Meeting Helsinki Declaration: Citizen Science and Research Ethics Committee Application


Meeting Helsinki 2024 Requirements: A Guide to Your Research Ethics Committee Application
Securing approval from a Research Ethics Committee (REC) or an Institutional Review Board (IRB) is a critical milestone for any scientific project. However, the rules governing this process have recently shifted. It's what every reviewer looks for in a proposal: community engagement and research integrity. To break down exactly what these changes mean and how you can seamlessly incorporate them into your protocol, Professor Khalid Khan (Distinguished Investigator at the University of Granada) sat down with Professor Aurora Bueno, Chair of the Research Ethics Committee in Granada.
Here is how you can address the four fundamental ethical principles under the new Helsinki 2024 standards.
1. Respect for Persons and Autonomy
Informed consent is no longer just a bureaucratic paperwork exercise. It now requires meaningful citizen participation right from the design phase.
  • The Key Shift: Involve patients and citizens directly in preparing the Patient Information Sheet (PIS) and designing the consent process.
  • Why It Matters: Having patients actively participate is the best way to ensure autonomy. It drastically increases the ethical rigor of the consent process and builds deep research trust.
2. Beneficence: Science for the Sake of Society
Ethics committees are not focused on your publication metrics in the way scientists are; they care about the tangible value the research brings to the community.
  • Societal Relevance: The research objective must address a real uncertainty in society. This could be a lack of information regarding how to best prevent, diagnose, or treat a disease, or a high level of clinical practice variability.
  • The Patient’s Voice: Individuals who live with the condition under study must have a voice in determining if your research questions are genuinely relevant.
  • Intellectual Honesty: For a study to be useful, it must features a robust methodology conducted with absolute scientific integrity.
3. Non-Maleficence: Managing the Inevitable Risks
In medical research, there is no such thing as zero risk. Your protocol must clearly outline how participant safety will be safeguarded.
  • Risk Benchmarking: Generally, the risk faced by research participants should remain equivalent to that of ordinary clinical practice.
  • Actionable Safeguards: The protocol must explicitly specify the measures put in place to detect, treat, and compensate for any potential harm.
  • Independent Oversight: Utilizing an Independent Data Monitoring Board that features community representatives among its board members is an excellent way to demonstrate compliance with these new integrity standards.
4. Justice and Equity
The principle of justice demands that the opportunity to participate in and benefit from science is distributed fairly.
  • Fair Eligibility Criteria: The probability of taking part in a study should be similar across different subgroups of patients with a static condition. To achieve this, citizens need to be engaged in formulating the inclusion and exclusion criteria.
  • Radical Transparency: True justice requires research integrity throughout the entire process. Researchers must demonstrate this by adhering to three core professional standards:
    • Advance study registration.
    • Prior publication of the protocol and statistical analysis plan.
    • Open data sharing.
Checklist for Your Next REC Application
To successfully pass your next ethics committee session, ensure your study protocol explicitly demonstrates the following (1:20):
  1. Active Community Engagement: Show how the community was actively engaged in protocol development, consent design, and establishing selection criteria.
  2. Researcher Undertakings: Provide explicit declarations regarding the avoidance of scientific misconduct, clear conflict of interest disclosures, and a commitment to professional standards. 
Ultimately, modern medical research is no longer just conducted for or about citizens—it must be undertaken with and by them.


Written by Professor Khalid Khan, Distinguished Investigator at the University of Granada and author of "Integrity of Randomized Clinical Trials". To access specialized courses in research writing and clinical integrity, visit profkhalidkhan.com. 



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