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Ethical considerations in research published in the CMI
Clinical Microbiology and Infection xxx (2016) 1
Contents lists available at ScienceDirect
Clinical Microbiology and Infection journal homepage: www.clinicalmicrobiologyandinfection.com
Editorial note
Ethical considerations in research published in the CMI We believe that editors and journals have a duty to publish only ethical research. The studies we publish should comply with the Helsinki Declaration (http://www.wma.net/en/30publications/ 10policies/b3/index.html). They should also observe local (or European when applicable) ethical standards for conducting research in humans. The best way to ensure that your study indeed observes such standards is to ask for the approval of the local Research Ethics Committees. We cannot accept any study describing an intervention in humans without the approval of a Research Ethics Committee, obtained before the study's start. This includes all randomized trials; and studies (of any design) reporting on experimental interventions, outside the accepted clinical practice. The exceptions are interventions or procedures that were introduced as qualityenhancement measures, and the articles describe the consequences of their introduction. In these cases we will consider whether there were solid grounds to consider the intervention a qualityenhancement measure; whether the decision to implement the intervention was not influenced by research or publication motives; that data were collected for internal, institutional purposes; and that the local rules for publication of data collected for purposes other than research were honoured. As a rule, all such interventions (but for quality-enhancement measures) demand the patient's consent. There are exceptions: people in no condition to give their consent; or participants in a cluster randomized trial. The researcher should make clear what the reason for waiving informed consent was; and that waiving consent was approved by the Research Ethics Committee. We have encountered studies in which a new laboratory test was performed in real time in a research project, without submitting the study protocol to the Research Ethics Committee. This is inadmissible, because of a possible infringement on the autonomy of the patient, and also because a question about patient safety might arise. Studies in which a new laboratory test is performed in real time, and the result linked to a patient's data, should be approved by the Research Ethics Committee. Prospective observational studies (in which the data collection and follow up are structured and more stringent than clinical
practice) should also be submitted for the approval of the Research Ethics Committee. For retrospective use of patient data we will respect local procedures. Surveys will be considered case by case. For example, a survey of teenagers addressing behaviour and past infections should be approved by the Research Ethics Committee. In the case of a survey asking physicians for their practice, we will ask the author about local rules and legislation. In all cases, a statement on ethics should be included in the Methods section. For retrospective studies it might just state that local regulations allow use for research of data collected for other purposes, without the approval of the Research Ethics Committee. We should respect the patients' right for privacy. When writing a case-report, or describing a small group of people, please remove unnecessary details that might identify the person. For example, many times describing the patient as in her/his fifties would suffice instead of providing the exact age; the region of residence might suffice instead of the town or city; the season or month of occurrence instead of the exact date. If anonymity cannot be guaranteed we will ask for the patient's consent for publication. Guidance on research ethics and their reflection in publications is provided in The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans (please see above); and in the International Committee of Medical Journal Editors Uniform Requirements for manuscripts submitted to Biomedical journals, http://www.icmje.org/recommendations/ browse/roles-and-responsibilities/protection-of-researchparticipants.html. Authors are well advised to read them. Now and then there will be questions with no clear answers. In this case please contact us and we will try to help. L. Leibovici Clinical Microbiology and Infection Editorial E-mail address: [email protected]. Available online xxx
Editorial note: not peer-reviewed. http://dx.doi.org/10.1016/j.cmi.2016.08.006 1198-743X/© 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Leibovici LEthical considerations in research published in the CMI, Clinical Microbiology and Infection (2016), http://dx.doi.org/10.1016/j.cmi.2016.08.006
Contents lists available at ScienceDirect
Clinical Microbiology and Infection journal homepage: www.clinicalmicrobiologyandinfection.com
Editorial note
Ethical considerations in research published in the CMI We believe that editors and journals have a duty to publish only ethical research. The studies we publish should comply with the Helsinki Declaration (http://www.wma.net/en/30publications/ 10policies/b3/index.html). They should also observe local (or European when applicable) ethical standards for conducting research in humans. The best way to ensure that your study indeed observes such standards is to ask for the approval of the local Research Ethics Committees. We cannot accept any study describing an intervention in humans without the approval of a Research Ethics Committee, obtained before the study's start. This includes all randomized trials; and studies (of any design) reporting on experimental interventions, outside the accepted clinical practice. The exceptions are interventions or procedures that were introduced as qualityenhancement measures, and the articles describe the consequences of their introduction. In these cases we will consider whether there were solid grounds to consider the intervention a qualityenhancement measure; whether the decision to implement the intervention was not influenced by research or publication motives; that data were collected for internal, institutional purposes; and that the local rules for publication of data collected for purposes other than research were honoured. As a rule, all such interventions (but for quality-enhancement measures) demand the patient's consent. There are exceptions: people in no condition to give their consent; or participants in a cluster randomized trial. The researcher should make clear what the reason for waiving informed consent was; and that waiving consent was approved by the Research Ethics Committee. We have encountered studies in which a new laboratory test was performed in real time in a research project, without submitting the study protocol to the Research Ethics Committee. This is inadmissible, because of a possible infringement on the autonomy of the patient, and also because a question about patient safety might arise. Studies in which a new laboratory test is performed in real time, and the result linked to a patient's data, should be approved by the Research Ethics Committee. Prospective observational studies (in which the data collection and follow up are structured and more stringent than clinical
practice) should also be submitted for the approval of the Research Ethics Committee. For retrospective use of patient data we will respect local procedures. Surveys will be considered case by case. For example, a survey of teenagers addressing behaviour and past infections should be approved by the Research Ethics Committee. In the case of a survey asking physicians for their practice, we will ask the author about local rules and legislation. In all cases, a statement on ethics should be included in the Methods section. For retrospective studies it might just state that local regulations allow use for research of data collected for other purposes, without the approval of the Research Ethics Committee. We should respect the patients' right for privacy. When writing a case-report, or describing a small group of people, please remove unnecessary details that might identify the person. For example, many times describing the patient as in her/his fifties would suffice instead of providing the exact age; the region of residence might suffice instead of the town or city; the season or month of occurrence instead of the exact date. If anonymity cannot be guaranteed we will ask for the patient's consent for publication. Guidance on research ethics and their reflection in publications is provided in The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans (please see above); and in the International Committee of Medical Journal Editors Uniform Requirements for manuscripts submitted to Biomedical journals, http://www.icmje.org/recommendations/ browse/roles-and-responsibilities/protection-of-researchparticipants.html. Authors are well advised to read them. Now and then there will be questions with no clear answers. In this case please contact us and we will try to help. L. Leibovici Clinical Microbiology and Infection Editorial E-mail address: [email protected]. Available online xxx
Editorial note: not peer-reviewed. http://dx.doi.org/10.1016/j.cmi.2016.08.006 1198-743X/© 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Leibovici LEthical considerations in research published in the CMI, Clinical Microbiology and Infection (2016), http://dx.doi.org/10.1016/j.cmi.2016.08.006