Ethical Challenges in COVID-19 Biospecimen Research
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, The Print 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 the 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 judgment 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 -
The institutional review board (IRB) can use the following strategies to approach the situation:
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:
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:
Read the full article: https://www.mayoclinicproceedings.org/