POLICY FOR HUMAN-SUBJECTS RESEARCH FOR ADJURIS – INTERNATIONAL ACADEMIC PUBLISHER
- Application of the Policy
The books or conference proceedings describing research on human subjects must comply with the requirements below. Failure to comply with these requirements may constitute grounds for rejection. If issues are discovered after publication, depending on their severity, we may issue a correction or even retract the books or conference proceedings as appropriate. We also reserve the right to contact the author’s institution.
- Definition of Human Subjects Research
ADJURIS – International Academic Publisher follows the Definition of Human Subjects Research adopted by the United States Department of Health and Human Services. According to 45 CFR 46, a human subject is “a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
- Clinical Studies
Clinical investigations must be conducted according to the principles expressed in the Declaration of Helsinki.
- Clinical Trials
4.1. Definition
ADJURIS – International Academic Publisher follows the World Health Organization’s (WHO) definition of a clinical trial: a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes […] Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.
4.2. Principles for including clinical trials in books or conference proceedings
All clinical trials submitted to ADJURIS – International Academic Publisher must be entered in a publicly accessible registry approved by the World Health Organization’s (WHO). See the list of approved registries.
Clinical trial reports must adhere to the relevant reporting guidelines for their study design, such as CONSORT for randomized controlled trials, TREND for non-randomized trials.
4.3. Informed Consent
Informed consent is a process in which the researcher informs the subjects about their rights, the purpose of the study, the procedures that will be performed, and the potential risks and benefits of participation.
The subjects must understand all these aspects of the study to provide their consent; the materials must be provided at an appropriate reading level, presented verbally for illiterate subjects, and translated if necessary. For participants that cannot understand this information (e.g., a child), consent from a guardian must be obtained.
Subjects must willingly give their permission for the study without feeling coerced; for example, participation in the study must not influence other aspects of the subject’s medical care.
4.4. Patient Privacy
The books or conference proceedings must respect the Patient Privacy. We uphold the right to anonymity and take all necessary steps to protect the privacy of those who participate in research. Authors must avoid providing identifying information unless strictly necessary for the submission. For submissions that include identifying information, or potentially identifying information of patients or other participants, authors must confirm that the individual has provided written consent for the use of that information.
- Research Involving Surveys or Interviews
5.1. Principles
Research Involving Surveys or Interviews will be carried out taking into account the principles provided in AAPOR Code of Professional Ethics and Practices and in The International Sociological Association’s (ISA) Code of Ethics .
Research authors must ensure that:
– Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits;
– The subject selection is equitable;
– Anonymity of survey participants;
– Privacy and confidentiality are protected;
– Informed consent processes meet the requirements provided by the point 4.3 of this Policy and the regulations in force.
5.2. Vulnerable groups
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 that raise ethical issues) must be supplied. Additionally, when studies describe groups by race, ethnicity, gender, disability, disease, etc., an explanation regarding why such categorization was needed must be clearly stated.
- Ethical Approval
The existence of ethical approval is mandatory in all biomedical research and also in all research on human subjects that include vulnerable populations, or in situations that could bring, in any way, harm to the participant.
If the study contains any of these elements, the author will request ethical approval from the appropriate Research Ethics Committee (usually national scientific research ethics committees, as it is The National Ethics Council of Scientific Research, Technological Development and Innovation in Romania).
Some studies that do not require ethical approval include those involving information freely available in the public domain (e.g. published biographies, newspaper accounts, reports about situations of public notoriety), and the analysis of datasets, either open source or obtained from other researchers, where the data are properly anonymised and informed consent was obtained at the time of original data collection.
Director of the Publishing House
Associate professor Phd. Habil. CĂTĂLIN-SILVIU SĂRARU,