Patient consent

Read this article about informed consent including a couple case studies.

Source: editage.com/insights/informed-consent

Informed consent

You’ve completed a study about AIDS prevalence in Africa, and you feel the need to 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?

One such article was published in the Canadian Medical Association Journal (CMAJ) in April 1998.¹ 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 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

In studies involving human participants, written informed consent is important for the following reasons⁶:

• 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).
• 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.
• 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 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.
• 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
• 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.

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

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

Bibliography

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 https://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 at https://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 https://poynter.indiana.edu/
5. 59th WMA General Assembly, Seoul. (2008). World Medical Association Declaration Of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Available at https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/doh-oct2008/
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 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670580/
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 https://www.the-scientist.com/?articles.view/articleNo/27876/title/Consent-issues-nix-blood-samples/
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/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html
10. The American Journal of Psychiatry. Guidelines For Authors On Preparing Manuscripts. Available at https://ajp.psychiatryonline.org/ajp_ifora.aspx
11. Journal of the American Medical Association. Instructions for Authors. Available at https://jama.jamanetwork.com/public/InstructionsForAuthors.aspx
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 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3330645/

Case study: The need for informed consent

Source: editage.com/insights/case-study-the-need-for-informed-consent

Case

A study proposed a new wound healing technique and involved needle puncture on patients from two medical centers. It was mentioned in the paper that an institutional ethical review board has given ethical approval for the study. However, the process of puncturing, healing, and cleaning the vascular access was done without informed consent.

Action

On being informed of the need for patient consent, the authors asked if they could correct the situation by obtaining informed consent retrospectively. Our expert explained to the authors that journals would have an issue with human experimentation conducted without active consent of the subjects and that this requirement ought to be fulfilled before experimentation. The authors did not know about this and thanked us. They informed us that they would conduct the experiments involving invasive procedures once again, this time with prior informed consent from the patients.

Summary

Informed consent involves clearly explaining the procedures, risks, and benefits of the medical tests performed on the patients and taking their freely given consent, preferably in written form. Any study on patients, patient groups, and/or volunteer participants requires informed consent, which must be documented in the paper before submission to a journal. This is a non-negotiable ethical requirement of human experimentation. As per research protocol, journals should specify the requirement for informed consent in their instructions for authors, and published articles should indicate that informed consent has been obtained. In most cases, peer reviewers or ethical review committee members raise the alarm if the informed consent forms are missing or inadequate. Many reputed journals would reject a manuscript if it does not contain proper documentation of informed consent. Universities and journals should make authors aware of all ethical requirements of scientific research so that their work is not rendered ineligible for publication because of an ethical lapse.

Case study: Protecting the identity of enrolled subjects in case reports and clinical trials

Source: editage.com/insights/protecting-the-identity-of-enrolled-subjects-in-case-reports-and-clinical-trials

Case

We received a case report for editing, which described a major facial surgery conducted on an accident victim. The report contained photographs of the patient showing some areas of her face. Since the eyelids and the area below one eye were majorly affected, those parts had to be shown to make the results of the treatment clear. For that purpose, the author had not masked the eyes in the patient photographs and he had included this explanation in the manuscript. Our editor pointed out that protection of the patient’s identity might be a concern with the journal, but the author said that he had obtained the patient’s consent for photographs to be published. So we edited the manuscript, but the photographs were not edited as the author was sure he had followed regulations and there would not be any problems.

However, after the manuscript was submitted, the journal reviewers instructed the authors that the patient’s identity should be protected as far as possible in order to maintain confidentiality. As per ICMJE guidelines, “nonessential identifying details of patients should be omitted and informed consent should be obtained from the patients.” For example, if patients’ pictures are being used, the eye region should be masked to protect their anonymity. However, authors must be careful that this does not distort the scientific meaning of the study.

Additionally, the consent obtained from the patient for publishing the photographs was not valid because as per the case history, the patient was suffering from trauma, which could possibly lead to a temporary impairment of her decision-making ability. The journal mentioned that in such cases, consent from a guardian is required. This is valid for juvenile subjects too.

Action

The author approached us seeking our guidance on the best course of action. Our editors helped him mask the eye partially in the photograph, while keeping the eyelids unmasked. That way, the identity of the patient was not disclosed, yet the surgical procedure on the eyelids was also visible.

Regarding the informed consent of the guardian, the author informed us that the patient's parents had already given their verbal consent for publication of the case report. Therefore, it was not too difficult for the author to get the written consent. The revised consent document and the partially masked photographs of the patient were then sent to the journal, after which the manuscript got accepted.

Summary

Respect for enrolled subjects is an important ethical concern and should be strictly maintained. The privacy of the subjects should be respected by maintaining confidentiality. For instance, all personal and identifiable information like the subject’s name, date, or place of treatment, etc. should be removed. If photographs of patients are required to be published, prior consent should be obtained. Additionally, the identifying features should be masked in photographs as far as possible.

Authors should always do a thorough research on ethical issues related to reporting of clinical data and strictly follow the relevant guidelines. ICMJE has a set of guidelines concerning the protection of research participants in a clinical trial. FDA also has a detailed document covering the specifications of informed consent. Authors would do well to study these guidelines first and form a clear idea about the possible ethical issues that might arise and keep all the necessary documentation ready at the time of submitting their manuscript.

Related links

• The Declaration of Helsinki – A statement of ethical principles for medical research that involves human subjects
• Uniform requirements for manuscripts submitted to biomedical journals – A set of guidelines on the ethical requirements of 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
• 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
• American Medical Association Manual of Style – Includes guidelines on ethical and legal considerations in preparing an article for publication in a medical journal