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Use of anonymized data prevented us from assessing if there were multiple admissions of the same patient.
Another limitation was the use of anonymized data, which prohibited us from identifying repeat patient visits and patients from the same family or household [ 11].
This study was approved by Memorial Sloan Kettering Cancer Center's Institutional Review Board (IRB 13-186; registered under www.clinicaltrials.gov identifier number NCT02016872), and all subjects signed a written informed consent regarding the examination and use of anonymized data for research and publication purposes.
The use of anonymized data before and after treatment constitutes the basis for the clinical adaptation and validation process.
The need to obtain informed consent was waived due to the use of anonymized data.
Participating centres were obliged to inform parents about the scientific use of anonymized data.
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In the fertility clinic of the Academic Hospital Maastricht, all couples are informed at intake about possible use of their anonymized data and stored sera for research purposes, and a "no objection procedure" is followed.
Participating units were obliged to inform parents about the scientific use of the anonymized data.
They were entitled to object to the use of their anonymized data, but nobody did.
Subjects gave written informed consent for use of their anonymized data in studies led by the responsible investigator.
Recent changes to regulatory guidance in the US and Europe [ 1- 3] have further complicated oversight of secondary research by focusing narrowly on risks related to individual identifiability, rendering most uses of anonymized data exempt from human subjects oversight.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com