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Involving pregnant people in health and COVID-19 research: ethics, challenges and solutions – a blog by Michael Pettit

Last updated on 4 Aug 2021

A new study funded by the Department of Health and Social Care is looking at the best coronavirus (COVID-19) vaccine dose interval for pregnant people. The Preg-CoV study, led by St George’s, University of London, aims to develop evidence-based guidelines on the use of vaccines during pregnancy.

Pregnant people are more likely to develop severe COVID-19 and to die from it, compared to those who are not pregnant. Pregnant people who develop COVID-19 symptoms are also around two times more likely to give birth early.

With this in mind, pharmacist and lecturer Michael Pettit looks at the importance of involving pregnant people in health research – particularly into COVID-19 – and how we address the ethical issues around this. Michael is Vice Chair of the HRA’s Surrey Research Ethics Committee (REC), but was not involved in the review of the study. The study was approved by the HRA’s Newcastle and North Tyneside 1 REC.

Michael is also part of a group of representatives from the HRA is working with the Association of the British Pharmaceutical Industry’s Maternal Health Project Group looking at ways to address the lack of licensed medicines and treatments designed and researched for use in pregnancy and breastfeeding.

Difficult choices

The image shows blog author Michael Pettit.

‘Pregnant people are usually excluded from new vaccine trials, and there is limited data from clinical trials for COVID-19 vaccines given during pregnancy. Data about use in pregnancy for many common prescription and over-the-counter medications is also limited.

This means pregnant patients often face difficult choices about whether to have COVID-19 vaccines, continue with medications for chronic conditions, or whether to take medications for new conditions, some of which are pregnancy related.

It is therefore important to include pregnant people in clinical trials where the safety profile of a new treatment option shows it would be acceptable. Doing so enables us to collect useful data, and helps pregnant people make an informed choice about taking medications during pregnancy.

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Managing risks

There will always be a level of risk with any trial. The key is to ensure the risks are known, managed and mitigated against. We all do things in everyday life that carry a risk: crossing the road, or travelling by car or bicycle. We accept the risk because of the benefit these activities bring us. We mitigate them by having rules and processes: the Highway Code, planning road layout and use, and the provision of pedestrian crossings, traffic lights and cycle lanes.

Risks in research are similarly managed. The HRA has RECs across the country, which work to protect participants by assessing the risk and benefits of research proposals. RECs try to ensure risk is minimised, proportionate and properly explained; and that participants’ interests and their confidentiality are protected.

Careful consideration

A REC will look at a range of information. It will consider the questions the research aims to answer; the methods (the Highway Code, if you like); the public and patient involvement in the study design and their opinion of the research; and an independent expert review of the proposal.

The information given to potential participants and the consent forms they sign are also extremely important. A REC will consider if these clearly explain what will happen and the potential benefits and risks to participants; and whether the form enables appropriate consent to be given and withdrawn.

For studies involving pregnant people – in COVID-19 research and health research more broadly – there is also the concern about potential effects on the unborn baby. If a study is considering the treatment of pregnancy-related problems, the REC will assess how prevalent the disease is in pregnant people and the potential harm to the women and unborn babies. They will also examine whether the risk of treatment or intervention outweighs the risk or potential harm of no treatment or intervention.

Informed choices

A REC will look at a range of information. It will consider the questions the research aims to answer; the methods (the Highway Code, if you like); the public and patient involvement in the study design and their opinion of the research; and an independent expert review of the proposal.

The information given to potential participants and the consent forms they sign are also extremely important. A REC will consider if these clearly explain what will happen and the potential benefits and risks to participants; and whether the form enables appropriate consent to be given and withdrawn.

For studies involving pregnant people – in COVID-19 research and health research more broadly – there is also the concern about potential effects on the unborn baby. If a study is considering the treatment of pregnancy-related problems, the REC will assess how prevalent the disease is in pregnant people and the potential harm to the women and unborn babies. They will also examine whether the risk of treatment or intervention outweighs the risk or potential harm of no treatment or intervention.

Some patients who are receiving treatment for chronic debilitating diseases may become pregnant. A REC must consider the treatment of the disease in such cases. Again, they must weigh up the risk from the disease if treatment is stopped or changed against the treatment’s own risk. Where unknowns exist, ethical scientific research is crucial to answer these questions.

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Helping research happen

RECs help this research to happen. Their work is not just about providing ethical approval for a study. As well as considering the evidence and discussing the ethical and moral issues presented, they also help researchers make the risks and potential benefits clear to participants in a way that enables an informed choice.

For COVID-19 research in pregnancy, a REC will specifically consider:

  • What is the infection risk – is it increased?
  • What are the consequences of COVID-19 infection – increased hospitalisation, need for intensive care, long COVID, death?
  • What are the risks of COVID-19 to the unborn baby?
  • What are the benefits and risks of the COVID-19 vaccine or treatment in the general population?
  • What is known about the benefits and risks of the COVID-19 vaccines or treatment in pregnancy already?
  • Is the information on the research and risks/ benefit appropriately explained and easy to understand, so that it allows pregnant women to give informed consent if they wish to participate?

Ultimately, those who are pregnant and breast-feeding must have access to the treatments and medications they need. These must be safe and effective, and the information about them must be clear. Finding ways to enable pregnant or breast-feeding people to participate in research is therefore essential, and something everyone within the health research system should think about in their work.’

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