How to Know Right From Wrong: Ethics in Research
Written by Erin Stacey
Thumbnail and Header Photo by Science in HD on Unsplash
On December 10th, 1948, in the city of Paris, France, the United Nations General Assembly met to proclaim the Universal Declaration of Human Rights – a document that was created to set a standard for all people and nations. The Universal Declaration of Human Rights includes 30 articles, with each article being their own basic right.
The articles within the Declaration protect us and promote a better quality of life, such as article 4, where it states “No one shall be held in slavery or servitude; slavery and the slave trade shall be prohibited in all their forms,” or article 12 which states “No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks”.
How does the Universal Declaration of Human Rights influence research, though? Article 5 in particular directly connects to research, with the article stating: “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.”
Looking back through history, there have been many blatant violations of article 5 in the pursuit of knowledge. Although there are many ways to conduct research, experiments are by far the most popular. Some of the most well known experiments to have blatantly violated article 5 were conducted during World War 2, which in turn catalyzed the creation of the Universal Declaration of Human Rights.
During World War 2, a German physician named Josef Mengele performed countless inhumane experiments on victims brought to the concentration camps. The experiments were a part of a program located at Auschwitz-Birkenau, the largest of the Nazi concentration camps. Between 1939 and 1945 over 1.1 million people lost their lives at Auschwitz-Birkenau, with a minimum of 15, 754 victims of the medical experiments.
At least 70 different medical research projects were conducted on unconsenting human test subjects in Nazi concentration camps between the years 1939 and 1945. These projects were conducted by official institutions of the Third Reich. There were three research goals for these experiments:
A primary focus of Josef Mengele was the study of twins. When prisoners arrived at the concentration camp, they would undergo a selection process to determine where they would be sent. The selection process would determine who was fit enough to be used for labour, who would be killed, and who would be sent to the laboratory. Twins would be separated from their families during these selection processes and sent to the laboratory to be examined. Josef Mengele would use one twin as a subject for his experiments and the other as a control group. By doing this, he was able to see exactly how the experiments were impacting the body of the test subject twin. Nowadays, ethical experiments are still performed on twins to learn about aging, genetics and epigenetics. Mengele’s experiments included procedures like blood transfusions, forced inseminations, amputations and injections with diseases. If the victim died during the experiments, they would undergo an autopsy, with the control twin murdered and autopsied as well.
Situations are not always black and white when talking about ethics. Though you can easily conclude that what happened to the victims of Josef Mengele was an extremely unethical abuse of power, it is not always this clear. In some situations it may be hard to tell what the right thing to do is, like when dealing with animals. This is why there are committee boards and even jobs centred around the assessment of ethics within a medical and research atmosphere.
Ethicists are professionals who study for an advanced degree to identify the “right” thing to do in a given situation. A bioethicist explicitly tackles issues relating to fields of science and health care. Some responsibilities of a bioethicist include analyzing the ethical elements of both the actual and potential actions of a healthcare provider, and providing counsel for the decision. They may be consulted in cases where the best course of action is uncertain and may even be requested for specific cases when the ethics of the situation are in question.
In order to comply with the Tri-Council Policy Statement (TCPS), which is the Canadian guideline to performing ethical research involving human participants, Saint Mary’s University (SMU) has their own Research Ethics Board (REB). The Tri-Council Policy Statement is a joint policy of the three federal research agencies of Canada: the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). These agencies worked together to create a policy that ensured that any research performed in Canada with the use of human participants would be performed ethically. Although the policy was formed for Canada, it has taken into consideration ethics norms from all over the world. SMU’s REB requires researchers at SMU who are using human participants to submit an application to review and clear the prospective research. This application is done before the recruitment of participants even begins.
The Saint Mary’s Research Ethics Board is composed of faculty members, staff, and graduate students elected to the committee. The board meets regularly to review the applications and decide whether to clear, reject, suggest modifications, suspend, and even terminate projects.
Photo by Jørgen Håland on Unsplash
Humans are not the only point of interest for research though, oftentimes animals are involved in research. In the case of animals, SMU has another committee very similar to the Research Ethics Board called the Animal Care Committee (ACC). The ACC adheres to the policies and standards provided by the Canadian Council on Animal Care (CCAC), as required by both the Canadian Institute of Health Research (CIHR) and the Natural Sciences and Engineering Research Council of Canada (NSERC). Approval must be gained before any research or activities involving vertebrates or higher invertebrate animals (e.g. an octopus) is conducted, whether it be in the lab or the field. Furthermore, the direct or indirect use of animal tissues must also be approved by the ACC Coordinator to ensure they fall under all the correct policies and guidelines that the CCAC has put forth.
There are seven steps to filling out and reviewing the REB application, and it begins with the principal investigator filling out the application. Although this first step sounds simple, it actually requires a lot of research and planning to ensure everything is correct and that all policies and guidelines are strictly followed. Next, the REB suggests submitting your draft work to the Research Ethics Officer for a preliminary screening of the application. The screening is to ensure that the application is complete and coherent. If it is not, the Research Ethics Officer will make suggestions for the application and identify any potential problems that can be easily fixed before the application is registered.The third step is to submit the complete application, which can include consent forms, interview scripts, and online survey URLs.
The fourth step is a Level of Review Assessment which determines what committee will review the application. The Level of Review Assessment determines the risk and vulnerability of the participants; if the risk and vulnerability are high, then the application is reviewed at a full board review. If the risk and vulnerability of the participants are low, then the application is sent for a delegated review.
Once the application has been reviewed, the fifth step is waiting to hear from the REB indicating whether the application was approved as is or declined due to violations of the TCPS. If declined, the investigator may fix issues and resubmit the application. The sixth step is to receive approval and determine the duration period of approval, which is typically a year. Once the duration period has passed the investigator must resubmit their application for review if more time is needed for the study. Lastly, the seventh and final step is for the investigator to report any unexpected issues that may occur during their research.
Clearly, it is no easy task to receive approval from an REB to perform research. It requires a lot of time and dedication to ensure participants, whether human or animal, are respected and safe.
Throughout history, there is no question that ethics have been called into question when respect for fundamental human rights was blatantly ignored. This is especially true in the world of research. Thankfully, we have placed precautions and protocols to respect fundamental human rights and ensure that the ethical course of action is taken during research projects in Canadian society.