Editors’ note regarding Blood pressure normalization post-jugular venous balloon angioplasty

Authors should accurately describe the nature of their study and ensure the accuracy of authorship including author(s)’ institutional affiliation(s). They should also follow all other ethical guidelines. A corrigendum has recently been published regarding the above referenced article. ¹ The corrigendum contained corrections/clarifications that the paper was a retrospective review, corrected the affiliation of one of the authors (Z Sternberg), and included the Institutional Review Board (IRB) protocol number. Please see the below reference for a link to the published corrigendum. ²

The study, which involved patients seen between 2011 and 2012, was approved by Biomed IRB. The Editors have recently been made aware that the FDA sent a warning letter on 29 March 2012 to Mr. Fred Fox, Executive Director of the Biomedical Research Institute of America dba Biomed IRB. The letter stated, “We have determined that the IRB significantly violated applicable federal regulations governing the operation and responsibilities of IRBs as published in Title 21, Code of Federal Regulations (CFR), Part 56…” The FDA decided to withhold approval of all new studies subject to 21 CFR Part 56 and that no new subjects were to be enrolled in any on-going studies subject to 21 CFR Part 56 and approved by the IRB. These restrictions were to remain in effect until written notification that adequate corrections had been made. The full letter is available here: http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm298607.htm

The FDA sent a close out letter to BioMed IRB on 16 January 2013, following an evaluation of their corrective actions in response to the warning letter. The close out letter stated, “it appears that you have addressed the violations contained in the Warning Letter.” The full close out letter can be found here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm336186.htm

Phlebology is committed to publishing ethical works of high integrity. This relies on all those involved behaving ethically. Authors, reviewers, Editors, and interested readers should consult the SAGE Editor, author or reviewer gateway respectively for SAGE’s policies on publication ethics: http://www.uk.sagepub.com/journalgateway/ and the Committee on Publication Ethics (of which Phlebology is a member) website for more general guidelines on publication ethics. Authors should always consult the Phlebology manuscript submission guidelines prior to submission, which clearly outline the journal’s publication policies: http://www.sagepub.com/journals/Journal202199/manuscriptSubmission.

Editors:

Alun H Davies

Steven E Zimmet