In doubtful cases the editor may ask the authors to provide protocol documentation, informed consents, EC/IRB reports, or simply more methodological details to form their own judgement about the conduct of the research.
The following data were included: 1) year of publication, 2) country affiliations of first, corresponding and middle authors, 3) country affiliations of participating centers and additional investigators (where available), 4) trial characteristics, 5) types of treatment, 6) documentation of ethics, informed consent and funding sources, and 7) whether relevance of study to LMCs was discussed.
Individual participants were visited in their homes, signed informed consent documentation, and were asked to complete a questionnaire which documented demographic information, including the participant's age, marital status, education level, and annual salary.
The Western Institutional Review Board and institutional review boards at each enrolling institution approved the protocol, patient instructions, and informed consent documentation.
The protocol was approved by the Human Subjects Cancer Internal Review Board of The Ohio State University Medical Center and informed consent documentation was obtained for participants.
The final study protocols, any amendments, and informed consent documentation were approved by the Institutional Review Board(s) and/or Independent Ethics Committee(s) at each investigational center.
The protocols, patient instructions, and informed consent documentation were approved by the US FDA, the Western Institutional Review Board, and the institutional review boards of each enrolling institution.
