A Right, Not a Privilege: Informed Consent in Clinical Trials

As a public health researcher deeply invested in participant engagement, I often wonder:

Do we truly empower participants to make informed decisions, or are we just checking regulatory boxes?

Despite significant progress in research ethics, regulatory oversight, and the use of technology, informed consent in clinical trials remains one of the most challenging aspects of the research process. The 2025 Lancet series on ‘Clinical Trials in Global Health’ emphasizes the value of engaging participants meaningfully across a trial’s lifecycle to generate better evidence.

Consent ≠ Comprehension

Most clinical trials treat consent as a legal hurdle. It ends up being a long document with lots of technical jargon. Study team explains the purpose, risks and benefits of the study and expects the participant to sign and move to the next steps. The process does not necessarily guarantee comprehension. Current methods often assume literacy and health literacy which might not hold true in the real-world settings, especially low resource and in marginalized communities.

Why is it still so hard to get this fundamental piece right?

• Complexity of information and language - information is carried over from research protocol without simplification. It’s often lengthy and filled with complex scientific concepts - overwhelming and difficult to grasp for those outside the research world.

• Imbalance of power - Participants can feel compelled to consent out of reverence for the doctors or a desperate hope for treatment, without truly grasping the implications. Particularly critical in low-resource and marginalized communities. 

• Cultural disconnect - Consenting language and process often misses cultural adaptation. For example, consenting can be communal in many settings and this dynamic is often overlooked.

• Rushed timelines - Recruitment pressures can push researchers to rush consent, giving participants little time for deliberation or discussion.

• Consent as single transaction / agreement - Treating consent as a one-time task undermines ongoing engagement - especially in long, evolving trials.

• Lack of emotional context - People suffering from health conditions might be more emotionally vulnerable and participate in hope or desperation of getting some treatment. This might impact their ability to make informed, rational decisions.

Despite technological advancements and stricter regulations, these underlying human and systemic factors continue to make truly informed consent elusive.

Public health trials often operate in complex, community-based environments - offering valuable lessons in engagement and adaptation.

What can be learnt from public health trials?

• Start with community / key stakeholders - Engage relevant stakeholders like local organizations, community leaders and key decision makers early. Make co-designing with community an integral part of research to ensure cultural adaptation. Pilot test consent documents and the process and incorporate insights.

• Simplification / dramatization - Use visual aids, storytelling and examples that are relevant for the community to simplify complex concepts like research, blinding, randomization etc. Contextualize entire process for them to better understand and appreciate the value of trial, their participation and making an informed choice.

• Consenting as a process and not a paper-work - Incorporate verbal confirmations, feedback loops and regular check-ins to help maintain participant agency throughout the trial. Establish honest and clear communication and offer opportunities to the participants to ask questions throughout their journey.

• Train the team differently - Train researchers and field staff beyond ethics – communication skills, respect for participant, cultural sensitivity.

• Measure understanding, not just signature - Use of strategies like teach-back methods or comprehension assessments that can shift focus from a mere formality to true understanding of the context of participants and their decisions.

• Optimize technology for participants, not just researchers - Design and use tech solutions that are human-centered and do not widen the digital gap between researchers and participants. Tech should be used beyond just efficient implementation of the trial, to make process simpler, accessible, trustworthy and a truly participatory experience.

Clinical trials exist to push the boundaries of science but ultimately, they must serve people. Informed consent is not just the first step in this process, it is the foundation. It must evolve beyond a legal necessity into a meaningful, human exchange. For us as researchers, it is an opportunity to foster respect, affirm agency and build trust. It should be a moral obligation - for understanding isn’t a privilege to be offered, it’s a right that must be upheld.