Obtaining subjects’ consent to publish identifying personal information: current practices and identifying potential issues

BMC Medical Ethics

Shinji Kosugi³  Hiromi Murakami¹  Yuri Dowa²  Akiko Yoshida³ 

[1] Department of Clinical Genetics, Kyoto University Hospital, Shogoin-Kawara-cho, Sakyo-ku, Kyoto 6068507, Japan;Department of pediatrics, Graduate School of Medicine, Kyoto University, Shogoin-Kawara-cho, Sakyo-ku, Kyoto 6068507, Japan;Department of Medical Ethics/Medical Genetics, Kyoto University School of Public Health, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan

关键词: Identifying information;    Consent forms;    Consent;   

Others  :  799636
DOI  :  10.1186/1472-6939-14-47

 received in 2013-05-10, accepted in 2013-11-21,  发布年份 2013

【 摘 要 】

Background

In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information.

Methods

Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted.

Results

Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects’ right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained.

Conclusion

Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study objective, subjects’ right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed.

【 授权许可】

   
2013 Yoshida et al.; licensee BioMed Central Ltd.

【 图 表 】

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Figure 2.

【 参考文献 】

• [1]Neely JG, Karni RJ, Nussenbaum B, Paniello RC, Fraley PL, Wang EW, Rich JT: Practical guide to understanding the value of case reports. Otolaryngol Head Neck Surg 2008, 138:261-264.
• [2]Nayak BK: The significance of case reports in biomedical publication. Indian J Ophthalmol 2010, 58:363-364.
• [3]Albrecht J, Meves A, Bigby M: Case reports and case series from Lancet had significant impact on medical literature. J Clin Epidemiol 2005, 58:1227-1232.
• [4]Gibson E: Publication of case reports: Is consent required? Paediatr Child Health 2008, 13:666-667.
• [5]Antommaria AH: Do as I say, not as I do: Why bioethicists should seek informed consent for some case studies. Hastings Cent Rep 2004, 34:28-34.
• [6]The International Committee of Medical Journal Editors (ICMJE): Uniform Requirements for Manuscripts Submitted to Biomedical Journals. [http://www.icmje.org/urm_main.html webcite] (Accessed 14 October 2013)
• [7]Committee on Publication Ethics (COPE): Code of Conduct and Best Practice Guidelines for Journal Editors. [http://publicationethics.org/ webcite] (Accessed 14 October 2013)
• [8]Bennett RL: Pedigree parables. Clin Genet 2000, 58:241-249.
• [9]Botkin JR, McMahon WM, Smith KR, Nash JE: Privacy and confidentiality in the publication of pedigrees: a survey of investigators and biomedical journals. JAMA 1998, 279:1808-1812.
• [10]Rogers WA, Draper H: Confidentiality and the ethics of medical ethics. J Med Ethics 2003, 29:220-224.
• [11]Aldridge RW: Simplifying consent for publication of case reports. BMJ 2008, 337:a1878.
• [12]Saxena AK, Ghai B, Makkar JK: Patient’s consent for publication of case report: need for developing a universal consent form. Arch Dis Child 2006, 91:717.
• [13]Bal AM, Collier A, Dowie A, Ghosh S: Journals and consent forms. Policy needs to be revisited. BMJ 2010, 341:c6147.
• [14]Isaacs D, Kilham HA, Jacobe S, Ryan MM, Tobin B: Gaining consent for publication in difficult cases involving children. BMJ 2008, 337:a1231.
• [15]Singer PA: Consent to the publication of patient information. BMJ 2004, 329:566-568.
• [16]Oberklaid F: Consent to publication–no absolutes. BMJ 2008, 337:a1233.
• [17]Newson AJ, Sheather J: Consent and confidentiality in publishing–the view of the BMJ’s ethics committee. BMJ 2008, 337:a1232.
• [18]Woollard FM: Consent to the publication of patient information: seeking consent is morally essential. BMJ 2004, 329:916-917.
• [19]John CM, Mathew DE: ‘Universal’ patient consent form for case reports. Acta Paediatr 2009, 98:612.
• [20]Levine SB, Stagno SJ: Informed consent for case reports: the ethical dilemma of right to privacy versus pedagogical freedom. J Psychother Pract Res 2001, 10:193-201.
• [21]Sorinola O, Olufowobi O, Coomarasamy A, Khan KS: Instructions to authors for case reporting are limited: a review of a core journal list. BMC Med Educ 2004, 4:4. BioMed Central Full Text
• [22]WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. [http://www.wma.net/en/30publications/10policies/b3/ webcite] (Accessed 14 October 2013)
• [23]Ghai B, Saxena AK: Patient’s consent for publication. Anaesthesia 2005, 60:289. discussion 289
• [24]Kidd MR, Hrynaszkiewicz I: Journal of Medical Case Reports’ policy on consent for publication. J Med Case Rep 2010, 4:173. BioMed Central Full Text