Template:WikiJournal/Draft of statement on human research

Human research and cases

Informed consent

Journal participants must ensure that proper consent for publication has been obtained from individuals who are reported on in a submitted work, or from a proxy thereof. This includes case details optional addition. The individual(s) being reported on should be aware of the possible consequences of that reporting. For case studies, and in any work where a study subject may be identified, WikiJournal requires authors to assert that a written informed consent was received and that the patient or study subject. The author must specify whether or not the subject or proxy has seen the final version the details to be published (including pictures). If a final version has not been shown, the author should specify what the study subject or proxy has seen and that he or she has agreed to include in the publication. This requirement also applies when a report involves deceased persons. Journal participants do not themselves collect the signed consent forms, but it should be kept by the author. The consent form must include:

• Specifics about what material will be published.
• An agreement to the online publication of the material.
• Place for the name as well as for the signature of the subject.
• Revocation rights: Information to the subject that she/he may revoke the consent at any time. The signer should receive contact information to the person who has explained and administered the form. Before an article is published, a revoked consent must result in the removal of subject details from the submitted work. After article publication, removal of subject details may not be possible, but consideration should be made to minimize the amount of subject details.

The wording of the form should make it clear that, even with the best efforts at keeping confidentiality, anonymity cannot be guaranteed. There is a risk that the patient may be identified by someone, somewhere, once the work is published.

Additional information is included in certain cases:

• For patients, the form should indicate that signing it does not remove their rights to privacy.
• Hazards: A statement of regulatory compliance is required if the work involves chemicals, procedures or equipment that have any unusual hazards inherent in their use.
• If the study subject is not the signer, the relationship of the signer (i.e., the proxy) to the subject must be included. The form should include a statement to indicate that the individual or group does not have legal, mental, or physical capacity to consent, and the reason why. Examples include underage children, persons with cognitive or intellectual disabilities, or deceased persons.
• If one person is signing for a family or other group, that person should attest that all relevant members of the family or group have been informed.
• If there is a compensation or any form of financial benefit to the subject, the nature thereof should be clearly stated on the form. Preferably, study subjects should not expect to derive any financial benefit from publication of the case.

Further reading

• Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports, by COPE