Journals will not publish your paper if your study involves human subjects and you have not obtained informed consent.

1. Informed Consent
Helping you get published

2. Informed Consent
You’ve completed a study about AIDS prevalence in Africa, and you
feel the need provide your readers with a better idea of the
patients you studied. So, you include in your manuscript a
photograph of a smiling young boy (and a caption mentioning the
disease he had), taken during your fieldwork. What’s wrong with
doing this?

3. Informed Consent
One such article was published in the
Canadian Medical Association Journal (CMAJ)
in April 19981. It attracted strong criticism from
Did you know?
a reader,2 who wondered whether the parent
“Informed consent” arose as an
or guardian of the boy had consented in
ethical issue in research and
writing to the publication of the photo (and
publishing after outrage at the
the violation of confidentiality that this
atrocities committed by the
publication involved). The reader went on to
notorious “Nazi Doctors” under
question whether this violation was essential
Hitler’s regime.4
for scientific purposes. Subsequently, the
editor-in-chief of CMAJ published an apology
for having “goofed and published not only
information about a patient’s case, but also
the patient’s picture, although consent had not
been obtained.”3

4. Ethical Guidelines
In medical research involving competent human subjects, each potential subject
must be adequately informed of the aims, methods, sources of funding, any
possible conflicts of interest, institutional affiliations of the researcher, the
anticipated benefits and potential risks of the study and the discomfort it may
entail, and any other relevant aspects of the study. The potential subject must be
informed of the right to refuse to participate in the study or to withdraw consent to
participate at any time without reprisal. Special attention should be given to the
specific information needs of individual potential subjects as well as to the methods
used to deliver the information. After ensuring that the potential subject has
understood the information, the physician or another appropriately qualified
individual must then seek the potential subject’s freely-given informed consent,
preferably in writing.- Declaration of Helsinki5

5. Informed Consent
In studies involving human participants, written informed consent is important for the
following reasons6:
1. These documents serve as a permanent record of details that the participant may wish
to know even after they have consented to taking part in the study (e.g., whom to
contact if they want to withdraw).
2. The information in such documents is more detailed (e.g., telephone and fax numbers)
and cannot be effectively conveyed through a conversation with the participant.
3. Ethics committees or institutional review boards may not have the resources to
monitor the conversations in which consent is sought from the participants.
Therefore, written informed consent is often essential for the study to obtain ethical
approval from such bodies.

6. Informed Consent
4. Informed consent forms can serve as legal documents and can be used as evidence (by
either party) in the case of a lawsuit related to the study.
5. If participants are made aware of the fact that the researcher is following appropriate
ethical practices, they are more likely to trust the researcher, which can lead to long-
term benefits. “To put it simply, if we cannot guarantee sound research in general—
and patients’ safety in particular—public support for gene therapy and other
potentially lifesaving treatments will evaporate. Volunteers will not show up”.7
6. Those who want to use the data for the participants later (e.g., for a follow-up study)
could use these documents to obtain the contact details of the participants.

7. Informed Consent
Failure to obtain informed consent at the beginning of your study can be very costly. For
instance, in one case in the US, over 5 million blood samples had to be destroyed
because informed consent had not been taken.8
Ethical Guidelines
Patients have a right to privacy that should not be violated without informed
consent. Identifying information, including names, initials, or hospital numbers,
should not be published in written descriptions, photographs, or pedigrees unless
the information is essential for scientific purposes and the patient (or parent or
guardian) gives written informed consent for publication. Informed consent for this
purpose requires that an identifiable patient be shown the manuscript to be
published.- Uniform Requirements for Manuscripts Submitted to Biomedical
Journals9

8. Informed Consent
Moreover, many reputed journals consider failure to obtain informed consent sufficient
grounds for rejecting a manuscript. For instance, the American Journal of Psychiatry
states, in its guidelines for authors: “If your submission does not contain written
informed consent or Institutional Review Board approval, it will not be
reviewed.”10 Other journals like the Journal of the American Medical Association require
that the Methods section of a paper mentions the formal review and approval/waiver by
an appropriate institutional review board or ethics committee.11
In conclusion, obtaining and reporting informed consent are essential for your research
and manuscript respectively. Doing so establishes your credibility as a scientist and
writer. At present, journal editors “will not publish a manuscript, however scientifically or
educationally worthy, when anonymity cannot be absolutely guaranteed or informed
written consent has not been obtained.”2

9. Informed Consent
The Declaration of A statement of ethical http://www.wma.net/en/
Helsinki principles for medical 30publications/10policies/b3
research that involves /17c.pdf
human subjects
Uniform Requirements for A set of guidelines on the http://www.icmje.org/
Manuscripts Submitted to ethical requirements of
Biomedical Journals manuscripts submitted to
biomedical journals
Publication Manual of the Provides a detailed http://www.apa.org/
American Psychological description of the rights and pubs/books/4200066.aspx
Association, Sixth Edition confidentiality of research
participants, particularly in
the case of the behavioral
sciences

10. Informed Consent
The Council of Science A list of examples of actions http://www.councilscienceed
Editors’ White Paper on that constitute mistreatment itors
Promoting Integrity in of research subjects .org/i4apages/index.cfm?
Scientific Journal pageid=3360
Publications
American Medical Includes guidelines on ethical http://www.amamanualofstyl
Association Manual of and legal considerations in e
Style preparing an article for .com/oso/public/index.html
publication in a medical
journal

11. Informed Consent
References
1. Rasid, M. (1998). AIDS in Africa: A personal experience. Canadian Medical Association Journal,
158(8). 1051–1053. Available
at http://ukpmc.ac.uk/articles/PMC1229229/pdf/cmaj_158_8_1051.pdf
2. Barnes, R. (1998). Confidentiality in medical publishing. Canadian Medical Association Journal,
159(5). 443. Available
at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1229634/pdf/cmaj_159_5_443.pdf
3. Hoey, J. (1998). Patient consent for publication—an apology. Canadian Medical Association Journal,
159(5). 503–504. Available
athttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1229651/pdf/cmaj_159_5_503.pdf
4. Pedron, J. A., & Pimple, K. D. (2001). A Brief Introduction to Informed Consent in Research with
Human Subjects. Available at http://poynter.indiana.edu/sas/res/ic.pdf
5. 59th WMA General Assembly, Seoul. (2008). World Medical Association Declaration Of Helsinki:
Ethical Principles for Medical Research Involving Human Subjects. Available
athttp://www.wma.net/en/30publications/10policies/b3/17c.pdf
6. Resnik, D. B. (2009). Do informed consent documents matter? Contemporary Clinical Trials, 30(2).
114–114. doi: 10.1016/j.cct.2008.10.004. Available
at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670580/

12. Informed Consent
References
7. Shalala, D. (2000). Protecting research subjects—what must be done. New England Journal of
Medicine, 343(11) 808–810.
8. Akst, J. (2009). Consent issues nix blood samples. The Scientist. Available at http://classic.the-
scientist.com/blog/display/56230/%20and%20http://www.texascivilrightsproject.org/?p=1096
9. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts
Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research:
Privacy and Confidentiality. Available at http://www.icmje.org/ethical_5privacy.html
10. The American Journal of Psychiatry. Guidelines For Authors On Preparing Manuscripts. Available
athttp://ajp.psychiatryonline.org/misc/ifora.dtl
11. Journal of the American Medical Association. Instructions for Authors. Available at http://jama.ama-
assn.org/site/misc/ifora.xhtml#EthicalApprovalofStudiesandInformedConsent
12. Levine, S. B., & Stagno, S. J. (2001). Informed consent for case reports: The ethical dilemma of right
to privacy versus pedagogical freedom. Journal of Psychotherapy Practice and Research, 10. 193–
201. Available at http://jppr.psychiatryonline.org/cgi/content/full/10/3/193

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