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, essays, commentaries, and case studies 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 involving pregnant women and the fetus;
• research with prisoners, children, 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).

Author Guidelines

How to Submit a Manuscript

New submissions should be made via the Research Exchange submission portal. You may check the status of your submission at any time by logging on to submission.wiley.com and clicking the “My Submissions” button. For technical help with the submission system, please review our FAQS or contact submissionhelp@wiley.com.

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)

4500-8500 words (not including references, figures, tables, appendices, or other supplementary materials)

Essays and Commentaries

1400 words or more

Case Studies

1400 words or more

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.

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, email address
• coauthors’ names, professional titles, institutional affiliations, telephone numbers, and email addresses
• acknowledgments: Authors must disclose all financial support for the research and development of the manuscript
• 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. This can be placed in the “methods” section of the paper. If ethics approval was not obtained, an explanation must be provided

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). 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. Submit all supplementary materials (e.g., tables and figures) as separate Word documents. All supplementary materials should have a short title.

Conflict of Interest

Authors will be asked to disclose any conflicts of interest. expects all prospective contributors and reviewers to declare any potential 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

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 here: https://authorservices.wiley.com/author-resources/Journal-Authors/open-access/author-compliance-tool.html

Other licensing agreements such as open access will be handled between Wiley, the publisher that distributes the journal, and the authors.

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.

Manuscript Format

Submit a Word document with text in Times-New Roman 12-point font, double-spaced, with 1-inch margins.

ORCID

This journal encourages ORCID. Please refer to Wiley’s resources on ORCID.

Article Preparation Support

Wiley Editing Services offers expert help with English Language Editing, as well as translation, manuscript formatting, figure illustration, figure formatting, and graphical abstract design – so you can submit your manuscript with confidence. Also, check out resources for Preparing Your Article for general guidance about writing and preparing your manuscript.

Article Promotion Support

Wiley Editing Services offers professional video, design, and writing services to create sharable video abstracts, infographics, conference posters, lay summaries, and research news stories for your research – so you can help your research get the attention it deserves.

Author Name Change Policy

In cases where authors wish to change their name following publication, Wiley will update and republish the paper and redeliver the updated metadata to indexing services. Our editorial and production teams will use discretion in recognizing that name changes may be of a sensitive and private nature for various reasons including (but not limited to) alignment with gender identity, or as a result of marriage, divorce, or religious conversion. Accordingly, to protect the author’s privacy, we will not publish a correction notice to the paper, and we will not notify co-authors of the change. Authors should contact the journal’s Editorial Office with their name change request.

References

Authors will be required to reformat references once a paper is accepted if they do not conform to the style described below.

We are now using the AMA Style (American Medical Association) for references. References should appear only at the end of the manuscript. Do not insert references as footnotes at the bottom of manuscript pages.

• Each reference in the body of the paper receives one reference number. Use the numerals outside periods and commas, but inside colons and semicolons. Add page numbers to direct quotations in parentheses after the citation number if page numbers are available. Note that the superscript may include more than one page number, citation of more than one reference, or both, with no spaces.  All numbered references should appear in the reference section with the number used in the body of the paper. Information on how to format is described below.

Example:

In a recent report,¹ experts found samples of cancerous tissue. Other reports^2,3 found benign tissue. “Benign tissue was better.”^4(p.34) If cancerous tissue¹ was found, more research was needed.⁵

Articles in Journals

Article—One Author

Format:

1. Author. Title of article. Abbreviated Journal Title. Year;Volume(Issue number):Inclusive page numbers. doi: (if supplied)

Example:

1. Subauste CS. Autophagy as an antimicrobial strategy. Expert Rev Anti Infect Ther. 2009;7(6):743-752. doi:10.1586/eri.09.41

Article—Multiple Authors

Format:

1. First Author, Second Author [if there are more than six authors, use “et al” after the third author]. Title of article. Abbreviated Journal Title. Year;Volume(Issue number):Inclusive page numbers. doi: (if supplied)

Example:

1. Crompton J, Imms C, McCoy AT, et al. Group-based task-related training for children with cerebral palsy: a pilot study. Phys Occup Ther Pediatr. 2007;27(4):43-65.

Books and Other Monographs

Entire Book—Single Author

Format:

1. Author. Book Title. Edition number (2nd edition or above). Name of Publisher; copyright year.

Example:

1. Snell RS. Clinical Anatomy by Regions. 9th ed. Lippincott Williams & Wilkins; 2012.

Entire Book—Multiple Authors

Format:

1. First Author, Second Author [if there are more than six authors, use “et al” after the third author]. Book Title. Edition number [2nd edition or above]. Name of Publisher; copyright year.

Example:

1. Shamus E, Stern DF. Effective Documentation for Physical Therapy Professionals. 2nd ed. McGraw-Hill; 2011.

Entire Book—Editor as Author

Format:

1. Author(s), eds. Book Title. Edition number [2nd edition or above]. Name of Publisher; copyright year.

Example:

1. O’Sullivan SB, Schmitz TJ, eds. Physical Rehabilitation. 5th ed. F.A. Davis Company; 2007.

Chapter or Article within a Book

Format:

1. Author(s) of Article. Title of chapter or article. In: Editor’s name(s), ed(s). Book Title. Edition number [2nd edition or above]. Name of Publisher; copyright year:Inclusive chapter page range.

• If the author of the chapter is also an editor for the book, the name is given in both places: as author of the chapter and as editor of the book.

Example:

1. Solensky R. Drug allergy: desensitization and treatment of reactions to antibiotics and aspirin. In: Lockey P, ed. Allergens and Allergen Immunotherapy. 3rd ed. Marcel Dekker; 2004:585-606.

Government Materials (Print)

Format:

1. Author or Authoring Body (if given). Title of Report. Name of Issuing Bureau/Agency/Department or Governmental Division; Year. Page numbers (if specified). Publication number (if given). Series number (if given).

Example:

1. National Institute of Child Health and Human Development. Health Disparities: Bridging the Gap. From Cells to Selves. National Institute of Child Health and Human Development; 2000.

Government Agency Reports (Online)

Format:

1. Author or Authoring Body. Title of report. [Date published]. Updated [date]. Accessed [date] (if only date available). URL

Example:

1. World Health Organization. Research for universal health coverage. 2013. http://prx- usa.lirn.net/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=edsghw&A N=edsgcl.365455960&site=eds-live

Newspaper/Online Articles

Format:

1. Author. Title of article. Name of Newspaper*. Publication Month Day, Year:Section. Accessed Date. URL

Example:

1. Harju N. Physical therapy needs after COVID-19. Daily Herald. July 20, 2020. Accessed September 1, 2020. https://my.usa.edu/ICS/Academics_2017-08-22T17-14-45- 332/IRB/Institutional_Review_Board.jnz?portlet=Free-form_Content

*Newspaper names are not abbreviated

Websites

Format:

16. Author or responsible body, if given (often no authors are given). Title of item cited (if none is given, use the name of the organization responsible for the site). Name of the Website. [Date published, if given]. Updated [date]. Accessed [date]. URL

Example:

16. American Physical Therapy Association. Ethics & professionalism. Updated June 5, 2019. Accessed February 12, 2020. http://www.apta.org/EthicsProfessionalism/

Secondary Sources (source within a source)

1. Cauley JA, Lui L-Y, Ensrud KE, et al. Osteoporosis and fracture risk in women of different ethnic groups. JAMA. 2005;293(17):2102-2108. Cited by: Acheson LS. Bone density and the risk of fractures: should treatment thresholds vary by race [editorial]? JAMA. 2005;293(17):2151-2154.

2. Kato S, Sherman PM. What is new related to Helicobacter pylori infection in children and teenagers? Arch Pediatr Adolesc Med. 2005;159(5):415-421. Quoted by: Prazar G. How many pediatricians does it take to change a practice? or how to incorporate change into practice [editorial]. Arch Pediatr Adolesc Med. 2005;159(5):500-502.

Legal

Court Cases

Format:

1. First party v Second party*, Volume number and Official reporter abbreviation (if given) and series number (if given) First page of case, specific pages used (Deciding court and Year of decision).

Example:

1. Forte v Redmond, 95-266 US 518, 522 (DC Cir 1996).

Statutes

Format:

1. Official Name of the Act, the title number, the abbreviation of the code cited, the section number (designated by §), and the date of the code edition cited. If the law is available online, the URL may also be included.

Example:

1. Americans With Disabilities Act of 1990, 42 USC § 12101 et seq. (1990). https://www.ada.gov/pubs/adastatute08.htm.