Evolving ethos of medical research: A retrospective analysis of the declaration of Helsinki (1964-2024)

Table 1 1964-2024 versions of declaration of Helsinki with key points

Month, year	City, country	WMA general assembly	Remarks
June, 1964	Helsinki, Finland	18th	First version of the guiding principles of clinical research by international collaboration mentions ‘freely given consent’ from patient
October, 1975	Tokyo, Japan	29th	(1) Clinical research changed to biomedical research; (2) Patient – changed to human subjects; (3) Consent – changed to informed consent with mention of written consent; (4) Introduced concept of doctor-patient relationship; (5) Strengthened protection of vulnerable populations; (6) Oversight of specially appointed independent committee (concept of Institutional Review Boards); and (7) Guidance on publication of research
October, 1983	Venice, Italy	35th	(1) Doctor – changed to physician; (2) Minor assent/consent emphasis if applicable; and (3) Subjects termed as volunteers for non-therapeutic research
September, 1989	Hong Kong	41st	(1) The independent committee should have impartial oversight to minimize conflict of interest; and (2) The independent committee should be free from the influence of both the researcher and the sponsor
October, 1996	Somerset West, RSA	48th	(1) Emphasis on the wellbeing of the patient/subject; (2) The responsibility extends beyond obtaining informed consent, including monitoring for safety and welfare; (3) Adds a clarification - use of placebos is acceptable in studies only when there is no proven diagnostic or therapeutic method; and (4) Reinforces the need for extra caution when obtaining informed consent in vulnerable populations
October, 2000	Edinburgh, Scotland	52nd	(1) Replaced ‘biomedical’ with ‘medical’ and explicitly includes research on identifiable human material and data; (2) Highlights the challenges of obtaining consent from individuals who may be under duress or coercion; (3) The role and responsibilities of independent ethics committees are expanded; (4) Adds the condition that the research should only be done if the population involved will directly benefit from the research findings; and (5) In publication, stresses the necessity of transparency by including information on funding, sponsors, and potential conflicts of interest
October, 2002	Washington DC, United States	53rd	(1) Clarification of placebo use - a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under specific circumstances
October, 2004	Tokyo, Japan	55th	(1) Clarification on post-trial access - Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review
October, 2008	Seoul, Republic of Korea	59th	(1) Regarding vulnerable populations, it reiterates that research is only justified when it directly addresses their health needs and there's a reasonable likelihood of benefit; (2) Enhances the authority and responsibilities of ethics committees; (3) Mandates that all clinical trials must be registered in a publicly accessible database before the enrolment of the first participant. This improves transparency; and (4) Re-emphasizes the importance of publishing both positive and negative findings and reporting conflicts of interest in research publications
October, 2013	Fortaleza, Brazil	64th	(1) Emphasizes the importance of transparency and public access to research data; (2) Explicitly states that the research ethics committees must have the authority to monitor ongoing studies and ensure that the researchers provide timely and complete information, especially regarding serious adverse events; (3) Biobanks included alongside identifiable human material and data; and (4) Compensation must be provided to research participants who are harmed as a result of participating in a study
October, 2024	Helsinki, Finland	75th	(1) Broadened accountability for all individuals, teams, and organizations; (2) "Subject" replaced by "participant" for autonomy and engagement; (3) Inclusion of healthy volunteers as participants; (4) "Informed consent" changed to "free and informed consent"; (5) Emphasis on community consultation and engagement; (6) Emphasizes meaningful engagement with participants and their communities before, during, and after the study; (7) Essential to uphold principles during public health emergencies; (8) Promoting environmental sustainability; and (9) Substantial changes in vulnerability section

Table 2 Regional and topical meetings convened for 2024 revision

City	Topic
Tel Aviv	Implications of big data, machine learning, artificial intelligence
Sao Paulo	Ethical considerations on use of placebo
Copenhagen	Emerging trial designs
Tokyo	Research during public health emergencies/pandemics
Vatican	Research in resource-poor settings, global justice
Johannesburg	Community inclusiveness, post-trial access, vulnerability
Munich	Specific and particularly vulnerable groups
Washington DC	Final consolidation

Adapted from: https://www.youtube.com/watch?v=hvcQ1hj_Xqs&t=2796s (Accessed on January 6, 2025).