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IRB Submission Guidelines

Authors’ Instructions

IRB: Ethics & Human Research is a peer-reviewed journal that publishes scholarly articles offering insight on issues of critical importance to research with human subjects, including findings and analysis of empirical studies. Article manuscripts are typically 3,500 words (text, references, tables, and figures), though we welcome longer and shorter pieces. We also welcome brief commentary (1,000-1,500 words) and letters to the editor (800 words). All references in articles and commentary should be to the most pertinent and up-to-date sources; letters to the editor should not have references.

Manuscripts are considered with the understanding that they are not under consideration elsewhere and that they represent original work that has not been published previously in any format. Manuscripts should be prepared and submitted according to the requirements in the Author Submission Checklist.

Author Submission Checklist

Submit one copy of the manuscript, including the materials listed below, as an email attachment in Word to editorial@thehastingscenter.org. Manuscripts will be acknowledged on receipt. Please specify that the manuscript is being submitted to IRB: Ethics & Human Research.

Cover Letter: A brief cover letter should acknowledge submission of the manuscript. Authors must confirm that the manuscript or any of its content, including tables and figures, have not been published elsewhere or are not in press at another publication.

Manuscript Cover Page: A separate cover page should include:

  • Title of manuscript
  • Estimated word count (inclusive of references, tables, etc.)
  • Contact author’s name, professional title, institutional affiliation, mailing address, telephone and fax numbers, email address
  • Coauthors’ names, professional titles, and institutional affiliations
  • Acknowledgments: Individuals who did not contribute to the work as authors should be named in the Acknowledgments with a description of the assistance they provided. 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) approved the study. If IRB approval was not obtained, an explanation must be provided.

Conflict of Interest Form: Submit the completed COI form for each author with the manuscript.

Abstract: Submit an abstract of 150 words or less and 4-6 keywords for indexing purposes.

Manuscript:
 Manuscripts are blind reviewed. 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). The review period will be approximately 10-12 weeks. 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.

References: 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 and/or most useful sources. See below for how to refer to multiple references1 and how second and subsequent citations to a work should be referenced in the endnote section.2
  • Journal titles are always spelled out in full, except JAMA and NEJM.
  • 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), 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, D.C.: 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.

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, http://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/.


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.

2. Christopher et al., “Enrolling in Clinical Research While Incarcerated.”