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EDITORIAL
Year : 2018  |  Volume : 6  |  Issue : 2  |  Page : 43-44

Ethics in medical research


Department of Ophthalmology, P.D. Hinduja National Hospital and MR Centre, Mumbai, Maharashtra, India

Date of Web Publication20-Jun-2018

Correspondence Address:
Barun K Nayak
Department of Ophthalmology, P.D. Hinduja National Hospital and MR Centre, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcor.jcor_52_18

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How to cite this article:
Nayak BK. Ethics in medical research. J Clin Ophthalmol Res 2018;6:43-4

How to cite this URL:
Nayak BK. Ethics in medical research. J Clin Ophthalmol Res [serial online] 2018 [cited 2018 Nov 15];6:43-4. Available from: http://www.jcor.in/text.asp?2018/6/2/43/234824



Ethics has to be followed in all walks of life; however, the understanding of ethics is not very clear as its boundary is not well defined and keeps on changing always. The purpose of this editorial is to discuss the present understanding of ethics in relation to medical research.

As per the Oxford dictionary, ethics means a set of moral principles and ethics is the moral philosophy. The word “moral” means adhering to the code of behavior that is considered either right or acceptable. In nutshell, the ethics is the science of morals, based on ethos, which is the characteristics spirit of a culture, era, or community as manifested in its aspirations and attitude.

As evident from the ensuing discussion, ethics keeps on changing and evolves based on various instances of the past. There are three types of ethics which form the basis in the evolution of ethics and its final acceptance. First is the “normative ethics” which is the practical method of arriving at a moral course of action. Second is “meta-ethics” dealing with the theoretical meaning and references of moral and philosophies. Third is the “applied ethics” which we all are concerned with. It defines the action a person is permitted or obligated to take in various situations.

The medical science is changing rapidly. Some of the recent advancements such as stem cell research, organ transplants, and cloning have raised ethical concerns about safety of the community and proper use of emerging science which is socially acceptable. Lot of debates takes place for euthanasia, legal position of abortion, and use of animals in research. There is no unanimity in the use of foods which are genetically modified. It is clear that as the science advances, the new challenges appear concerning ethical issues.

Why now are people concerned so much about the ethics in medical research? Many experiments, done in the past on a captive population such as war prisoners, are bone chilling. I will enumerate a few to highlight the cruelty done on human beings in the name of the research in concentration camps and prisoners of war.

The “mustard gas experiment” (1939–1945) involved exposure to mustard gas and phosgene to normal subjects to find a treatment. The “malaria experiments” (1939–1945) was inhuman wherein healthy persons were first infected with salivary extract of infected mosquitoes and then followed by high or even lethal doses of chemicals to test the drug and immunization. In the “sterilization experiment” (1933), people with hereditary diseases were forcibly sterilized. “Head injury experiment” (1942) involved inflicting head injury of various degrees after tying the subjects to a chair so that the subject cannot move. The “sulfonamide experiment” (1942–1943) involved intentionally infecting wound with Clostridium perfringens and Clostridium tetani to test the efficacy of sulfonamide. The “experiments with poison and incendiary bomb” (1943–1944) was conducted by giving poisonous food, poison on bullets, and phosphorous containing incendiary bombs to test the medicines and the best method of treatment. “Potable seawater experiment” (1944) was conducted by not giving the subjects any food and providing them with only seawater to drink. The “Unit 731” (1939–1945) experiment involved subjects for secretly testing biological and chemical warfare. The “Tuskegee syphilis study” started in 1932 to know the natural course of syphilis. The 600 enrolled subjects were misinformed about the study. The study was originally designed for 6 months only, but it lasted till 1972. The subjects were lured by offering them free medical examination, free food, and burial insurance. In 1947, penicillin was established as treatment for syphilis, but all subjects were denied this treatment in the pretext of the study. The detail description of these studies is out of scope of this editorial, and interested readers can read the details from the appropriate source. There are many more “infamous” studies as this which took place in the past.

Nuremberg trials started after the Second World War by the United States Authorities for the war crimes of German doctors. The 12 trials were collectively called the “Trials of War Criminals before the Nuremberg Military Tribunals” which is now known as “Nuremberg Trials.” The “Nuremberg Code” in relation to medical research ethics emerged from the trials itself. This contains ten main points which must be known to all involved in the research and strictly adhered to.[1] The subjects should give informed consent without coercion for participation. The experiment should be for the good of the society, and it should be designed based on the earlier experiments and knowledge. There should be no risk of suffering and injury either physically or mentally. No experiment should be done if death or serious injury is inbuilt. The risk taken should not exceed the consideration of humanitarian importance. Preparation should be there to tackle against all possible untoward happenings. The experiment should be done by qualified personnel only. The subjects should be free to leave at any time during the course of the experiment. The researcher also should be ready to terminate if they feel it is not safe to continue these experiment. These are like ten commandments of research in protecting the subjects' human rights. Subsequently, the Universal Declaration of Human Rights was adopted by General Assembly of United Nations in 1948. The fundamental international document in biomedical research ethics was adopted by the 18th World Medical Assembly, Helsinki, Finland, in June 1964 and is known as “Declaration of Helsinki.” This was amended by the 29th World Medical Assembly, Tokyo, Japan, in October 1975 and the 35th World Medical Assembly, Venice, Italy, in October 1983.[2] The purpose of biomedical research involving human subjects should be to enhance the prophylactic, diagnostic, and therapeutic procedures and the better understanding of the etiology and pathogenesis of the disease.

The bioethics is not restricted only to human beings; hence, it encompasses the three main partners; medical ethics, animal ethics, and environmental ethics.

The basic ethical principles involving research will be taken care of if we follow the following four points:

  1. Autonomy (respect for the subjects)
  2. Beneficence
  3. Nonmaleficence
  4. Justice.


Each researcher should be adhering to these principles in order to be ethical in research. They are supposed to have read the “Nuremberg Code” and “Declaration of Helsinki.” “Institutional review board” or “ethics committee” ensures that these principles are followed in the research. Readers are recommended to read various aspects of research before starting any research so that avoidable mistakes can be taken care of.[3]



 
  References Top

1.
The Nuremberg Code. Available from: https://www.history.nih.gov/research/downloads/nuremberg.pdf. [Last accessed on 2018 May 26].  Back to cited text no. 1
    
2.
Declaration of Helsinki. Available from: https://www.wma.net/wp-content/uploads/2016/11/DoH-Jun1964.pdf. [Last accessed on 2018 May 26].  Back to cited text no. 2
    
3.
Bali J, Kant A, editors. Basics of Biostatistics: A Manual for Medical Practitioners. New Delhi: Jaypee the Health Science Publisher; 2016.  Back to cited text no. 3
    




 

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