Research Involving Human Subjects
Research Involving Human Subjects
When reporting on research that involves human subjects, human material, human tissues, or human data, authors must declare that the investigations were carried out following the rules of the Declaration of Helsinki of 1975 (https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/), revised in 2013. According to point 23 of this declaration, an approval from the local institutional review board (IRB) or other appropriate ethics committee must be obtained before undertaking the research to confirm the study meets national and international guidelines. As a minimum, a statement including the project identification code, date of approval, and name of the ethics committee or institutional review board must be stated in Section ‘Institutional Review Board Statement’ of the article.
Example of an ethical statement: "All subjects gave their informed consent for inclusion before they participated in the study. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of XXX (Project identification code)."
For non-interventional studies (e.g. surveys, questionnaires, social media research), all participants must be fully informed if the anonymity is assured, why the research is being conducted, how their data will be used and if there are any risks associated. As with all research involving humans, ethical approval from an appropriate ethics committee must be obtained prior to conducting the study. If ethical approval is not required, authors must either provide an exemption from the ethics committee or are encouraged to cite the local or national legislation that indicates ethics approval is not required for this type of study. Where a study has been granted exemption, the name of the ethics committee which provided this should be stated in Section ‘Institutional Review Board Statement’ with a full explanation regarding why ethical approval was not required.
A written informed consent for publication must be obtained from participating patients. Data relating to individual participants must be described in detail, but private information identifying participants need not be included unless the identifiable materials are of relevance to the research (for example, photographs of participants’ faces that show a particular symptom). Patients’ initials or other personal identifiers must not appear in any images. For manuscripts that include any case details, personal information, and/or images of patients, authors must obtain signed informed consent for publication from patients (or their relatives/guardians) before submitting to an BIA journal. Patient details must be anonymized as far as possible, e.g., do not mention specific age, ethnicity, or occupation where they are not relevant to the conclusions. A template permission form is available to download. A blank version of the form used to obtain permission (without the patient names or signature) must be uploaded with your submission. Editors reserve the right to reject any submission that does not meet these requirements.
You may refer to our sample form and provide an appropriate form after consulting with your affiliated institution. For the purposes of publishing in BIA journals, a consent, permission, or release form should include unlimited permission for publication in all formats (including print, electronic, and online), in sublicensed and reprinted versions (including translations and derived works), and in other works and products under open access license. To respect patients’ and any other individual’s privacy, please do not send signed forms. The journal reserves the right to ask authors to provide signed forms if necessary.
If the study reports research involving vulnerable groups, an additional check may be performed. The submitted manuscript will be scrutinized by the editorial office and upon request, documentary evidence (blank consent forms and any related discussion documents from the ethics board) must be supplied. Additionally, when studies describe groups by race, ethnicity, gender, disability, disease, etc., explanation regarding why such categorization was needed must be clearly stated in the article.