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Bioethics and Research Protections News 2015

Governments routinely cover up scientific misdeeds. Let's end that Ivan Oransky and Adam Marcus STAT News 2015-12-15: http://www.statnews.com/2015/12/15/governments-scientific-misdeeds/

Exclusive: Major Clinton Donor Faces 'Criminal Profiteering' Charges Richard Pollock Daily Caller News Foundation 2015-12-06: http://dailycaller.com/2015/12/06/exclusive-major-clinton-donor-faces-criminal-profiteering-charges/

Bacteria on the Brain Emily Eakin The New Yorker 2015-12-07: http://www.newyorker.com/magazine/2015/12/07/bacteria-on-the-brain

Special Series World War II Secret Mustard Gas Testing National Public Radio November, 2015 http://www.npr.org/series/417162462/world-war-ii-secret-mustard-gas-testing

Findings of Research Misconduct, Anil Potti, M.D. Duke University 80 FR 69230 2015-11-09: https://www.federalregister.gov/articles/2015/11/09/2015-28437/findings-of-research-misconduct

Drug Problems: European Regulator Investigating Trial Led by FDA Nominee David S. Hilzenrath POGO Blog 2015-11-20: http://www.pogo.org/blog/2015/11/regulator-investigating-clinical-trial-led-by-fda-nominee.html

Drug Problems: Nominee to Head FDA Led Clinical Trial FDA Faulted David S. Hilzenrath POGO Blog 2015-11-12: http://www.pogo.org/blog/2015/11/fda-nominee-robert-califf-led-faulted-fda-trial.html

Dr. Robert Califf on Vioxx PBS NewsHour 2004-11-03: http://www.pbs.org/newshour/bb/health-july-dec04-cahill-vioxx/

Drugmakers Kept One-Third of Trial Results Secret, Study Finds Doni Bloomfield 2015-11-12 http://www.bloomberg.com/news/articles/2015-11-12/drugmakers-kept-one-third-of-trial-results-secret-study-finds

Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012 BMJ Open 2015;5:e009758 http://bmjopen.bmj.com/content/5/11/e009758.full?sid=687394a9-4854-47a3-b50d-090d2cd2747d

Toward Protecting Participants' Privacy Ruth Williams The Scientist 2015-10-15: http://www.the-scientist.com/?articles.view/articleNo/44369/title/Toward-Protecting-Participants--Privacy/

Drug Problems: Dangerous Decision-Making at the FDA David S. Hilzenrath POGO Blog 2015-10-15: http://www.pogo.org/our-work/reports/2015/drug-problems-dangerous-fda-decision-making.html

The Life of a Professional Guinea Pig Cari Romm The Atlantic 2015-09-23: http://www.theatlantic.com/science/archive/2015/09/life-of-a-professional-guinea-pig/406018/

UMN psychiatric research oversight called lax in new report Josh Verges Pioneer Press 2015-06-18: http://www.twincities.com/nation/ci_28337126/evidence-lax-umn-psychiatric-research-oversight-mounts

University of Minnesota Department of Psychiatry Industry-Sponsored Clinical Studies: 2004-2014 State of Minnesota Office of Legislative Auditor 2015-06-18: http://www.auditor.leg.state.mn.us/sreview/psychstudies.pdf

2 Univ. of Minnesota psychiatric research doctors may have broken privacy law Jeff Baillon Fox9.com 2015-07-17: http://www.myfoxtwincities.com/story/29343333/2-univ-of-minnesota-psychiatric-research-doctors-under-investigation

Doctor with revoked license continues to sell unproven stem cell treatments Alan Zarembo LA Times 2015-05-16 : http://www.latimes.com/local/california/la-me-stem-cell-injections-20150517-story.html

Panel: U of M needs more protections for research subjects Alex Friedrich MPR News 2015-05-18: http://www.mprnews.org/story/2015/05/18/uofm-research-subjects-report

Review finds U of M psychiatry researcher violated patient safety procedures Alex Friedrich MPR News 2015-05-15: http://www.mprnews.org/story/2015/05/15/review-finds-u-of-m-psychiatry-researcher-violated-patient-safety

Independent Assessment of a University of Minnesota Institutional Review Board Non-Compliance Determination FTI Consulting 2015-03-11: http://www.health.umn.edu/sites/default/files/FTI-Release.pdf

Former U of M psychiatry chief resigns from major medical post Alex Friedrich MPR News 2015-05-15 : http://www.mprnews.org/story/2015/05/15/dr-charles-schulz-resigns-from-major-medical-post

FDA Reviews Trial at University Where Research Practices Were Slammed Ed Silverman Pharmalot 2015-05-07: http://blogs.wsj.com/pharmalot/2015/05/07/fda-reviews-trial-at-university-where-research-practices-were-slammed/

Public grills health officials over research practices Charlie Bartlett Minnesota Daily 2015-05-05: http://www.mndaily.com/news/campus/2015/05/05/public-grills-health-officials-over-research-practices

FDA investigates U of M drug researcher amid department criticism Jeff Baillon Fox9.com 2015-05-04: http://www.myfoxtwincities.com/story/28975613/fda-conducting-investigation-on-u-of-m-drug-researcher

Tensions Run High at U of M Town Hall about Drug Trials Josh Rosenthal ABC News 2015-05-04: http://kstp.com/news/stories/S3786168.shtml

U's handling of drug study suicide earns an F among peers Alex Friedrich MPR News 2015-04-23: http://www.mprnews.org/story/2015/04/23/university-of-minnesota-markingson-case

A Dispute Flares Over Data for a Nascent ALS Drug and an FDA Review Ed Silverman Pharmalot 2015-04-20: http://blogs.wsj.com/pharmalot/2015/04/20/a-dispute-flares-over-data-for-a-nascent-als-drug-and-an-fda-review/

A Drug Trial's Frayed Promise Katie Thomas NY Times 2014-04-17: http://www.nytimes.com/2015/04/19/business/seroquel-xr-drug-trial-frayed-promise.html

No Apparent Consequences for U Researcher Who Recruited Dan Markingson Susan Du Minneapolis City Pages 2015-04-12: http://blogs.citypages.com/blotter/2015/04/no_apparent_consequences_for_u_of_m_researcher_who_recruited_dan_markingson.php

India Threatens to File Complaints to the EU and WTO on Behalf of a CRO Ed Silverman Pharmalot 2015-04-13: http://blogs.wsj.com/pharmalot/2015/04/13/india-threatens-to-file-complaints-to-the-eu-and-wto-on-behalf-of-a-cro/

FDA forces UCLA researchers to stop touting experimental dementia scan Alan Zarembo LA Times 2015-04-10: http://www.latimes.com/science/sciencenow/la-sci-sn-brain-scan-warning-taumark-20150410-story.html

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Markingson case: University of Minnesota can't regain trust under current leadership Arne H. Carlson Star Tribune 2015-04-10: http://www.startribune.com/opinion/commentaries/299415621.html

U of M psychiatry chief steps down amid criticism Alex Friedrich NPR Morning Edition 2015-04-09: http://www.mprnews.org/story/2015/04/09/psychiatry-chief-steps-down

U of M names research reform team Alex Friedrich NPR Morning Edition 2015-04-08: http://blogs.mprnews.org/oncampus/2015/04/u-of-m-names-research-reform-team/

The Fix is In Leigh Turner, Ph.D. Health in the Global Village 2015-04-09: http://www.healthintheglobalvillage.com/2015/04/09/the-fix-is-in/

Kaler talks fees, Dan Markingson case Christopher Aadland Minnesota Daily 2015-04-07: http://www.mndaily.com/news/campus/2015/04/07/kaler-talks-fees-dan-markingson-case

Hopkins faces $1B lawsuit over role in government study that gave subjects STDs Scott Dance Baltimore Sun 2015-04-01: http://www.baltimoresun.com/health/bs-hs-hopkins-guatemala-lawsuit-20150401-story.html

Superior Court Issues Opinion in Case Involving Clinical Trial Death Press Release Laywers and Settlements 2015-03-31: http://www.lawyersandsettlements.com/articles/medical_malpractice/clinical-trial-death-20554.html#.VSL5NIembx4

Beverly H. Scheer v James F. Burke, D.O. et al. No. 1901 EDA 2013 (Memorandum) Appeal from the Judgment Entered June 18, 2013 2015-03-25: http://www.circare.org/lex/scheer-2015-1901-eda-2013.pdf

Researchers chafe at halt of psychiatric trials Sara Reardon Nature News 2015-03-30: http://www.nature.com/news/researchers-chafe-at-halt-of-psychiatric-trials-1.17203

Kaler acknowledges U misstatements on drug study Maura Lerner Star Tribune 2015-03-28: http://www.startribune.com/lifestyle/health/297799831.html

INVESTIGATORS: Robert's case still secret amid U of M's commitment to improve Jeff Bailion Fox News 2015-03-24: http://www.myfoxtwincities.com/story/28605693/investigators-roberts-case-still-secret-amid-u-of-ms-commitment-to-improve

AstraZeneca to Disclose Trial Data, but how Independent is its Review Panel? Ed Silverman Pharmalot 2015-03-24: http://blogs.wsj.com/pharmalot/2015/03/24/astrazeneca-to-disclose-trial-data-but-how-independent-is-its-review-panel/

A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case State of Minnesota Office of Legislative Auditor 2015-03-19: http://www.circare.org/dw/markingson-mnola-20150319.pdf

Controversial Marshall Health neurosurgeon defends prior practices Randy Yohe WOWK-TV 2015-03-10: http://www.wowktv.com/story/28360681/13-news-exclusive-controversial-marshall-health-neurosurgeon-defends-prior-practices

What A Scathing External Report On Protections In Research Missed – Or Ignored. Judy Stone Forbes 2015-03-11: http://www.forbes.com/sites/judystone/2015/03/11/what-an-external-report-on-protections-in-research-missed-or-ignored/

UMN's Clinical Research Practices: Far From Beyond Reproach Judy Stone Forbes 2015-03-11: http://www.forbes.com/sites/judystone/2015/03/10/umns-clinical-research-practices-far-from-beyond-reproach/

Research methods under fire Harley Haley University of Minnesota Daily 2015-03-09: http://www.mndaily.com/news/campus/2015/03/08/research-methods-under-fire

Outside review faults University of Minnesota on research ethics Jeremy Olsen Star Tribune 2015-02-27: http://www.startribune.com/lifestyle/health/294451471.html

University of Minnesota Human Research Protections Program: AAHRPP Final Report and Prefatory Note 2015-02-26: http://www.circare.org/dw/uminn-aahrppreport-20150226.pdf

University of Minnesota Human Research Protections Program: AAHRPP Final Report, Appendices 2015-02-26: http://www.circare.org/dw/uminn-aahrppreport-append.pdf

Statement from President Kaler regarding the independent review of human subject research 2015-02-27: http://discover.umn.edu/news/vision-leadership/statement-president-kaler-regarding-independent-review-human-subject-research

Index of documents related to AAHRPP review from the UM web site : http://www.research.umn.edu/news/external-review.html#.VPNbEIfQnpQ

A Failed Trial in Africa Raises Questions About How to Test H.I.V. Drugs Donald J. McNeil NY Times 2015-02-04: http://www.nytimes.com/2015/02/05/health/failed-trial-in-africa-raises-questions-about-how-to-test-hiv-drugs.html

Pariah Treatment Promises to Be Heart Disease Game-Changer - But Will NIH Fund It? Steve Plamann Newsmax 2015-02-10: http://www.newsmaxhealth.com/Headline/chelation-heart-lamas-nih/2015/02/10/id/623813/

Are Your Medications Safe? Charles Seife Slate 2015-02-09 : http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.html?wpsrc=fol_fb


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Last Updated: 2016-04-20

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