January 18, 2019
Institutional Compliance Partners with Operational Support Services in the Intentionally Inclusive Challenge
November 19, 2018
FDA Issues Proposed Rule on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
In today’s edition of the Federal Register, the Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” FDA is proposing to amend its regulations to implement section 3024 of the 21st Century Cures Act. This proposed rule, if…
June 13, 2018
UAMS Course for Community Research Partners Available
ArCRT
May 7, 2018
UAMS’s Amy Jo Jenkins elected President of the Society of Clinical Research Associates
Congratulations to UAMS’s own Amy Jo Jenkins on being elected President of the Society of Clinical Research Associates. https://www.socra.org/about/board-of-directors/2018-election-results/
April 27, 2018
Ohio State Reveals Resignation of PI for Misconduct
Six months after the fact, the Ohio State University announced that a research professor resigned amid a finding of “intentional” research misconduct; at the same time, Ohio State took the rare step of publicly releasing parts of its investigative report. Ohio State officials said Ching-Shih Chen, formerly a professor of medicinal chemistry and chair of…
April 13, 2018
Manifestly Untrustworthy’ Former UAB Researcher Debarred for 10 Years
Following a ruling in January by an administrative law judge, the HHS Office of Research Integrity (ORI) has debarred a former University of Alabama at Birmingham (UAB) researcher for 10 years for misconduct that included falsifying data published in nine papers and deposited in a registry. In an April 10 notice on its website, ORI…
March 27, 2018
Pitt Professor Agrees to Pay Government to Resolve Claims That He Falsified IRB Approvals to Get Federal Research Grants
A star researcher at the University of Pittsburgh has agreed to pay the U.S. government more than $130,000 to resolve allegations that he submitted false documents to the National Science Foundation to get more than $2.3 million in federal research grants, the U.S. Attorney’s Office in Pittsburgh announced Wednesday. (link to full story at http://www.post-gazette.com/news/education/2018/03/21/University-of-Pittsburgh-Christian-Schunn-false-claims-act-national-science-foundation-grants/stories/201803210135…
March 22, 2018
NYU Professor Debarred for Three Years for Research Misconduct
Bhagavathi Narayanan, a former research associate professor in the Department of Environmental Medicine at New York University (NYU), has been debarred for three years from involvement in federal contracting, according to the HHS Office of Research Integrity (ORI). Narayanan “trimmed and/or copied Western blot images from unrelated sources, manipulated them to obscure their origin, and…
February 22, 2018
ORI: NIH Fellow Falsified Dozens of Figures in Two Published Papers
In its first research misconduct finding of 2018, the HHS Office of Research Integrity (ORI) announced that Colleen Skau committed research misconduct when she was a postdoctoral fellow at the National Heart, Lung, and Blood Institute. In a 2/19/18 announcement posted on its website, ORI said Skau falsified, fabricated and otherwise skewed data in dozens…
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…