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Author Instructions

Manuscripts with suspected ethical problems will be investigated according to COPE Guidelines.

3.1.1 Consent to Participate
For all studies involving human subjects, informed consent to participate in the studies must be obtained from participants,
or their parents or legal guardians for children under 16. Statements regarding consent to participate should be included in a
declaration statement of Ethical Approval and Consent to Participate in the manuscript. If informed consent is not required,
the name of the ethics committee granting the exemption and the reason for the exemption must be listed. If any ethical
violation is found at any stage of publication, the issue will be investigated seriously based on COPE Guidelines.

3.1.2 Consent for Publication
All articles published by RDODJ are freely available on the Internet. All manuscripts that include individual participants’
data in any form (i.e., details, images, videos, etc.) will not be published without Consent for Publication obtained from that
person(s), or for children, their parents or legal guardians. If the person has died, Consent for Publication must be obtained
from the next of kin. Authors must add a declaration statement of Consent for Publication in the manuscript, specifying
written informed consent for publication has been obtained.

3.1.3 Ethical Approval and Informed Consent for Retrospective/Database Studies
Researchers must confirm they have obtained ethical approval from ethical review boards to perform the study, as well as
permission from the dataset owner to use the information in databases for the purposes of the research they are performing.
If permission to use information from a database is not required (e.g., it is publicly available and unrestricted re-use is
permitted under an open license), a statement explaining this must be included in the manuscript. For studies which ethics
approval has been waived, authors must state clearly in the manuscript and provide brief details of the waive policy. The
statement should include details of the policies under which the waive was granted.
Authors must keep data anonymized. If participants’ details are not to be anonymized, authors must ensure that written
informed consent, including consent for publication, was obtained from each participant, and consent statement must be
included in the manuscript.
3.1.4 Ethical Approval and Informed Consent for Survey Studies
Researchers must ensure the participant’s right to confidentiality has been considered, and they must inform all participants
about the aims of the research and if there are any possible risks, and how the collecting data is being stored. The voluntary
consent to participate of participants should be recorded and any legal requirements on data protection should be adhered
to. Same with all research studies, ethics approval from IRB/local ethics committee for survey studies must be obtained
before performing study. If ethics approval for certain survey study is not required, authors must include a statement to
explain this clearly in the manuscript.

3.1.5 Trial Registration
RDODJ requires all authors to register all relevant clinical trials that are reported in manuscripts submitted. RDODJ
follows the World Health Organization (WHO)’s definition of clinical trials: “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, other biological products, surgical
procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.”.
In line with International Committee of Medical Journal Editors (ICMJE) recommendation, RDODJ requires the registration
of clinical trials in a public trial registry at or before the time of first patient enrollment. RDODJ accepts publicly accessible
registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform or in
ClinicalTrials.gov. The trial registration number should be listed at the end of the Abstract section.
Secondary data analyses of primary (parent) clinical trials should not be registered as a new clinical trial, but rather
reference the trial registration number of the primary trial.
Editors of RDODJ will consider carefully whether studies failed to register or had an incomplete trial registration. Because
of the importance of prospective trial registration, if there is an exception to this policy, trials must be registered and the
authors should indicate in the publication when registration was completed and why it was delayed. Editors will publish
a statement indicating why an exception was allowed. Please note such exceptions should be rare, and authors failing to
prospectively register a trial risk its inadmissibility to RDODJ.
Authors who are not sure whether they need trial registration may refer to ICMJE FAQs for further information.

3.2 Research Involving Animals
Experimental research on animals should be approved by an appropriate ethics committee and must comply with
institutional, national, or international guidelines. RDODJ encourages authors to comply with the AALAS Guidelines,
the ARRIVE Guidelines, and/or the ICLAS Guidelines, and obtain prior approval from the relevant ethics committee.
Manuscripts must include a statement indicating that the study has been approved by the relevant ethical committee and the
whole research process complies with ethical guidelines. If a study is granted an exemption from requiring ethics approval,
the name of the ethics committee granting the exemption and the reason(s) for the exemption should be detailed. Editors

Rare Disease and Orphan Drugs Journal