WHO guidance for human genome data collection, access, use and sharing: why granularity maximisation in informed consent should be reconsidered

SUMMARY BOX.

• The 2024 WHO Guidance for human genome data collection, access, use and sharing introduces a ‘granularity maximisation’ principle, requiring informed consent to be as detailed as possible.

• This principle conflicts with established data protection frameworks that balance individual privacy rights with societal benefits.

• By imposing excessive detail, the granularity maximisation principle risks undermining participant autonomy and trust through information overload.

• A participant-centred materiality standard is proposed as a more effective alternative, focusing on the communication of information that a reasonable research participant would find material to their decision to participate.

The recently published 2024 WHO Guidance for human genome data collection, access, use and sharing¹ introduces a granularity maximisation principle, requiring informed consent to be ‘as granular as possible’ in relation to the potential uses of the data, benefits and risks, infrastructure hosting the data (including its location and access modalities) and intended data sharing for purposes such as artificial intelligence training. While assumedly intended to enhance transparency and respect for autonomy, we suggest that this approach is flawed. This comment critiques the granularity maximisation principle and contends that it conflicts with established international instruments on research ethics and data protection frameworks and will ultimately be counterproductive in practice.

The latest generation of data protection laws, such as South Africa’s Protection of Personal Information Act, the European Union’s General Data Protection Regulation and India’s Digital Personal Data Protection Act, typically require consent to be informed and specific. These requirements embody sufficing principles, meaning they require that enough information must be provided for a data subject’s consent to be meaningful (but not as much information as possible), and consent by the data subject must be specific enough to avoid ambiguity (but not as specific as possible).

This position is consistent with a range of international instruments on research ethics and data governance, which emphasise proportionality, clarity and meaningfulness in information disclosure, rather than maximal detail. For instance, the Declaration of Helsinki provides that research participants must be ‘adequately informed’ using ‘plain language’ (Article 26).² Similarly, the UNESCO Universal Declaration on Bioethics and Human Rights requires that consent be based on ‘adequate information’ and expressed in a ‘comprehensible form’ (Article 6).³ The Organisation for Economic Co-operation and Development (OECD) Guidelines on Human Biobanks and Genetic Research Databases also follow this approach, stipulating that participants must receive ‘sufficient information’ (Principle 4.1) and that consent materials should be drafted in ‘clear, concise and simple language’ (Principle 4.3).⁴ Collectively, these instruments prioritise comprehensible, relevant and context-sensitive communication, recognising that effective informed consent depends not on the volume of information, but on its usability and meaning for participants to make, what the Nuremberg Code⁵ dubs, an ‘enlightened decision’.

The sufficing principles enshrined in these instruments and statutes reflect a deliberate balance between individual privacy rights and broader societal interests, such as the public good derived from data sharing for scientific research. By imposing a maximising principle, the WHO disrupts these delicate legislative balancing acts, creating an undue burden on researchers tasked with implementing exhaustive and overly detailed consent processes. This, in turn, could slow the pace of genomic research and indirectly undermine the public’s right to benefit from scientific advancements. By focusing more on granular detail than on practical implementation, the principle risks prioritising bureaucratic perfection over meaningful progress in global health and scientific innovation.

The granularity maximisation principle is also fundamentally self-defeating. While it aims to empower participants by providing them with as much detailed information ‘as possible’ to facilitate autonomous and informed decision-making, excessive information can have the opposite effect. When participants are presented with overly complex or excessively long consent documents, there is a risk that they may sign without fully grasping the implications of their participation. Research consistently shows that overwhelming participants with excessive detail diminishes their capacity to make informed choices,⁶,⁹ as critical information is buried under immaterial details—an effect known as ‘information overload’.^{8 9} Instead of fostering understanding, the process can feel like an incomprehensible legal exercise and becomes a superficial formality. This, in turn, erodes trust in the consent process. To genuinely respect autonomy, the informed consent process must strike a balance—providing sufficient and relevant information without inundating participants with exhaustive detail about every potential use, benefit or risk. This brings us to the question: what constitutes sufficient information in practice?

Many well-established ethical guidelines direct that details such as the ‘aims, methods, anticipated benefits and potential risks and burdens’² and so on, be provided to participants. But how much detail is required on these aspects in order for it to be ‘sufficient’? Insights from clinical informed consent jurisprudence offer valuable guidance. Many jurisdictions have adopted a patient-centred materiality standard, requiring disclosure of all information that a reasonable patient would find material to their decision-making.¹⁰,¹² Several courts have warned against information overload, recognising that it may cause fear and confusion.^{13 14} Applying this reasoning to the genomic research context, informed consent should adopt a participant-centred materiality standard. The participant-centred standard is reflected in the updates to the US Federal Policy for the Protection of Human Subjects, more commonly known as the Common Rule, which directs that consent must include information that ‘a reasonable person’ would want in order to make an informed decision about participation (§45 CFR 46.116(a)(4)) and that this information should be presented in a way that begins with a ‘concise and focused presentation of the key information’ which will most likely assist prospective participants in understanding the reasons they might or might not choose to participate (§45 CFR 46.116(a)(5)(i)).¹⁵

Of course, identifying who is the ‘reasonable person’ in the research context—and determining what such a person would ‘want’ to know—has been the subject of ongoing debate.¹⁶ Nonetheless, thoughtful proposals have emerged. For example, Dresser¹⁶ highlights the extensive body of empirical research that sheds light on what information various groups—including the general public, prospective participants and experienced research subjects—deem important when considering research participation. Such evidence should inform the decisions of ethics committees. Individuals who have previously participated in studies are uniquely positioned to reflect on what information was essential, what was missing and what could have been omitted. Their experiences offer valuable, practical insight into what a reasonable participant ought to know in order to make an informed decision.

The participant-centred approach prioritises the communication of information that a reasonable participant would find material to their decision to participate, considering the specific circumstances of the research and the participant’s position. This avoids the potential pitfalls of exhaustive granularity while respecting autonomy. The granularity maximisation principle, as framed in the WHO guidance, risks swinging the pendulum too far. Turning to the Goldilocks metaphor, while providing too little information to participants would undermine informed decision-making, providing excessive detail is equally detrimental. The optimal approach lies in the golden mean: delivering information that a reasonable research participant would consider material to their choice, without overloading them with unnecessary minutiae.

We call on the WHO to reconsider the granularity maximisation principle and recalibrate its approach to informed consent. By aligning with a participant-centred materiality standard, the WHO can respect autonomy while avoiding the pitfalls of information overload. Such a recalibration will ensure that genomic research remains both ethically robust and practically feasible, preserving public trust and facilitating meaningful participation in the pursuit of global health advancements.

Data availability statement

There are no data in this work.