Trials begin with participants

Clinical trials are meant to be patient-centered, designed to generate medical knowledge for public welfare. Some argue that as trials are initiated and funded by sponsors, their outputs are private property. This view ignores the fact that no research can proceed without participants’ involvement. Yet it remains common to see participants framed as passive data points [4], rather than as partners in the scientific enterprise.

Approaching clinical trials as a collective enterprise for public benefit demands a shift in mindset. Researchers become stewards, not proprietors, of shared knowledge. Only through meaningful involvement of patients and the public can trials be ethically justified and socially impactful; by mandating transparency, enabling equitable access, and valuing inclusive participation, it realigns research practice with its public purpose.

Extending open science to participants

Engagement begins with information. Before the trial, participants must be clearly informed about the study’s purpose, risks, potential benefits, and their legal rights—now a legal standard ensuring autonomy and protection. After the trial, results should be shared in plain language and through appropriate channels. Transparent reporting, regardless of whether findings are positive, negative, or unexpected, reinforces the credibility of research and meets societal expectations. Initiatives like AllTrials [5], a global campaign calling for the registration and reporting of all clinical trials, and TranspariMED [6], an advocacy group that works to end evidence distortion by pushing for rapid public disclosure of all clinical trial results, have mobilized global support and helped recover thousands of trial results that would otherwise have been lost.

Even when researchers wish to share results, practical barriers often stand in the way [3]. From the review, more than half respondents in one study reported financial constraints that hampered dissemination, while two-thirds of health researchers in another study reported difficulty in dissemination because of missing contacts or remote settings. The review found no consensus on best practices, and while existing frameworks to guide result dissemination are “now in early development,” they have remained invalidated across diverse settings, populations, or clinical domains [3]. Dissemination also requires time, dedicated resources, and institutional support, which are often lacking. Training in how to prepare lay summaries or communicate sensitive or distressing results was often limited [3]. These are crucial skills when findings may provoke anxiety, disappointment, or even grief. Without adequate funding, guidance, and capacity-building, dissemination risks being treated as an unfunded add-on rather than a core responsibility of ethical research (see Box 1).

A second level is involvement. The public can be consulted in trial design, result interpretation, and even co-develop research protocols—extending into citizen science. Patients bring lived experience that can highlight what outcomes matter most and how interventions are perceived. Such collaboration enhances trial relevance, feasibility, and public acceptance [11]. Research demands a clear alignment of study inquiries with patient needs. Without patient and public involvement, trials risk inadequate participant recruitment, suboptimal study design, and unresponsiveness to patients’ experiences and feedback [12], producing less meaningful outcome and wasting resources.

Open science practices must be part of IRB assessments

Institutional Review Boards (IRBs) are essential in maintaining the integrity of study processes and serve as custodians of participant trust. Scientific trustworthiness comes from methodological rigor, verifiability, and transparency, whereas research ethics is grounded in protecting human rights, dignity, and welfare. However, as outlined in the Declaration of Helsinki, ethical obligations extend further to include scientific integrity, encompassing the dissemination of results to both trial participants and the public.

To keep up with the evolving expectations, open science practices should also be systematically reviewed and explicitly encouraged by IRBs, including open access publications, responsible data sharing, and dissemination of findings to participants and the public. For example, the WHO’s recommended protocol format already requires a section on dissemination, covering scientific publication and communication with participants, communities, and policy-makers. This shows such requirements are feasible and ethically recognized. IRBs could similarly require trial protocols to include concrete dissemination plans outlining how and when results will be returned to participants, in what format, and what resources or training are allocated for this. The boards could then assess whether these plans are realistic, ethically sound, and culturally appropriate, just as they currently review informed consent procedures. Embedding such requirements would ensure accountability and normalize dissemination as a core ethical duty, addressing the lack of institutional guidance and consistency highlighted in the systematic review [3].

A final message

Open science seeks to break down barriers, foster transparency, and ensure that the benefits of research are shared broadly, especially including those who participated in making it happen. Returning results to participants is a cornerstone of ethical and open research, where IRBs play a key role in ensuring that such practices are implemented correctly and evaluated adequately. Inclusivity of the public balances out the current skewed power dynamics in science, leading to health democracy. After all, trials are done for patients, but they all begin from patients.