc Pedod Prev Dent 2021;39:16-21
|How to cite this URL:|
Patil VH, Hugar SM, Gokhale NS, Kajjari S, Saxena N, Dialani PK. Assessment of knowledge and attitude toward informed consent and assent for biomedical research involving children among health-care professionals in Belagavi city: A questionnaire study. J Indian Soc Pedod Prev Dent [serial online] 2021 [cited 2021 Jun 21];39:16-21. Available from: https://www.jisppd.com/text.asp?2021/39/1/16/314355
| Introduction|| |
Over the recent decades motivated by the need to improve health, medical research has greatly increased in many countries. Such research needs to be guided by fundamental ethical principles as it involves human participants to protect their rights and well-being. To understand the social and behavioral characteristics, advancement of knowledge in health, disease, and therapeutics, the pediatric research has become vital. For this, the informed consent and the child assent which are prudent agreement to participate in research have become the important element. Wherein, informed consent is a process which discloses appropriate information by the researcher or health-care provider to the patient or guardian so as to make voluntary choice to accept, participate, or refuse a research or treatment; and the assent is the child's agreement to participate in research.
The Nazi physicians due to scientific aspiration committed the most horrid of atrocities due to racial discrimination in the human subjects who were prisoners. To prevent such calamities from happening in future, the Nuremberg military tribunal formed a code of conduct called the Nuremberg code, according to which voluntary informed consent had to be obtained from all research participants. However, it excluded individuals who cannot legally consent like the mentally handicapped, unconscious individuals, and the minors. Knowing this weakness, the legally authorized representatives were permitted to give consent for research for such individuals by the Helsinki Declaration of 1964. In 1976, the American Academy of Pediatrics published the term “Informed Consent” which was relatively a new concept at that time. It acknowledged the importance of informed consent in an extensive and well written report as a comprehension of procedures to be undertaken on minor by the patient's whole family. Later in 1982, the Council for International Organizations of Medical Sciences in collaboration with the World Health Organization for the first time gave the concept of assent which has evolved considerably since then.
Health-care professionals and researchers as per the regulations governing research must obtain informed consent and assent for any biomedical research involving children. Considerable studies have been done with this regard in the Western world, but very few studies have been done in India. Hence, the aim of this study is to compare and evaluate the knowledge and attitude among health-care professionals toward informed consent and assent for biomedical research involving children in Belagavi city.
| Materials and Methods|| |
A cross-sectional questionnaire study was conducted in the department of pediatric and preventive dentistry after obtaining ethical approval from the Institutional Review Board and permission to conduct study among house surgeons of different faculties was taken from the corresponding institution head. A sample size of 296 was calculated using standard sample size formula which was rounded to 300. The samples were divided into four groups (Group A, B, C, and D) with 75 participants in each from medical, dental, nursing, and Ayurveda respectively.
We developed the questionnaire based on our study objectives by taking the guidance from the previous literature published regarding knowledge and attitude toward informed consent and assent for biomedical research involving children among different health professionals. The study tool consisted of two parts. The first part assessed the participant's knowledge by asking them to select the correct answer from the multiple choice questions. The second part assessed their attitude on a 5-point Likert scale.
The inclusion criteria for the study included house surgeons from medical, dental, nursing, and Ayurveda institutions in Belagavi city. The exclusion criteria for the study were undergraduates who are still studying, postgraduates, and participants who did not give consent for the study.
The questionnaire was distributed to the participants, and the data collected from them were entered in excel sheet and were analyzed using SPSS version 20 (SPSS Inc., Chicago, IL, USA).
| Results|| |
Knowledge among health professionals
When comparison of knowledge scores was tested using Chi-square test among medical, dental, nursing, and Ayurveda house surgeons, there was statistically significant (P < 0.05) difference in knowledge between groups with respect to as to from whom the consent and assent has to be obtained, Helsinki declaration for informed consent, account of the child's developmental level to obtain assent, the age for obtaining oral assent, the governing bodies which regulate consent and assent norms, conditions where in consent can be waived off or deferred, and the elements that the informed consent must include. However, there was no statistically significant difference in knowledge among groups regarding knowledge on the terminologies of consent and assent, how the consent has to be obtained in case of an illiterate parent or legally authorized representative, when the re-consent may be needed and Nuremberg code [Table 1].
|Table 1: Comparison of four groups of professionals with correct knowledge in each item|
Click here to view
The Chi-square test was used to find the association between levels of knowledge (low, average, and high) among groups and was found to be statistically significant. The dental group showed high level of knowledge and nursing group showed low level of knowledge in our study [Table 2].
When comparison for mean knowledge was done for the four groups using one-way ANOVA, it was found to be statistically significant [Table 3]. Pair-wise comparison of knowledge was done using Tukey's multiple post hoc procedure, and it was found statistically significant for all pairs except for medical versus Ayurveda and dental versus Ayurveda group [Table 4].
|Table 3: Comparison four groups of professionals with mean knowledge and attitudes by one-way ANOVA|
Click here to view
Attitude among health professionals
When comparison of attitude scores was tested using Kruskal–Wallis ANOVA among medical, dental, nursing, and Ayurveda house surgeons, there was a statistically significant (P < 0.05) difference in attitude between groups with respect to as to that every researcher should take consent and assent before start of a study, the curriculum should strengthen the topics on consent and assent, information shared with consent and assent should differ as per gender, information of research should be shared in consent and assent, consent and assent to be taken because of modern ethical issues and patient autonomy, alternative treatment, risks and uncertainties to be mentioned in consent and assent forms, and risk of invasion of privacy of ethical documents during sharing of patient care among professionals. However, there was no statistically significant difference in attitude among groups regarding the necessity of governing body to regulate the norms of consent and assent, researcher facing hurdles to obtain consent and assent for research involving children, and the presence of predominant paternalistic culture in India may have an influence to get consent and assent [Table 5].
|Table 5: Comparison of four groups of professionals with attitude scores in each item by Kruskal-Wallis ANOVA|
Click here to view
The Chi-square test was used to find the association between levels of attitude (low, average, and high) among groups and was found to be statistically significant. However, with respect to attitude, the Ayurveda group showed the high level of attitude compared to other professionals with the least being among nursing professionals [Table 2].
When comparison for mean attitude was done for the four groups using one-way ANOVA, it was found to be statistically significant [Table 3]. Pair-wise comparison of attitude was done using Tukey's multiple post hoc procedure, and it was found statistically significant for all pairs except for medical versus Ayurveda and dental versus Ayurveda group [Table 4].
Correlation between knowledge and attitude among health professionals
Karl Pearson's correlation coefficient revealed that there was no significant correlation between knowledge and attitude as a whole and in each group of professionals (P > 0.05) [Table 6].
|Table 6: Correlation between knowledge and attitude scores in each group by Karl Pearson's correlation coefficient method|
Click here to view
| Discussion|| |
The pediatric and adolescent research trails have increased in number all over the world. The protection of safety, well-being, rights, and dignity of participants is the prime responsibility of every researcher. For this, they should be aware of the medical, scientific, legal, ethical, and social requirements in a research proposal and should also comply with it. For this, the researcher should have through knowledge and an attitude toward informed consent and assent for biomedical research involving children.
The child's right weather to participate as research subject and parents participation in health-related decision have been acknowledged all over the world through ethical guidance in clinical research since the Helsinki Declaration in 1964. The power of authority of child's assent should increase by age according to some of the international instruments regulating human research., In UK, the age is defined as school age by the Royal college of Pediatrics. Moreover, in the United States, the child's seventh birthday is set as age by which assent can be obtained as per the National Commission for the Protection of Human Subjects of Biomedical and Behavioral research. In India as per Indian Council of Medical research, the verbal/oral or written assent, as approved by the EC, should be obtained from children of 7–18 years of age.
Informed consent is essential in pediatric research as it protects the participating children from any possible harm and reflects respect to an individual by their enrollment in research. The requirement of simple consent may be dated back to eighteenth century English law for surgical procedures, it was only in the 1950's the doctrine of true informed consent was developed by the American courts. As children lack the intellectual capacity to make decisions, the authority to allow a child to participate in research rests on parents/legally authorized representatives.
This study was conducted among 300 house surgeons of medical, dental, nursing, and Ayurveda to appraise their knowledge and attitude toward informed consent and assent for biomedical research involving children. The study showed that only 11% of house surgeons had high level of knowledge on informed consent and assent, with an average knowledge level being 66.33% and low level knowledge being 22.67%. When compared among different faculty house surgeons, the high level of knowledge was seen more among dental professionals followed by Ayurveda, Medical with the least being among the nursing professionals.
Nearly 60% of participants have an idea as to who is the authority person to give informed consent and the developmental level of child to be taken into account to obtain assent from the child. However only around 42%–49% of them had knowledge on how informed consent to be taken from an illiterate person, from whom consent and assent to be taken as well as who can give incase of research involving minimal risk. Many of them fared poor knowledge in answering about when exempt can be given for re-consent, Nuremberg code, Helsinki Declaration, age of child for oral assent to be taken, condition when consent can be waived off and differed.
However in case of attitude, only 17.33% of participants had high attitude level, with an average being 68% and least attitude among 14.67%. When compared among different faculties, the Ayurveda house surgeons had high level of attitude, followed by the medical, dental with the least being among the nursing house surgeons.
Nearly 55% of the participants strongly agreed that consent and assent to be taken before the start of the study. Around 51%–54% of them agreed that they face hurdles to obtain consent and accent and they feel that the presence of predominant paternalistic culture may have an influence to obtain it for research in children. Furthermore, 43% felt that it is helpful in today's scenario because of modern ethical issues and patient autonomy. However, nearly 17% of participants remained neutral with attitude and 70% (strongly agree and agree) of them felt that information shared in consent and assent should differ by gender of research participant.
Thus this study illustrates that there is dissimilar knowledge and attitude and no correlation between knowledge and attitude among different faculty house surgeons on informed consent and assent for biomedical research involving children. There are certain limitations in this study. First, only house surgeons were involved in the study. It did not include postgraduates, academicians, and private practitioners. Hence, there could be difference of knowledge among them. Second, the knowledge type questions asked were of basic information regarding informed consent and assent and did not cover broad range of topics in them. Moreover, finally, we did not collect any information regarding these topics being taught in their course content of their profession.
| Conclusion|| |
This study revealed that the house surgeons of the medical, dental, nursing, and Ayurveda had unbalanced knowledge and dissatisfactory attitudes, thereby emphasizing training and need for education and practice by current recommendations by the guidelines put forth by competent authorities to be given regarding legal jurisprudence for research involving children at the undergraduate training.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
El-Dessouky HF, Abdel-Aziz AM, Ibrahim C, Moni M, Abul Fadl R, Silverman H. Knowledge, awareness, and attitudes about research ethics among dental faculty in the Middle East: A pilot study. Int J Dent 2011;2011:1-13.
Khabour OF, Alomari MA, Al-Sheyab NA. Parental perceptions about informed consent/assent in pediatric research in Jordan. J Empir Res Hum Res Ethics 2017;12:261-8.
Khare A, Saxena V, Jain M, Sharva V, Singh P, Dayma A. Knowledge and attitude toward informed consent in medical and dental practitioners, of Bhopal City, India. J Dent Res Rev 2017;4:17-20. [Full text]
Leibson T, Koren G. Informed consent in pediatric research. Pediatr Drugs 2015;17:5-11.
Sarmiento RV, Da Motta MV. Clinical research involving children: Consideration relating to assent. Revista de Bioética y Derecho 2013;29:51-61.
National Ethical Guidance for Biomedical and Health Research Involving Human Participants. New Delhi: Director-General, Indian Council of Medical Research; 2017. p. 5-61.
The Council of Europe: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine-Explanatory Report. Europe: Council of Europe; 1997. p. 5.
World Medical Association (WMA). Human Experimentation. Code of Ethics of the World Medical Association. Declaration of Helsinki. Br Med J 1964;2:177.
Royal College of Paediatrics. Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 2000;82:177-82.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Report and Recommendations: Research Involving Children. Washington: The National Commission for the e Protection of Human Subjects of Biomedical and Behavioral Research; 1977.
Katz AL, Webb SA, Committee on Bioethics. Informed consent in decision-making in pediatric practice. Pediatrics 2016;138:e1-6.
National Ethical Guidelines for Biomedical Research Involving Children. Director General, Indian Council of Medical Research; 2017.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]