Last updated November 6, 2014
Informed Consent Statement
Any research article describing a study (clinical research and case report) involving humans should contain a statement in the title page clearly stating that all involved persons (subjects or legally authorized representative) gave their informed consent (written or verbal, as appropriate) prior to study inclusion. In general, the BPG requires that any and all details that might disclose the identity of the subjects under study should be omitted or anonymized. In the rare situation that a study participant’s identifiable information is crucial to the case presentation, the statement of informed consent is absolutely necessary, unless the participant is deceased. In addition, a copy of any approval document(s)/letter(s) or waiver should be provided to the BPG in PDF format.
Waiver of informed consent for human study subjects may be justifiable under certain rare and specific conditions, such as for a trial with demonstrated minimal risk or cases of emergency care. Authors may petition BPG for waiver of informed consent, but there is no guarantee that the petition will be granted. In general, BPG favors the requirement of informed consent for all reports of information (anonymized or identifiable) and reserves the right to refuse publication of such if informed consent was not obtained.
Sample wording: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.