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Maintenance of Human and Animal Rights

Institutional Review Board Approval

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In prospective studies involving human subjects, the ethical approval of an institutional review board (IRB) is required prior to the onset of patient involvement and must be referenced within the manuscript methods. The Protocol should follow the recommendations of the World Medical Association’s Declaration of Helsinki. In studies where no intervention is included (e.g. surveys, retrospective analyses, etc.), where no ethical approval is required or where an exemption has been granted, this should be revealed within the methods.

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Whenever a grouping by race, ethnicity, age, disease, disability, religion, sex, gender, sexual orientation, etc. has been found necessary, no stigmatizing or discriminatory language is acceptable. An explanation should be included describing the need for any type of grouping.

 

Case Reports

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Due to the potential of identifying a specific patient from their symptoms and/or signs, a case report requires consent to publish a statement in addition to the informed consent. This should also be revealed within the methods section of the manuscript. Maximum effort should be affected to retain the anonymity of the patient.

 

Retrospective analyses of patient records

 

Permission of the owner of the patient records is required, but if one of the co-authors is the owner of the patient records, permission is presumed. Otherwise, a statement in the methods to that effect should be present.

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No patient identities should be revealed and anonymity should be maintained throughout the publication. Otherwise, the consent of patients to allow publication is required and a statement describing this should appear within the methods.

 

Surveys

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If an IRB approval or exemption is required for the particular type of survey undertaken, it should be so stated and described within the manuscript. Subjects should be informed of the purpose of the survey and how anonymity will be included. This description should also be included in the manuscript. The survey participants should be volunteers, have consented to it, and given the option to opt-out.

 

Research using covert observation

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Although this method is not commonly used in dental research, any such study needs to protect the privacy of all participants. A post-collection opt-out or collection of consent is strongly recommended, along with information regarding any risks and a listing of the benefits, depending on the specific circumstances. A description of the reasons for this approach and ethical approval are required to be disclosed in the manuscript.

 

Informed Consent and Consent to Publish

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Participants selected for a study must be fully informed and then allowed to provide their written consent to participation. This is expected to be a routine procedure in every case of a therapeutic intervention, but also when no therapeutic intervention is anticipated. The ability to opt-out at any point in the study is also required. All such permissions need to be described within the manuscript.

The anonymous review of patient records of patients that have previously been fully informed and have provided written consent do not require a redundant procedure or consent to publish. However, separate consent to publish is required by this journal if any identifiable information is revealed, as in certain case studies. The specific circumstances of the study should be clearly described within the manuscript.

 

Protection of Animals Involved in Research

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Since ADT&T is a clinical dental research journal, it is not anticipated that animals will be involved in any of its publications. However, in the event that animals are involved, the relevant regulatory requirements are to be observed. Suitable approvals are expected, international guidelines should be followed and fully described within the manuscript. Authors are recommended to consult and follow the Guide for the Care and Use of Laboratory Animals: Eighth Edition for accepted procedures. ADT&T does not anticipate that any research studies involving plants will be submitted.

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