Ethical Challenges in COVID-19 Biospecimen Research

by

Introduction

COVID-19 has infected more than 110 million individuals worldwide, with about 2.5 million deaths. It is very crucial to find an intervention that successfully prevents or mitigates morbidity and mortality. Biospecimen research can provide novel insights into the disease, clinical trials, and the development of effective and life-saving treatments. However, any such study raises ethical concerns plus practical challenges for investigators and participants. 

The University of Cambridge introduced a weekly asymptomatic testing program for students as part of its efforts to reduce the spread of COVID-19. Dr Caitriona Cox, NIHR Academic Clinical Fellow at THIS Institute and project lead, said: “The framework and checklist are freely available and will hopefully act as valuable and timely resources for higher education institutions seeking ethically sound ways to keep people safe and support public health efforts.” (1)

In March 2021, ThePrint reported (2) that the use of placebo controls in clinical trials remains controversial, and researchers are increasingly questioning its role in testing Covid-19 vaccines. “We want to critique it (the WHO ad hoc group’s position), we do not agree with such a kind of position. Long back in 1990s, when the HIV epidemic was prevalent in different countries, this issue was settled, there are informational guidelines, and the Helsinki declaration that says that if you have an effective vaccine available, you cannot use placebo-controlled trials,” Dr Amar Jesani, the editor of IJME, told ThePrint.

On 15th March 2021, the Netherlands (3) and Ireland (4) announced the suspension of the AstraZeneca vaccine amid blood clot reports, followed by other countries like Germany, Italy, and France (5). “The decision has been made… to suspend the use of the AstraZeneca vaccine as a precaution, hoping that we can resume it quickly if the judgement of the EMA allows it,” Mr Macron told a press conference, adding that an announcement by the EMA was expected on Tuesday afternoon.

This article casts light on the ethical issues associated with autonomy, benignity, and justice in COVID-19 research. It describes the strategies to manage the practical challenges, emphasizing human research participants’ rights and welfare. The 1978 Belmont Report established the foundation for research oversight with three ethical principles. These principles include: 

Respect for Persons

COVID-19 biospecimen research faces several issues that complicate its ethical oversight, such as 

  1. Vulnerable groups are disproportionately affected by COVID-19. These individuals may lack the capacity to give informed consent. The heightened anxiety faced by legally authorized representatives (LARs) can result in delays in obtaining consent.
  2. In the current situation, blood samples from patients with COVID-19 are crucial for improving scientific understanding of the virus and its consequences. However, sometimes a participant or their LAR cannot be located. 

The institutional review board (IRB) can use the following strategies to approach the situation:

  1. Account for these multiple obstacles in obtaining informed consent from patients or their LARs. In case the LARs cannot be located, the samples must be destroyed or de-identified.
  2. Be sensitive to the medical issues while recruiting human participants for COVID-19 biospecimen research.

Beneficence

Violation of participant privacy and breach of confidentiality are significant risks in biospecimen research. Another issue is the exploitation of protected and vulnerable groups. COVID-19 study offers the hope that participants would receive the social benefits of advancements quickly. COVID-19 research proponents anticipate that their work will have a high impact on mitigating the disease.

To protect the participants and the research study:

  1. Maintain patient privacy and keep health records private.
  2. Treat minority and economically disadvantaged communities equally.
  3. Create a population-friendly environment- build trust and understand the public’s perspective. 
  4. Make sure that the participants are aware of short-term and long-term benefits.

Justice

Every pandemic evokes new questions about what justice requires, even as the pandemic also potentially worsens existing inequalities. Expediting pandemic-related research and allowing waivers of informed consent for the initial biospecimen collection procedures relies on social arguments about the responsibility to participate in research that likely yields collective benefits. In the COVID-19 situation, the most vulnerable groups have suffered. During such cases, IRBs must:

  1. Prioritize research that will deliver the greater public good. 
  2. Consider meeting the demands of justice in the initial review of COVID-19 research protocols and subsequent requests for access to biospecimens.
  3. Ensure fair access to the therapeutic benefits of research and promote the inclusion of vulnerable groups.
  4. Focus on equitable recruitment and inclusion to allocate the research benefits and burdens.
  5. Engage susceptible people in the post–COVID-19 era to assess whether the public agrees with a waiver of consent and what types of research they are willing to engage in without giving explicit informed consent. 

Acknowledgments

Read the full article here: https://www.mayoclinicproceedings.org/article/S0025-6196(20)31208-8/fulltext 

References

https://web.archive.org/web/20120426013513/http://ohsr.od.nih.gov/guidelines/belmont.html#gob1