Signing Their Rights Away: The Heightened Importance of Informed Consent in COVID-19 Vaccine Trials

By Aadhira Pramod, Ria Parikh, Amna Hassan

While clinical ethics are not a novel concept, the emergence of vaccine development during the Coronavirus pandemic has illuminated a number of ethical injustices. These injustices have disproportionately affected third world countries and violated some of their undeniable and basic human rights, such as “their right to health” and “the right to participate in decisions that affect their lives” [1]. The ethical concerns surrounding COVID-19 vaccine testing are actually twofold: protecting the integrity of the study, as well as protecting the safety of the test subjects.

Ideally, clinical trials would be transparent: test subjects would be thoroughly informed about the benefits and risks of the trial and would thereafter be able to make an educated, informed decision. Receiving proper informed consent in clinical trials is difficult largely because the verbage used to communicate information needs to be extremely precise, especially when many prospective subjects are not familiar with the design of a clinical trial [2]. While some ethical intricacies and moral obligations of clinical trials may seem obvious to those designing and conducting these trials, certain parameters of treatment and care are still largely unknown to the general public.

Clinical Project Management Consultant Samantha Sharpe said that while she has not encountered any new concerns with COVID-19 vaccine trials, she agrees that some pre-existing clinical concerns are amplified during this time, such as transparency and informed consent.

“Our biggest challenge with all of these studies is transparency to the general public and how we’re addressing that in a way that is able to be understood by a wide range of people,” Sharpe said. “At the end of the day, signing up for the study or agreeing to participate in the study is an individual decision, and obviously receiving the vaccination is an individual decision. But, the environment around the vaccine study is certainly something that I think is most concerning.”

Informed consent is more than just a signature. In the United States and around the world, people impacted by a myriad of social vulnerabilities may participate in clinical trials to access medical treatment early or free of charge. Of note, there is an alarmingly large intersection between the majority of socially vulnerable populations and their susceptibility to contracting COVID-19. A few of these vulnerable populations include the socioeconomically disadvantaged, the homeless population, the incarcerated, and racial minorities [3]. In addition, many of the aforementioned populations are very poorly treated by the current national healthcare system [4]. Thus, many members of these populations would understandably participate in clinical trials if they are under the impression that they will receive free treatment and proper care.

Although it is certainly not the responsibility of clinical researchers to provide treatment, it is inarguably their responsibility to communicate the parameters of the trial in a way that allows subjects to become aware of the guidelines and their role. This responsibility also applies to the incorporation of placebos and taking careful consideration to properly communicate an uncertainty of whether a test subject will actually receive a vaccine or not. Sharpe worries that without proper knowledge, all subjects may act as if they have been undoubtedly vaccinated, potentially worsening progress made on eradicating the contagious virus from society.

“A worry, if someone is participating in a COVID-19 vaccine trial that is placebo-controlled, is, perhaps that individual would not be as cautious in the general public, thinking ‘Well, possibly, I got a vaccine,’” Sharpe said. “I think that is always a concern to have, but especially in a global pandemic.”

Sharpe’s concern outlines a miscommunication that ultimately affects the integrity of the study design. Neither these concerns nor these communication errors are minor, as they could violate the rights of the subjects and potentially damage their health. In the United States, there have been discussions led by the Office for Human Research Protections, and the Department of Health and Human Services about rectifying large issues with informed consent by streamlining forms to highlight indelible information often overlooked [5]. Though these productive discussions have offered some solutions to protect human rights, they will only truly benefit those affected if they are put into action. It is not only fair but imperative that prospective test subjects understand that when they participate in a clinical trial, they are not guaranteed treatment nor personal follow-up medical care. To those looking for a vaccine, a clinical trial might sound appealing; therefore, the piece of paper serving as communication for potentially life-altering information during this infodemic should, without question, be transparent and digestible to people from all socioeconomic statuses and educational backgrounds.

On a global scale, these ethical concerns in third-world countries are magnified and produce the same detrimental effects on human rights. In fact, while conducting trials in these countries, researchers should take into account the other outstanding conditions in those countries such as poor resources and language barriers. If gone unnoticed, these challenges can amplify the communication issues involved with informed consent that are already so prevalent in the United States.

For instance, in many African countries, “the medical infrastructure (hospitals, doctors, drug storage, patient records, etc.) is not sufficient to conduct trials” [6]. With low resources, the study has to account for these factors when considering the ethical guidelines of performing tests with all parties having complete awareness of every intricate component. Irene Schipper, a senior researcher at SOMO Centre for Research on Multinational Corporations, performed studies on “low-resource settings” and found that “adequately informed consent” was an ethical violation [6]. Poor resources and lack of access to healthcare results in those who live in these environments to be more exploited during clinical trials.

In addition to the lack of resources, language barriers may impact transparency and informed consent. Due to these barriers, the subjects may misunderstand the goal of the study, which would prevent them from being informed of the appropriate requirements and criteria. When conducting clinical trials on non-English speaking subjects, the Office for Human Research Protections requires consent to be obtained from a document in the subject’s native language [7]. Understandably, there is a chance that important information will get lost in translation, some of which might have impacted the subject’s decision to participate in the trial. In regard to the placebo effect, language barriers can play a significant role; many people who participate in clinical trials hope to receive treatment and when these people are misinformed or interpret the information incorrectly from these translations, they may think that receiving a placebo test will result in a definite treatment. Despite the ethical validity of double blind studies for the data itself, Sharpe worries that all participants will remain under the impression that they are vaccinated and thereby pose a greater threat to themselves and the environment. Not only could a potential placebo ruin those chances of receiving a vaccination, but it also prevents people from receiving proper treatment throughout the duration of the study.

These ethical concerns surrounding informed consent do not detract from the validity of clinical trials as an effective method of research and vaccine development. As Sharpe mentions, it is important to include subjects from all populations in vaccine testing, in order to maximize the efficacy of the trial.

“When we are testing a vaccine candidate or any drug or device, it is very important to include special populations and a diverse representation of what the world’s population looks like,” Sharpe said. “When we talk about third-world countries, it is very interesting to think about malnutrition or other ailments that might be more common in those populations. For a vaccine to be a global-vaccine candidate, having populations represented during clinical study is very important so that we can ensure that the vaccine is safe, no matter the environment in which it is going to be deployed.”

Diverse representation in clinical trials is vital, especially during a pandemic that targets socially vulnerable populations. However, vaccine testing should be conducted around the world with special consideration of the methods that are utilized to communicate parameters of the study to vulnerable test subjects, especially to those that are not necessarily familiar with the scientific jargon or experimental design. Clinical trials are an unquestionable necessity for developing an effective COVID-19 vaccine, but human rights should be inalienable now and always. In order to maintain the integrity of a test subject’s basic human rights, clinical research should assume the responsibility of effective communication and design consent forms with these values in mind. If communication is ignored in the context of vaccine trials, vulnerable people around the world might just be unknowingly signing their rights.

References:

[1] UNFPA (2005). Human Rights Principles. UNFPA.

[2] Informed Consent for Clinical Trials (2018, Jan. 04). U.S. Food & Drug Administration.

[3] Kuy, S., Tsai, R., Bhatt, J., Chu, Q. D., Gandhi, P., Gupta, R., Gupta, R., Hole, M. K., Hsu, B. S., Hughes, L. S., Jarvis, L., Jha, S. S., Annamalai, A., Kotwal, M., Sakran, J. V., Vohra, S., Henry, T. L., & Correa, R. (2020). Focusing on Vulnerable Populations During COVID-19. Academic medicine: journal of the Association of American Medical Colleges, 10.1097/ACM.0000000000003571. Advance online publication. https://doi.org/10.1097/ACM.0000000000003571

[4] Access to Health Services (2020). Office of Disease Prevention and Health Promotion. Social Determinants of Health.

[5] Meeting New Challenges in Clinical Research (2018, Sept. 07). Office for Human Research Protections, Department of Health and Human Services.

[6] Shipper, I (2020, July 08). The ethics of clinical trials in times of corona. The Centre for Research on Multinational Corporations. Research.

[7] Informed Consent of Subjects Who Do Not Speak English (1995, Nov. 09). Office for Human Research Protections, Department of Health and Human Services.

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