January 18, 2018

Federal Policy for the Protection of Human Subjects

On January 17,  the U.S. Department of Health and Human Services and 15 other federal departments issued an interim final rule to delay the implementation of the revised Federal Policy for the Protection of Human Subjects (“Common Rule”) for six months, until July 19, 2018 to provide regulated entities additional time to make the necessary…

June 22, 2017

Admission Leads to First ORI Misconduct Finding in 10 Months

Eleven figures in a 2016 paper were fabricated or falsified by a former NIH “research training awardee” who admitted to the misconduct and agreed to a three-year supervisory plan should she receive HHS research support in the future, according to a notice in the June 20 Federal Register. The HHS Office of Research Integrity (ORI)…

June 7, 2017

ICMJE Announces Requirement for Clinical Trial Data Sharing Statements

At the link below is a proposed policy published in 2016, ICMJE today announced its requirements for data sharing in the near future (attached). Key points: As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement Clinical trials that begin enrolling participants…

February 13, 2017

FDA Issues Warning Letter to UC San Diego Ophthalmology Prof

The Food and Drug Administration (FDA) found numerous “objectionable conditions” during an inspection last summer of research conducted by Kang Zhang, professor of ophthalmology and chief of ophthalmic genetics at University of California San Diego, the agency said in a Jan. 5 “warning letter” recently posted online. “[W]e conclude that you did not adhere to…

October 21, 2016

ORI Finds Former PostDoc Fellow Engaged in Research Misconduct

Andrew R. Cullinane, Ph.D., National Institutes of Health:  Based on Respondent’s admission, an assessment conducted by the National Institutes of Health (NIH), and analysis conducted by ORI in its oversight review, ORI found that Dr. Andrew R. Cullinane, former postdoctoral fellow, Medical Genetics Branch, National Human Genome Research Institute (NHGRI), NIH, engaged in research misconduct…

July 5, 2016

A Top N.Y.U. Researcher Dismissed from Research Study

Alexander Neumeister, M.D., former head of the molecular imaging program at New York University (NYU) School of Medicine, conducted psychiatric research without providing appropriate oversight, states a Feb. 6 warning letter issued by the Food and Drug Administration (FDA), which cited a host of problems uncovered in two protocols during an inspection from July 16-Aug….

June 20, 2016

Misconduct: Lessons from Researcher Rehab

Please follow link for Full Article: http://www.nature.com/news/misconduct-lessons-from-researcher-rehab-1.20029

May 26, 2016

ORI Finds Investigator Committed Misconduct at Two Institutions

ORI Finds Investigator Committed Misconduct at Two Institutions The HHS Office of Research Integrity (ORI) has entered into a voluntary settlement agreement calling for the supervision of a researcher found to have committed misconduct at two different universities over a six-year period. In a May 24 notice on its website, ORI said Ricky Malhotra committed…

May 12, 2016

ORI Finds Two Committed Research Misconduct

A researcher has agreed to a five-year debarment for misconduct while another’s work, if involving Public Health Service (PHS) support, will be supervised for three years, according to the HHS Office of Research Integrity (ORI). The debarment was agreed to by John Pastorino, an associate professor in the Department of Molecular Biology at Rowan University…

March 21, 2016

FDA: Accept Human-focused Preclinical Tests to Improve Drug Safety

Patient deaths halted at least two pharmaceutical clinical trials in the last two months. The good news is, Robert Califf, M.D., who was confirmed by the Senate last week as commissioner of the Food and Drug Administration, has an opportunity to address this issue. In his new role, Dr. Califf is in a position to…

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