Ethical approval, informed consent, and patient data

Ethical approval

An ethical approach is necessary not only in the final stage of manuscript preparation: all research must conform to set ethical standards. You may also need to check your target journal for specific requirements: for example, whether you need to include any explicit ethics statements in your manuscript and cover letter. Two ethics codes you should be familiar with are the Declaration of Helsinki and the Nuremberg Code

 

Declaration of Helsinki

The Declaration of Helsinki states that research on human participants should be clearly explained in study protocols. These protocols should be submitted to an independent ethical review board (an ethics committees or an institutional review board) for approval. Authors should also state clearly whether the research was conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2013 (e.g., “This study was approved by the Institutional Review Board of Baskent University and was conducted according to the principles of the Declaration of Helsinki.”).

The Declaration of Helsinki will be discussed in more detail later in this module.

 

Nuremberg Code

The Nuremberg Code states that voluntary consent of the human subject is essential for participation in a clinical trial. Informed consent is obtained when every potential participant is informed, at their level of understanding, about the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the expected benefits and potential risks of the study, any side effects, their rights and responsibilities, possible research outcomes, and potential forms of dissemination of the results. 

The patient must also be informed of the right to refuse to participate in the study or to withdraw at any time. This means that the patient can make an informed and voluntary decision regarding whether to participate in the study, and that he or she provides written consent. Patient informed consent forms should be archived as indicated by local laws and regulations. Some journals require authors to provide proof that written informed consent was obtained, and some require the actual forms. 

 

Whereas some journals require submission of their own informed consent forms (e.g., The BMJ), others accept more generic forms, such as those obtainable from the World Health Organization.

 

Informed consent

Information about ethical approval and informed consent must be given for all research on humans, bodily organs and tissue, fetuses, and corpses. If informed consent was waived, then the reasons for this should be explained. Most biomedical journals require that authors of all investigations on human participants, medical records, and human tissues/organs state whether the study was approved by a national or institutional review board or ethics committee and describe how patient consent was obtained. 

Journals that follow the publication guidelines of the International Committee of Medical Journal Editors(ICMJE) expect that ethical approval and informed consent must be reported. Papers that do not comply with this requirement will not be accepted by these journals. 

There are exceptions in which informed consent is not required. One example might be when conducting retrospective studies based on data obtained from databases in which patients cannot be identified. In these cases, the need for the consent must be waived by the research ethics committee or the institutional review board. A rare exception is based on a Food and Drug Administration regulation that applies to a very limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and have no legal representative. 

In case reports and case series, formal ethical approval may not be appropriate or necessary. Nevertheless, it is important that the patient has given consent to participate in the research and to have the case published in an academic journal. You should also document that all ethical issues have been considered to protect the patient’s rights. 

 

If you would like to publish a case report, but you cannot contact the patient to ask for consent, you can consider obtaining a consent waiver from your university’s institutional (ethics) review board. If they feel that the information is important for public health and the patient cannot be identified, they may be willing to issue a waiver. But it is still up to the discretion of journal editors if they will accept a manuscript under these conditions.

 

Journal guidelines and ethical requirements

Journal requirements may vary regarding whether appropriate institutional review board approval and patient consent needs to be mentioned in the article text or in a separate section—in the submission cover letter, for example. But it is still important that the authors include this information in the actual text of the article so that readers know that such ethical standards were followed. 

Reporting the institutional review board approval and patient consent for study participation and for publication of data is important. It ensures that the highest scientific and ethical standards are maintained, thereby protecting research participants during the course of medical research.

 

Patient data

The right to privacy, including confidentiality of health information, is protected by many international and regional laws and policies. In the field of medical communication, it is the researchers’ obligation to maintain and protect patient confidentiality. 

It is therefore important to take care to remove or mask patient identifiers, such as:

  • Names
  • Initials
  • Identifying numbers from laboratory reports
  • Radiographs
  • Other evaluations being reported

It is also important to ensure that a patient may not be recognized in photographs and images. In many cases patients can be easily identified in photographs even if their eyes are masked. For this reason, as stated by the International Committee of Medical Journal Editors (ICMJE), authors should inform patients if any potentially identifiable piece of information might become available with the publication. Patients should consent to the inclusion of this information before a manuscript is submitted. 

 

Less obvious personal identifiers should also be avoided. For example, an unusual case occurring in a small community can be easily identified by readers if a detailed description is given. The details of a patient admitted to a hospital for treatment of an uncommon condition on a specific date may also make them easy to identify. Personal patient data should be limited by not reporting unnecessary details or any information that is not relevant to the specific assignment, case report, or case series. 

 

To help protect confidentiality, a number of simple measures can be done while photographing patients:

    • Ask patients to remove jewelry that may be recognizable 
    • Ask patients with long hair to pull their hair back and out of sight
    • Avoid inclusion of birthmarks or tattoos if possible

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