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The Million Women study and the role of ethics review

Last updated on 4 Feb 2022

To mark World Cancer Day (4 February) we spoke to the study team from the Million Women study at Oxford Population Health to find out about their work and how the HRA has helped with this important research.

The Million Women Study started recruiting participants more than 20 years ago, in 1996, and is the largest epidemiological study of its kind. The initial stimulus was to obtain robust prospective information on the risk of breast cancer associated with use of different types of menopausal hormone therapy.

What is the Million Women Study investigating?

While the initial stimulus was to study the risk of breast cancer and other conditions associated with the use of menopausal hormones, most of the women who joined the study had reached adulthood in the 1960s and had considerably different lifestyles to those of previous generations. For example, large proportions had begun smoking and using oral contraceptives as teenagers and young adults. The prevalence of obesity was also increasing and there were claims that other behaviours, such as diet, had important effects on health. To answer questions about the effects of these factors on health reliably requires large scale population-based evidence. The Million Women Study is therefore investigating the short-term and long-term effects of these and many other factors on women’s risk of developing or dying from different types of cancer, heart disease, stroke, dementia and other mental and neurodegenerative disorders, and many other conditions in middle and in old age.

It aims to improve population health by providing reliable evidence on the effects of potentially modifiable factors that affect women’s health as they age.

What role has ethics approval and the HRA played in your study?

Over the many years that the Million Women Study has been running, the ethics reviews have been helpful in ensuring we consider the burden on our participants and honour our promise to them to use the data they supply to us for the benefit of public health research.

We recognise that Research Ethics Committees play an important role in ensuring that the safety, rights, health and wellbeing of potential participants will be protected at all times. The REC has been an independent assessor of the ethical considerations of our research, which has been very helpful. Over the years, the REC has become more probing regarding research methodology and the collection and management of data and human tissue. The HRA now provides guidance regarding presenting information for potential participants in plain language and seeking consent.

You started recruiting participants more than 20 years ago, before the HRA was established. How do you think ethics reviews have evolved and changed for the Million Women study over the years?

The regulatory requirements relating to biological samples and data protection have changed substantially since the study began and with the help of HRA guidance we have modified our methods to incorporate these regulations.

How do you ensure your work is ethical?

In accordance with HRA best practice, we ensure our research is designed and undertaken in a way that ensures integrity, quality and transparency. Every aspect of our work that involves participants has to be approved by an ethics committee before we make changes. Our protocols and documents for participants are reviewed regularly and ethics approval is sought for any amendments made to the study protocol.

Our scientific work is peer-reviewed at the outset by funding bodies to ensure the work is worthwhile and likely to have benefits to the wider population.

We have recruited a representative group of study participants onto our Participant Panel. The Participant Panel meets regularly throughout the year and are consulted on all aspects of our research. They also provide valuable feedback on the appropriateness and transparency of participant facing materials.

We ensure our research is conducted in accordance with the UK Policy Framework for Health and Social Care Research. For example, the confidentiality of records of the participants remains protected, in accordance with the latest legislation (for example Data Protection Act and GDPR). We explain how we do this in our privacy notice on our website.

World Cancer Day this year is about recognising the power of knowledge. How important is transparency in your work and keeping participants updated with information that’s clear and easy to understand? How do you do the latter?

We believe it is very important to keep participants updated. To ensure transparency, we have a Million Women Study website and a newsletter, where individuals can find updated information on study findings. We aim to present information in a clear and concise manner, and we try to avoid using complex scientific terminology in our participant information.

With recognised inequalities in cancer care, how do you ensure the participants of your study represent a diverse range of women?

The study includes women with a wide range of backgrounds, behaviours and lifestyles, and they are broadly representative of all UK women born between 1935 and 1950. The population is geographically diverse as it covers 66 breast screening centres in England and Scotland.

Do you have any advice for researchers who are about to start their journey with the HRA?

Think ahead

Know your study population

Pilot your research to justify your methodology

Patient and public involvement

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