A Review On The Guidelines For Nutritional Assessment for HNC (Head and Neck Cancer) Patients Managed By Surgery
Shivananda S1*, Vidya G Doddawad2
1 Associate Professor, Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, A Constituent College of JSSAHER,
Mysore-570022, India.
2 Associate Professor, Department of Oral Pathology and Microbiology, JSS Dental College and Hospital, A constituent college of JSSAHER,
Mysore-570022, India.
*Corresponding Author
Dr. Shivananda S BDS, MDS,
Associate Professor, Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, A Constituent College of JSSAHER, Mysore-570022, India.
Tel: 9343322433
E-mail: dr.shivanandas@jssuni.edu.in
Received: February 05, 2021; Accepted: October 01, 2021; Published: October 21, 2021
Citation: Shivananda S, Vidya G Doddawad. The Assessment of Proficiency in Research Ethics Among Researchers in Academic Institutions. Int J Dentistry Oral Sci. 2021;8(10):4790-4796. doi: dx.doi.org/10.19070/2377-8075-21000971
Copyright: Shivananda S©2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.
Abstract
Introduction: The research ethics provides guidelines to apply moral regulations and professional codes of conduct in the
various steps of research. The research ethics plays a very vital role in the collection, analysis, reporting, and publication of
details about research subjects, in particular active acceptance of participant’s right to privacy, confidentiality and the informed
consent of the participant.
Aims: To assess the Knowledge, awareness and attitudes about research ethics among the faculty and students of medical and
dental colleges and the requirement for a regular teaching about research ethics among the faculty and students of medical
and dental colleges.
Materials & Methods: A cross-sectional study was conducted by assessing the responses to 39 selected basic questions regarding
Knowledge, awareness and attitudes about research ethics among a total of 415 faculty members and post graduate
students of the medical and dental institutions in Karnataka. The questionnaire was made into 5 categories. Chi-square tests
was used to determine, in bivariate analyses, the association of each of the independent variables like their speciality, their
academic position, prior ethics training, and their prior involvement with research with each of the main outcome of interest.
The students t-test was done to assess the respondents scores on the 5-point Likert scale ranging from 1 to 5 (1-strongly
disagree, 2-disagree, 3-not sure, 4-agree and 5-strongly agree). The average of their scores were compared among the various
variable like their specialty and academic position by using the ANOVA test.
Results: A total of 415 responses were obtained from the participants of the study. Out of this we had 273 respondents as
female and 142 respondents as male. Among these 225 respondents were from the medical speciality and 190 from the dental
speciality. The P value was kept at 0.05 for this study.
Conclusion: The participants of the questionnaire survey showed that the institutional ethics committees would be very
useful for promoting health research and are imperative for appraisal of the health research projects.The majority of the
respondents agreed that they were well aware of the ethical guidelines governing the human research, but when we assess the
respondent’s knowledge and attitudes towards research ethics there seems to be a lacuna in complete awareness and knowledge
of research ethics. The results of the study also helped us to assess the requirement for a regular teaching about research
ethics among the faculty and students of medical and dental colleges.
2.Introduction
3.Materials and Methods
3.Results
4.Discussion
5.Conclusion
5.References
Introduction
Research is defined as the systematic investigation into and study
of the materials and sources in order to establish facts and reach
new conclusions. Another definition of research was given by
John W. Creswell, which states that "research is a process of steps
used to collect and analyse information to increase our understanding
of anissue or topic". It consists of three steps: to pose a
question, to collect data to answer the question, and to present an
answer to the question.
Ethics is the branch of philosophy which deals with the moral
aspects of human behaviour.The ethics deals with the principles
and the theories of values and the basic perceptions & justifications of values.
The research ethics provides guidelines to apply moral regulations
and professional codes of conduct in the various steps of
research. The research ethics plays a very vital role in the collection,
analysis, reporting, and publication of details about research
subjects, in particular active acceptance of participant’s right to
privacy, confidentialityand the informed consent of the participant.
The research ethics provides guidelines for the responsible
performance of research on human participants.
Need for the Study
The researchers have to take the whole and sole responsibility for
the ethical conducting of their research in an ethically. First and
the foremost responsibility of a researcher is to take care of the
safety, well-being, dignity, and rights of the participants. Researchers
have to be very careful of the various other issues at different
stages of the research process. Both the participants and researcher
have many important roles to play. The researchers have to take
care of the participants’ right and must consider their research
from the participants' perspective.
The researcher must make sure that their research shall be done
honestly. The research should be done impartially, without any
prejudiceand absence of bias. The researcher should never forget
to follow integrity and probity while conducting research. The researcher
must seek consent from the participants for their participation.
They must respect people, their cultures, values, religions,
economic status and so on. Researchers have an obligation to take
care of the confidentiality and personal information or identity
of the participants as per her choice. Researchers should avoid
experiments which may pose a threat to both the participants and
the researchers themselves. Apart from the participant's, the researcher
has also an obligation towards society, her colleagues or
other researchers and funders of the project.
On the other side, the participants have the exclusive right to give
consent to participate, withdraw from, or refuse to take part in
research projects. Participants have right to seek confidentiality
and stop personal information or identifiable data from publishing
or sharing. They have right to seek their safety and security.
Whenever required, the data should be kept secure and participants
should not be exposed to unnecessary or disproportionate
levels of risk.
The regulatory bodies like Central Drugs Standard Control Organization
(India) mandatorily recommends that any type of research
on human participants requires the ethics clearance from
the accredited ethics committee. The researcher should compulsorily
obtain the ethics clearance for his/her research study on human
participants. And hence it has become an obsolete necessity
for the researcher that the principles of research have to be learnt,
understood and strictly followed while doing any type of research
on human participants.
Good Knowledge about research ethics among the faculty and
PG students in Health Institutions has become very important
for the benefit of researcher & his team, to provide good quality
of ethically made research not only for the benefit of the participants
of the study, but for the whole humanity.
However, there has been very few studies which have investigated
the attitudes of medical & dental faculties toward concepts of research
ethics, including the acceptability of regional or institutional
ethics committees. This study will help us to know the level of
understanding, the attitude and practice of following principles
of research ethics while doing research on human participants
at professional institutions. Understanding about the Knowledge,
awareness and attitudes regarding research ethics among the faculty
and PG students in health institutions shall help us to know
the necessity for teaching research ethics related classes/courses
among them.
Review of Literature
The Nuremberg code (1946-1947), Helsinki declaration (1964-
2013), and Belmont report (1979) provided the basis of systematic
ethically uniform research to which stringent rules and
consequences for violating them were mentioned. The laws
ofgovernment and regulations concerning the responsible conductof
researches have ever since been developed for research
that involves both human beings and animal subjects.
In India, the detailed requirement & guideline for undertaking the
clinical trial are specified under schedule Y of said rule and this
schedule further provide that clinical trial are required to be conducted
and data generated, documented and reported in compliance
with the approval protocol and Good clinical Practice (GCP)
guidelines published by Central Drug Standard Control Organization
(CDSCO), Directorate General of health services, Govt. of
Indian as well as application regulation. It is therefore, necessary
that the clinical trial is conducted in compliance to the provision
of the Drug &Cosmetics Rule and the care is taken to protect the
right, safety and well-being of the subjects participating in the
Clinical trial and data generated is scientifically and ethically and
sound.
As the regulatory world is dynamic and the flow of new information
from clinical trial is arising at rapid rate and issues related
to clinical trial involving more and more. The changes should be
made to the existing regulations and amendments to address and
resolve these evolving issues.
Recently changes in Schedule Y, then how clinical trial or pharmaceutical
industries affected. Since Jan. 2013 to last update of
28 June 2014 the Indian regulatory authorities have announced a
spate of laws and guidelines, which will have a huge impact on the
clinical trial sector in India.
Aim of the study
To assess the Knowledge, awareness and attitudes about research
ethics among the faculty and students of medical and dental colleges
by using an online questionnaire survey.
Objectives of the study
To statistically measure the Knowledge, awareness and attitudes
about research ethics among the faculty and students of medical
and dental colleges by using an online questionnaire survey.
To assess the requirement for a regular teaching about research
ethics among the faculty and students of medical and dental colleges.
Materials and Methods
Source of Data: The faculty and post-graduate students of various
dental and medical colleges in Karnataka.
Inclusion Criteria: The faculty and the post graduate students
of Institutions in Karnataka who are interested to participate in
the online questionnaire study.
Exclusion criteria: The participants who are not willing to give
written the consent to answer the questions in the online questionnaire.
Methodology
• A cross-sectional study was conducted by assessing the responses
to 39 selected basic questions regarding Knowledge, awareness
and attitudes about research ethics among a total of 415 faculty
members and post graduate students of the medical and dental
institutions in Karnataka.
• A link for answering the online questionnaire survey was sent
to the Head of the Institution/ Principal through an email. The
Head of the Institution/ Principal were requested to circulate
the link for submitting the response to the questionnaire and the
participant information letter to all the faculty and post-graduate
students of his/her dental or medical Institutions. The request
letter to the principal also included the ethics approval certificate
obtained for this study.
• The participants of the online questionnaire survey were mandatorily
requested to give their consent for participation before
starting to submit their response to the questionnaire.
• The participants of the online questionnaire survey were allowed
at any time to withdraw from the questionnaire study before
submitting their response.
• The participants were mandatorily made answer all the 39 questions
in the online Questionnaire before the final submission of
their responses.
• The questionnaire was made into 5 categories. Before beginning
the questionnaire, the in the first category we had set of questions
to collect the demographic information of the participants like
age, gender, academic position, prior participation in human research
subjects, number of research projects involved in and their
prior training in research ethics.
• The second part of the questionnaire was used to assess the participants
self-awareness towards ethical principles and functions
of the ethical committees.
• In the third part of the questionnaire the respondents were
asked to choose their response about research ethics committee
from a 5-point Likert scale ranging from 1 to 5(1-strongly disagree,
2-disagree, 3-not sure, 4-agree and 5-strongly agree).
• In the fourth part the respondents were asked again choose from
the 5-point Likert scale regarding their attitudes towards practicing
of research like obtaining the informed consent from the participant,
the involvement of vulnerable individuals in their study,
confidentiality and conduct of researchin a responsible manner.
• The fifth part of questionnaire had questions regarding assessment
of knowledge about research ethics.The questions were
based on case scenarios regarding the informed consent, describing
risks and benefits to the participants, research-involving children,
retrospective research on stored human tissue samples originally
collected for clinical purposes and also about maintaining
confidentiality in the research.
• Once the participants submitted their responses to the online
questionnaire, these responsesweresent to google forms account
of the researcher, which was digitally protected through a password
by the researcher. The researcher never collected the email
id, name of the participants or the name of the Institution of the
participant.
• A total of 415 responses from the participants was collected and
stored in a password protected electronic format. This data was
statistically analyzed and conclusions were drawn depending on
the results obtained.
• To protect the confidentiality of the participant, the survey did
not contain any type of information that will personally identify
the participant like their email ID, name, designation or the name
of their Institute.
• This study was a self-funded by the Principle Investigator and
the participants were not given any kind of monetary benefits for
their participation.
• Timeline for the study: The online questionnaire survey will be
carried out for a period of three months from September to October
2018.
Statistical analysis
All the responses obtained from the participants were entered in
the excel spread sheet as a result score. The collected data was
statistically analyzed by using the non-parametric statistical test
using the SPSS software. Chi-square tests was used to determine,
in bivariate analyses, the association of each of the independent
variables like their speciality, their academic position, prior ethics
training, and their prior involvement with research with each
of the main outcome of interest (dependent responses involving
knowledge, awareness, and attitudes). The students t-test was
done to assess the respondents scores on the 5-point Likert scale
ranging from 1 to 5 (1-strongly disagree, 2-disagree, 3-not sure,
4-agree and 5-strongly agree). The average of their scores were
compared among the various variable like their speciality and academic
position by using the ANOVA test. The P value was kept
at 0.05 for this study.
Results
A total of 415 responses were obtained from the participants of
the study. Out of this we had 273 respondents as female and 142
respondents as male. Among these 225 respondents were from
the medical speciality and 190 were from the dental speciality. We
assessed the responses from the following categories of the respondents.
(Table no:1)
Table 1. We assessed the responses from the following categories of the respondents.
Table 2. The responses to details regarding involvement of the respondents in research ethics earlier.
Table 3. The responses of the respondents to the knowledge and awareness-based questions on research ethics.
Table 4. The number of participants responses to attitudes towards the research ethics committees and research ethics education.
Table 5. The number of participants responses to attitudes regarding practices in research ethics.
Table 6. The responses in percentage regarding case scenarios regarding Knowledge involving various aspects of research.
Discussion
The results of our study showed some very interesting facts regarding
the knowledge, awareness and attitudes of the medical
and dental professional from various academic positions like
professors, reader/associate professors, senior lecturers and post
graduate students. The responses for our study was obtained
from various medical and dental institutions in Karnataka state.
The participants of the questionnaire survey showed a high acceptance
for the requirement of research ethics committee and
were had a truistic opinion that the institutional ethics committees
would be very helpful and useful for promoting health research
and are imperative for appraisal of the health research projects.
It was very evident from our study that most of the respondents
were aware of the research ethics committee’s importance in doing
health research. Majority of our respondents showed that they
already had prior knowledge about research ethics and have undergone
some type of training Though about 67% of the population
have shown that they had prior training in research ethics.
The proportion of the respondents 141 (34 %) who have mentioned
that they have not attended any type of research training,
were all post graduate students. Whereas the professors, reader/
associate professors, senior lecturers have mentioned they had attended
any type of research training programs earlier. It is reasonably
clear from our study that most of the faculty and students
at medical and dental institutions do studies on human subjects
compared to studies done on human samples. The majority of
the respondents agreed that they were well aware of the ethical
guidelines governing the human research, but when we assess the
respondent’s knowledge and attitudes towards research ethics
there seems to be alacuna in complete awareness and knowledge
of research ethics. A similar finding was also observed regarding
the functioning of institutional ethical committees.
The response to the question in the section five was a case scenario question regarding the requirement of the informed consent
from the patient for conducting a retrospective research on stored
human tissue samples originally collected for clinical purposes. It
was very surprising to know that nearly 50 % of the respondent’s
responses were wrong. The response to this question from all the
post graduate students was wrong. It is only the faculties who
have answered this question correctly. This is very evident from
this information that the post graduates are unaware and uneducated
regarding the mandatory requirement of informed consent
from patients while doing any type of research on the already
collected biological samples of humans.
The respondents showed a deal of optimistic and pragmatic opinion
regarding the role of the institutional ethics committees in
reviewing research protocols. Majority of the respondents were
very propitious attitude towards the institutional ethics committees.
A vast majority of the respondents very clearly showed their interest
in learning about research ethics on regular and systematic
manner by means of research ethics teaching modules. This information
from our study should be utilised to encourage the authorities
in the academic field of medical and dental speciality at
central and local bodies to formulate systematic teaching modules
on research ethics. Such well-planned and fastidiously constructed
teaching modules must be established and regularly conducted at
every institution where health related researches are done.
The findings of our studycongruous with the study done by R.
Sudhakara Reddy et al (2018) in their cross-sectional questionnaire-
based survey carried out among 100 dental professionals in
a dental institution in southern part of India. Their suggestion
regarding having a teaching module in research ethics was found
to be consistent with the results of our study done on both medical
and dental speciality and at multicentric study unlike the single
centre study involving only the dental professionals by RSudhakara
Reddy et al.
The results of our study regarding acceptance of regional ethics
committee by the medical and dental speciality of various academic
positions at multicentric level was found to be very complaisant
with findings of the study by Hadir F. El-Dessouky et al.
(2007), who conducted a study to understand the level of knowledge,
awareness and attitudes regarding ethics in research and ethics
committees among the dental faculty members.
We had several limitations in our study. Firstly, for our study the
responses from the participants were obtained through a convenience
sampling. Hence, due to potential selection bias, the
responses of our participants might not be representative of their
respective faculties and post graduate students in each of the participating
institutions.
Another important limitation that appears with theuse of a selfreport
questionnaire is that of possibility of a social desirability
bias, i.e., the tendency ofrespondents to reply in a manner that will
be viewedfavourably by others. Another factor that might havereduced
the reliability of our responses includes involvingrespondents
who have limited or noinvolvement inresearch like the first
year post graduate students of the medical and dental speciality, in
which case their responses regarding researchethics and the institutional
ethics committeesmight not have much relevancy.
Despite these limitations, our study provided the details about
faculty and post graduate students in the medical and dental speciality
the knowledge and awareness with ethical principles that
steer the conduct of research and their awareness ofthe roles of
the institutional ethics committees, the extent of their previous
trainingin research ethics, and their attitudes towards issues in researchethics
and the towardsinstitutional ethics committees.
In our online questionnaire study, we were able to demonstrated
that participants with prior ethicstraining stated they were more
aware of principles of research ethicsand the functionsof the institutional
ethics committees. compared with thosewithoutprior
training like the post graduate students of both medical and dental
speciality. The participants with prior trainingin ethics comparatively
with participants without training in research ethicswere
more likely to agree with several questionablepractices regarding
research ethics.These findings of our studyhighlight the need for
conducting a well-structuredresearch ethics training to faculty and
post graduate students of the medical and dental speciality possibly
as part of anobligatory module during their academic progress
and postgraduate course.
Conclusion
This study was indeed very useful study to statistically measure
the Knowledge, awareness and attitudes about research ethics
among the faculty and students of medical and dental colleges by
using an online questionnaire survey. The results of the study also
helped us to assess the requirement for a regular teaching about
research ethics among the faculty and students of medical and
dental colleges. But it is necessary to more such multicentric studies
at many more institutions where health research related activities
are done. We recommend that the central and local health
educational bodies should implement teaching of health research
teaching modules in the health education in India among all the
faculties and students in health institutions.
We also recommend a study to evaluate the knowledge, awareness,
attitudes and practice of health research should be conducted
among the undergraduate, post graduate students, faculties
and also the nursing staff and students and medical, dental and
nursing institutions in India and abroad. Studies should also be
done at regular intervals to assess their knowledge, awareness, attitudes
and practice of research ethics before and after the taring
in research ethics. The information obtained from such studies
will be very useful and also guide to construct improved training
programs and modules on research ethics.
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