By Michaela Hefti and Rasita Vinay.

Currently, there are no specific ethics guidelines informing biomedical research in breastfeeding and lactation – despite the potentially vulnerable populations involved.

On 10 March 2022, EFBRI – An Evolving Ethical Framework Informing Breastfeeding Research and Interventions, was introduced via a LactaWebinar to address this gap and discuss the practical application of ethical frameworks.

This blogpost provides a key summary of the panel discussion held by experts during the LactaWebinar.

Professor Biller-Andorno introduces EFBRI as an open access compilation of how established international research ethics standards can be broken down to provide ethical rules and principles guiding biomedical research within the scope of breastfeeding and lactation. The framework can facilitate global understanding of ethical issues surrounding breastfeeding and lactation research, especially for international research and collaboration, review and funding activities.

EFBRI is an ethical framework – not a code of conduct – and leaves room for specification and interpretation, she stresses.

Professor Biller-Andorno notes that EFBRI is a living document. The goal is to elicit user feedback and suggestions from real-life cases within the research community to build a comprehensive resource that evolves with global ethics and user needs.

Consensus and disagreement amongst guidelines

Human rights and ethical considerations should be the same anywhere. Nevertheless, ethics frameworks and how they are understood differ in different cultural settings, as do views on what is ethical or not. Context matters.

Dr Subramani opens the panel discussion with the question ‘Is there consensus among international guidelines for participants in biomedical research?’. Dr Muhudhia says yes, but notes international guidelines need to be interpreted in relevance to the context in which the research takes place.

Dr Asif says a perfect situation is when national and international guidelines are aligned with each other. Yet in Pakistan for example, the national ethics review guidance is only two decades old, therefore not as fully developed as international guidance in other parts of the world.

She adds that within different regions, healthcare systems and regulatory systems could be at different levels of maturity. If a national guidance has not yet been developed to address relevant ethical questions, one may need to use international guidance as a reference or proxy. However, as ethics is a national-level matter, researchers must use international guidance with caution and efforts should be taken to develop comprehensive national level guidance, policies and regulations for uniformity and harmonisation across the country.

Exploring the roles of context and gender

Dr Muhudhia highlights that many people living in rural or low resource communities are faced with special vulnerabilities that are intertwined with gender.

He gives an example of when context sensitivity arises: with informed consent. In certain communities, the voluntariness – and capacity – of women to decide for themselves is brought to question. When research is conducted where literacy rates and a general understanding of health is poor, or where women do not hold equal status as men in society, as Dr Asif adds, there is greater likelihood that women would be dependent on their male partners (or fathers) to make decisions on their behalf.

For Dr Asif, questions about a woman’s voluntary participation are especially pertinent when research involves financial incentives, hence gender laws that function as safeguards in impoverished communities. Dr Muhudhia points out how healthcare workers may be perceived as powerful and omniscient, more so than in wealthier regions, further illustrating why context plays such a critical role.

It is important, says Dr Asif, to ensure sensitivity to and awareness of such scenarios. She adds it would be worthwhile to promote the use of guidance (EFBRI and other frameworks) and provide training for researchers, stakeholders and ethics committees on navigating these complex issues and developing skills to apply universally acceptable guidance irrespective of the country.

Dr Muhudhia elaborates further that the need to respect local cultural norms and circumstances is highlighted within the Council for International Organizations of Medical Sciences (CIOMS) guidelines (2016), included in EFBRI.

For instance, he says that in Kenya, research guidelines on infant feeding share similar characteristics to those that could be applied to breastfeeding and lactation. Although here he cautions that the interests of both research participants – mother and infant – must be considered and the questions remain, whose interests, between mother and infant, have higher value, or are they equal?

Professor Biller-Andorno stresses that ethical guidelines adapt over time. As an example, the versions of the World Medical Association Declaration of Helsinki (1964/2013) evolved in how they integrate vulnerable people into research. She further notes it is essential to clarify where explicit detail is necessary and where room for cultural adaptation is reasonable.

Monitoring field work

Dr Muhudhia comments that special attention and awareness also must be given to monitoring field-research, particularly by ethics committees responsible for approving and recommending ethical implementations.

Professor Biller-Andorno points out a weakness: even good ethics committees are unable to provide effective monitoring of each research study, leaving researchers to conduct studies in good faith without ongoing assessments. This is an example where she sees that EFBRI could help with decision-making processes, to sensitise and train researchers, stakeholders and ethics committees on how to best use applicable frameworks and guidance within different contexts.

Opportunities and future challenges

Dr Asif says that as biomedical research is global, funding and publication opportunities will arise across the globe; therefore, it is necessary and helpful to compile available resources to allow user friendly and comprehensive access, and EFBRI on LactaHub is one such example.

Dr Subramani concludes with the observation that breastfeeding and lactation research falls into the public health research domain. Yet, guidelines referenced during this discussion are heavy on biomedical research, and she asks if different angles – such as public health ethics – should be covered in future itinerations as well.

Professor Biller-Andorno agrees and says classical research ethics have largely focused on clinical trials, but it is also important to acknowledge other types of research. For example, in research focusing on behaviour, relationships may affect outcomes, where not only individual research participants but population groups are involved. She notes the challenge to see how these forms of research, which go beyond key normative documents, can be integrated into EFBRI. Currently, there are initiatives underway which look at interventions and implementation research, and how to best integrate them into EFBRI.

About the EFBRI vision

Dr Lichtner stresses EFBRI is not meant to replace national ethics legislation and standards. Rather, it is a resource that provides a summary of useful, generally accepted international guidelines for conducting research in the area of breastfeeding and breastmilk involving human participants. It could serve in contexts where national guidelines are being developed or evolving and provides a benchmark of standards that are already agreed by many countries. Furthermore, it can be very helpful in the context of multinational collaboration or funding situations.

About the EFBRI LactaWebinar

A recording is available here on LactaHub, a partnership project of The Global Health Network (University of Oxford) and the Family Larsson-Rosenquist Foundation (FLRF).

Hosted by: Institute of Biomedical Ethics and History of Medicine (IBME), University of Zurich (UZH), The Global Health Network and LactaHub

Moderated by: Arancha de la Horra Gozalo and Dr Supriya Subramani, featuring experts Dr Farah Asif (Clinical Research Administrator at Shaukat Khanum Memorial Cancer Hospital & Research Centre, Pakistan), Dr Stephen Ombok Muhudhia (Specialist Paediatrician at Nairobi Hospital, Kenya and Adjunct Professor of Bioethics at Trinity International University), Dr Katharina Lichtner (Managing Director, FLRF) and Professor Nikola Biller-Andorno (MD PhD, Director, IBME, UZH, Switzerland)

A second webinar (previewed in the Swiss Medical Weekly), discussing the use of financial incentives for participants in health and breastfeeding research, took place on 13 of April and is available here on LactaHub.

 

Author names: Michaela Hefti¹ and Rasita Vinay²

Affiliations:

1. Family Larsson-Rosenquist Foundation, Frauenfeld, Switzerland
2. Institute of Biomedical Ethics and History of Medicine, University of Zurich, Switzerland

Competing interests: MH is employed by the Family Larsson-Rosenquist Foundation; The creation of EFBRI is a project funded by the Family Larsson-Rosenquist Foundation

Social media accounts: Twitter: @RasitaVinay @uzh_ibme

LinkedIn: linkedin.com/in/michaela-hefti-07269b1a2  linkedin.com/in/rasita-vinay; https://www.linkedin.com/company/family-larsson-rosenquist-foundation