As we all know, the growth of medical science is driven by performing regular experiments on living organisms for understanding deeply about the effects of medicines on a living body. Currently, research for the covid-19 vaccine is an ongoing process and clinical trials are also being performed for better knowledge. You might be anxious about the risk of this human trials. Let discuss about it in depth. Human research is scientific research which can be either interventional or observational. The research leads to the incorporation of both collections of data and its analysis for getting an answer for a specific question.
Human subject research is conducted for many fields, including:
- Advanced Biology
- Clinical medicine
- Nursing
- Psychology
- Sociology
- Political science
- Anthropology
The research conducting for human subjects has become formalized, by introducing formal guidelines, mainly due to the abuses of human subjects.
Human Subjects
The United States Department of Health and Human Services (HHS) claims human research subjects to be an investigation about a living individual, by professional or a student, for obtaining data through:
- Intervention - manipulation of the subject or the environment and physical process of gathering data.
- Interaction - personal interaction between the researcher and the subject.
- Private Information - The information provided by an individual expecting it to be not disclosed to the public and the information regarded the actions by which the individual realizes that no investigation is taking place.
- Identifiable Information - Information used for identifying an individual
Rights of a Human Subject
- Informed consent
- Respect for persons: treated as autonomous agents
- The right to end participation in the research at any time
- Protection from physical, mental, and emotional harms
- Access to information regarding the research
- Protection of privacy and well-being
Ethical Guidelines
The investigation during biomedical research, which involves human subjects, is governed by the ethical guidelines which were put in place in the United States for the protection of the subjects from abuses. Regulatory bodies such as Food and Drug Administration (FDA) and Institutional Review Boards (IRBs) were introduced that laid policies that served to reduce mental and physical harm to the human subject.
The Common Rule - It was introduced in 1981, holds statements regarding biomedical and behavioral research involving human subjects in the United States. These are the baseline standard by which any government-funded research is held in the U.S. All institutes follow these guidelines of rights regardless of funding.
It holds the requirements for:
- Assuring Compliance by research institutes
- Researcher's obtaining, waiving, and documenting informed consent
- Institutional board's membership, function, operation, review of research and record-keeping
For more information visit https://en.wikipedia.org/wiki/Common_Rule
Nuremberg Code - This guideline stated the requirement of "the voluntary consent of the individual before conducting the research". It was meant to protect prisoners, soldiers, and patients from any human subject abuse. It was also necessary to inform the individual about the good and bad consequences of the research.
For more information visit https://en.wikipedia.org/wiki/Nuremberg_Code
The declaration of Helsinki - These guidelines were laid in 1964, by the World Medical Association, for the doctors involved in biomedical research in which humans were the subject. It stated that "the research protocols should be reviewed by an independent committee prior to initiation and that research should be based on the results from the laboratory animals and experiments". It was known as a cornerstone document on medical ethics.
For more information visit https://en.wikipedia.org/wiki/Declaration_of_Helsinki
The Belmont Report - This guideline was created for the ethical behaviors that involved human subjects for the investigation. It is followed by three standards which shows how the subject should be researched:
- Beneficence - It states the protection of well being of the persons and increasing the benefits of the research and minimizing any harm to the human subject.
- Justice - Sharing of the result with the person and conducting research by being fair and not biased.
- Respect - It should be the decision of the person whether he wants to participate in the research or not. The decision should be respected and less harm should be ensured by the researcher to the subject.
For more information visit https://en.wikipedia.org/wiki/Belmont_Report
Issues with the Ethics
- With the immense growth of medical science, updating the guidelines became a complex process. The interest in revisiting the ethics of human trials led to the conduction of ethics classes for the students studying for becoming health care professionals, as well as discussing the issues present in this process.
- It became a duty of the researchers for protecting the human subjects during trial. Enrolling patients was one of the most challenging tasks after the implementation of ethical guidelines.
- Another concern was that even the rules were ethical, they may not be logical or helpful for conducting their research.
- Recently, conducting research studies has been shifted from institutions to rural communities. The study about the influence by which participation of human subjects will increase in the research process was conducted by Ann Cook and Freeman Hoas.
- They identified that role of funding was important for assuring compensation to the subject, for the clinical trial.
Examples of real-life Unethical experiments
Unethical Human experiments are a violation of the principle of medical ethics. It was earlier performed by Nazi Germany, Imperial Japan, North Korea, the United States of America, and the Soviet Union.
Let's talk about some of the real-life examples of unethical experiments performed:
- Nazi Germany performed experiments on a large number of prisoners (including children) largely Jews, and also Romani, Sinti, ethnic Poles, Soviet POWs, and Disabled Germans, in its concentration camps in the early 1940s, during world war 2. Prisoners were not asked for any consent and were forced the participation in a human trial. It resulted in death, trauma, disfigurement, or permanent disability. This doctor's trial, after the war, led to the development of the Nuremberg code.
- Unit 731, a department of the Imperial Japanese Army, conducted experiments on prisoners by performing vivisections, dismemberments, and bacterial inoculations. It resulted in epidemics on a very large scale from 1932 onwards through Second-Sino Japanese War. They also performed biological and weapons tests on prisoners and captured POWs. During world war 2, similar units were organized in cities such as Nanking, Beijing, Guangzhou, and Singapore.
- From the 1950s-60s, Chester M. Southam, a virologist and cancer researcher, injected HeLa cells into cancer patients, healthy people, and prisoners to observe if cancer could be transmitted as well as whether the people could become immune to cancer by developing the acquired immune response.
Human experimentations are gradually leading to the development of more medical facts and technology, for saving lives. As we discussed earlier in this article, it is necessary to conduct proper research for inventing medications, without any harm to the living beings of our planet. The research should be conducted by ensuring the ethics of medical science. Medical science has developed so much that it is possible to cure diseases within a few days. Let's hope for the best and support our doctors for making available the most effective medicines to us in future.