A Study to assess the Knowledge on Ethical considerations in research among Health Sciences Teaching Faculty under Kerala University of Health Sciences

 

Mrs. M. Marie Rosy

Associate Professor, KVM College of Nursing, Cherthala, Kerala

 

ABSTRACT:

Although codes, policies, and principles are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require considerable interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and to act ethically in various situations. The study was to assess the knowledge on ethical considerations in research among health sciences teaching faculty. Quantitative approach and descriptive survey design. The study was conducted among 30 health sciences teaching faculty in selected health sciences colleges at Alappuzha district. The obtained data were analyzed by descriptive and inferential statistics. The overall knowledge on ethical consideration of research was 46.7% and range was 3, mean 2.50 and the standard deviation 0.777 there was a significant association between the level of knowledge on ethical consideration on research with health stream nursing ᵡ² =2.216, P<0.529^* at 0.05,gender ᵡ² 1.735, P<0.629^*,qualification ᵡ² =6.263, P<0.100^*,institution has IEC ᵡ² =3.319, P<0.345^* and ethical guidelines ᵡ² =1.916, P<0.590^* level of significant at 0.05. Majority of the health teaching faculty has good knowledge on ethical consideration on research. If “deviations” from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher’s understanding of ethics and by sensitizing him or her to the issues.

 

 

INTRODUCTION:

Ethics” is defined as “norms for conduct” that distinguishes between reasonable and unreasonable behavior.1 However, ethical norms are learnt since childhood at home, school, society, religious places, etc.2 It is affected throughout the life by various experiences in life which explains the subjective variability in interpretation of ethical norms among different individuals.³

 

Research ethics govern the standards of conduct for scientific researchers. Following ethical norms is vital because it protects the medical practice against immoral use of that elite knowledge which has been acquired in an attempt to offer real benefits to suffering people.^4,5

 

Human subjects’ participation in medical research has often raised ethical concerns. After Nazi exploitation; various Guidelines & Declarations were prepared, but still unethical behaviour of healthcare practitioners is being reported. After graduation and entering into practical field, sudden exposure to challenges makes it difficult to take decisions, which shows a lacuna in traditional medical training. There are debates about inclusion of practical ethics in medical curricula.¹³

 

To maintain ethical standards in health research and publication certain norms are laid down by various National and International Agencies. Some of these are as follows: (i) National Institute of Health, (ii) Food and Drug Administration, (iii) National Science Foundation, etc. The Nuremberg Code and Declaration of Helsinki by World Medial Association is the benchmark in ethical standards followed worldwide for biomedical research and uniform requirements for manuscripts submitted to biomedical journals (formulated by International Committee of Medical Journal Editors) for publication in scientific journals.⁶

Regardless of the existing guidelines for research ethics, in the developing nations regulations do not exist and there is an alarming concern about the existence of functional ethical review systems of individual and institutional research ethics.7 The values of ethics should be imparted to every dental graduate as a responsibility toward achieving the highest standards of dental health services.8 

Research Ethics Committees (RECs) are mandated to protect human participants by conducting ethical reviews of biomedical research. To date, there is a dearth of information on the structure, functioning, and outcomes of RECs in Africa. Available empirical evidence suggests that challenges hampering the effective functioning of RECs included lack of membership diversity, scarcity of resources, insufficient training of members,inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation. Relatively little data on the review outcomes of African RECs were described. There is an ongoing need for concerted efforts from various stakeholders to support capacity development and enhancement of African RECs.9

OBJECTIVES OF THE STUDY:

1    To assess the level of knowledge on ethical considerations in research among health science teaching faculty.

2    To find out the association between the knowledge on ethical considerations in research among health science teaching faculty with the demographic variables.

 

STATEMENT OF THE PROBLEM:

A study to assess the knowledge on ethical considerations in research among health sciences teaching faculty under Kerala university of health sciences, Trissur.

 

REVIEW OF LITERATURE:

A aim of the review is to provide current updates on regulations for ethics committees and researchers in India. Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question "what makes clinical research ethical" is significant and difficult to answer as multiple factors are involved. The review result revealed the research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines. In the conclusion of the review article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled. The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.10

A cross sectional survey study was conducted To assess the pattern of instructions regarding the ethical requirements given to authors in Indian Dental Journals and tried to compare the same with British Dental Journals. The material used was Instructions to authors of Indian and British Dental Journals indexed in PubMed were reviewed for guidelines with regard to seven key ethical issues. The result of the study was the 10 Indian Dental Journals, 7 (70%) cited ethical guidelines such as International Committee of Medical Journal Editors, Committee on Publication Ethics, Indian Council of Medical Research guidelines whereas out of 27 British Dental Journals, 16 (59.25%) cited these. Protection of human subjects such as approval from an institutional/independent ethics committee, obtaining informed consent and maintenance of confidentiality of patient records was covered with 8 (80%) Indian and 19 (70.3%) British Dental Journals. Four (40%) Indian and 13 (48.1%) instructed about animals welfare. Nine (90%) of the Indian and 25 (92.5%) British Dental Journals required declaration of conflicts of interest by authors. Publication issues and authorship/contributor ship criteria were specified by all 10 Indian and 25 (92.5%) and 24 (88.8%) British journals respectively. 6 (60%) of Indian and 11 (40.75%) of British Journals explained about data management, in case of clinical trials. A significant proportion of Indexed Indian and British Dental Journals did not provide adequate instructions to authors regarding ethical issues.11

A cross-sectional, questionnaire-based study was conducted to assess the knowledge, attitudes and practice of medical faculty regarding research ethics and research ethics committees (RECs) in ESIC medical colleges in Bangalore among faculty using a validated questionnaire. Majority (76%) of faculty had not undergone training in research ethics. Less than half of the participants answered correctly to a question on guidelines in research ethics, 60% responded correctly to question on research involving children. Majority responded correctly to question on role of a research ethics committee and confidentiality, informed consent and to question on composition of Institutional Ethics Committee. 68% taught that ethical review of research by an ethics committee would delay research. >90% were favorable towards research ethics training. Faculty held attitudes regarding certain research ethics practices that were not optimal, 96% believed that it is okay to fabricate data, 68% taught that if no surrogate is available to give informed consent for vulnerable groups, they could still be included. The study conclude that among the medical faculties participating in our study, there is acceptance of RECs and training in research ethics, while there are knowledge gaps in research ethics guidelines, research involving children. There is need to train researchers and students to make them aware about various aspects of research.¹²

 

A Cross sectional study was conducted to assesses the knowledge, attitude and practices of healthcare ethics among doctors in a government teaching hospital. A self-administered structured questionnaire was devised, tested and distributed (n = 172). Faculty and residents were compared using Chi square test and the residents’ responses in different years of residency were compared using Chi square test followed by Kendall’s tau-c test to find correlation. Faculty was more aware of the guidelines. About 77.8% faculty and 48.5% residents were aware of Institutional Ethical Committee (IEC), and about 37.5% from faculty and 23.5% from residents were satisfied with IEC. Faculty encountered ethical problems more often (62.5% vs 45.5%) than residents. Source of knowledge of bioethics was multiple. Departmental lectures were not preferred mode of learning (8.8%). Colleague was most preferred mode of consultation for any problem. Some residents faced ethical problem in publication. All faculty and 94.1% residents felt the need for further education on bioethics. There was negative correlation (-0.3, p<0.001) between the frequency of ethical problems and residency years. There is an urgent need to include formal training of practical ethics and make departmental learning more interesting.¹³

 

DELIMITATIONS:

Study is delimited to

1.     It confines to health sciences faculty among Kerala university of health sciences.

2.     Sample size is 30.

 

RESEARCH METHODOLOGY:

a. RESEARCH APPROACH:

Quantitative- Non Experimental approach

 

b. RESEARCH DESIGN:

Descriptive Survey Research design

 

VARIABLES:

RESEARCH VARIBLES:

Knowledge on ethical consideration on research

 

SOCIODEMOGRAPHIC VARIABLES:

Health science stream, gender, qualification, designation, Institution has IEC, Have you been member in IEC, Has part of research project and source of knowledge on bioethics principle.

 

c. SETTING:

The study conducted in selected health sciences institutes affiliated with Kerala university of health sciences, Trissur.

 

d. POPULATION, SAMPLE AND SAMPLING TECHNIQUE:

TARGET POPULATION:

All health sciences teaching faculty under Kerala university of health sciences, Trissur.

 

ACESSIBLE POPULATION:

All health sciences teaching faculty under Kerala university of health sciences in Alappuzha districts.

 

SAMPLE AND ITS SIZE:

30, health sciences teaching faculty under Kerala university of health sciences, and who fulfills inclusion and exclusion criteria in Alappuzha districts.

 

SAMPLE TECHNIQUE:

Convenience sampling technique

 

INCLUSION CRITERIA:

Health sciences teaching faculty

·       Who were teaching under Kerala university of health sciences, Trissur.

·       Who were  residing in Alappuzha districts.

·       Who were willing to participate in the study.

 

EXCLUSION CRITERIA:

Health sciences teaching faculty

Who has doing certificate program on basic sciences and ethics under Kerala university of health sciences, Trissur.

 

Tools/ Instruments:

In this study the instruments used were:

·         Socio-Personal proforma - To assess the socio personal variables of the subject includes Health science stream, gender, qualification, designation, Institution has IEC, Have you been member in IEC, Has part of research project and source of knowledge on bioethics principle

·         Semi- structured questionnaire - To assess the Knowledge on ethical considerations among heath teaching faculty.

 

TECHNIQUE:

Structured questionnaire technique

 

METHOD OF DATA COLLECTION:

The investigator obtained formal approval from KVM College of nursing, Cherthala and S.H College of nursing, Cherthala. The investigator selected 30 samples by using a convenience sampling technique. After a brief self introduction the investigator explained the purpose of the study and obtained consent from them. On the first day demographic data and semi structured knowledge questionnaire on knowledge of ethical considerations in research was given to each subject to complete. The time required was 30-40 minute.

 

The existing level of knowledge score was found. Each day around 2-3 samples were selected for data collection. The data was collected for the period of two weeks.

 

Plan for data analysis:

The obtained data was planned to analyze on the basis of the objectives of the study using descriptive and inferential statistics.

 

Ethical considerations:

The study was approved by the research committee.

 

ANALYSIS:

The analysis and interpretation of the data was presented based on the objectives of the study.

 

OBJECTIVES OF THE STUDY:

1    To assess the level of knowledge on ethical considerations in research among health science teaching faculty.

2    To find out the association between the knowledge on ethical considerations in research among health science teaching faculty with the demographic variables.

 

Organization of findings:

Section I: Findings related to description of socio demographic variable of health sciences teaching faculty.

 

Section II: Findings related to level of Knowledge on ethical considerations in research among health sciences teaching faculty.

 

Section III: Association between level of knowledge on ethical consideration in research with demographic variables among health sciences teaching faculty.

 

Section I: Findings related to description of socio demographic variable of health sciences teaching faculty.

 

Table 1:     N=30

Sl. No	Demographic variables	Frequency (f)	Percentage (%)
1	Health Science Stream
	Medicine	0	0
	Dental	0	0
	Ayurveda	0	0
	Nursing	17	56.7
	Homeopathy	0	0
	Allied Health sciences	13	43.3
	Pharmaceutical sciences	0	0
	Total	30	100
2	Gender
	Male	4	13.3
	Female	26	86.7
	Total	30	100
3	Qualification
	B.sc	3	10
	M.sc	27	90
	Total	30	100
4	Designation
	Senior lecturer	7	23.3
	Asst. Professor	15	50
	Asso. Professor	8	26.7
	Professor	0	0
Sl. No	Demographic variables	Frequency (f)	Percentage (%)
5	Institute has IEC
	No	6	20
	Yes	21	70
	Don’t know	3	10
	Total	30	100
6	Member of IEC
	No	16	53.3
	Yes	14	46.7
	Total	30	100
7	Part of any research
	No	4	13.3
	Yes	26	86.7
	Total	30	100
8	Source of Knowledge
	curriculum	21	70
	Training	0	0
	Books	6	20
	Journals	3	10
	Others (specify)	0	0
	Total	30	100
9	Ethical guidelines
	None	24	80
	Belmont report	6	20
	ASU-GCP	0	0
	CIOAMS Guidelines	0	0
	ICMR Guidelines	0	0
	Helsinki Declaration	0	0
	Total	30	100

 

Table 1: depicts that, 56.7% of respondents were nursing stream, 86.7 % female participants, 90% of them qualified M.Sc Nursing, 50% assistant professor, 70% of the respondents had IEC in their institution, about 53.3% were not a member of IEC, 86.7% had a Part of research, 70% of participants source of information through curriculum and 80% had not known about any ethical guidelines.

 

Section II: Level of knowledge on ethical consideration on research among health sciences teaching faculty.

 

Table 2: Frequency, and percentage distribution of level of knowledge on ethical consideration on research among health sciences teaching faculty.

N=30

Sl. No	Level of knowledge	Frequency (f)	Percentage (%)
	Poor	3	10
	Average	11	36.6
	Good	14	46.7
	Excellent	2	6.7
	Total	30	100

 

Table 2, indicates that, 46.7% had good knowledge on ethical consideration on research among health sciences teaching faculty.

 

 

Table 2.1 denotes that, the overall knowledge on ethical consideration of research was 46.7% and range was 3, mean 2.50 and the standard deviation 0.777.

Table 2.1 Range, Mean, Median, Standard Deviation, standards error of level of knowledge on ethical consideration on research among health sciences teaching faculty. N=30

Sl. No	Range	Mean	Median	Standard Deviation	Standard Error	Levelof significant
	3	2.50	3	0.777	0.142	2.79

 

Section III: Association between pretest level of knowledge on ethical consideration in research with demographic variables among health sciences teaching faculty.

 

Table 3: chi square test to find out the association between the pretest level of faculty knowledge on ethical consideration in research with demographic variables among health sciences teaching faculty. N=30

Sl. No	Demographic Variables	Pretest level of Knowledge				Total	df	ᵡ2 value	Level of significant
		Poor	Average	Good	Excellent		3	2.216	0.529*
1	Health Science Stream
	Medicine	0	0	0	0	0
	Dental	0	0	0	0	0
	Ayurveda	0	0	0	0	0
	Nursing	1	6	8	2	17
	Homeopathy	0	0	0	0	0
	Allied Health sciences	2	5	6	0	13
	Pharmaceutical sciences	0	0	0	0	0
	Total	3	11	14	2	30
2	Gender						3	1.735	0.629*
	Male	0	1	3	0	4
	Female	3	10	11	2	26
	Total	3	11	14	2	30
3	Qualification						3	6.263	0.100*
	B.sc	0	2	0	1	3
	M.sc	3	9	14	1	27
	Total	3	11	14	2	30
4	Designation
	Senior lecturer	0	3	2	2	7	6	12.735	0.047
	Asst. Professor	2	3	10	0	15
	Asso. Professor	1	5	2	0	8
	Professor	0	0	0	0	0
	Total	3	11	14	2	30
5	Institute has IEC						3	3.319	0.345*
	No	2	4	8	2	16
	Yes	1	7	6	0	14
	Don’t know	0	0	0	0	0
	Total	3	11	14	2	30
6	Part of Research
	No	0	1	1	2	4	3	14.097	0.003
	Yes	3	10	13	0	26
	Total	3	11	14	2	30
7	Source of Knowledge
	curriculum	3	5	11	2	21	6	8.224	0.222
	Training	0	0	0	0	0
	Books	0	3	3	0	6
	Journals	0	3	0	0	3
	Others (specify )	0	0	0	0	0
	Total	3	11	14	2	30
8	Ethical guidelines
	None	3	9	11	1	24	3	1.916	0.590*
	Belmont report	0	2	3	1	6
	ASU-GCP	0	0	0	0	0
	CIOAMS Guidelines	0	0	0	0	0
	ICMR Guidelines	0	0	0	0	0
	Helsinki Declaration	0	0	0	0	0
	Total	3	11	14	2	30

 

Table 3 depicted that, there was a significant association between the level of knowledge on ethical consideration on research with health stream nursing ᵡ² =2.216, P<0.529^* at 0.05,gender ᵡ² 1.735, P<0.629^*, qualification ᵡ² =6.263, P<0.100^*, institution has IEC ᵡ² =3.319, P<0.345^* and ethical guidelines ᵡ² =1.916, P<0.590^* level of significant at 0.05.

 

There was no signification association between the level of knowledge on ethical consideration on research designation ᵡ² =12.735 ‘P’ Value 0.047, Have you a part of research ᵡ² =14.097 ‘P’ Value 0.003 and the source of information ᵡ² = 8.224 ‘P’ Value 0.222

 

DISCUSSION:

The present study showed that 46.7% had good knowledge, 36.6 % had average knowledge, 10 % had poor knowledge, and 6.7% had excellent knowledge on ethical consideration on research among health sciences teaching faculty. The study was consistent with the results that Mohammad M, Ahmad F, Rahman SZ, Gupta V, Salman T (2011), majority (76%) of faculty had not undergone training in research ethics. Less than half of the participants answered correctly to a question on guidelines in research ethics, 60% responded correctly to question on research involving children. Majority responded correctly to question on role of a research ethics committee and confidentiality, informed consent and to question on composition of Institutional Ethics Committee. 68% taught that ethical review of research by an ethics committee would delay research.13

Another study was supported Gopinath NM¹, John J², Senthilkumar E³, Nagappan N⁴ (2014) with the results that, More than half were familiar with research ethics, principles and functions of the research ethics committee. Though there were some faculties whose attitude regarding research ethics principle was not optimal.7

 

The present study results revealed that, there was a significant association between the level of knowledge on ethical consideration on research with health stream nursing ᵡ² =2.216, P<0.529^* at 0.05,gender ᵡ² 1.735, P<0.629^*, qualification ᵡ² =6.263, P<0.100^*, institution has IEC ᵡ² =3.319, P<0.345^* and ethical guidelines ᵡ² =1.916, P<0.590^* level of significant at 0.05. Similar Study was consistent with Mohammad M et.al (2011), The responses of graduates in different years of residency were compared using Chi square test followed by Kendall’s tau-c test to find correlation between residency experience and knowledge, attitudes and practices towards bioethics. A ‘p’ value of (< 0.05) was considered statistically significant.⁸

 

CONCLUSION:

There is good knowledge of research ethics among health sciences teaching faculty. Ethical norms should be strictly followed by giving due respect to confidentiality or privacy of research participants to achieve the goal of minimal risks and maximum benefits to participants.

 

LIMITATIONS:

1.     The sampling technique used was convenient sampling with small sample size.

2.     The study was assessed only the knowledge aspects of research ethics among the teaching faculty.

 

RECOMMENDATIONS:

·       To initiate educational events in the developing regions of the Country to increase knowledge, awareness and acceptance of principles of research ethics among researchers.

·       Faculty or students should be educated by holding seminars or continuing educational programs.

·       The curriculum for students needs to be more detailed in regard to research ethics.

 

CONFLICT OF INTEREST:

Nil.

 

SOURCE OF SUPPORT:

Kerala Univeristy of health science, Trissur and KVM College of Nursing, Cherthala, KV Institute of paramedical sciences, Cherthala and S.H College of nursing, Cherthala

 

REFERENCES:

1.        Resnik DB. What is ethics in research and why is it important? [Last accessed on 2011 Jul 17]. Available from: http://www.niehs.nih.gov/research/resources/bioethicswhatis.cfm.

2.        World Health Organization. Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. 59th WMA General Assembly, Seoul, Republic of Korea. 2008 Oct

3.        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. [PubMed]

4.        Shah N. Ethical issues in biomedical research and publication. J Conserv Dent. 2011;14(3):205–7.[PMC free article] [PubMed]

5.        Bhutta ZA. Ethics in international health research: A perspective from the developing world. Bull World Health Organ. 2002;80(2):114–20. [PMC free article] [PubMed]

6.        Deolia SG, Prasad K, Chhabra KG, Kalyanpur R, Kalghatgi S. An insight into research ethics among dental professionals in a dental institute, India - A pilot study. J Clin Diagn Res. 2014;8(9): ZC11–4. [PMC free article] [PubMed]

7.        7.Gopinath NM, John J, Senthil Kumar E, Naggapan N, J Contemp Dent Pract. 2014 Sep 1;15(5):608-13.

8.        8.Mohammad M, Ahmad F, Rahman SZ, Gupta V, Salman T (2011) Knowledge, Attitudes and Practices of Bioethics among Doctors in a Tertiary Care Government Teaching Hospital in India. J Clinic Res Bioeth 2:118. doi: 10.4172/2155-9627.

9.        Silaigwana B(1), Wassenaar D(2). Biomedical Research Ethics Committees in sub-Saharan Africa: a collective review of their structure, functioning, and outcomes, J Empir Res Hum Res Ethics. 2015 Apr;10(2):169 doi:10.1177/1556264615575511. Epub 2015 Mar 6.

10.      Mahuli AV (1), Mahuli SA (2), Patil S (3), Bhandi S(4).Institutional Ethics Committee Regulations and Current Updates in India. J Contemp Dent Pract. 2017 Aug 1;18(8):738-741.

11.      Mathur VP (1), Dhillon JK, Kalra G, Sharma A, Mathur R. Survey of instructions to authors in Indian and British Dental Journals with respect to ethical guidelines. J Indian Soc Pedod Prev Dent. 2013 Apr-Jun;31(2):107-12. doi:10.4103/0970-4388.115711.

12.      Swetha Munoli, Niveditha G., Deepthi R. Knowledge, attitude and practice of research ethics among medical faculty in a teaching hospital JIBCP doi :101/1036.

13.      Mohammad M, Ahmad F, Rahman SZ, Gupta V, Salman T (2011) Knowledge, Attitudes and Practices of Bioethics among Doctors in a Tertiary Care Government Teaching Hospital in India. J Clinic Res Bioeth 2:118. doi: 10.4172/2155-9627.1000118

 

 

 

 

Received on 17.04.2019          Modified on 25.05.2019

Accepted on 21.06.2019     © A&V Publications all right reserved