Declaration of Helsinki revisions: our response to the consultation

How the Declaration of Helsinki informs our work

Although the document is addressed primarily to healthcare professionals, the WMA encourages others involved in medical research involving humans to adopt the principles, such as researchers, research ethics committees and governments.

The Declaration’s principles inform our work every day and help guide us in our strategy to make it easy to do research that people can trust.

For example, our Research Ethics Committee (REC) members operate according to the principles, by helping to ensure research participants have adequate information to make an informed decision on whether to take part in research.

What does the Declaration of Helsinki mean for the HRA?

The Declaration of Helsinki is very important to our work.

While the Declaration is not a legal document, it is referred to in both the UK's Clinical Trials legislation and the UK Policy Framework for Health and Social Care Research. The Framework sets out the principles of good practice in health and social care research in the UK.

Our response to the consultation

We coordinated a response which included input from public contributors who are members of the HRA’s public involvement network and members of NHS Research Ethics Committees. It was also developed in consultation with the UK’s Four Nations Policy Leads Group, which brings together:

• Health Research Authority
• Health and Social Care in Northern Ireland
• Chief Scientist Office in Scotland and NHS Research Scotland
• Welsh Government and Health and Care Research Wales

We found the majority of the proposed changes to the Declaration helpful in providing clarification, updating the text in line with changes in practice and legislation, and ensuring consistency throughout.

Please see below a summary of our feedback to the consultation:

We think the claim that the principles contained within the Declaration have primacy over all national and international laws and regulatory norms and standards remains insufficiently justified

This creates practical difficulties where national legal and regulatory instruments do not require certain categories of research to be the subject of an application to a REC or allow for certain aspects to be considered by bodies other than RECs. This is made more problematic where national and international legal instruments include specific references to the Declaration of Helsinki.

We propose that the new wording should give clarity on the process for making minor and substantial changes to research studies

We think that the difference between minor and substantial changes should be clarified, and there should be consideration of the implications for the safety or welfare of participants, and/or the information that participants might need, so that they can give informed consent to continue to participate in the research after the changes are made.

We believe that the current document should be revised to ensure RECs embrace diversity and inclusion – explicitly including patient and public members
The revisions to the Declaration proposed the introduction of new language to specify that RECs must have sufficient resources to fulfil their important duties. We welcomed the opportunity to make it clear that RECs should embrace diversity (so that they mirror the communities they are working on behalf of) and also that they should explicitly include patient and public members.

As currently stated, the committee could be composed entirely of healthcare professionals and still meet the standards required by the declaration. We believe that the current document could benefit from revised wording that acknowledges lived experience as well as professional experience.

We welcome the proposal to update and clarify the language on documenting informed consent

There is an opportunity to emphasise that consent is not simply a one-time event at the beginning of the research study, and should be considered as an iterative and ongoing process with participants, who should be provided with information throughout their involvement in the study.

This can be particularly important where new information becomes available that might impact on the risks or benefits that the study poses.

We welcome and agree with the proposed update to remove the dehumanising term 'subjects'

Although the Declaration is written by and is primarily for physicians, we support an update to the current document to remove the outmoded and dehumanising term “subjects”. This also recognises that participants in medical research include both patients and healthy volunteers.

We welcome the proposal to specifically mention social value as a primary purpose of research

The HRA want everyone to benefit from research. We advocate diversity in research to provide a better understanding of the most effective treatment, device, and care for different groups of people.

This information can ensure people get the best healthcare for them, and will help reduce health inequalities. We suggest that the term ‘accessibility’ should be expanded to state an ethical obligation to reduce health inequalities, ensuring clinical research is designed to include people who could benefit from the findings. This should include people from marginalised populations who are frequently underrepresented in or excluded from research to ensure they are not overlooked.

We welcome and support the further emphasis of the ethical importance of environmental sustainability when designing studies

We support the inclusion of the term “promotes sustainability” alongside minimising possible harm to the environment. This is consistent with language the WMA adopted in revisions to the International Code of Medical Ethics .

We welcome the proposal to help reduce research waste

We support a change to emphasise the ethical importance of ensuring scientifically sound design in order to reduce research waste. There should also be an acknowledgement that research should address issues important to the people likely to benefit from the research.

We welcome the proposals to update the references to consent requirements and participant protection in relation to the use of samples or personal data stored after trials

We highlighted that the requirement for approval from a REC for samples where consent is impossible or impractical may contradict aspects of the UK’s Human Tissue Act, in relation to research use of samples from the deceased. For example, where an adult has refused to give consent as this cannot be revoked after their death.

If you would like to request a copy of the HRA’s full consultation response document, please contact us via email or phone including details of any accessibility needs which would require a specific format.

Our response to the second phase of the consultation

We’ve responded to the second phase of the consultation on revisions to the Declaration of Helsinki (DOH).

The response was submitted on behalf of the Health Research Authority with input from public contributors who are members of the HRA’s public involvement network.

Community Engagement

We welcome the proposed new language on global justice and meaningful engagement with research participants and their communities. This people-centred approach emphasizes the importance of addressing questions and outcomes that are valuable to those who benefit from or are affected by research. We suggest that the word 'empower' should be replaced with 'enable' to highlight the active role and agency of participants and communities as equal partners in research.

Inclusive Research Practices

We encourage active inclusion of underrepresented groups in research, by considering who the research is for and about and how underrepresented populations can be actively engaged. This should be linked to the new emphasis in the Declaration on addressing inequities and engaging with communities. We also support the updated language on vulnerability, stressing the importance of specific measures to protect vulnerable groups and ensuring responsible inclusion in research.

Research Ethics Committees

We welcome the explicit recognition that ethics committees should collectively have adequate 'diversity' in addition to education, training and qualifications, in order to effectively evaluate each type of research it reviews and have sufficient familiarity with local circumstances and context.

Responsibilities for Participant Protection

While we agree that the primary responsibility for participant protection lies with physicians and qualified researchers, we stress that participants also have responsibilities for their safety and to ensure the integrity and success of the research study more broadly, such as adhering to study protocols and reporting side effects appropriately. Researchers must provide necessary information and support to facilitate participants in fulfilling these responsibilities.

Appropriate Supervision of Research

Paragraph 13 of the Declaration states that 'Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional'. While we support the need for appropriate supervision in medical research, we believe this statement requires further clarification. Specifically, it should be clear whether this requirement applies exclusively to medical or clinical research. Without this distinction, the current wording could mistakenly imply that professional researchers, such as psychologists or social researchers with appropriate ethics and scientific education, training, and qualifications, cannot conduct research without the oversight of a physician or healthcare professional.

International Research

We endorse the update to be consistent with the proposed edits which require host country ethics committee approval for international research. However, as we previously noted in phase one of the consultation, we think the claim that the principles contained within the Declaration have primacy over all national and international laws and regulatory norms and standards remains insufficiently justified.