Date: Sat, 2 Aug 2003 10:59:33 -0600
From: Barbara Nash <firstname.lastname@example.org>
Subject: Publication ethics and J. Michael Bailey
Cc: email@example.com, firstname.lastname@example.org
August 2, 2003
Hard copy to follow
Stephen Mautner, Executive Editor
The National Academies Press
The Joseph Henry Press
500 Fifth Street, NW
Washington, DC 20001
Dear Mr. Mautner,
We are writing in response to your recent open letter regarding your publication of the Man Who Would Be Queen by J. Michael Bailey. You are probably now aware that several individuals who were subjects of Bailey's research have filed formal complaints with his institution to the effect that he apparently did not seek review or approval by Northwestern's Institutional Review Board for the research involving human subjects described in detail in his book. In particular, they were not informed that they were subjects of his research nor did they sign consent forms as is required by federal regulations governing protection of human research subjects.
Federal regulations define research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". Human subject "means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual", where interaction "includes communication or interpersonal contact between investigator and subject". The Joseph Henry Press describes Professor Bailey's work as based on his own research, and the book contains detailed interviews with human subjects.
In recent years publishers of scientific research involving human subjects have established procedures to assure that research studies whose results they publish have complied with ethical standards for the treatment of human subjects, and that authors have stipulated in writing that the conduct of their research was in compliance with those legally mandated standards. For example, instructions to authors for Nature Genetics state:
In cases where a study involves the use of live animals or human subjects, the Methods section of the manuscript should include a statement that all experiments were performed in compliance with the relevant laws and institutional guidelines, and should identify the institutional committee(s) that have approved the experiments. A statement should also be included that informed consent was obtained for any experimentation with human subjects. Referees may be asked to comment specifically on any cases in which concerns arise.
Similar requirements are adhered to by other major publishers of scientific research, and we have appended the guidelines for several publications, including JAMA, the New England Journal of Medicine, Science, and journals of the American Psychological Association which has its own comprehensive statement of Ethical Principles that provides for the protection of human subjects.
In your letter you say that "Our intention in publishing it was ... to offer insight into how one scientist has arrived at his views on certain aspects of sex and human behavior", and that "we hope that the publication will inspire a productive discussion about future directions and methodologies in research on gender and sexuality..." In regard to how Professor Bailey "arrived at his views" and "discussion about ... methodologies", we have two questions to ask of you.
1. Does the National Academies Press - Joseph Henry Press require that authors affirm in writing that their research involving human subjects has been approved by an appropriate institutional review committee and that informed consent was obtained from human subjects involved in the research?
2. If such a policy is in place for the Joseph Henry Press, did J. Michael Bailey stipulate to having adhered to that policy?
If you do not have a policy that requires authors to stipulate that they have adhered to ethical standards for research involving human subjects, we strongly urge you to develop one along the lines of other publishers of scientific research. Note that Genetics Nature invites comment from reviewers in cases where there may be concern about the ethical use of human subjects. It is clearly inappropriate for the National Academies to publish and promote the results of research that fails to conform to federally mandated requirements for the protection of human subjects in research.
We appreciate your assistance in answering our inquiry and in addressing these serious concerns about the conduct of the research in question.
Barbara Nash., Ph.D.
Professor of Geology and Geophysics
University of Utah
Lynn Conway, Ph.D.
Professor of Electrical Engineering and Computer Science, Emerita
University of Michigan
Member, National Academy of Engineering
Deirdre McCloskey, Ph.D.
UIC Distinguished Professor of Economics, History, and English
University of Illinois at Chicago
Tinbergen Professor of Philosophy, Economics, and Art and Cultural Studies,
Erasmus University of Rottterdam
Ben Barress, M.D., Ph.D.
Professor of Neurobiology and Developmental Biology
Joan Roughgarden, Ph.D.
Professor of Biological Sciences
c: Bruce Alberts, President, the National Academy of Sciences
Harvey V. Fineberg, President, the Institute of Medicine
Addendum: Examples of editorial policies regarding publication of research involving human subjects.
"In cases where a study involves the use of live animals or human subjects, the Methods section of the manuscript should include a statement that all experiments were performed in compliance with the relevant laws and institutional guidelines, and should identify the institutional committee(s) that have approved the experiments. A statement should also be included that informed consent was obtained for any experimentation with human subjects. Referees may be asked to comment specifically on any cases in which concerns arise."
Journal of the American Medical Association:
"Ethical Requirements. For human or animal experimental investigations, appropriate institutional review board approval is required and should be so stated. For those investigators who do not have formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed. For investigations of human subjects, state in the Methods section the manner in which informed consent was obtained from the study participants."
New England Journal of Medicine
"In appropriate places in the manuscript please provide the following items:
* If applicable, a statement that the research protocol was approved by the relevant institutional review boards or ethics committees and that all human participants gave written informed consent."
"Conditions of Acceptance: When a paper is accepted for publication in Science, it is understood that:
* Informed consent was obtained for studies on humans after the nature and possible consequences of the studies were explained."
American Journal of Psychiatry
"Manuscripts and letters to the Editor that report the results of experimental investigation and interviews with human subjects must include a statement that written informed consent was obtained after the procedure(s) had been fully explained. "
"Empirical reports of data derived from studies with human participants should briefly but explicitly describe in the methods section what ethical safeguards were in place in the study, e.g., IRB approval, confidentiality protections, informed consent, conflict of interest disclosure, etc."
American Psychological Association (over 40 journal
"Authors will be required to state in writing that they have complied with APA ethical standards in the treatment of their sample, human or animal, or to describe the details of treatment. A copy of the APA Ethical Principles may be obtained electronically or by writing the APA Ethics Office, 750 First Street, NE, Washington, DC 20002-4242."
Professor of Geology and Geophysics
University of Utah
135 South 1460 East, Rm 719
Salt Lake City, UT 84111