Aims & Scope

Ethics & Human Research (formerly IRB: Ethics & Human Research) aims to foster critical analysis of issues in science and health care that have implications for human biomedical and behavioral research. For example, in addition to covering topics related to informed consent for research, genetic research with human biospecimens, ethics committee review of research protocols, and research with children and other vulnerable populations, E&HR will publish work on rapid developments in science and medicine that bring new challenges to the ethical, regulatory, and policy frameworks that govern research with humans in the United States and elsewhere.

E&HR invites articles, commentaries, case studies, letters, and book reviews that address topics including, but not limited to,

• review, approval, and oversight of human research by institutional review boards (IRBs), research ethics committees (RECs), and other oversight bodies (e.g., those of funders and regulators and those at the national and transnational levels);
• regulatory and legal developments related to research with humans and to the privacy and confidentiality of their medical and other personal data;
• informed consent for participation in research;
• consent, privacy, and oversight issues related to research with human biospecimens and associated genetic and medical data;
• research with organ donors, transplant organs, and transplant recipients;
• research involving learning health care systems;
• research with digital data from social media and other “big data” collections and platforms;
• ethical issues surrounding novel trial designs, such as basket trials, umbrella trials or platform trials;
• ethical issues in the testing and development of computational technologies from machine learning and artificial intelligence;
• human research involving novel biotechnologies such as genome-editing techniques, cell-, gene-, and tissue-based interventions, and preventive and therapeutic neurological drug and device interventions;
• research on nonhuman subjects and the ethical implications for the conduct and oversight of biomedical and behavioral human research and for the potential harms and benefits to people who participate in human research studies;
• the implications of the quality and reporting of preclinical research involving animals and other models (e.g., in vitro assays, epidemiological studies, computer simulations) for the ethical translation of such research to human clinical trials;
• the intersection of human research ethics with other lines of analysis and regulation in research (e.g., issues related to responsible research and innovation);
• patient-centered research and community-based participatory research;
• research with immigrants and with populations based on gender, socioeconomic class, race, and ethnicity, including with American Indians, Alaskan Natives, and other indigenous peoples and communities;
• research with prisoners, children, pregnant women, and other individuals who may be considered vulnerable (e.g., individuals who are cognitively impaired, homeless, or have substance use disorders);
• human research in low- and middle-income countries;
• human research in refugee populations and among internally displaced people; and
• human research in global health emergencies (e.g., natural disasters, war and other violent conflicts, infectious disease outbreaks).

How to Submit a Manuscript

Submit manuscripts to E&HR via ScholarOne here.

III. Types of Manuscripts

Listed below are the suggested minimum and maximum word counts for each type of manuscript. The editor may commission manuscripts for these sections. Placement of manuscripts under section headings is at the editor’s discretion.

Articles (conceptual pieces or empirical studies)

4,500-8,500 words, shorter manuscripts will also be accepted (word count does not include references, figures, tables, appendices, or other supplementary materials).

Essays and Commentaries

1,400 words or more

Case Studies

1,400 words or more

Book Reviews

700-1,400 words

Author Submission Checklist

Cover Letter

A brief cover letter should acknowledge submission of the manuscript. Authors must confirm that neither the manuscript nor any of its content, including tables, figures, and other supplementary materials, has been published elsewhere or is in press at another publication.

When uploading the cover letter (and any other document that identifies the author[s]) into the manuscript review system (ScholarOne, or Manuscript Central), be sure to designate the file as “Additional file NOT for review and NOT for publication.”

Abstract for Articles

Up to 200 words and 4-6 keywords for indexing purposes.

Manuscript Cover Page

A separate cover page should include

• title of manuscript;
• estimated word count (not including references, tables, and other supplementary materials);
• contact author’s name, professional title, institutional affiliation, mailing address, telephone and fax numbers, and email address;
• coauthors’ names, professional titles, institutional affiliations, telephone numbers, and email addresses;
• acknowledgments disclosing, if relevant, all financial support for the research and development of the manuscript (acknowledgments must NOT appear with the manuscript itself or in any document intended for review); and
• human subjects protection statement. If research was conducted with human participants, a statement is required indicating that an institutional review board (IRB) or other relevant ethics review committee approved the study. If ethics approval was not obtained, an explanation must be provided.

When uploading the cover page (and any other document that identifies the author[s]) into the manuscript review system, be sure to designate the file as “Additional file NOT for review and NOT for publication.”

Manuscript

Manuscripts are blind reviewed by peer reviewers. Author identification should be removed from the text and references. This can be accomplished by referring to your work in the third person and citing the references in the usual manner (do not delete your name from the references). Acknowledgments should also be removed from the manuscript and endnotes.

Manuscripts recommended for publication may be subject to revisions, additional review, and standard copyediting. Manuscripts will not be returned to authors. Copyright is transferred to The Hastings Center upon acceptance.

Conflict of Interest

Authors will be asked to disclose any conflicts of interest. Conflicts of interest include any personal or professional affiliations, any financial interests, and/or any past, present, or anticipated activities that may compromise the quality or objectivity of a manuscript or review. The rough test that we ask authors to employ is, Is there anything that would likely cause readers to second-guess your objectivity if it were to emerge after publication? Authors will be asked to disclose conflicts of interest when a manuscript is submitted for consideration to E&HR.

The Use of Generative AI Tools

Authors who have used large language models or other generative AI tools to develop or compose their paper should describe, in the cover letter and in a disclosure section or other relevant part of the manuscript, how in particular they used such tools. In describing the use of AI, err on the side of too much, rather than too little, transparency. AI tools cannot be listed as authors. For more on this topic, see Editors’ Statement on the Responsible Use of Generative AI Technologies in Scholarly Journal Publishing.

Author Licensing Options

If a paper is accepted, a licensing agreement must be signed by one or more of the authors before the paper can be published. Authors may choose to publish under the terms of the journal’s standard copyright transfer agreement, or they may purchase open access under the terms of a Creative Commons license. Information about open access is available here.

Authors who are using the copyright transfer agreement will receive it to fill out (along with the journal’s conflict-of-interest form, which every author must fill out) shortly after receiving their galley for review. Permitted uses of different versions of the paper (submitted, accepted, and final published versions) are described in the CTA.

Authors who would like to purchase open access should email the managing editor, Julie Chibbaro (chibbaroj@thehastingscenter.org), for the Creative Commons license to begin the process; she will then put someone from Wiley, the publisher that distributes the journal, in touch with the authors to facilitate the process. Note that certain funders require a particular type of Creative Commons license. If you know which type your funder requires, please tell the managing editor.

Work Funded by the National Institutes of Health

Pursuant to NIH mandate, authors who received NIH funding for their work are required to deposit the accepted version of their manuscript to PubMed Central. By “accepted version,” we refer to the version of a manuscript following any revisions or corrections that the author(s) made following peer review and before editing by the E&HR editorial staff. Authors are responsible for sending the accepted version of their manuscript to PubMed. The title should be updated if it is changed for publication. This accepted version will be made publicly available 12 months after publication. For further information, see www.wiley.com/go/nihmandate.

Statement about IRB Approval

When relevant, authors should incorporate information about IRB approval into the methods section or another appropriate section of their manuscript, redacting the institution’s name for peer review. For example, in a “Study Methods” section of the manuscript, authors may add, “The [name of] University School of Medicine’s IRB approved this study under its expedited review process.” 

Manuscript Format

• Submit a Word document of the manuscript with text in Times-New Roman 12-point font, double-spaced, with 1-inch margins.
• Submit all supplementary materials (e.g., tables and figures) as separate Word documents. All supplementary materials should have a short title.
• References are to be endnotes—they should be at the end of the manuscript. Do not insert references as footnotes, at the bottom of manuscript pages.
• Consecutively number all pages of text and references. (Each endnote number should appear only once in the text, never repeating.)

Please note that we are now using a modified Chicago style for manuscripts and references (no longer a modified Vancouver style). Articles accepted for publication must conform to the modified style shown below when submitted for final formatting into galleys.

• References should be enumerated consecutively as endnotes that appear at the end of the text. The first time a source is used, embed a superscript number in the text and provide the full citation at the end of the manuscript. Please try to limit the number of cited works in each endnote to the three most important or most useful sources. See below for how to list multiple references¹ in a single endnote and how to abbreviate second and subsequent citations to a given work in the endnote section.²
• Journal titles are always spelled out in full, with “The” omitted from the start of journal titles.
• Direct quotations from sources should be referenced with the specific page number(s) on which the quoted passage occurs.

Articles in Journals

One author

King, N. M. P., “Research with Human Subjects: Humility and Deception,” IRB: Ethics & Human Research 40, no. 2 (2018): 12-14.

More than three authors

Christopher, P. P., et al., “Enrolling in Clinical Research While Incarcerated: What Influences Participants’ Decisions?,” Hasting Center Report 47 (2017): 21-29.

Citing a specific page following the full-page range for a piece

Resnik, D. B., “Centralized Institutional Review Boards: Assessing the Arguments and Evidence,” Journal of Clinical Research Best Practices 8, no. 11 (2012): 1-13, at 6.

Citing a specific page when the full citation for a piece appears earlier in the endnotes

Resnik, “Centralized Institutional Review Boards,” 11. [Note that, as in the example in note 2 below, an abbreviated form of the citation is used because the full citation has already been provided.]

Books and Other Monographs

Author(s)

Klitzman, R., The Ethics Police? The Struggle to Make Human Research Safe (New York: Oxford University Press, 2015).

Editor(s) or compiler(s) as author

Annas, G. J., L. H. Glantz, and B. F. Katz, eds., Informed Consent to Human Experimentation: The Subject’s Dilemma (Cambridge, MA: Ballinger, 1977).

Organization as author and publisher

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, DC: Government Printing Office, 1979).

Book chapter

Lederer, S. E., and M. A. Grodin, “Historical Overview: Pediatric Experimentation,” in Children as Research Subjects: Science, Ethics, and Law, ed. M. A. Grodin and L. H. Glantz (New York: Oxford University Press, 1994), 3-28. [Note that “ed.” means “edited by” here, not “editor,” so the plural “eds.” is not used.]

Newspaper article

Kolata, G. A., “A Cancer Conundrum: Too Many Drug Trials, Too Few Patients,” New York Times, August 12, 2017.

Online Materials

Website

Centers for Disease Control and Prevention, https://www.cdc.gov/.

Other Materials

“Clinical Trials and Human Subject Protection,” U.S. Department of Health and Human Services, Food and Drug Administration, accessed August 13, 2018.

Declaration of Helsinki, World Medical Association, October 2000, https://www.wma.net/e/policy/17-c_e.html.

Miller, F. G.,  and A. D. Lyerly, “Navigating Ethics Review of Human Infection Trials with Zika,” Bioethics Forum (blog), April 30, 2018, https://www.thehastingscenter.org/navigating-ethics-review-human-infection-trials-zika/.

Multiple References in an Endnote and Second (or Any Subsequent) Reference to a Given Work

1. Gewirth, A., The Community of Rights (Chicago: University of Chicago Press, 1996); P. P. Christopher et al., “Enrolling in Clinical Research While Incarcerated: What Influences Participants’ Decisions?,” Hasting Center Report 47 (2017): 21-29; Ornstein, C., and K. Thomas, “Sloan Kettering’s Cozy Deal with Start-up Ignites a New Uproar,” New York Times, September 20, 2018.
2. Christopher et al., “Enrolling in Clinical Research While Incarcerated.”