One centre had only one participant recruited, and it seemed unreasonable to undergo the effort of study submission to the Ethics Committee for this single case.
Journal adoption of the CONSORT statement at the time of data abstraction was defined as the article's journal endorsing, encouraging or enforcing the CONSORT statement for study submissions at the time the article was reviewed for this study.
For combined clinical and non-clinical study submissions, 92.1% were referred back to the investigators and approved after clarification/revision, while 2.7% were deferred due to major/critical changes, and 2.1% not approved due to substantial violations of ethical principles.
Regarding the results of initial review for combined clinical and non-clinical study submissions, 92.1% (268/291) were referred back to investigators and approved after satisfactory clarification and/or revision, while 2.7% (8/291) were deferred, and 2.1% (6/291) not approved.
BW was an employee of MedImmune, LLC, at the time of the study and manuscript submission.
Children were included in the study only after submission of the written consent of their parents or legal guardians.
We thank Rene Hawkes for providing support and coordination on the study, including IRB submission, materials development, and provider recruitment.
RDP designed the study, completed ethical submission, consented patients for study, performed, analysed and interpreted gene expression profiling and immunohistochemistry and wrote the manuscript.
As Principal Investigator of the Program Project Grant for acupuncture at MGH, he provided advice for the implementation of the study and manuscript submission.
If an honest broker system/service is to be used to obtain de-identified Protected Health Informations, this fact must be identified in the study's IRB submission.
