ETHICAL APPROVAL AND INFORMED CONSENT
When reporting trials on human subjects, authors should indicate whether the procedures were in accordance with the ethical standards set by the responsible human experimentation committee (institutional and national) and latest version of the Declaration of Helsinki given by World Medical Association. Ethical approval (institutional or national) should be obtained for every study that includes a collection of additional patient sample of any biological material (more than those required for the medical evaluation).
All subjects should sign an informed consent form and this information should be provided in the manuscript. Signed informed consent forms should be archived by the authors. The authors have to provide a statement that they have received and archived all patient informed consent forms, as required during the manuscript submission process. It should be noted that informed consent to participate in the research does not imply consent to publish personal individual data (names, pictures, hospital identification). Therefore, for publication that includes any individual data, patient must give his written consent. This is especially applied when it is not possible to obtain anonymity of the data without distorting scientific evidence.
Regardless of the preserved anonymity, patients presented in case report articles should always sign informed consent. Case reports without patientsâ€™ consent are not eligible for publication in Jurnal Teknologi Laboratorium (Journal of Laboratory Technology). Specific types of case reports, extra-analytical mysteries, are not obliged to obtain informed consent as long as there are no patientâ€™s personal data revealed. If there is need to publish patientâ€™s rare diagnosis or specific demographic or personal data by which patientâ€™s identity can be implied, than the authors must obtain patientâ€™s signed informed consent.
In the spirit of promoting best practice guidelines given by COPE (available at: https://publicationethics.org/core-practices), Jurnal Teknologi Laboratorium (Journal of Laboratory Technology) will not consider for publication manuscripts in which best ethical practice is not ensured, i.e. Informed consent is missing and/or Ethical approval is omitted. To simplify the decision-making process on whether a type of study requires Informed consent and/or Ethical approval, authors are encouraged to consult the table below reprinted from Borovecki A, Mlinaric A, Horvat M, Supak Smolcic V. Informed consent and ethical approval in laboratory medicine. Biochem Med (Zagreb) 2018;28(3):030201.
|Type of study||Study design||Informed consent||Ethical approval|
|Research||The material from patients/healthy donors is collected for research purpose.||Required||Required|
|Method/instrument validation||The use of residual material||Not required||Required|
|The material from patients/healthy donors is collected for research purpose||Required||Required|
|Research showing standard clinical/laboratory practice or the advancement of the standard practice||If it does not include a new method or instrument||Not required (it is implied that the informed consent was previously given for the scope of the treatment)||Not required (it is considered that this is not research but clinical/laboratory practice)|
|Incidence/epidemiological research||The use of residual material or retrospective data collection.||Not required||Required|
|Laboratory Information System (database) data extraction||Retrospective data collection.||Not required||Required|
|Laboratory management||Studies that do not include human subjects but collect data for measuring quality indicators (i.e. turnaround time, test utilization, non-conformities, etc.).||Not required||Not required|
|Survey||The participants are notified in the survey about the nature of the research and the future use of the data (publishing, etc.).||Not required (it is implied)||Not required|
|Survey asking more intimate questions.||Required||Not required|
|Case report||Required||Not required|
|Preanalytical case report||Patient specific information are not presented (patient is not identifiable).||Not required||Not required|