Informed Consent

Helping you get published

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?

Informed Consent

Informed Consent

One such article was published in the

Canadian Medical Association Journal (CMAJ)

in April 19981. It attracted strong criticism from

a reader,2 who wondered whether the parent

or guardian of the boy had consented in

writing to the publication of the photo (and

the violation of confidentiality that this

publication involved). The reader went on to

Did you know?

“Informed consent” arose as an

ethical issue in research and

publishing after outrage at the

atrocities committed by the

notorious “Nazi Doctors” under publication involved). The reader went on to

question whether this violation was essential

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

notorious “Nazi Doctors” under

Hitler’s regime.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 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

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) 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.

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”.7potentially lifesaving treatments will evaporate. Volunteers will not show up”.

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.

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 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

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 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

Informed Consent

The Declaration of

Helsinki

A statement of ethical

principles for medical

research that involves

human subjects

http://www.wma.net/en/

30publications/10policies/b3

/17c.pdf

Uniform Requirements for

Manuscripts Submitted to

Biomedical Journals

A set of guidelines on the

ethical requirements of

manuscripts submitted to

http://www.icmje.org/

Biomedical Journals manuscripts submitted to

biomedical journals

Publication Manual of the

American Psychological

Association, Sixth Edition

Provides a detailed

description of the rights and

confidentiality of research

participants, particularly in

the case of the behavioral

sciences

http://www.apa.org/

pubs/books/4200066.aspx

Informed Consent

The Council of Science

Editors’ White Paper on

Promoting Integrity in

Scientific Journal

Publications

A list of examples of actions

that constitute mistreatment

of research subjects

http://www.councilscienceed

itors

.org/i4apages/index.cfm?

pageid=3360

American Medical Includes guidelines on ethical http://www.amamanualofstylAmerican Medical

Association Manual of

Style

Includes guidelines on ethical

and legal considerations in

preparing an article for

publication in a medical

journal

http://www.amamanualofstyl

e

.com/oso/public/index.html

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 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/

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 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

Connect

http://www.facebook.com/Editage

http://www.twitter.com/Editagehttp://www.twitter.com/Editage

http://www.linkedin.com/company/cactus-communications