Ethics and biosecurity

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Ethics policy

Studies involving animals and human research participants

All authors of life sciences manuscripts complete an editorial policy checklist to verify their compliance with the Nature Portfolio journals’ editorial policies.

For primary research manuscripts in the Nature Portfolio journals (Articles, Letters, Brief Communications, Technical Reports) reporting experiments on live vertebrates and/or higher invertebrates, the corresponding author must confirm that all experiments were performed in accordance with relevant guidelines and regulations. The manuscript must include a statement identifying the institutional and/or licensing committee approving the experiments, including any relevant details. Sex and other characteristics of animals that may influence results must be described. Details of housing and husbandry must be included where they are likely to influence experimental results. We recommend following the ARRIVE reporting guidelines when documenting animal studies (PLoS Bio 8(6), e1000412,2010). We also recommend consulting the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals (2020), as a comprehensive resource for guidance on veterinary best practice for the anesthesia and euthanasia of animals. 

Research involving human research participants must have been performed in accordance with the Declaration of Helsinki . Authors must identify the ethics committee approving the research, including the name and reference number of the committee in submitted manuscripts. If the study has been granted exemption from requiring ethics approval, details of the committee granting exception should be included in the manuscript. Manuscripts must also include a statement affirming that informed consent was obtained from all human research participants

Studies involving vulnerable groups

For manuscripts reporting studies involving vulnerable groups where there is the potential for coercion or where consent may not have been fully informed, extra care will be taken by the editor. The manuscript may be referred to an internal editorial oversight group for further scrutiny. Consent must be obtained for all forms of personally identifiable data including biomedical, clinical, and biometric data. Documentary evidence of consent must be supplied if requested.

Phase II and III trials

Authors reporting phase II and phase III randomized controlled trials should refer to the CONSORT Statement for recommendations to facilitate the complete and transparent reporting of trial findings. Reports that do not conform to the CONSORT guidelines may need to be revised before formal review.

Tumor marker prognostic studies

Authors reporting tumor markers prognostic studies are encouraged to follow the REMARK guidelines for complete and transparent reporting.

Clinical trial registration

All interventional trials must be registered before enrollment of the first participant. Trial registration records must be available in a primary register of the WHO International Clinical Trials Registry Platform (ICTRP), in, or in any publicly accessible database that meets the minimum 24-item trial registration dataset, including the ISRCTN registry, which is administered and published by BMC (BMC is part of Springer Nature).

The trial number must be clearly indicated in the abstract and methods section of the manuscript. 

Human biospecimens

For describing human biospecimens, we recommend referring to the BRISQ reporting guidelines (Biospecimen Reporting for Improved Study Quality) and ensuring at least Tier 1 characteristics are provided (doi: 10.1002/cncy.20147).

Human transplantation studies

Authors must also include a statement in their manuscript attesting that no organs/tissues were procured from prisoners and providing details of the institution(s)/clinic(s)/department(s) via which organs/tissues were procured while taking care to not violate privacy of donors. For retrospective transplantation studies, authors must include a testament confirming that informed consent was obtained from all participants or that the need for informed consent was waived by the ethics committee/institutional review board.

Publishing images from human research participants

When publishing identifiable images from human research participants in Nature Portfolio journals, authors include a statement in the published paper affirming that they have obtained informed consent for publication of the images. All reasonable measures must be taken to protect patient anonymity. Black bars over the eyes are not acceptable means of anonymization.  In certain cases, we may insist upon obtaining evidence of informed consent from authors. Images without appropriate consent will be removed from publication.

Sex and Gender in Research

We encourage our authors to follow the ‘Sex and Gender Equity in Research – SAGER – guidelines’ and to include sex and gender considerations where relevant. Authors should use the terms sex (biological attribute) and gender (shaped by social and cultural circumstances) carefully in order to avoid confusing both terms. Article titles and/or abstracts should indicate clearly what sex(es) the study applies to. Authors should also describe in the background, whether sex and/or gender differences may be expected; report how sex and/or gender were accounted for in the design of the study; provide disaggregated data by sex and/or gender, where appropriate; and discuss respective results. If a sex and/or gender analysis was not conducted, the rationale should be given in the Discussion. We suggest that our authors consult the full guidelines before submission. These guidelines apply to studies involving humans, vertebrate animal and cell lines.

Definition of Sex and Gender (from Office of Research in Women’s Health, NIH):

Sex - refers to biological differences between females and males, including chromosomes, sex organs, and endogenous hormonal profiles.

Gender -  refers to socially constructed and enacted roles and behaviors which occur in a historical and cultural context and vary across societies.

Studies involving human embryos, gametes and stem cells 

Manuscripts that report experiments involving the use of human embryos and gametes, human embryonic stem cells and related materials, and clinical applications of stem cells must include confirmation that all experiments were performed in accordance with relevant guidelines and regulations.

The manuscript must include an ethics statement identifying the institutional and/or licensing committees approving the experiments and describing any relevant details. The ethics statement must also confirm that informed consent was obtained from all recipients and/or donors of cells or tissues, where necessary, and describe the conditions of donation of materials for research, such as human embryos or gametes. Copies of approval and redacted consent documents may be requested by the editors.

We encourage authors to follow the principles laid out in the 2016 ISSCR Guidelines for Stem Cell Research and Clinical Applications of Stem Cells. Editors are guided by these principles in their evaluation of the ethical and regulatory aspects of the reported research.  When appropriate, ethical and regulatory advice is sought in parallel with the scientific peer review process.

In deciding whether to publish papers describing modifications of the human germline, we are guided by safety considerations, compliance with applicable regulations, as well as the status of the societal debate on the implications of such modifications for future generations. We have established an editorial monitoring group to oversee the consideration of these concerns. (The monitoring group includes the Editor-in-Chief of Nature Portfolio publications, the Nature Editorial Director, the Head of Editorial Policy, Nature Portfolio Journals and the Executive Editor, Life Sciences.) As always, the decision whether to publish a paper is the responsibility of the Chief Editor of the Nature Portfolio journal concerned.

Nature Portfolio journals' editorials:

  • Nature editorials formalize ethics standards for human embryo and stem-cell papers. Nature Announcement: stem cell policy, 2 May 2018 

  • Some cells have a remarkable capacity to organize into tissue-like structures in vitro. As methods to enable self-organization improve, ethical aspects of some of these experiments will need to be considered. Nature Methods. Do we need an ethics of self-organizing tissue?October 2015.

  • Discussion and regulation of genetic alterations in human germ cells and embryos is urgently needed. Nature Medicine. Germline editing: time for discussion, April 2015.

  • Ethical and scientific concerns require continued debate before mitochondrial replacement can reach the clinic. Nature Medicine. Mitochondrial manipulations, May 2014.

  • Scientists who screen the genes of volunteers for research should tell participants if they find information relevant to their health. Nature. Incidental benefits, 22 March 2012.

  • Germany must do more to encourage dialogue on animal experimentation. Nature. Animal talk, 27 October 2011.

  • Researchers should contribute to a US analysis of the case for chimpanzee research. Nature. Great ape debate, 16 June 2011.

  • Researchers and activists alike benefit from dialogue—and a clear line between legal and illegal acts. Nature. An act of distinction, 22 July 2010.

  • The successful transplantation of a synthesized genome highlights unresolved ethical and security issues posed by synthetic biology. Nature. Challenges of our own making, 27 May 2010.

  • Higher peer-review scrutiny applied to reports making strong claims or where there are unusual ethical concerns. Nature. Replicator review, 22 November 2007.

  • Researchers who work with animals should join the discussion on animal experimentation. Nature. An open debate, 14 December 2006.

  • Dialogue about animal research between scientists and the public is essential for research. Nature Genetics. Animal research and the search for understanding, May 2006.

  • In the wake of the Hwang scandal, journals have been reviewing their refereeing procedures. Nature. Standards for papers on cloning, 19 January 2006.

  • Any changes in animal experimentation should occur as a result of dialogue between the public, scientists and legislators. Nature Methods. Of guinea pigs and men, October 2005.

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Biosecurity policy

Nature Portfolio journal editors may seek advice about submitted papers not only from technical reviewers but also on any aspect of a paper that raises concerns. These may include, for example, ethical issues or issues of data or materials access. Very occasionally, concerns may also relate to the implications to society of publishing a paper, including threats to security. In such circumstances, advice will usually be sought simultaneously with the technical peer-review process. As in all publishing decisions, the ultimate decision whether to publish is the responsibility of the editor of the Nature Portfolio journal concerned.

The threat posed by bioweapons raises the unusual need to assess the balance of risk and benefit in publication. Editors are not necessarily well qualified to make such judgements unassisted, and so we reserve the right to take expert advice in cases where we believe that concerns may arise. We recognize the widespread view that openness in science helps to alert society to potential threats and to defend against them, and we anticipate that only very rarely (if at all) will the risks be perceived as outweighing the benefits of publishing a paper that has otherwise been deemed appropriate for a Nature Portfolio journal. Nevertheless, we think it appropriate to consider such risks and to have a formal policy for dealing with them if need arises.

Authors of any paper describing agents or technologies whose misuse may pose a risk must complete the dual use research of concern section of the Nature Portfolio Reporting Summary. This provides an opportunity not only to highlight potential hazards, but also to explain the precautions that have been taken and the benefits of publishing the research. The Reporting Summary is made available to editors, reviewers and expert advisors during manuscript assessment, and is published with all accepted manuscripts.

We have established an editorial monitoring group to oversee the consideration of papers with biosecurity concerns. The monitoring group includes the Editor-in-Chief of Nature Portfolio publications, the Head of Editorial Policy, Nature Portfolio and the Nature Portfolio Editorial Director and it is responsible for maintaining a network of advisors on biosecurity issues.

Once a decision has been reached, authors will be informed if biosecurity advice has informed that decision. Please see the joint statement by journal editors.

Nature Portfolio journals' editorials:

  • Imperfect global biosafety standards and a threat to researchers' motivations from biosecurity concerns are among the significant risks in current flu research. Nature. Publishing risky research, May 2012.

  • Frank debate is needed about the balance between beneficial and detrimental uses of research. Scientists must be the first to open discussions. Nature. For better or worse, April 2012.

  • Although more debate is needed, the benefits of publishing sensitive data outweigh the risks that have so far been made public. Nature. Flu papers warrant full publication, February 2012.

  • Secure virus stocks in the United States and Russia may still prove useful and should not be destroyed. A political compromise is the best way to make that happen. Nature. Smallpox should be saved, January 2011.

  • The US Department of Homeland Security should not be put in charge of biodefence research. Nature. Containing risk, October 2009.

  • The fight against agricultural diseases in the United States has been boosted by fresh funds and a national monitoring network. But these advances are being undermined by inflexible bureaucracy. Nature. Growing pains, March 2008.

  • A key advisory committee is helping the scientific community act more responsibly when conducting and publishing biological research that could carry security risks. Nature. Towards better biosecurity, April 2006.

  • Only biologists can effectively police the misuse of biological agents. Nature. Network of concern, February 2006.

  • Biologists may soon have little option but to sign up to codes of conduct. Nature. Rules of engagement, July 2005.

  • Negotiations over a sensitive scientific publication that could be misused by bioterrorists highlight trouble ahead unless appropriate guidelines are developed. Nature. Risks and benefits of dual-use research, June 2005.

  • Is a consensus building on where to draw some lines concerning benefit to the public versus the risk of misuse? Nature Immunology. Biosecurity with 'bio-sense', December 2004.

  • Communicating important technological advances responsibly, relying on editorial procedures established to identify and debate potential security issues. Nature Methods. The challenge of responsible methods, February 2004.

  • The importance of balancing the free flow of scientific information with security concerns. Nature Immunology. Dealing with potential dangers, March 2003.

  • Scientific openness and security as related to the publication process. Nature. Statement on the consideration of biodefence and biosecurity, February 2003.

  • Scientific freedom must not be undermined for the sake of political expediency. Nature Medicine. Freedom of information, September 2002.

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