Human life as we know it has been getting better and better every single day. Overtime we have seen a better increase in the quality of life amongst us. Complications such as diseases and other health threatening issues that once hindered our ability to live leaving us confused and dazed, are now understood better than ever finally allowing us to thrive and civilization operating as it must. With the average life expectancy boosting from 70 to 80 In a matter of decades, you may wonder what could have caused such a drastic change. What is keeping you and I healthy every single day throughout our lives. Well over the years, through the evolution of technology and studies, we have been able to crack the human code allowing us to go in depth on how we are made and how we function. Known as genomics, it is a type of study that test the genes of individuals to see how they interact and how these interactions could affect a person’s health. With this information, we were able to create the tools needed to help cure, halt, and prevent diseases and other illnesses that exist. But all this information didn’t just spawn out of thin air. It is through the courage and participation of many individuals who allowed themselves to be studied on and researched, sharing their results with medical facilities that we are here today. Although, as good as this is there are several concerns and questions many have regarding participating within these types of studies. Many show concerns for the types of studies being conducted as well as whether these tests are truly ethical. Many participants express concern on the utilization of their information and whether it is safe.
As a form genetic testing, many fear and don’t feel the need to know their results as it might uncover surprising sensitive information, news they’re not ready to tackle. Many individuals also believe that the wellbeing of society shouldn’t rely solely on their results from these tests as they are risking their wellbeing for another person somewhere they don’t know. As these are all valid points; these types of tests are very important as they benefit society greatly. But it is also important for all to understand that no one should be forced to take part in such studies if they don’t feel the need to or if they’re concerned for themselves. For this, regulations should be in place to protect the information and privacy of those such. For this, in our current age, companies who perform these studies and test require an informed consent process for participants. This is key as “the informed consent process is an important touchstone to maintain research participant autonomy” (Genome.gov 2022). Protecting the rights and privacy of people should be the top priority with studies like this. Therefore, people should have a say when It comes to taking part in these types of tests. It is important for researchers who conduct these experiments to be humane and respect people’s individuality and not see participants as mere objects whom they can simply use.
But this wasn’t always the case as back then people were used without their permission for horrific experiments. During WW2 for example “Nazi physicians and researchers conducted horrific experiments on human subjects without their consent” (Genome.gov 2022). This went on for 12 years between 1933 – 1945. Similarly, here in America similar studies were held. For example, a study known as the Tuskegee study was conducted between 1932 and 1972. During this time around 400 African American men we’re being wrongly experimented and tested on by the Public Health Service (PHS) and Centers for Disease Control and Prevention for untreated syphilis. This was mainly a sign of racism within the health care system but also opened the eyes of many to these wrongful experimentations on human beings. “The egregious actions taken by the U.S Government during the Tuskegee Syphilis study led to the creation of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research” in 1974 (Genome.gov 2022). “The commission was tasked with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to ensure that such research is conducted in accordance with those Principles” (HHS.gov 2022). Eventually “four years later, this commission published the Belmont Report, which laid out the essential need for informed consent in human research” (Genome.gov 2022). Informed consent is very important and ethical when it comes to healthcare researchers and doctors respecting their patients and their well-being. In an article published by Stefan C. Grant on Jama Network, he states, “Informed consent is fundamental to the ethical and legal doctrines respecting research participants’ voluntary participation in clinical research” (Stefan 2021). I heavily agree on this point as it is through the kindness and generosity of these people who participate that science, and our medical system keeps advancing every day. But we need to understand is that no one is obliged to participate in these types of studies. But such participation is needed if we wish for the wellbeing of us all. This is well expressed in an article published on the National Institute of Health (NIH) as it states, “participating in research can help future generations lead healthier lives” (NIH.gov 2023). Furthermore, it goes on to say, “major medical breakthroughs could not happen without the generosity of clinical trial participants young and old, healthy, or diagnosed with a disease” (NIH.gov 2023). By taking part in these clinical trials, people are helping scientists develop new medicines and other strategies to help treat and prevent diseases. Many treatments that are used today such as vaccines and medications prescribed to you would not exist without research participants.
Furthermore, if these needs are not upheld by these companies, we could see many people start to become hesitant when it comes to participating in clinical trials and we could see a major decline resulting in a halt and sink with the progress in our health care system. This would be a major letdown for society as a whole. Unfortunately, over the years medical facilities have already started seeing a decline in clinical trials around the world. For example, expressed by Dr. Jennifer Harris Head of the Research Policy Association of the British Pharmaceutical Industry she explains how the number of clinical trials performed in the UK have been declining and continue to decline. She expresses how “in 2017, 667 commercial clinical trials were initiated and in 2020, 508 were Initiated, representing a decrease of 24%” (Harris 2023). She goes on to add how “the UK continues to lag behind international comparators in recovering enrolment in commercial studies” as enrolment in clinical trials in June 2021 was 15% lower than in June of 2019. During covid 19 a decline in clinical trials also occurred. “The activity of clinical trials was decreased as the number of COVID-19 patients was increased, and a statistically negative correlation was observed between the prevalence of COVID-19 and the percentage decrease in the number of clinical trials stared or reported results.” This change was mainly due to the pandemic shifting the focus of clinical trials for other diseases to Covid-19 as it was urgent but also with the fear it induced into people. Over the years it is pretty evident that there is a decrease in clinical trials, and it mainly has to do with factors such as, concerns of side effects, eligibility, and most importantly lack of understanding and engagement with these types of studies. Many people have major trust issues when it comes to testing their health and well-being. This was pretty evident especially with the vaccine trials during Covid-19. People nowadays are not willing to participate in such studies due to the uncertainties they have regarding them. This is why an informed consent process could be helpful and possibly the solution to all of this. Informed consent not only respects the rights of individuals but also educates and informs them before-hand on these clinical tests and medical procedures they may take part in. Informed consent allows all of us to participate in our health care. Best said by healthline.com “informed consent is your understanding and agreement to any medical procedure or treatment you receive before it proceeds.” Informed consent ensures that your healthcare provider effectively communicates with you regarding your treatment and involvement in these clinical studies. This is very important especially when it comes to making that final decision regarding your health. Our health care will evolve continuously every day like it has been for the past decades. From this point on and soon there will be new health challenges in the brisk of society. If we wish to tackle them head on, we will need our health care system to be better than it is today. But this can’t be done without the help of us all and our corporation and participation in our healthcare system. Therefore, there should be regulations in place to make sure we feel safe taking part in such procedures and Informed consent is one way we could get this done.
Reference page:
Grant SC. Informed Consent—We Can and Should Do Better. JAMA Netw Open. 2021;4(4):e2110848. doi:10.1001/jamanetworkopen.2021.10848
Grant SC. Informed Consent—We Can and Should Do Better. JAMA Netw Open. 2021;4(4):e2110848. doi:10.1001/jamanetworkopen.2021.10848
Bazzano LA, Durant J, Brantley PR. A Modern History of Informed Consent and the Role of Key Information. Ochsner J. 2021 Spring;21(1):81-85. doi: 10.31486/toj.19.0105. PMID: 33828429; PMCID: PMC7993430.
Ruth Macklin [email protected] & Lois Shepherd (2013) Informed Consent and Standard of Care: What Must Be Disclosed, The American Journal of Bioethics, 13:12, 9-13, DOI: 10.1080/15265161.2013.849303
Nishiwaki S, Ando Y. COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective. Front Med (Lausanne). 2021 Dec 24;8:812370. doi: 10.3389/fmed.2021.812370. PMID: 35004791; PMCID: PMC8739772.
Why Informed Consent Matters (clevelandclinic.org)
Why is informed consent required? (genome.gov)
Informed Consent FAQs | HHS.gov
What Are Clinical Trials and Studies? | National Institute on Aging (nih.gov)
An opportunity for growth: Clinical research in the UK (abpi.org.uk)
