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Year : 2022  |  Volume : 20  |  Issue : 2  |  Page : 118

Ethics review for case studies

1 Indian Institute of Public Health, Hyderabad, Telangana, India
2 Department of Community Medicine and School of Public Health, PGIMER, Chandigarh, India
3 Department of Psychiatry, All India Institute of Medical Sciences and Research, Kalyani, West Bengal, India

Date of Submission29-Nov-2021
Date of Decision12-Dec-2021
Date of Acceptance17-Dec-2021
Date of Web Publication07-May-2022

Correspondence Address:
Dr. Sirshendu Chaudhuri
Indian Institute of Public Health, Hyderabad, Telangana
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/cmi.cmi_105_21

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How to cite this article:
Chaudhuri S, Goel K, Basu A. Ethics review for case studies. Curr Med Issues 2022;20:118

How to cite this URL:
Chaudhuri S, Goel K, Basu A. Ethics review for case studies. Curr Med Issues [serial online] 2022 [cited 2023 May 29];20:118. Available from: https://www.cmijournal.org/text.asp?2022/20/2/118/344924

Clinicians often use case studies to describe the clinical features, diagnosis, and treatment of rare conditions or to describe the rare presentations of common conditions. Case studies are considered as an observational research method that helps the peer group across the world to understand a rare disease or rare presentation of a disease and thus help in improving the clinical practice.[1] If this is the clear advantage of case reports for many clinicians or researchers, the flip side is the participants or patients are at risk of harm unknowingly. For any research, the four cardinal principles of ethics, namely autonomy, beneficence, nonmaleficence, and justice, must be followed.[2] These four cardinal principles can be breached in publishing a case report. The participant(s) or the legally accepted representatives (LAR) are often anxious about the clinical condition and the treatment's uncertainty. Hence, the patient's (or research participant's/LAR's) autonomy (the first principle) could be at stake.[3] Similar to other study designs such as trials, diminished autonomy could be due to the fear of not getting the treatment if she/he does not consent for the clinical condition's proposed publication. Of course, there is no direct benefit (the second principle) for the patient (or research participant) out of a case report, but the researchers must state it clearly to the patients (or the LARs) before recruiting the patient as a participant. However, there is enough scope for harm (The third principle) for the patients. Description of a single patient's information in a case report, sometimes with the institute's name (author's affiliation), can compromise the data confidentiality. Publishing a photograph poses a patient at greater risk of identity disclosure even if the eyes are covered or the name is hidden from investigational report/s. Moreover, sharing the consent form with the journal also bears the risk of identity disclosure.[4] The fourth principle, justice, must be seen from an angle that whether such case reporting is needed or not. In other words, if substantial evidence is available, researchers or clinicians must review the need for publishing such case reports whether such publications will add any value to the existing knowledge or the practice the same principle that we follow for conducting any research.

The institutional ethics committee must examine the ethical issues in publishing a case report. However, an infrequent proposal review meeting of the ethics committees in the Indian institutes is the major challenge in reviewing the case reports. Moreover, the “National Ethical Guidelines for Biomedical and Health Research Involving Human Participants”[2] mention that the ethics committee approval must be prospective. It is indeed challenging for the clinicians to obtain a prospective ethics committee clearance for case reports too. Hence, we strongly suggest developing sub-committees by the institutional ethics committees who can promptly review such short studies, especially the consent form and the manuscript to protect the participants from potential harm from identity disclosure. At the journal level, the editor must examine the need of an informed consent (If not mandatory for a journal) before publication based on the identifiable content of the case report.[5] In addition, we recommend incorporating the detailed case study review process by ethics committees in the future editions of national ethical guidelines.

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There are no conflicts of interest.

  References Top

Solomon J. Case studies: Why are they important? Nat Clin Pract Cardiovasc Med 2006;3:579.  Back to cited text no. 1
Indian Council of Medical Research. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: Indian Council of Medical Research; 2017.  Back to cited text no. 2
Shevell MI. The ethics of case reports. Paediatr Child Health 2004;9:83-4.  Back to cited text no. 3
ICMJE | Recommendations | Protection of Research Participants. Available from: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html. [Last accessed on 2021 Mar 23].  Back to cited text no. 4
Neavyn M, Murphy C. Coming to a consensus on informed consent for case reports. J Med Toxicol 2014;10:337-9.  Back to cited text no. 5


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