Research and Publication Ethics: What Have We Learned Thus Far?

Download as pdf or txt
Download as pdf or txt
You are on page 1of 3

OOOOE

10 Letters to the Editor January 2011

tumor thickness in the sentence, “In addition, all of the however, this does not negate the fact that the histo-
tumors that were positive for nodal metastasis had a logic features of the synchronous lesions presented are
depth of invasion ⬎4 mm.” However, we do not see a less aggressive, because the criteria used were well
need to go into the depth of correlating all the histologic defined and accepted.
features with the lymph node metastasis, because it is We believe our explanations have answered the is-
out of the scope of this study and only a single syn- sues raised in the letter to editor regarding this article.
chronous case out of 28 was positive for lymph node
metastasis. Waruna L. Dissanayake, BDS
Wanninayake M. Tilakaratne, BDS, MS, PhD,
REFERENCES FDSRCS, FRCPath
The values of 5-year survival of synchronous and Department of Oral Pathology
single primary OSCCs were based on references 1 and Faculty of Dental Sciences
4 of the article. University of Peradeniya
Sri Lanka
ARE THEY REALLY SYNCHRONOUS TUMORS?
We also agree that there is a possibility to have an
doi:10.1016/j.tripleo.2010.09.071
underneath connection between 2 tumors of closely
associated sites. However, we were meticulous in this
aspect to include only lesions well apart from each Research and publication ethics:
other. Although commenters have proposed that “the What have we learned thus far?
histologic examination of normal tissue is mandatory to
rule out any underneath connection between the syn- To the Editor:
chronous OSCCs,” it is highly questionable whether it It was not surprising that Dr. Spångberg, an OOOOE
is ethically correct to section normal mucosa of a pa- editor, recently showed possible radiographic “falsifi-
tient with 2 well-apart lesions with clear margins just to cation” in a submitted manuscript.1 Indeed, several
see whether the tumor is connected. It is automatically research and publication ethics standards have been set
understood that when the excision margin is clear, there up since World War II. These include the Nuremberg
is no connection between 2 tumors. Further, most of the Code, the Declaration of Helsinki, the International
tumors in the study were either bilateral or from 2 Committee of Medical Journal Editors’ Uniform Re-
different sites. quirements for Manuscripts to Biomedical Journals,
and recommendations by the World Association of
TNM, HABITS, DURATION Medical Editors and the Committee on Publication
The clinical data such as relevant habits, TNM stage, Ethics.2-7 However, many notorious experiments have
and duration of the lesions could not be retrieved ade- still occurred, such as Japan’s Unit (late 1930s-1940s),
quately as to present in the article because of the lack of malaria studies and mustard gas experiments (USA,
access to patient records. As mentioned in the article, 1940s), post–World War II experimentation with radi-
the lack of clinical and survival data was the major ation (USA, 1950s-1960s), the Tuskegee syphilis study
limitation of this study. (USA; 1932-72), and studies of hepatitis transmission
in Willowbrook State School (USA; 1950s).2,4,6,7
VALIDITY CONCLUSION Recently, fabrication of the cloning research results
Because the given results cannot be explained by the by Woo Suk Hwang, a Korean professor; fraudulent
prevailing knowledge, it may not be scientific to say nutritional researches by Ram B. Singh, an Indian phy-
that the results are incorrect. As we also have stated, the sician; and a Chinese clinical trial on esophageal cancer
lack of survival data is a major limitation of this study. without the patient’s consent were extensively criti-
However, it does not negate the validity of the results, as cized.2,4-7 There is much evidence that financial con-
there is a significant difference in histologic features. The flicts of interest are found with individual researchers,
question we have raised in the discussion, “whether the departmental chairs, Ethics Committee members, and
synchronous OSCCs behave in a different way clinically even journal editors and peer reviewers. The financial
despite their less aggressive histological features or if interests are continuing unabated in a large proportion
some unknown factors affect the survival of these pa- of medical researches and higher rates of research ci-
tients,” was just to emphasize the importance of further tations.5
research in this context. As Altman and Bland8 remind us, “Absence of evi-
In summary, the lack of survival and clinical data to dence is not evidence of absence,” the absence of
support the results of the study is a major limitation; ethical documentation does not mean that the study

Downloaded for Anonymous User (n/a) at University of Guadalajara from ClinicalKey.com by Elsevier on October 09,
2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
OOOOE
Volume 111, Number 1 Letters to the Editor 11

complies with ethical standards or is ethically accept- sion of the author with redundant or repetitive publica-
able. Our investigative series revealed the lack of dis- tions for 3 and 5 years, respectively.7,16
closures of human subject protection (obtaining ethical In a forceful effort, Editors-in-Chiefs of 13 leading
approval and subject’s consent), financial conflicts, and otolaryngology journals created a consortium to main-
academic-industry relationship in oral-maxillofacial tain the integrity of the journals. They will share with
surgery (OMS) journals and innovations.2-5 Funding each other the name of the author and details of ethical
sources were disclosed in only 26.4% of controlled violation: plagiarism, duplicate publication, undisclosed con-
trials published in OMS journals.4 Our recent studies flicts of interest, inappropriate authorship, and breaches in
(as yet unpublished) demonstrated that 9 of 29 clinical research and publication ethics, including lack of human
studies (31%) on piezoelectric OMS procedures were subject protection, fair and unbiased data presentation, and
dual or fragmented publications in journals of different outright scientific fraud. The unethical author will be
disciplines or different languages and that OMS authors punished regarding future publication in these 13 journals
had a considerably different understanding of research for a specified period of time. Each editor could indepen-
ethics. dently undertake other actions, including notification of
Multiple factors may contribute to such scientific the dean, departmental chair, or chair of the scientific
misconduct. These include inadequate research experi- integrity committee at the author’s institution.17,18 Unfor-
ence, bias from career self-interest or financial gains, tunately, a similar joint commitment is still lacking among
ignorance about research and publication ethics, or a dental journals’ editors.
combination of these.5-7 The shortage of experience, Taken together, it is high time for dental journals to
role models, encouragement, and mentorship/support have appropriate oversight of ethical breaches and im-
increase unfamiliarity with research, lack of scientific plement the measures as a standard in peer-review
works, and risks of research misconduct.4,9 It is prob- publishing. An author/investigator has to strictly adhere
able that formal research education is not included to ethical research guidance. Adequate research train-
during residency training. Once a trainee becomes a ing would help reduce scientific malpractice, both in-
consultant or a faculty member, it may be difficult for tentional and unintentional.2,3,6,7 For details on research
him or her to serve as a good research worker and misconduct, please refer to Gilbert and Denison,16 and
educator, because of the lack of research and pedagogic Pitak-Arnnop et al.7,19
experiences. This leads to a vicious cycle of problems.
On the other hand, research misconduct might go Poramate Pitak-Arnnop, DDS, MSca,b
undetected or undertreated because of the journals Kittipong Dhanuthai, DDS, MSca,c
themselves. Many journals fail to take immediate ac- Alexander Hemprich, MD, DMD, PhDa
tion to deal with the ethical burdens, especially when Niels Christian Pausch, MD, DMD, PhDa
a
senior researchers are involved. A number of editors are University Hospital of Leipzig, Leipzig, Germany
b
unfamiliar with handling such situations and some are University Paris 5 (René Descartes), Paris, France
c
unaware of potential ethical problems that may Chulalongkorn University, Bangkok, Thailand
arise.6,10,11 This may explain partly why retraction of
articles owing to unintentional error occurred twice as REFERENCES
1. Spångberg LS. Ethics in publication. Oral Surg Oral Med Oral
often as retraction due to scientific misconduct.12 More- Pathol Oral Radiol Endod 2010;109:797-8.
over, guidelines for authors are usually limited and 2. Pitak-Arnnop P, Sader R, Hervé C, Dhanuthai K, Bertrand JC,
inconsistent among different journals.13,14 Recently, we Hemprich A. Reporting of ethical protection in recent oral and
maxillofacial surgery research involving human subjects. Int
found that although similar to those of plastic surgery J Oral Maxillofac Surg 2009;38:707-12.
and otolaryngology journals, ethical issues in the in- 3. Pitak-Arnnop P, Hemprich A, Sader R, Dhanuthai K, Bertrand
structions to authors of leading OMS journals were JC, Hennig C, et al. An analysis of studies on piezoelectric
surgery in the oral and craniomaxillofacial region with regard to
incomplete.6 human subject protection and financial conflicts. Int J Oral Max-
Journal mechanisms against scientific misconduct illofac Surg 2009;38:1011-3.
remain variable. Plastic and Reconstructive Surgery 4. Pitak-Arnnop P, Sader R, Rapidis AD, Dhanuthai K, Bauer U,
Hervé C, et al. Publication bias in oral and maxillofacial surgery
and the International Journal of Oral and Maxillofacial journals: an observation on published controlled trials. J Crani-
Surgery have now followed longer-established medical omaxillofac Surg 2010;38:4-10.
journals’ policies. They will no longer accept any sub- 5. Pitak-Arnnop P, Pausch NC, Dhanuthai K, Sappayatosok K,
Ngamwannagul P, Bauer U, et al. Endoscope-assisted subman-
mission without statements on human subject protec- dibular sialadenectomy: a review of outcomes, complications
tion, financial support, and potential conflicts of inter- and ethical concerns. Eplasty 2010;10:293-304.
ests. The ethical statements are published regularly in 6. Pitak-Arnnop P, Bauer U, Dhanuthai K, Brückner M, Hervé C,
Meningaud JP, et al. Ethical issues in instructions to authors of
every publication of both journals.4,6,15 The Amercian journals in oral-craniomaxillofacial/facial plastic surgery and
Journal of Radiology and Chest sanction the submis- related specialities. J Craniomaxillofac Surg in press.

Downloaded for Anonymous User (n/a) at University of Guadalajara from ClinicalKey.com by Elsevier on October 09,
2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
OOOOE
12 Letters to the Editor January 2011

7. Pitak-Arnnop P, Schouman T, Bertrand JC, Hervé C. Comment autoimmune conditions, such as systemic lupus ery-
éviter la non-conformité de la recherche biomédicale? Recom-
mandations aux chirurgiens. J Chir (Paris) 2008;145:534-41.
thematosus, rheumatoid arthritis, and celiac disease
8. Altman DG, Bland JM. Absence of evidence is not evidence of have also been simply found to be associated with
absence. BMJ 1995;311:485. autoimmune thyroid diseases,17 but without great and
9. Rehman KU, Parmar S, Williams R, Dover S, Lalani El-N.
Research training for oral and maxillofacial surgery. Br J Oral
definitive evidence.
Maxillofac Surg 2008;46:343. Hence, the association between OLP/OLL and thy-
10. Trikalinos NA, Evangelou E, Ioannidis JP. Falsified papers in roid diseases/thyroid medication, in particular hypothy-
high-impact journals were slow to retract and indistinguishable
from nonfraudulent papers. J Clin Epidemiol 2008;61:464-70. roidism, have been reported in some studies18-20 up to
11. Wager E, Fiack S, Graf C, Robinson A, Rowlands I. Science the recent study by Siponen et al.,1 who analyzed
journal editors’ views on publication ethics: Results of an inter- retrospectively 222 OLP/OLL patients and 222 con-
national survey. J Med Ethics 2009;35:348-53.
12. Nath SB, Marcus SC, Druss BG. Retractions in the research trols, with a marginal significant association (95% con-
literature: misconduct or mistakes? Med J Aust 2006;185:152-4. fidence interval [CI] ⫽ 1.03 to 4.90) between OLP/
13. Atlas MC. Emerging ethical issues in instructions to authors of OLL and hypothyroidism (10% versus 5% in controls).
high-impact biomedical journals. J Med Libr Assoc 2003;91:
442-9. Finally, the authors suggested that the association of
14. Sorinola O, Olufowobi O, Coomarasamy A, Khan KS. Instruc- OLP and hypothyroidism could be linked to a similar,
tions to authors for case reporting are limited: a review of a core but still unknown, immune-mediated mechanism, war-
journal list. BMC Med Educ 2004;4:4.
15. Rohrich RJ. Ethical approval of clinical studies, informed consent, ranting further studies in a different population.
and the declaration of Helsinki: what you need to know. Plast With this regard, we would like to share our findings
Reconstr Surg 2007;119:2307-9. from a cross-sectional study performed in Sicily (West
16. Gilbert FJ, Denison AR. Research misconduct. Clin Radiol
2003;58:499-504. Mediterranean area). We consecutively recruited 125
17. Benninger MS, Jackler RK, Johns MM, Johnson JT, Kennedy resident patients, of these 74 had Hashimoto’s thyroid-
DW, Ruben RJ, et al. Consortium of otolaryngology— head and itis or Graves disease (70 female and 4 male; mean age:
neck surgery journals to collaborate in maintenance of high
ethical standards. Arch Otolaryngol Head Neck Surg 2005; 47 ⫾ 15.2 years; range: 14 to 79 years; of which 58
131:381-2. patients had Hashimoto’s thyroiditis and 16 had Graves
18. Johnson JT, Niparko JK, Levine PA, Kennedy DW, Weber PC, disease) as the test group; these 2 autoimmune pathol-
Weber RS, et al. Standards for ethical publication. Arch Otolar-
yngol Head Neck Surg 2007;133:7-8. ogies share with OLP a common immune-mediated
19. Pitak-Arnnop P, Hemprich A, Dhanuthai K, Pausch NC. Ethical pathogenesis, causing hypothyroidism and hyperthy-
conduct of human research: some controversies. Otolaryngol
Head Neck Surg 2010;143:469-70.
roidism, respectively. Controls were 51 patients (42
female; 9 male; mean age: 54.6 ⫾ 11.5 years; range: 24
to 73 years) suffering from goiter, an endemic disease
doi:10.1016/j.tripleo.2010.10.001
in Sicily without autoimmune pathogenesis,21 and were
found to be matched for age and gender with the test
Association of oral lichen planus group (P ⬎ .2 by Student t).
with thyroid disease in a Finnish In all samples, thyroid diseases were diagnosed
population: A retrospective case- both serologically and histologically; all patients un-
derwent total thyroidectomy and subsequent replace-
control study: “A different finding ment with thyroxin medication. All patients under-
from a Mediterranean area” went oral examination, independently, by 2 of the
authors (C.D. and C. P.), both experts in oral medi-
To the Editor: cine. In our study, all patients who were HCV-
Siponen et al.1 report an association of oral lichen positive or with OLL potentially associated with
planus/oral lichenoid lesions (OLP/OLL) with thyroid drugs,22 amalgam fillings, or topical allergens were
disease in the Finnish population. As they point out, excluded, different from Siponen et al.,1 to reduce
OLP has been associated with a number of systemic biases on the final results.
disorders, generally of autoimmune origin (myasthenia One patient with Hashimoto’s thyroiditis showed
gravis, Sjögren’s syndrome, ulcerative colitis, psoria- oral lesions with a reticular aspect bilaterally on the
sis, celiac disease, some liver diseases, thymoma, and buccal mucosa and atrophic/erosive features on the
lupus erythematosus); however, only in a few condi- masticatory mucosa, compatible with the diagnosis of
tions has this link been confirmed.2-6 For example, the OLP. The patient underwent incisional oral biopsy and
correlation between chronic hepatitis C virus (HCV) the subsequent histologic examination confirmed the
infection and OLP would be one of these, even if many diagnosis of OLP. None of the controls showed clinical
contrasting results have been published,7-14 and the signs of OLP/OLL.
partial dependency on geographic factors as well as Different from Siponen et al.,1 we did not find any
genetic differences has been focused.15,16 Furthermore, significant association between autoimmune thyroid

Downloaded for Anonymous User (n/a) at University of Guadalajara from ClinicalKey.com by Elsevier on October 09,
2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.

You might also like