Researchopedia
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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

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.

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