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ORIGINAL ARTICLE  
Year : 2013  |  Volume : 3  |  Issue : 1  |  Page : 34-39
Knowledge, awareness and attitudes about research ethics among dental professionals in a dental institution of south India


1 Department of Oral Medicine and Radiology, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India
2 Department of Orthodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India
3 Department of Prosthodontics, Vishnu Dental College, Bhimavaram, Andhra Pradesh, India

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Date of Web Publication13-Feb-2014
 

   Abstract 

Background: The field of dentistry has developed rapidly over the past century based on the Hippocratic principles. Research in dentistry is aimed at investigating the causes and treatment of dental disease and is based on the same ethical standards that govern the field of medicine. Very little research has investigated the attitudes of dental professionals toward the concepts of research ethics and the acceptability of research ethics committees, accordingly a cross sectional study was designed in our institution.
Aims and Objectives: The objectives of our study were to assess the knowledge awareness and attitudes of dental faculty regarding research ethics committees and research ethics.
Materials and methods: A cross sectional survey was carried out in our institution with the consent of the ethical committee. The study was designed in a questionnaire form which was used to assess attitudes, awareness of dental professional regarding research ethics committee and knowledge in practices of research ethics. A total of 115 proformas were distributed and 100 completely filled proformas were analysed.
Results: The dental faculty is favourable towards research ethics training and role of research ethics committee in conducting quality dental research. About greater than half of the participants (51%) had a prior experience in research involving human subjects. Among people involved in prior research about 49% participants have conducted < OR = 3 projects, while 2-3% of the people were involved in > 3 research projects. The attitudes towards practices in research ethics showed that greater than 90% (94-98%) of the patients responded positively. The results from the survey recommends the institutional authorities about the need for training in research ethics with special emphasis on vulnerable participants, aspects related to responsible conduct of research and the roles and functions of research ethics committees.
Conclusion: Adequate knowledge of the dental professionals regarding research ethics and their attitudes towards practices of ethical principles and ethical committees will favour quality research and provide a caring society.

Keywords: Ethics, research, research ethics committees

How to cite this article:
Reddy R S, Ramya K, Raju M, Rayudu G S, Kiran CS, Jyothirmai K. Knowledge, awareness and attitudes about research ethics among dental professionals in a dental institution of south India. J Educ Ethics Dent 2013;3:34-9

How to cite this URL:
Reddy R S, Ramya K, Raju M, Rayudu G S, Kiran CS, Jyothirmai K. Knowledge, awareness and attitudes about research ethics among dental professionals in a dental institution of south India. J Educ Ethics Dent [serial online] 2013 [cited 2019 Dec 12];3:34-9. Available from: http://www.jeed.in/text.asp?2013/3/1/34/126942



   Introduction Top


The field of dentistry like medicine is a Hippocratic profession and is committed to ongoing research motivated by the need to improve the overall health of the patients. [1] The field of dentistry has developed rapidly over the past century based on the Hippocratic principles. Research in dentistry is aimed at investigating the causes and treatment of dental disease is based on the same ethical standards that govern the field of medicine. [2]

Research can be defined as ''a detailed study of a subject, especially in order to discover (new) information or reach a (new) understanding." Hippocrates incorporated into his school at cos three ingredients which have survived into contemporary health care practice (Lloyd, 1978): First, there was a skill or art which was learned by apprenticeship in dealing with actual cases. Second, there was a search for the natural explanations of disease and an attempt to build up a body of scientific knowledge which could be used to inform one's skill. Third, there was an ethos of caring and respect for human beings.

The first two elements laid the foundation for a tradition of health care to continue to the present scientific era. Apart from accumulation of case based skill, attempt to achieve explanations for disease phenomenon has lead to the paths of modern research combined with the fact that the art which is being practiced should be surrounded by the ethical commitments. [1] Following ethical standards is crucially important because it protects the medical practice against unscrupulous use of that specialized and privileged knowledge which has been obtained in an attempt to offer real benefits to suffering people. [3],[4]

Knowing what constitutes ethical research is important for all people who conduct research projects or use and apply the results from research findings, to ensure the safety of research subjects and to prevent sloppy or irresponsible research because ignorance of policies designed to protect research subjects is not considered a viable excuse for ethically questionable projects. Therefore, the duty lies with the researcher to seek out and fully understand the policies and theories designed to guarantee upstanding research practices. [3],[4]

Research is a public trust that must be ethically conducted, trustworthy, and socially responsible if the results are to be valuable. research ethics are a set of principles or guidelines that will assist the researcher in making difficult research decisions and in deciding which goals are most important in reconciling conflicting values. (Ethics, From Belmont Report Psychology 6018). Despite the existing guidelines for research ethics, in the developing countries regulations do not exist and there is an alarming concern about the extent of individual and institutional research ethics capacity including the existence of functioning ethical review systems [5] There is a question regarding the functioning of the existing research ethics committee and the challenges being faced by them. [6] Review of the existing studies from developing world including Middle East, Egypt and other countries also justify the existing condition. [7],[8],[9]

Very little research has investigated the attitudes of dental professional toward the concepts of research ethics including the acceptability of research ethics committees and their desire for training in research ethics, accordingly a cross sectional study was designed to be carried out in our dental school in this regard.

Aims and objectives

The objectives of our study were to assess the knowledge, awareness and attitudes of dental professional regarding research ethics committees and research ethics.

To report the institutional authorities to develop programs in research ethics, so as to improve the quality of dental research.


   Materials and Methods Top


A cross sectional survey was carried out in the institution with the consent of the ethical review board of the institution. The study participants included post graduate students, and faculty members (assistant professors, readers, professors). The study was designed in a questionnaire form based on the objectives of our study (assessment of knowledge, awareness and attitude).

The questionnaire consisted of following parts: the first part consisted of the demographic information of the participants: age, gender, academic position, prior participation in human research subjects, number of research projects involved in and prior training in research ethics. The second part of the questionnaire assessed the participants self awareness toward ethical principles and functions of the ethical committees. In the third part of the questionnaire the respondents were asked to choose about research ethics committee from a 5 point Likert scale ranging from 1 to 5 (1-strongly agree, 2-agree, 3-not sure, 4-disagree and 5-strongly disagree). In the fourth part respondents were asked to again choose from the 5 point Likert scale regarding attitudes toward certain practices in conduct of research like informed consent, enrolment of vulnerable individuals, confidentiality and responsible conduct of research. The fifth part of questionnaire involved questions regarding assessment of knowledge which were based on case scenarios involving informed consent describing risks and benefits, research involving children, retrospective research on stored samples originally collected for clinical purposes and finally confidentiality in medical research.

A total of 115 questionnaires were distributed among post graduates and faculty members of the institution. The participants were asked to return the filled proformas back anonymously by placing it in a general mail box in the department. Of the total 115 questionnaires, 15 were excluded from the study as these questionnaires were not completely filled. Only completely filled in proformas were considered for analysis.

The data obtained were subjected to statistical analysis using the SPSS -16 software. The responses were represented in the form of percentages of responses. Multivariable logistic regression model was done for self awareness toward ethical principles and attitudes and knowledge to determine the independent predictors of the dependent responses. For those associations which were significant odds ratio and confidence limits were expressed, the P-value was set significant at 0.0001.


   Results Top


[Table 1] shows the demographic details of the participants. The age range of the participants was between 20-50 years of which the highest percentage of participants ranged between 20-30 years (67%) . Of the total participants about 56% were males while 46% were females. The percentage of subjects based on the academic qualification showed that highest percentage of participants were postgraduates (59%) followed by senior lecturers (21%), professors (17%) and readers (3%).
Table 1: Showing demographic details of participants – age, sex and qualification expressed in terms of N%

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[Table 2] shows the percentage of people and their research experiences. About greater than half of the participants (51%) had a prior experience in research involving human subjects. Among people involved in prior research about 49% participants have conducted < OR = 3 projects, while 2-3% of the people were involved in > 3 research projects. Regarding the prior training in research ethics though greater than half of the participants, 67% had undergoing training in research ethics, but still greater than half of the participants, 61% agreed that they were not completely aware of the research ethics. There was almost an equal response regarding the awareness of the functions of the ethical committee between the participants. While 54% were aware of the functions of ethics committee 46% were not completely aware of it.
Table 2: Showing details about involvement in prior research ethics expressed as % yes or % no

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While analysing the awareness regarding the functions of research ethics committees [Table 3] and research ethics educations - more than 80% (80-95%) of the participants responded positively (i.e., represented by strongly agree, agree) regarding the role of research ethics committee, need for it, the need for research to be reviewed by the committee, training to the investigators and the aspect of including research ethics in post graduate module.
Table 3: Attitudes of participants regarding research ethics committees and research ethics education

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There were varied responses regarding few aspects like - whether ethical review is only necessary for international collaborative research - while about 18% agreed that it is only necessary for international collaborative research, 19% were not sure about it, 66% did not agree with this. Similarly regarding the delay of research caused by the research ethical committee 26% agreed with it, 27% were not sure while 47% disagreed with it.

The attitudes toward practices in research ethics [Table 4] showed that greater than 90% (94-98 %) of the patients responded positively (i.e., represented by strongly agree, agree) with regard to various aspects of protecting data from accidental exposure and aspects of informed consent but there was wide variation in relation to aspects like - whether patients should be told about the potential risks of a study because they may not enroll in the study - in this aspect 70% were against this but around 25% agreed with it while 7% were not sure of this. In the aspect of obtaining informed consent for blood samples for clinical tests - 10% were not sure of this while 5% did not agree with it. In obtaining informed consent from vulnerable groups - participants almost equally agreed and disagreed to this while 10% were not sure of this condition. Regarding the question of including vulnerable subjects in the absence of surrogate one-fourth of the participants are of the opinion that these subjects can be included while another one-fourth of the participants were not sure of whether these subjects can be included the rest half of the participants were against including those vulnerable subjects without informed consent from surrogates in the research. When it was asked if data can be fabricated in order to improve the outcome of the research as long as there is no harm to the patients - participants equally agreed and disagreed to it (approx 40% each) while 13% were not sure whether this can be done or not.
Table 4: Attitudes regarding practices in research ethics

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In analysing the last objective of our study, i.e. to assess the knowledge [Table 5] - varied results were obtained from the participants. The participants showed a better knowledge regarding informed consent describing risks and benefits (86% correct and 14% wrong). In the aspect of research involving children - 67% had accurate knowledge. In view of the confidentiality in medical research only a few greater than half of the participants (56%) had accurate knowledge. From the data obtained it was observed that participants had poor knowledge regarding the use of stored samples originally collected for clinical purposes (30% - correct, 70% were wrong).
Table 5: Knowledge involving various aspects of research

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When Multivariable logistic regression model was done for self awareness toward ethical principles it was found that females significantly had much awareness compared to males with P < 0.0001 , 95% confidence interval between 1.27-4.55 and odds ratio 2.39 . Similar results were obtained with attitudes toward practices in research ethics where females again showed significance over males with P < 0.0001 confidence interval 1.29, 4.44 and odds ratio 2.66. When attitudes where assessed in regard to the academic qualification senior lecturers showed better attitudes toward practices in research ethics with P-value <0.0001 confidence limit 1. 67, 3.68 and odds ratio 2.56.


   Discussion Top


The results of this study showed some interesting facts regarding the awareness, knowledge and attitudes of dental professional of our dental school. The participants of the survey showed a high endorsement for the existence of research ethics committee and were of a generalized opinion that these committees would be helpful for promoting research and are necessary for reviewing the research projects, this is in correlation of the previous studies conducted in various other countries like Sudan, Egypt, Middle East. [2],[10],[11]

Though about 67% of the population have shown that they had prior training in research ethics, but they still agreed that they were not completely aware of the ethical guidelines governing the human research. This shows the lacunae in complete awareness of research ethics. A similar finding was observed regarding the functions of ethical committee which emphasize the need of ethical review board and its functioning in the institutions.

While the faculty in this study endorsed the existence of research ethics committee, almost one-fourth of them held the opinion that such committees would delay research and make it more difficult to perform research. While other one-fourth were not aware of it. A similar finding was identified from western countries where it was of the opinion that excessive bureaucratic details caused delay in research. [12],[13],[14] In our study the possible reason that may be behind this opinion is that their might not be an understanding among the participants regarding the extent of processes needed for adequate review of research or because of their unfavorable experiences with the committees. Indeed about few less than half of the participants (46%) were not fully aware of the functions of research ethics committees highlighting that efforts are needed to enhance awareness of the operations of research ethics committees. These findings suggest that further qualitative research involving in depth interviews is warranted to further explore the basis of faculty attitudes regarding the process of research review by research ethics committees.

Our study also yielded certain interesting facts regarding attitudes of practices in ethics. The dental professionals of the institution appeared to be aware of practices regarding confidentiality protections and several aspects regarding informed consent process. This is in contrast to that identified from other parts of world like Egypt. [15] Another concern we discovered regarding informed consent is that almost 40% of the faculty believed that certain vulnerable subjects (e.g., children and the mentally ill) could provide informed consent to participate in research. This result raises the underlying issue of how "informed" is informed consent for subjects who might lack decision making capacity. This result is made more significant by the findings of another study showing that research participants who participated in studies on oral health in Nigeria had poor understanding of several key elements of the informed consent process. [16] Accordingly, we suggest future training efforts for dental faculty to be focused on informed consent issues, including those issues involved with concepts of understanding and vulnerability.

A part, but significantly major number of participants (approximately 40%) thought it is permissible to fabricate data as long as there is no harm to the patients. This percentage is close to the one in previous study where about 27% were willing to select or omit data to improve the results. [17] The reasons for this controversy could not be elicited but could be stated as not having a positive approach toward quality research and this needs to be addressed properly.

In assessing the knowledge of the participants toward research ethics we found that the participants had good knowledge regarding various aspects of ethics like informed consent describing risks and benefits, research involving children. In the aspect of confidentiality in medical research nearly less than half were wrong while in the retrospective research on stored samples originally collected for clinical purposes, more than three quarters had no adequate knowledge. These results raise the issue the area where the current research training programs should be focused upon and further research probe for the factors that account for any differences in knowledge gaps.

The limitations of our study include convenience sampling, smaller sample size, the type of questions used to assess knowledge may completely not represent the broad range of topics in research ethics and we did not obtain detailed information regarding the types of courses and workshops that the faculty had attended as well as the methods of instructions used in their training. Despite these limitations our survey revealed that though gaps exist in research ethics, the dental professional is favorable toward research ethics training and role of research ethics committee in conducting quality dental research. The survey also recommends the further development of educational instruction in research ethics with special emphasis on vulnerable participants, responsible conduct of research and the roles and functions of research ethics committees. Finally we recommend qualitative studies to further explore the attitudes of faculty toward research ethics committees and practices in research committees.


   Conclusion Top


In conclusion, dentistry which is built on overall ethos of partnership among patient, professional and scientist will flourish with mutual enterprise directed toward health and well being of the patients and thus health care research becomes an integral part of this enterprise. Our study revealed that though gaps exist in research ethics, the dental professional is favorable toward research ethics training and the role of research ethics committee in conducting quality dental research. The survey also recommends the further development of educational instruction in research ethics with special emphasis on vulnerable participants, responsible conduct of research and the roles and functions of research ethics committees. Finally we recommend qualitative studies to further explore the attitudes of faculty toward research ethics committees and practices in research committees.

So the knowledge of the dental professionals regarding research ethics and their attitudes toward practices of ethical principles and ethical committees will favor quality research and provide a caring society.

 
   References Top

1.Gillett GR. Ethics and dental research. J Dent Res 1994;73:1766-72.  Back to cited text no. 1
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3.World Health Organization. Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. 59th WMA General Assembly, Seoul, Republic of Korea, October 2008.  Back to cited text no. 3
    
4.Council for International Organizations of Medical Sciences (CIOMS), international ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: Council for International Organizations of Medical Sciences; 2002.  Back to cited text no. 4
    
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10.Asem N, Silverman HJ. Perspectives of faculty at Cairo University towards research ethics and informed consent. In Proceedings of the Public Responsibility in Medicine and Research (PRIMandR '06), Nashville, Tenn, USA, 2009.  Back to cited text no. 10
    
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Correspondence Address:
R Sudhakara Reddy
Prof and HOD, Department of Oral Medicine and Radiology, Vishnu Dental College, Bhimavaram, Andhra Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-7761.126942

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