- Email: [email protected]
Ethical conduct of human research: Some controversies
Otolaryngology–Head and Neck Surgery (2010) 143, 469-471
LETTERS TO THE EDITOR Ethical conduct of human research: Some controversies We read the article titled “How to review journal manuscripts” by Rosenfeld1 with great interest. Although the article is very interesting, some details on ethical conduct deserve further discussion. First, the author reached the following conclusions: “All research with human subjects, or material obtained from human subjects (e.g., cadavers, surgical specimens) must have formal approval or exemption by a named IRB [Institutional Review Board] or research ethics committee (if an IRB is not accessible),” and “Formal approval or exemption, in writing, must still be obtained.” We wonder how editors and reviewers recognize the differences in local or national regulations with regard to ethical approval. It is noteworthy that the requirements for ethical review vary by country. For example, surveys of health care providers require ethical approval in the United Kingdom, but not in France and Germany (when no patient is involved).2 Formal written exemption from ethical review is not routinely given by the IRB. Indeed, types of research that require ethical approval are well identified and announced in these two countries. Many IRB administrative offices reject the submission of a proposal whose project is clearly exempted. However, if written approval is still necessary, should the IRB organize a special meeting to sign a paper in English? Or would the journal accept the document in languages other than English? If so, which other languages would be acceptable? Second, there is some evidence that the self-reported author’s disclosure is not always reliable.3,4 In our recent study (as yet unpublished), we found that corresponding authors of surgical publications had a considerably different understanding of the international research guidelines set forth in the Declaration of Helsinki and the International Committee of Medical Journal Editors’ Uniform Requirements for Manuscripts to Biomedical Journals. Should the editors and reviewers always believe the author’s disclosure? Third, scientific misconduct might be continuing unabated in a large portion of medical research because of the journals themselves. While Rosenfeld1 presented various guidelines for the reviewers, our recent study revealed that ethical issues in the instructions to authors of most journals within three different surgical specialties— otolaryngology, plastic surgery, and oral-maxillofacial surgery—were incomplete, regardless of specialty and impact factor.5 For details on research and publication ethics, please refer to our previous publications.2,5 Poramate Pitak-Arnnop, MSc, DDS Department of Oral, Craniomaxillofacial and Facial Plastic Surgery
Scientific Unit for Clinical and Psychosocial Research, Evidence-Based Surgery and Ethics in Oral and Maxillofacial Surgery Faculty of Medicine University Hospital of Leipzig Leipzig, Germany Laboratory of Medical Ethics and Legal Medicine Faculty of Medicine University Paris 5 (René Descartes) Paris, France E-mail, [email protected] Alexander Hemprich, MD, DMD, PhD Department of Oral, Craniomaxillofacial and Facial Plastic Surgery Scientific Unit for Clinical and Psychosocial Research Evidence-Based Surgery and Ethics in Oral and Maxillofacial Surgery Faculty of Medicine University Hospital of Leipzig Leipzig, Germany Kittipong Dhanuthai, MSc, DDS Department of Oral, Craniomaxillofacial and Facial Plastic Surgery Scientific Unit for Clinical and Psychosocial Research Evidence-Based Surgery and Ethics in Oral and Maxillofacial Surgery Faculty of Medicine University Hospital of Leipzig Leipzig, Germany Department of Oral Pathology Faculty of Dentistry Chulalongkorn University Bangkok, Thailand Niels Christian Pausch, MD, DMD, PhD Department of Oral, Craniomaxillofacial and Facial Plastic Surgery Scientific Unit for Clinical and Psychosocial Research Evidence-Based Surgery and Ethics in Oral and Maxillofacial Surgery Faculty of Medicine University Hospital of Leipzig Leipzig, Germany
References 1. Rosenfeld RM. How to review journal manuscripts. Otolaryngol Head Neck Surg 2010;142:472– 86. 2. Pitak-Arnnop P, Sader R, Hervé C, et al. Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects. Int J Oral Maxillofac Surg 2009;38:707–12. 3. Ilakovac V, Fister K, Marusic M, et al. Reliability of disclosure forms of authors’ contributions. CMAJ 2007;176:41– 6.
0194-5998/$36.00 © 2010 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. doi:10.1016/j.otohns.2010.06.815
470
Otolaryngology–Head and Neck Surgery, Vol 143, No 3, September 2010
4. Bhattacharyya N, Lin HW. Prevalence and reliability of self-reported authorship disclosures in Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg 2009;141:311–5. 5. Pitak-Arnnop P, Bauer U, Dhanuthai K, et al. Ethical issues in instructions to authors of journals in oral-craniomaxillofacial/facial plastic surgery and related specialities. J Craniomaxillofac Surg 2010 Mar 19 [Epub ahead of print].
doi:10.1016/j.otohns.2010.06.815
Pediatric otogenic intracranial abscesses We read with great interest the article “Pediatric otogenic intracranial abscesses” by Isaacson et al.1 They presented clinical analysis and management of otogenic intracranial abscesses in children. The authors presented 30 pediatric patients with epidural, subdural, intraparenchymal, and petrous apex suppurative complications of otitis media. We would like to make some comments concerning this problem, based on our experience and review of the literature. The authors reported that, out of 768 inpatients, complications of otitis media were identified in 151 (19.7%); 30 of them had intracranial abscess formation. We think this is a very high incidence. Currently, intracranial complication (IC) of otitis media in children occurs infrequently.2 Clinical manifestation of IC has also changed recently. The most common symptoms in our patients with IC were otalgia, headache, fever, and nausea. The change in clinical manifestations may be the result of common antibiotic therapy. The authors reported that 13 of 16 patients developed epidural abscesses in the area surrounding the infected clot in the sigmoid sinus, and only three patients developed this complication in the middle cranial fossa.1 In our records, epidural abscesses occurred most commonly in the vicinity of the sigmoid sinus and very rarely in the middle cranial fossa.2 Occurrence in the middle cranial fossa, although rare, may result from infection passing through sutures that have not grown together in the area of the tegmen tympani. The authors did not state which diagnostic methods were used to confirm final diagnosis. Development of intracranial abscesses is difficult to diagnose in the early stage, especially because some imaging methods have limited sensitivity. We would like to mention a patient of ours who developed epidural abscess as a result of otitis media with mastoiditis. The CT scan of this patient showed only osteolysis of the squama of the temporal bone, but not presence of the abscess. The MRI scan showed abscess in the middle cranial fossa at the border between the squama and the parietal bone (Fig 1). We present this to confirm that every otogenic IC should be diagnosed with both CT and MRI scans. The treatment of intracranial abscesses raises questions. Some clinics limit treatment of IC to intravenous antibiotics only.3 No agreement on a single, best method for treatment
Figure 1 Acute mastoiditis with epidural abscess in a sevenyear-old boy. Gadolinum enhanced T1-weighted MR image (coronal) shows the epidural abscess and pachymeningeal enhancement of the middle cranial fossa.
exists. In our opinion, the best solution is drainage of the abscesses followed by antibiotic therapy.4 Jerzy Kuczkowski, MD, PhD Tomasz Mionskowski, MD Wojciech Sierszen´, MD Department of Otolaryngology Medical University of Gdan´sk Gdan´sk, Poland E-mail, [email protected]
References 1. Isaacson B, Mirabal C, Kutz JW Jr, et al. Pediatric otogenic intracranial abscesses. Otolaryngol Head Neck Surg 2010;142:434 –7. 2. Kuczkowski J, Narozny W, Stankiewicz C, et al. Complications of acute mastoiditis in children. Otolaryngol Pol 2007;61:445–51. 3. Tov EE, Leiberman A, Shelef I, et al. Conservative nonsurgical treatment of a child with otogenic lateral sinus thrombosis. Am J Otolaryngol 2008;29:138 – 41. 4. Kuczkowski J, Dubaniewicz-Wybieralska M, Przewoüny T, et al. Otitic hydrocephalus associated with lateral sinus thrombosis and acute mastoiditis in children. Int J Pediatr Otorhinolaryngol 2006;70:1817–23.
doi:10.1016/j.otohns.2010.06.917
Response to: Pediatric otogenic intracranial abscesses, from Jerzy Kuczkowski et al I would like to thank Drs. Kuczkowski, Mionskowski, and Sierszen´ for their comments on the recently published article titled “Pediatric otogenic intracranial abscesses,”1 and for sharing their experience with intracranial complica-
LETTERS TO THE EDITOR Ethical conduct of human research: Some controversies We read the article titled “How to review journal manuscripts” by Rosenfeld1 with great interest. Although the article is very interesting, some details on ethical conduct deserve further discussion. First, the author reached the following conclusions: “All research with human subjects, or material obtained from human subjects (e.g., cadavers, surgical specimens) must have formal approval or exemption by a named IRB [Institutional Review Board] or research ethics committee (if an IRB is not accessible),” and “Formal approval or exemption, in writing, must still be obtained.” We wonder how editors and reviewers recognize the differences in local or national regulations with regard to ethical approval. It is noteworthy that the requirements for ethical review vary by country. For example, surveys of health care providers require ethical approval in the United Kingdom, but not in France and Germany (when no patient is involved).2 Formal written exemption from ethical review is not routinely given by the IRB. Indeed, types of research that require ethical approval are well identified and announced in these two countries. Many IRB administrative offices reject the submission of a proposal whose project is clearly exempted. However, if written approval is still necessary, should the IRB organize a special meeting to sign a paper in English? Or would the journal accept the document in languages other than English? If so, which other languages would be acceptable? Second, there is some evidence that the self-reported author’s disclosure is not always reliable.3,4 In our recent study (as yet unpublished), we found that corresponding authors of surgical publications had a considerably different understanding of the international research guidelines set forth in the Declaration of Helsinki and the International Committee of Medical Journal Editors’ Uniform Requirements for Manuscripts to Biomedical Journals. Should the editors and reviewers always believe the author’s disclosure? Third, scientific misconduct might be continuing unabated in a large portion of medical research because of the journals themselves. While Rosenfeld1 presented various guidelines for the reviewers, our recent study revealed that ethical issues in the instructions to authors of most journals within three different surgical specialties— otolaryngology, plastic surgery, and oral-maxillofacial surgery—were incomplete, regardless of specialty and impact factor.5 For details on research and publication ethics, please refer to our previous publications.2,5 Poramate Pitak-Arnnop, MSc, DDS Department of Oral, Craniomaxillofacial and Facial Plastic Surgery
Scientific Unit for Clinical and Psychosocial Research, Evidence-Based Surgery and Ethics in Oral and Maxillofacial Surgery Faculty of Medicine University Hospital of Leipzig Leipzig, Germany Laboratory of Medical Ethics and Legal Medicine Faculty of Medicine University Paris 5 (René Descartes) Paris, France E-mail, [email protected] Alexander Hemprich, MD, DMD, PhD Department of Oral, Craniomaxillofacial and Facial Plastic Surgery Scientific Unit for Clinical and Psychosocial Research Evidence-Based Surgery and Ethics in Oral and Maxillofacial Surgery Faculty of Medicine University Hospital of Leipzig Leipzig, Germany Kittipong Dhanuthai, MSc, DDS Department of Oral, Craniomaxillofacial and Facial Plastic Surgery Scientific Unit for Clinical and Psychosocial Research Evidence-Based Surgery and Ethics in Oral and Maxillofacial Surgery Faculty of Medicine University Hospital of Leipzig Leipzig, Germany Department of Oral Pathology Faculty of Dentistry Chulalongkorn University Bangkok, Thailand Niels Christian Pausch, MD, DMD, PhD Department of Oral, Craniomaxillofacial and Facial Plastic Surgery Scientific Unit for Clinical and Psychosocial Research Evidence-Based Surgery and Ethics in Oral and Maxillofacial Surgery Faculty of Medicine University Hospital of Leipzig Leipzig, Germany
References 1. Rosenfeld RM. How to review journal manuscripts. Otolaryngol Head Neck Surg 2010;142:472– 86. 2. Pitak-Arnnop P, Sader R, Hervé C, et al. Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects. Int J Oral Maxillofac Surg 2009;38:707–12. 3. Ilakovac V, Fister K, Marusic M, et al. Reliability of disclosure forms of authors’ contributions. CMAJ 2007;176:41– 6.
0194-5998/$36.00 © 2010 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. doi:10.1016/j.otohns.2010.06.815
470
Otolaryngology–Head and Neck Surgery, Vol 143, No 3, September 2010
4. Bhattacharyya N, Lin HW. Prevalence and reliability of self-reported authorship disclosures in Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg 2009;141:311–5. 5. Pitak-Arnnop P, Bauer U, Dhanuthai K, et al. Ethical issues in instructions to authors of journals in oral-craniomaxillofacial/facial plastic surgery and related specialities. J Craniomaxillofac Surg 2010 Mar 19 [Epub ahead of print].
doi:10.1016/j.otohns.2010.06.815
Pediatric otogenic intracranial abscesses We read with great interest the article “Pediatric otogenic intracranial abscesses” by Isaacson et al.1 They presented clinical analysis and management of otogenic intracranial abscesses in children. The authors presented 30 pediatric patients with epidural, subdural, intraparenchymal, and petrous apex suppurative complications of otitis media. We would like to make some comments concerning this problem, based on our experience and review of the literature. The authors reported that, out of 768 inpatients, complications of otitis media were identified in 151 (19.7%); 30 of them had intracranial abscess formation. We think this is a very high incidence. Currently, intracranial complication (IC) of otitis media in children occurs infrequently.2 Clinical manifestation of IC has also changed recently. The most common symptoms in our patients with IC were otalgia, headache, fever, and nausea. The change in clinical manifestations may be the result of common antibiotic therapy. The authors reported that 13 of 16 patients developed epidural abscesses in the area surrounding the infected clot in the sigmoid sinus, and only three patients developed this complication in the middle cranial fossa.1 In our records, epidural abscesses occurred most commonly in the vicinity of the sigmoid sinus and very rarely in the middle cranial fossa.2 Occurrence in the middle cranial fossa, although rare, may result from infection passing through sutures that have not grown together in the area of the tegmen tympani. The authors did not state which diagnostic methods were used to confirm final diagnosis. Development of intracranial abscesses is difficult to diagnose in the early stage, especially because some imaging methods have limited sensitivity. We would like to mention a patient of ours who developed epidural abscess as a result of otitis media with mastoiditis. The CT scan of this patient showed only osteolysis of the squama of the temporal bone, but not presence of the abscess. The MRI scan showed abscess in the middle cranial fossa at the border between the squama and the parietal bone (Fig 1). We present this to confirm that every otogenic IC should be diagnosed with both CT and MRI scans. The treatment of intracranial abscesses raises questions. Some clinics limit treatment of IC to intravenous antibiotics only.3 No agreement on a single, best method for treatment
Figure 1 Acute mastoiditis with epidural abscess in a sevenyear-old boy. Gadolinum enhanced T1-weighted MR image (coronal) shows the epidural abscess and pachymeningeal enhancement of the middle cranial fossa.
exists. In our opinion, the best solution is drainage of the abscesses followed by antibiotic therapy.4 Jerzy Kuczkowski, MD, PhD Tomasz Mionskowski, MD Wojciech Sierszen´, MD Department of Otolaryngology Medical University of Gdan´sk Gdan´sk, Poland E-mail, [email protected]
References 1. Isaacson B, Mirabal C, Kutz JW Jr, et al. Pediatric otogenic intracranial abscesses. Otolaryngol Head Neck Surg 2010;142:434 –7. 2. Kuczkowski J, Narozny W, Stankiewicz C, et al. Complications of acute mastoiditis in children. Otolaryngol Pol 2007;61:445–51. 3. Tov EE, Leiberman A, Shelef I, et al. Conservative nonsurgical treatment of a child with otogenic lateral sinus thrombosis. Am J Otolaryngol 2008;29:138 – 41. 4. Kuczkowski J, Dubaniewicz-Wybieralska M, Przewoüny T, et al. Otitic hydrocephalus associated with lateral sinus thrombosis and acute mastoiditis in children. Int J Pediatr Otorhinolaryngol 2006;70:1817–23.
doi:10.1016/j.otohns.2010.06.917
Response to: Pediatric otogenic intracranial abscesses, from Jerzy Kuczkowski et al I would like to thank Drs. Kuczkowski, Mionskowski, and Sierszen´ for their comments on the recently published article titled “Pediatric otogenic intracranial abscesses,”1 and for sharing their experience with intracranial complica-