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Researchopedia ISBN: 978-93-93166-28-9 For verification of this chapter, please visit on http://www.socialresearchfoundation.com/books.php#8 |
Medical And Research Ethics |
Dr. Digvijay Sharma
Assistant Professor and Director
School of Health Sciences
CSJM University
Kanpur, Uttar Pradesh, India
Apoorva Srivastava
Research Scholar
Physiotherapy
CSJM University
Kanpur, Uttar Pradesh, India
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DOI:10.5281/zenodo.8413587 Chapter ID: 18032 |
This is an open-access book section/chapter distributed under the terms of the Creative Commons Attribution 4.0 International, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
Ethics as the
name suggest to you refers to the form or pattern of any practise or
arrangement that is considered usual or that which abides by the laws. Ethics
in general refers to the format of performing any sort of activity or event
that is meant to be performed in a regularized and fixed manner in
order to yield appropriate and unbiased results. In this chapter we will study
about the general ethics which must be followed while performing or considering
any research article or research activity, and we will also come across the importance
of following these ethical principles while writing or performing researches.
Research is defined as a set of instructions or activity performed single time
or repeatedly to draw a conclusion from specific objectives which then embarks
the importance of that activity or event. The importance
of research can be studied in various aspects depending upon the type of
subject chosen by students in order to perform research activity. Ethical
importance is mandatory for all the streams or subjects of human interest
especially because they form a basis of reliability that the coming generations
can be dependent on their research and decision making is never questioned. The
formulation of ethical researches for performing any sort of research activity
or event or strategy dates back to the era when scientists were discovering the
basis of life on earth. But, relying on appropriate ethical principles for the
same dates back to 1947. The history of
research activity states that after world saw varied angles and dimensions of
research performed in Nazi Experiment and Tuskegee experiments, formulation of
ethical principles was mandatory to understand that research not only involves
finding newer techniques or newer opportunities in medical or varied sciences
but deals with their results being totally unbiased, reliable and safer for the
participants as well as the population which may use them in their daily
lifestyles. Researches could have a varied history of when and where the
process of researching through observations, collection of specimens, and
thorough processing of those specimens to derive a valuable knowledge come
from, but most of the researches performed then were lacking the procedure of
following ethical principles and humanitarian grounds were not considered as
important as the result of the study being undertaken. Research is an
activity which helps us to not only retain our knowledge, fulfil the literature
gap which we tend to increase while we stay away from certain topics and ideas
and which makes us revise and rejuvenate our thinking processes towards a
single goal or objective for which the topic is formulated. Since ancient time
in almost every field of science, mathematics, history, geography, etc.,
research plays a keen role in updating knowledge of individual researchers and
guide the students and the world about newer inventions, technologies,
strategies and protocols. Students studying medicine or allied health care have
equal importance of this research in their curriculum and day to day practise
which makes them render sufficient and appropriate treatment strategies to
patients with sound judgement strategies. Especially in
the field of medicine, research plays a keen role in mandating and updating the
drug usage, drug delivery technologies and varied other opportunities but
following adequate procedure and keeping in mind the security of individuals
which may harm through these researches is also a point of discussion. After
the successful completion of Nazi experiment, the whole world was shocked to
see the massive killing of individuals and brutal research methods adopted on
human being which denoted that there was a severe need of governing rules which
demanded equal rights for the individuals on whom the procedures were being
tested and for those who were conducting these trials. The Nazi experiment
however proved many to be of very much importance but the concept behind these
researches was not providing the world with appropriate knowledge and
literature gaps but the motive was to make the imprisoners pay back and take
revenge from the enemies. The prisoners of war were specifically made the
subject of these assignments which involved testing of the prisoners at higher
altitudes without appropriate coverings and materials to see the effect of cold
climatic conditions which will benefit the army to stay updated regarding the
minimal temperature human body can tolerate, sea water experimentation to
assess that what if human beings were made to live only drinking sea salty
water, live dissection of small children, forceful miscarriages of full term
pregnant females to see the holding capacity of pregnant females, head injury
experimentations, etc. These
experiments not only considered human subjects as materials but were also
considered harmful for future of the researches hence, after the results of
World War II and the Nazi experiments, in 1947, the world decided to formulate
some rules and regulations which are necessary for researchers to follow if
they want to involve human subjects in their researches. These rules and
regulations are termed as ethical principles which says that if any researcher
involves human subjects into their research, there must be some laws which will
govern the rights of the subjects and duties for the researchers so that no
subject is harmed before, during or after the procedure of research. This code
of ethics or this set of rules formulated to govern the research processes and
their result manipulations were called the Nuremberg Code of Ethics of Medical
Research. These ethical principles are formulated under the concept that, no
study or research project is above the values of humanitarian grounds. With the
help of these rules and regulations it was then possible to define research and
research procedures especially in medical field with no harm to subjects or
subject debris (i.e., remains after human death). The Nuremberg
Code of Medical Ethics stated some salient points which needs to be followed by
each and every researcher for their research project to be accepted worldwide
and to be reliable. These points include: a. It was
the first official statement issued in the interest of human population with
respect to the studies being undertaken in the name of human development or
human existence researches. b. It was
mandated that every research must be in line with the objectives it was meant
to serve for which it is very necessary to involve active participation of
subjects within the research studies. It was stated that involving participants
without their consent or involuntariness is a punishable offense and
can be reported to violation of medical rules and ethics. The subjects involved
in any study must be known to the procedures they are being rendered and the
possible outcomes, whether good or bad must be thoroughly explained to each and
every individual so that there is no discrepancy in between the results and the
outcomes explained before participation of the subjects. Also, it was made sure
that the researchers have to keep in mind the general safety rules and
fundamental rights of the subjects before taking them as participants in any of
their study procedures. c. It was
mandated that the researchers being uptake by the research fraternity or the
faculties or the students or the scientists themselves must serve the nation or
the society towards their betterment and their upliftment instead of harming
some individual or sentiments of other individuals. It was stated that results
define the future of any research project and researchers must be proceeded
which will benefit the sustenance and existence of society or reform the
society for the better working of the fundamental constitution of any region.
Any medical event or research benefitting the society must be duly appreciated
and must be taken full consideration of. d. It was
also mandated that it should be a matter of concern that those experiments
which tend to have a negative or may have serious negative outcomes or may go
wrong during the procedure of the study must first be implied on animals so
that the negative outcomes can be limited on animal study level and no
individual Is harmed during the process. Animal studies were stated to be
beneficial in understanding the procedural aspect of any research and to test
whether the procedure involve unforeseen events which might happen during the
course of the study. e. It was
documented that studies which involved the usage of human subjects to see the
ill effects or the negative effect of any drug or drug overuse must be stopped
and these studies must not float on ground. Avoiding harming human for the sake
of gaining extra knowledge was entirely prohibited and was considered
punishable. It also concluded that studies should not have any assessment or
treatment strategies I such a way that they tend to affect the mentality,
physicality, societal and financial pressure on any individual. Any sort of
suffering caused to human subjects shall be considered as an undesirable
outcome which could affect the credibility of the researcher and research as
well. f. There
should be minimal or no risk policy adopted by researchers to initiate or carry
on any research project. Any risk if involved must be firstly described to the
participant. The research must also be ready with the possible risk factors
which can take place during the course of the trial and hence must be ready for
the worst-case scenario and thus must describe about the necessary regimes that
the researcher will take if in case there are some negative outcomes of the
study. In many cases, human subjects can also ask for financial guidance and
monetary support form the researcher to combat the effects of the study. g. Experiments
or trials must be up taken by specialized and qualified researchers
and doctors in order to demand the credibility of the research work. Only
skilled and qualified personals must be involved in the research process to
work within the experiments. Any individual having no experience of research
work must be left alone in and in direct contact with the subjects. h. Each
and every participant involved in the study must be made aware of his/ her
rights and the benefits they will get from the study. But it was made mandatory
for the researchers to allow participants of the study to withdraw their
consent or approval at any time during the study. The participants must have
full authority to step back from the study procedure according to their will
and the researcher wont have any right to stop these participants from
withdrawing. Hence, the rights of the participants will be reserved here from
being handed over to the researcher and will have full control over their
action of signing the informed consent. i. Every
researcher will need to take full responsibility of the entire research
procedure and after effects of the research work once they have signed the
participant for involvement within the study. The researcher will have to take
complete responsibility of the positive as well as negative outcomes faced by
the participants before, during and after the procedure of the study. Even
after years of treatment and completion of the study, the researcher needs to
take a review of the actions and their tasks so as to overcome any negative
results on the longer run because of the research work. j. Every
researcher must adhere to the rules and regulations formulated within the Nuremberg
code of ethics compulsorily, because any lacuna in following these principles
might lead to serious violation laws acting on the researchers and demanding
extra financial or dependency level of punishments for the patients. In many
cases, the researchers if found not taking the rules seriously might be
prohibited from taking the research works further. These set of
rules were mandated and were believed to relief human subjects from injustice
and irregular medical research projects which could proof fatal and can lead to
severe disabilities too. These rules and
regulations were formed in 1947, however an act of same sort happened between
1932- 1972 under the Tuskegee Institute, Alabama, USA which involved the
research study of natural progression of the syphilis disease which was left
untreated in subjects. The scientists gave sham treatments to such patients and
were made to live in outskirts of the country in order to prevent normal
individuals from contracting the disease but the progression, symptoms, signs
and other factors were being studied for the whole duration of 40 years period
until 1972. In this trial only black people living in USA were targeted which
was again a matter of international issues and hence this trial was stopped and
it was documented to be a mistake done in order to study the disease
thoroughly. As a matter of
fact, research involves a cluster of questions whose answers are found on the
basis of the facts available and documentations collected, but researches are
only considered accurate and appropriate if they are morally and ethically
correct and have been done keeping in mind all the necessary safety measures.
Along side the code of medical ethics, the human subjects involved in study
must be made fully aware about the study and the objectives of the researcher
behind undertaking the study. The participants must not be forced to joint the
study or to complete the study. And the study which follows all the principles
correctly is credible and reliable and the results are justifiable. References: 1. Thornton
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M. Public health research ethics - Indian case studies. Indian J Med Ethics.
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JE, Tolich M. Research ethics and research governance. J Empir Res Hum Res
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10.1023/a:1022596812980. PMID: 12710558. 5. Resnik
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