Changes to the Declaration of Helsinki Designed to Strengthen Ethical Standards in Clinical Research Involving Humans

Researchers, clinicians, and compliance professionals are likely familiar with the World Medical Association’s Declaration of Helsinki that provides principles for medical researchers to guide the ethical conduct of research involving human participants. The content was recently revised to enhance the commitment to protections. These revisions, announced on Oct. 21, are designed to further strengthen ethical standards in clinical research involving humans, according to the World Medical Association (WMA).

“The 2024 revision of the Declaration of Helsinki provides for increased protection for vulnerable populations, improved transparency in clinical trials, and stronger commitments to fairness and equity in research,” according to the WMA.

“Previously, the Declaration of Helsinki addressed WMA members and constituents. The new version of the Declaration says that as physicians, it’s part of our moral obligation to ensure that our patients and the participants in research are respected and treated with dignity,” Dr. Jack Resneck, Jr, MD, Chair of the WMA Declaration of Helsinki revision workgroup said in WMA press statement.

PRIM&R Board Member Alex John London, PhD, who is the K&L Gates Professor of Ethics and Computational Technologies at Carnegie Mellon University summed up the revisions this way, “The Declaration of Helsinki is a living document, as this most recent revision illustrates.  One of the most notable changes is the effort to ensure that an appropriate ethical concern for vulnerability does not translate, in practice, to the exclusion of populations with distinctive health needs.  It thus holds that ‘harms of exclusion must be considered and weighed against the harms of inclusion.’ While I think this clarification is important, I would have liked to see language that encourages the conduct of research that seeks to reduce disparities in health or the provision of safe and effective health services.”

The WMA Declaration of Helsinki revision workgroup representatives came from 19 countries: Bangladesh, Belgium, Brazil, China, Denmark, Finland, Germany, Israel, Japan, Malaysia, Netherlands, Nigeria, South Africa, Taiwan, UK, Vatican, Uruguay and the United States.

“To really address the theme of distributive and global justice, this change means that the Declaration of Helsinki calls on researchers to carefully consider how the benefits, the risks, the burdens of research are distributed,” Resneck said.

The substantive changes to the Declaration of Helsinki, the WMA said, can be categorized in two areas:

• Participant-centered inclusion, respect and protection, including recognition of participant vulnerability, calls for community engagement, pursuit of global justice, obtaining informed consent, and use of participant-centered language.

• Research beneficence and value, including the pursuit of “individual and public health”, upholding scientific rigor and integrity, and considered distribution of benefits, risks and burdens.

The Declaration of Helsinki (DoH) is the WMA's best-known policy statement. The first version was adopted in 1964. This has been amended seven times since, now most recently in October 2024, according to the World Medical Association.

“This landmark revision of the Declaration of Helsinki highlights the World Medical Association’s commitment to reinforcing the ethical principles that guide medical research involving human participants, to safeguard patient rights and to ensure the integrity of scientific studies,” said Dr. Ashok Philip, who serves as the WMA president.

“This was a mammoth revision process spanning 30 months, and the World Medical Association extends its heartfelt thanks to everyone who participated,” Philip said.

Barbara Bierer, MD, professor of medicine at Harvard Medical School, and co-founder of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital (BWH) and Harvard (MRCT Center) published a commentary in JAMA on October 19, titled “Declaration of Helsinki—Revisions for the 21st Century”

The abstract of Bierer’s “viewpoint” published in JAMA, states:

Initially developed in the aftermath of World War II atrocities, the Declaration of Helsinki celebrates its 60th anniversary this year. The declaration represents the foundational ethical document addressing the design, conduct, and reporting of medical research, a document referred to internationally. Since the World Medical Association (WMA) first adopted the declaration in 1964, the 2024 declaration represents its eighth revision, synthesizing more than two years of global consultation, international meetings, and public input. The significant changes reflect a growing appreciation of global ethical challenges, fair and responsible inclusivity in research, community and local engagement, and the complexity of current interdisciplinary research.

“These revisions to the Declaration of Helsinki are critically important issues, which we wanted to share with the IRB community,” said PRIM&R Executive Director Ivy Tillman, EdD, CIP.