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The Declaration of Helsinki (DoH) was adopted by the World Medical Association (WMA) in 1964, as a statement of ethical principles, to provide guidance to physicians and other participants in medical research involving human subjects. Having undergone several amendments, the most recent version was approved on 18 October 2008, by the WMA General Assembly at Seoul, South Korea, replacing all previous versions. This version highlights issues such as, participant safety, the need to include participants from otherwise underrepresented groups, clinical trial registration, post-study access, usage of data and human tissues, compensating participants with research-related injury, and usage of placebo. In this article, we discuss the major aspects of the 2008 version, including the impact of this version on all stakeholders in research, including, investigators, ethics committee members, sponsors, authors, editors, and reviewers.

Background Stakeholders in medical research have roles in ensuring that research participants are protected. Medical journals play gatekeeping roles in the responsible conduct of research. They help guard against the publication of findings of unethical research, such as those with compromised participant welfare. Nigerian medical journals are being created to support the growing number of research enterprises. In this study, we aimed to determine the compliance of Nigerian medical journals with guidelines on research participant protection. Methods This was a descriptive cross-sectional study of Nigerian medical journals and articles. We used a checklist to obtain information on journal characteristics and the presence of recommendations from the International Committee of Medical Journal Editors (ICMJE) on the protection of research participants in the journal instructions to authors and articles. The data were analysed via IBM SPSS version 23. Results We studied 40 journals and 350 journal articles. Thirty-one (77.5%) journals required ethical approval and the Declaration of Helsinki statement in their instructions to the authors, while informed consent was present in 26 (65.0%) journals; 6 (15.0%) journals had no participant protection guidelines. Forty-one (11.7%) articles complied with all three recommendations on research participant protection, whereas 60 (17.1%) articles did not. Ethical approval was most common in 268 (76.6%) articles, whereas it was least common in statements on the Declaration of Helsinki in 50 (14.3%) articles. The presence of participant protection recommendations in instructions to authors was not associated with compliance with these recommendations in published articles ( p  > 0.05). Conclusion Although there is fairly good compliance of Nigerian medical journals with research participant protection recommendations, there are still gaps, which highlight the need for remedial measures.

Background In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of Helsinki in favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation. Methods We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities’ respective approaches to interpretation and implementation of the Declarations’ placebo paragraph in the conduct of medical research. Results Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of “serious harm” and “methodological reasons” are proposed as well as safeguards to avoid abuse of the option to use placebo-controls. Conclusion Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki’s character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard.

In this paper, we argue that the professional engineering institutions ought to develop a Declaration of Climate Action. Climate change is a serious global problem, and the majority of greenhouse gas emissions come from industries that are enabled by engineers and represented by the engineering professional institutions. If the professional institutions take seriously the claim that a profession should be self-regulating, with codes of ethics that go beyond mere obedience to the law, and if they take their own ethical codes seriously, recognising their responsibility to the public and to future generations (and also recognising a duty of “responsible leadership”), the professional institutions ought to develop a declaration for engineers, addressing climate change. Our argument here is largely inspired by the history of the Declaration of Helsinki. The Declaration of Helsinki was created by the medical profession for the profession, and it held physicians to a higher standard of ethical conduct than was found in the legal framework of individual countries. Although it was not originally a legal document, the influence of the Declaration can be seen in the fact that it is now enshrined in law in a number of different countries. Thus, we argue that the engineering profession could, and should, play a significant role in the abatement of climate change by making changes within the profession. If the engineering profession sets strict standards for professional engineers, with sanctions for those who refuse to comply, this could have a significant impact in relation to our efforts to develop a coordinated response to climate change.

Mosaic tablet, dynamic document, or dinosaur?

This section looks back on a ground-breaking contribution to public health, reproduces an extract of the original text and adds a commentary on its significance from a modern perspective. To complement the theme of this month’s issue, John R Williams looks at the Declaration of Helsinki and how it has evolved over time. The original declaration is reproduced here in full with permission of the World Medical Association.

AbstractObjectivesTo evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration.DesignCross sectional analysis.Data sourcesPubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports.Study selection criteriaRCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018.ResultsThis study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated.ConclusionsThis study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

The 10th Congress of the European Academy of Neurology is being held in Helsinki, Finland from 29 June to 2 July 2024, and Nature Reviews Neurology is publishing a series of Comments on the overarching theme, neuromodulation. We asked Programme Committee Chairs Ulf Kallweit and Reetta Kälviäinen about their roles and their expectations for the congress.

Reaction to the first draft, out for public consultation until June 15, has been polarised. Since the Declaration of Helsinki was originally published in 1964 by the World Medical Association (WMA), its primary purpose has been to set international ethical principles for research involving human participants. A research volunteer takes part in an AIDS vaccine trial, Bangkok, ThailandKaren Kasmauski/Science Faction/Corbis With regard to post-trial access, the draft now reads: \"In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the study.\" [...]in disadvantaged and vulnerable populations: \"Consideration should also be given to ensuring that the community receives a fair level of additional benefits.\"