Patient informed consent in case reports: current practice in our country

INVITED EDITORIAL

Patient informed consent in case reports: current practice in our country^*

Paulo Oscar Teitelbaum

Psychiatrist, psychoanalyst. Editor, Rev Psiquiatr RS.

Communication of case reports is known to be an important instrument for disclosure and debate of situations found by psychiatrists in their daily practice. Sharing the professional experience acquired when providing care to a patient or group of patients, through detailed description of clinical situations, decisions made or solutions found, enables multiplication of theoretical and/or clinical thinking, diagnostic reasoning, therapeutical applications, in addition to fostering new investigation and research hypotheses.

However, publication of a case report, based on bioethics, implies the need of discussing issues regarding, among others, the principles of professional secrecy, confidentiality and privacy, which widely justifies its insertion in this forum.

It is a topic filled with controversies and subjective interpretations, dependent on sociocultural contexts of different times in history, such as all that are part of the bioethics area.

In this sense, by proposing a discussion on the current status of such issue in our editorial setting, it seems important to briefly review some ethical concepts.

The first principle to be considered is confidentiality. Familiar to all physicians, it can be defined as the guaranty of not disclosing information received personally as a sign of trust and protection against its non-authorized disclosure. In other words, it is an ethical duty of respecting the patient's privacy at all levels. Breach of confidentiality is "the action of disclosing or allowing disclosure of personal and trust information" and it occurs "when information is used or when a patient is observed without his proper authorization".¹

Ethical duty relative to confidentiality is clearly stated in the Code of Medical Ethics, in the chapter dealing with professional secrecy. It is important to stress that patients value such principles and expect them to be respected by their physicians. For example, Jones,² in a recent study of 29 English voluntary patients, aged 16 years or older and receiving care by general practitioners, aimed at evaluating the importance given by them to confidentiality of information provided to their physicians. To do so, many clinical situations were presented and patients were requested to express their opinion on their development and outcome.

An important result was that, although 100% of individuals valued respect for confidentiality as crucial, only 72% believed it was really respected. Relativity and subjectivity of such ethical principle, however, was well characterized (as new clinical situations were being presented) by the finding that, while 83% of individuals considered that confidentiality should be respected with no exceptions, 80% admitted disclosure of some information with the patient's consent and 37% considered breach of confidentiality acceptable in special situations, even with no consent. Such special situations involved presence of sexually transmitted diseases and child abuse.

However, as previously said, duty of confidentiality is not absolute. Its breach is ethically admitted under specific circumstances, summarized in four prototypical situations, of which one is of direct interest at this moment: when a real benefit may result from such breach of confidentiality.

The concept of real or likely benefit that may result from breach of confidentiality is defined as the probability an individual or group of individuals have of benefiting from the adopted procedure. It can also be divided into individual or personal benefit (when it has direct consequences on the research individual) or diffuse benefit (when it has no direct consequence on the individual, but may bring benefits to another group or collectivity).

Such concepts and ethical duties seem to confirm that maintenance of information confidentiality and patient privacy will reflect a responsible balance between individual and public interests, a weighting between individual risks and collectivity benefits. If, on one hand, protection to patients' privacy is an ever-present duty, its ethical dimension can and should be questioned by considering the possible benefit disclosure of scientific material could possibly bring to the collectivity of patients, after proper care is taken.

Although renowned techniques of distorting some data, with the aim of protecting the patient's identity, are routinely used as a form of fulfilling the above-mentioned principles, there is no guaranty that they will make identification impossible, taking into account the growth of electronic publication, which has nearly universal access.

Bearing such concepts in mind, we come closer to the specific question of obtaining informed consent, or more precisely, informed consent of patients in case reports submitted for publication.

Publication of case reports, in theory, is subject to the Guidelines and Regulating Norms of Research Involving Human Beings (Resolution no. 196/1996, CNS), which determine that all studies should have previous and formal authorization by the participating patient(s). That same Resolution, however, admits the existence of "exceptional situations" in which informed consent may be dismissed. Care about reference to exceptional situations reaffirms that the principle of confidentiality has no absolute characteristics and should always be evaluated.

At international level, the International Committee of Medical Journal Editors (ICMJE), in the document Uniform Requirements for Manuscripts Submitted to Biomedical Journals, regarding privacy and confidentiality of patients and study subjects, advises that: "Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication." ³ The ICMJE goes even further and advises that potentially identifiable patients should have access to the manuscript to be submitted for publication, so that they can provide informed consent.

Even so, within such rigid standards of ethical treatment as to protection of patient privacy, the ICMJE concluded by claiming that "Informed consent should be obtained if there is any doubt that anonymity can be maintained."³

"If there is any doubt" is the expression that admits exception and consolidates the relativity of the principles involved from the ethical and bioethical perspective.

However, an issue that has no controversy for the ICMJE is that the need of obtaining informed consent from patients should be included in the instructions to authors and existence of such consent should be mentioned in the published article.³

Four scientific journals published in Brazil were reviewed with regard to such aspect: Revista de Psiquiatria do Rio Grande do Sul (Associação de Psiquiatria do Rio Grande do Sul), Jornal Brasileiro de Psiquiatria (Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro), Revista de Psiquiatria Clínica (Departamento e Instituto de Psiquiatria da Faculdade de Medicina da Universidade de São Paulo) and Revista Brasileira de Psiquatria (Associação Brasileira de Psiquiatria).

Revista de Psiquiatria do Rio Grande do Sul (base: v. 30, nº 1/2008), in the instructions to authors regarding case reports, states that "explicit reference should be made to the existence of an informed consent form signed by the patient agreeing with the publication of data (in print and electronically), or else the reason for its absence should be clear."

Jornal Brasileiro de Psiquiatria (base: v. 57, nº 2/2008) has a section entitled "Consent Terms" in its instruction to authors: "The articles involving research including human subjects must mention that individuals included in these studies gave an Written Informed Consent, according to the national and international ethical regulations."

Revista de Psiquiatria Clínica (base: http://www.scielo.br/revistas/rpc/iinstruc.htm)⁴ has a specific section with instructions for submission of case reports, but it has no reference to need or demand of informed consent from patients. There is only a specific reference to publication of patients' photography in the section relative to structure of manuscripts: "We do no encourage the publication of photography of patients. Whenever indispensable for the comprehension of the article, written informed consent must be signed by the patient or respective caregiver, and patient details must be removed from the illustration."

Revista Brasileira de Psiquiatria (base: v. 30, nº 1, mar/2008) does not accept submission of manuscripts as "Case Reports," according to the instructions to authors on manuscript categories accepted for publication. However, in the section "Letters to the editors," the "report of unusual cases" is admitted, but there is no reference to the need of informed consent form signed by patients whose cases are submitted. Further in instructions to authors there is a reference to the previously mentioned article, included in the ICMJE guidelines, with a link to its website.

Therefore, of the four Brazilian journals analyzed in terms of demand from authors of informed consent in case reports, two (Revista de Psiquiatria do Rio Grande do Sul and Jornal Brasileiro de Psiquiatria) explicitly fulfill such demand, while two others (Revista de Psiquiatria Clínica and Revista Brasileira de Psiquiatria) do not.

In conclusion, it is important to stress the importance of having proper spaces to debate such issue, since its results will inevitably point to an enhancement in psychiatric publications in Brazil at a bioethical dimension, along with its well known scientific qualities.

References

• 1. Goldim JR. Bioética e ética na ciência. http://www.bioetica.ufrgs.br Acessado em 05/ Ago/2008.
• 2. Jones C. The utilitarian argument for medical confidentiality: a pilot study of patients' views. J Med Ethics. 2003; 29(6): 348-52.
• ³
  International Committe of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. http://www.icmje.org Acessado em 05/Ago/2008.
• 4. Revista de Psiquiatria Clínica. http://www.scielo.br/revistas/rpc/iinstruc.htm Acessado em 05/Ago/2008.

*

Relatório apresentado no Fórum de Publicações – Ciência e Ética em Publicações em Psiquiatria, XXVI Congresso Brasileiro de Psiquiatria, Brasília, realizado em outubro de 2008.

Publication Dates

• Publication in this collection
  17 Mar 2009
• Date of issue
  Dec 2008