There is a need to re-think RoI in EU-wide research initiatives. In this blog, the Human Brain Project‘s Ethics Advisory Board(EAB) focuses on how we can leverage the HBP experience toward EBRAINSand a culture of reflective science practices by design. This is a text written by Kristin Bergtora Sandvik, member of the EAB. A reply from the HBP Ethics Director Bernd Stahl has been published in a separate post.

Introduction

As the Human Brain Project (HBP) moves towards a new research infrastructure for advancing neuroscience, computing and brain-related medicine called EBRAINS, transparency, accountability, and disclosure of conflict of interests are ever more central to protecting the integrity of the project, participants, and outputs. This means that relevant and user-friendly Registers of Interest (RoI) – and shared understandings of Conflict of interest (CoI) – are critical for managing and delivering on EBRAINS.  Building a culture of more reflective science practices will also help to position EBRAINS as a leader in the field globally.

As the societal, national security and economic stakes of human brain research – and outputs from AI-based research – are becoming increasingly evident, transparency with respect to CoI issues is vital. The possibility of monetizing research findings resulting from the analysis of large databases not yet freely accessible may soon become a reality. The transition from HBP to the EBRAINS RI opens new avenues for potential public concerns, including the possibility of founding start-ups that could later be acquired by BigTech. This lends urgency to the development of a better ‘culture of RoIs’. For EBRAINS, it is of utmost importance that the integrity of its findings, infrastructure, and participating researchers may not be subject to doubts and suspicion. All HBP board members have a ROI, but leading by example is not enough: To ensure transparency, a uniform culture of robust reporting regarding RoIs is required.  Here, drawing on its experience with reviewing project RoIs, the EAB offers a set of comments and critiques – and proposes steps needed to take the project forward.

The journey so far

According to the main legal documents governing members of the HBP[i], a “conflict of interests” exists if shared interests have influenced the contract’s/subcontract’s selection/award procedure; influenced the contract’s/subcontract’s price and this does not correspond to the market price; or affected the action’s performance, as measured by the appropriate quality standards. Beneficiaries/Partners must take all measures to prevent any situation where the impartial and objective implementation of the specific actions is compromised for reasons involving economic interest, political, or national affinity, family or emotional ties or any other shared interest (‘conflict of interests’). Crucially, members of Governance Bodies, Advisory Boards, and Coordination Committees shall register their potential conflict interests in the appropriate conflict of interest registry.

In 2016, the HBP adopted a Standard Operating Procedure (SOP) including further guidelines, levels and examples of expected disclosures, templates, plus processes to be followed, including actions to be taken when a CoI arise.  One of the checks in the SOP is a review by the EAB of all individual registers submitted. In 2020 and 2021, the EAB has reviewed all RoIs submitted by the different governing bodies, working groups and committees potentially affected by CoI. Insights and observations have been discussed with the Ethics Director and with the Directorate.

The EAB found that there was a large discrepancy in the contents of the RoIs, some being very exhaustive while others very scarce. A significant number of RoIs were mostly restricted to the participant’s professional affiliations. Across the submissions, there was no systematic reporting on Journal and editorial board memberships, Coordination, or partnership as PI in national/international collaborative projects, Remunerated consulting activities, Ownership of stocks, Ownership of companies and Ownership of patents. These reviews suggested that there is an urgent need for more standardized practice:

• The project needs to get better at tackling indifference, lack of awareness – and develop a more effective assessment mechanism to identify inadequate reports and suspected CoI.
• It is critical that individuals declaring their interests understand the value of the exercise – but also that society can trust that procedures are in place to ensure transparent and fair decisions.
• However, this cannot be a policing exercise: the focus must be on how to leverage the RoI as a tool for protecting the project and collaborators.
• Having a conflict of interest is not necessarily a problem – but it must be declared.

This blog is an invitation to avoid trouble and think about ways to motivate the project community to engage.

Toward EBRAINS: novel needs, challenges, and opportunities

The HBP provides a framework where teams of researchers and technologists work together to scale up ambitious ideas from the lab, explore the different aspects of brain organization, and understand the mechanisms behind cognition, learning, or plasticity. HBP documents list minimum standards. The main categories are financial, scientific, and interpersonal. The HBP is building EBRAINS as a lasting research infrastructure to help advance neuroscience, medicine, computing and brain-inspired technologies. This transition offers opportunities to shape a culture of transparency and disclosure, embedded at the core of EBRAINS by-design and by default, and included in the Ethics and Society vision that is currently undergoing a consultation with the communities. This entails a vision of CoI declarations as something more than an annual requirement: instead, CoI declarations should be thought of as a practice of proactive thinking and transparent behavior contributing to better management and fairer decision-making.

This means that we should look beyond traditional notions of CoI to incorporate more granular [ii] conceptualizations, including benefit from interest, conflict of loyalties and more reflective approaches to responsible research considerations. Practically, this could include such varied actions as abstaining from a vote, resigning from a position, or declining an invitation to join a board – or potential legal actions in case of a breach. This also includes alertness to latent CoIs that could foreseeably arise in the future.

The need for clear guidelines: some practical steps

A more comprehensive template: There is a need to develop a template that better accounts for categories of expected disclosures.  The following is a non-exhaustive inventory of what should be declared in a RoI:   

Minimum – Any interest with a link to the activity in the HBP / EBRAINS

• Employers over the last three years
• Any ownership or close financial or personal relationships with companies and sources of research funding
• Relevant patents or other types of intellectual property that may have an influence on decisions within the body
• Remunerated consulting activities
• Journal and editorial board positions at journal

Additional – not mandatory

• Ownership of stocks (with no obvious link to HBP EBRAINS activities)
• Ownership of companies (with no obvious link to HBP EBRAINS activities)
• Ownership of patents (with no obvious link to HBP EBRAINS activities)
• Relevant interests with no necessary financial implications, which may include personal relationships, scientific competition or other
• Coordination or partnership as PI in national/international projects / initiatives
• Ongoing collaborative or institutional relationships that may lead to a conflict or to biased decision-making
• Categories pertaining to conflict of loyalties, such as
  • A “double-hatted” role which may lead to choosing a side at the expense of another (employing institution vs/ consortium for example)
  • Holding a position in a governing body while being a potential beneficiary of a grant that is decided upon
  • Any political agenda that might be relevant

A better format: The project must empower people without adding bureaucratic layers. A digitized declaration format would provide a more meaningful and interactive exercise as well as two-way accountability between collaborators and project management. For example, those submitting RoIs will be asked to consider each point but also to revisit the spaces they have left blank and whether this signifies a blind spot.  The project is currently assessing available with a view to provide a tool that is accessible, secure, and compliant with GDPR specifications.

A more accountable system: Finally, EBRAINS should develop and resource a meaningful and effective system for reviewing submissions and detecting possible CoIs.

From compliance to implementing best practices

In sum, for EBRAINS to achieve its objective of upholding the highest scientific standards, and to protect the integrity of project, participants and outputs, a culture of transparency and disclosure is central. As has been discussed in this blog, the RoI and appropriate registration of CoIs are integral to this vision. We invite the project to provide an updated, sharp, and user-centered policy that highlights practical steps – and which encourages the ‘spirit of the exercise’ as articulated in this blog.

[i] The Grant Agreements 604102, 720270. 785907 and 945539 between the HBP and the EC and the Consortium Agreement between the HBP parties and are confidential documents. The FPA is available on the website here. The articles of interest for CoI are “2.0.1 41.1 Obligation to avoid a conflict of interests” and “2.0.2 41.2 Consequences of non-compliance”.

[ii] Nonprofit Conflict of Interest: A 3-Dimensional View – Jan Masaoka July 7, 2010