Analysis of the research with human beings ethical aspects included in the guidelines of thirty-eight orthopedics and traumatology journals

Abstracts

O objetivo do estudo foi analisar as normas relativas à ética da pesquisa em seres humanos contidas nas Instruções aos Autores de revistas de ortopedia e traumatologia. Trinta e oito revistas foram estudadas observando-se que 52,6% não fazem referência a aspectos éticos, 28,9% exigem aprovação por Comitê de Ética da Instituição, 15,7% seguem orientação dos Requisitos Uniformes para Manuscritos Submetidos a Revistas Biomédicas e 2,6% solicitam o consentimento do paciente. Aspectos relacionados à privacidade dos pacientes são citados em 36,8% das revistas estudadas. Os resultados indicam que a maioria das revistas de ortopedia e traumatologia apresenta pouca preocupação com os aspectos éticos de pesquisa em seres humanos nas Instruções aos Autores.

Ética; pesquisa; publicação

ARTIGO ORIGINAL

Analysis of the research with human beings ethical aspects included in the guidelines of thirty-eight orthopedics and traumatology journals^*

Trajano Sardenberg^I; Sergio S. Müller^II; Hamilton R. Pereira^II; Reinaldo A. de Oliveira^II; William S. Hossne^III

^IAssistant Professor

^IIAssistant Professor Doctor

^IIIEmeritus Professor

^{Correspondence}

SUMMARY

The aim of this study was to analyze the norms about ethics in research with human beings included in the guidelines of orthopedics and traumatology scientific journals. Thirty-eight journals were analyzed: 52,6% do not mention ethical aspects, 28,9% submit to approval by the Institution's Ethical Committee, 15,7% follow the orientation of the Uniform Requirements for manuscripts submitted to biomedical journals, and 2,6% ask the patients' consent; aspects related to the patients' privacy were found in 36,8% of the studied journals. The results indicate that most orthopedics and traumatology journals show little concern with the human beings research ethical aspects in their guidelines.

Key words: Ethics; research; publication

INTRODUCTION

The most important international document which orientates research with human beings is the Declaration of Helsinki of the World Medical Association (approved in 1964 and revised in 1996). It states that "reports of experiences out of the principles of this Declaration must not be accepted for publication"⁽⁶⁾. In 1996, the Ministry of Health National Council approved the Resolution 196/96 which regulates and orientates research with human beings in Brazil⁽⁴⁾. The Brazilian Code for Medical Ethics, 1988, has references to medical research and to the publication of scientific papers⁽³⁾.

Important journals of medicine and biomedicine make references to ethics in their guidelines^(1,5).

The aim of this study was to study the research with human beings ethics found in the guidelines of orthopedics and traumatology journals.

MATERIAL AND METHODS

The guidelines from 38 orthopedics and traumatology journals were analyzed according to the methodology developed by Amdur and Biddle⁽¹⁾ and adapted by Sardenberg et al ⁽⁵⁾.

The journals were classified according to the ethics contained in the guidelines in four groups:

1 - Ethics Committee or Commission: journals which make reference to the necessity of approval by the Ethics Committee or Commission, independently of other ethical recommendations;

2 - Uniform Requirements — journals which make direct reference to the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" of the International Committee of Medical Journals Editors⁽²⁾;

3 - Consent of the Pacient — journals which mention fundamentally the patient's consent;

4 - No Guidelines Concerning Ethics: journals which do not mention the ethical aspects of the research with human beings.

The journals which mention the Helsinki Declaration⁽⁶⁾, independently of other ethical demands were identified.

Aspects related to privacy as the non-utilization of images and names or initials which can identify the patients were analyzed as concerns their presence or absence.

RESULTS

The results are presented in (Tables 1 to 6).

DISCUSSION

In spite of the flexible criteria used in this study, that is, any direct or indirect reference to ethics in research with human beings contained in the guidelines was considered and analyzed, the number of journals which mention ethics was low (47.3%). The study⁽¹⁾ of medical and biomedical journals in the English language has shown that 76% of them mentioned ethics in their guidelines. However, studying 139 Brazilian scientific journals related to health, the authors⁽⁵⁾ observed that only 20.8% made ethical references in their guidelines.

In this sample, the journals which made references to ethics showed preference for the "Ethics Commission or Committee" approval (28.9%) followed by the orientations of the Uniform Requirements (15.7%)^(1,5).

The Helsinki Declaration states that research protocols for human beings must be analyzed by a committee independent from the author and that reports of experiences in disagreement with these principles must not be accepted for publication. The Declaration of Helsinki also demands that the patients give their consent to participate in the study.

The "Uniform Requirements" contain a more fragile ethical orientation, since they state only that the authors should inform "whether the procedures were performed in accordance with the ethical standards of the committee responsible for the human experimentation (institutional or regional) and with the 1975 Declaration of Helsinki, as well as the revised one in 1997⁽²⁾.

Preservation of the patients privacy when participating in scientific research is based in the medical ethics principles related to medical confidentiality, present in the Hyppocratic Oath and contemplated in the Declaration of Helsinki and in the Uniform Requirements. In this sample, only 36.8% of the journals make references to privacy, in general related to the identification of patients in photographs or by the use of names or initials.

CONCLUSIONS

The orthopedics and traumatology journals are little concerned with the ethical aspects of the guidelines.

Ethics in research with human beings and the publication of scientific papers are polemical themes; however, the world tendency is to demand high ethical standards in the realization of scientific studies to be published in the medical literature.

ACKNOWLEDGEMENTS

The authors thank Ms. Enilze de Souza Nogueira Volpato and Ms. Thereza de Fátima Gonzales Torres for obtaining material for this study.

REFERÊNCIAS BIBLIOGRÁFICAS

• 1. Amdur, R.J., Biddle, C.: Institucional review board approval and publication of human research results. JAMA 277:904-914, 1997.
• 2. Comitê internacional de editores de revistas médicas: Requisitos uniformes para originais submetidos a revistas biomédicas. J Pediatr 73:213-224, 1997.
• 3. Conselho Federal de Medicina: Código de ética médica, 1988.
• ⁴
  Conselho Nacional de Saúde — Ministério da Saúde: Diretrizes e normas regulamentadoras da pesquisa em seres humanos — Resolução 196,1996.
• 5. Sardenberg, T., Müller, S.S., Pereira, H.R., Oliveira, R.A., Hossne, W.S.: Análise dos aspectos éticos da pesquisa em seres humanos contidos nas Instruções aos Autores de 139 revistas científicas brasileiras. Rev Ass Med Brasil 45:295-302, 1999.
• 6. World Medical Association: Declaration of Helsinki. JAMA 277:925-926, 1997.

*

Work performed at the Orthopedics and Surgery Department from Faculdade de Medicina de Botucatu, Universidade Paulista Júlio de Mesquita Filho (FMB — UNESP)

Publication Dates

• Publication in this collection
  02 Sept 2005
• Date of issue
  June 2002

History

• Accepted
  28 Mar 2002
• Received
  10 Jan 2002