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Informed consent
 

Informed consent

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

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

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    Informed consent Informed consent Presentation Transcript

    • Informed Consent Helping you get published
    • Informed ConsentYou’ve completed a study about AIDS prevalence in Africa, and youfeel the need provide your readers with a better idea of thepatients you studied. So, you include in your manuscript aphotograph of a smiling young boy (and a caption mentioning thedisease he had), taken during your fieldwork. What’s wrong withdoing this?
    • Informed Consent One such article was published in theCanadian 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 anor guardian of the boy had consented in ethical issue in research andwriting to the publication of the photo (and publishing after outrage at thethe violation of confidentiality that this atrocities committed by thepublication involved). The reader went on to notorious “Nazi Doctors” underquestion whether this violation was essential Hitler’s regime.4for scientific purposes. Subsequently, theeditor-in-chief of CMAJ published an apologyfor having “goofed and published not onlyinformation about a patient’s case, but alsothe patient’s picture, although consent had notbeen obtained.”3
    • 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 beinformed 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 thespecific 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 ConsentIn studies involving human participants, written informed consent is important for thefollowing 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.
    • Informed Consent4. 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”.76. 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 ConsentFailure to obtain informed consent at the beginning of your study can be very costly. Forinstance, in one case in the US, over 5 million blood samples had to be destroyedbecause 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
    • Informed ConsentMoreover, many reputed journals consider failure to obtain informed consent sufficientgrounds for rejecting a manuscript. For instance, the American Journal of Psychiatrystates, in its guidelines for authors: “If your submission does not contain writteninformed consent or Institutional Review Board approval, it will not bereviewed.”10 Other journals like the Journal of the American Medical Association requirethat the Methods section of a paper mentions the formal review and approval/waiver byan appropriate institutional review board or ethics committee.11In conclusion, obtaining and reporting informed consent are essential for your researchand manuscript respectively. Doing so establishes your credibility as a scientist andwriter. At present, journal editors “will not publish a manuscript, however scientifically oreducationally worthy, when anonymity cannot be absolutely guaranteed or informedwritten consent has not been obtained.”2
    • Informed ConsentThe Declaration of A statement of ethical http://www.wma.net/en/Helsinki principles for medical 30publications/10policies/b3 research that involves /17c.pdf human subjectsUniform Requirements for A set of guidelines on the http://www.icmje.org/Manuscripts Submitted to ethical requirements ofBiomedical Journals manuscripts submitted to biomedical journalsPublication Manual of the Provides a detailed http://www.apa.org/American Psychological description of the rights and pubs/books/4200066.aspxAssociation, Sixth Edition confidentiality of research participants, particularly in the case of the behavioral sciences
    • Informed ConsentThe Council of Science A list of examples of actions http://www.councilscienceedEditors’ White Paper on that constitute mistreatment itorsPromoting Integrity in of research subjects .org/i4apages/index.cfm?Scientific Journal pageid=3360PublicationsAmerican Medical Includes guidelines on ethical http://www.amamanualofstylAssociation Manual of and legal considerations in eStyle preparing an article for .com/oso/public/index.html publication in a medical journal
    • Informed ConsentReferences1. 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.pdf2. 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.pdf3. 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.pdf4. 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.pdf5. 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.pdf6. 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 ConsentReferences7. 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=10969. 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.html10. The American Journal of Psychiatry. Guidelines For Authors On Preparing Manuscripts. Available athttp://ajp.psychiatryonline.org/misc/ifora.dtl11. Journal of the American Medical Association. Instructions for Authors. Available at http://jama.ama- assn.org/site/misc/ifora.xhtml#EthicalApprovalofStudiesandInformedConsent12. 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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