Statement on Ethical Principles for Medical Research Involving Vulnerable Groups and Individuals - World Patients Alliance

Statement on Ethical Principles for Medical Research Involving Vulnerable Groups and Individuals
(This statement was presented by Hussain Jafri, Executive Director of the World Patients Alliance in the context of the revision of the Declaration of Helsinki to The World Medical Association (WMA).)

(Munich, 14 May, 2024) The World Patients Alliance (WPA), representing over 1 billion patients worldwide and 501 member organizations from 125 countries, extends its deepest gratitude to the World Medical Association (WMA) for the opportunity to share our perspective on the revision of the Declaration of Helsinki.

At the WPA, our mission is to be the global voice of patients, advocating for patient empowerment, improved access to safe treatments, and patient-centered healthcare across the globe. Today, we focus on a critical issue: the ethical principles for medical research involving human subjects, especially vulnerable groups and individuals.

Vulnerable groups and individuals include children, the elderly with chronic conditions, women including pregnant women, ethnic and religious minorities, marginalized communities, refugees, immigrants, prisoners, individuals with disabilities, and others facing unique challenges. These individuals often find themselves at the intersection of medical research and ethical dilemmas. From the perspective of patients, ethical practices in medical research are not just about adhering to guidelines – they are about safeguarding the rights, dignity, and well-being of every individual involved. It is essential to ensure that vulnerable groups are not exploited or marginalized in the pursuit of scientific progress.

To achieve ethical research involving vulnerable groups, robust policies and procedures must be in place to protect against stigmatization and discrimination. The interests and rights of individuals must be prioritized, with decisions made collaboratively among researchers, patients, healthcare providers, and communities. Research efforts should align with the needs, preferences, and values of all involved, ensuring clear, transparent communication and ongoing engagement in governance and decision-making processes.

In the context of the revision of the Declaration of Helsinki, we must reaffirm our commitment to protecting vulnerable groups and individuals. Informed consent should be a meaningful dialogue between patients and researchers, not just a formality. Post-trial provisions must be in place to address any unforeseen harm that may arise. Most importantly, the advancement of medical knowledge should never come at the expense of those who are most in need of our protection. Medical research with vulnerable groups is only justified if it addresses the health needs or priorities of these groups and cannot be carried out in non-vulnerable groups. Additionally, these groups should benefit from the knowledge, practices, or interventions resulting from the research.

As representatives of the global patient community, we urge all stakeholders to prioritize the rights and well-being of vulnerable groups and individuals in the revision process. Let us work together to uphold the highest ethical standards in medical research, ensuring that every patient, regardless of their circumstances, receives the care and respect they deserve.

We are thankful to all for providing us this opportunity to advocate for a healthier, more equitable world for all patients.