Richard Jaensch, a self-employed plumber residing from Annandale, Va., was found guilty today by a federal jury sitting in Alexandria, Va., of one count of corruptly endeavoring to impede the Internal Revenue Service (IRS), one count of filing a false claim for a refund, and four counts of failing to file tax returns for 2004 through 2007.

An indictment was unsealed today charging Jack Ray Carr of Baton Rouge, La., with one count of corruptly interfering with the due administration of the Internal Revenue laws, four counts of filing false income tax returns, and one count of aiding and assisting in the preparation of a false income tax return.

The United States alleged that BCSO denied detainees access to books, magazines, newspapers or other expressive materials and denied them the right to practice their religion, in violation of the First Amendment and the Religious Land Use and Institutionalized Persons Act (RLUIPA).

Thomas W. Richardson was sentenced Thursday by U.S. District Judge Jane J. Boyle in Dallas to 105 months in prison and ordered to pay $30,649 in restitution, following his guilty plea in August 2011 to one count of theft of government property and one count of aggravated identity theft, the Justice Department announced today.

Roanne Eye, 57, of Plantation, Fla., was found guilty of tax charges late Thursday after a four-day jury trial, the Justice Department and Internal Revenue Service (IRS) announced

The former associate director of the Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy in Hines, Ill., his wife and their temporary staffing company were sentenced today for their participation in a conspiracy to defraud the VA and the Small Business Administration.

Elmo Antonio George and Nasheba Necia Hunte, formerly from the U.S. Virgin Islands and currently residents of Villa Rica, Ga., were found guilty today by a federal jury in Ft. Lauderdale, Fla., of conspiring to defraud the Internal Revenue Service (IRS) and filing false individual income tax returns for 2005 and 2006, the Justice Department and the IRS announced.

Curtis Morris, 43, of Elizabeth, Colo., and Richard Kellogg Armstrong, 77, of Prescott, Ariz., were found guilty on April 30, 2012, by a jury for mail fraud, filing false claims against the United States and conspiracy to file false claims against the United States, announced the Justice Department’s Tax Division, the U.S. Attorney’s Office for the District of Colorado and IRS-Criminal Investigation. In addition to these counts, Armstrong was also found guilty of engaging in monetary transactions in property derived from the mail fraud. The guilty verdicts were the result of a three week trial before U.S. District Court Judge Robert E. Blackburn. Morris and Armstrong are scheduled to be sentenced on Aug. 10, 2012.

Suzanne Land, a Cincinnati attorney, pleaded guilty today to obstructing and impeding the Internal Revenue Service (IRS) while representing the estates of two deceased clients, the Justice Department and IRS announced. District Court Judge Herman J. Weber presided over the guilty plea hearing.

Gregory K. Dupont, 38, of Plaquemine, La., was sentenced in U.S. District Court in Baton Rouge, La., to serve six months in prison, to be followed by four months in a half-way house and two years of supervised release for the first ever felony conviction and prison sentence resulting from the illegal hunting of American alligators.

William R. Herder of Bellville, Ohio, was arrested today on federal tax charges, Assistant Attorney General of the Justice Department’s Tax Division Kathryn Keneally, U.S. Attorney for the Northern District of Ohio Stephen M. Dettelbach and Special Agent in Charge, Internal Revenue Service (IRS) Criminal Investigation, Cincinnati Field Office, Darryl K. Williams announced. On June 19, 2012, a federal grand jury sitting in Cleveland returned an indictment against Herder, charging him with corruptly endeavoring to impair and impede the due administration of the Internal Revenue laws, failure to file tax returns, failure to pay taxes, and structuring transactions to evade currency reporting requirements.

Attorney General Eric Holder and Malaysian Minister for Home Affairs Datuk Seri Hishammuddin bin Tun Hussein met today, during the Attorney General’s official visit to Malaysia, to discuss transnational crime, terrorism and other areas of mutual law enforcement cooperation.

A federal judge in Worcester, Mass., sentenced William Scott Dion today to 84 months in prison for conspiring to defraud the United States, and for obstructing the Internal Revenue Service (IRS), the Justice Department and IRS announced. U.S. District Judge F. Dennis Saylor also ordered Dion to pay restitution in the amount of $3 million.

A federal judge in Worcester, Mass., sentenced Catherine June Floyd today to 60 months in prison for conspiring to defraud the United States and for obstructing the Internal Revenue Service (IRS), the Justice Department and IRS announced. U.S. District Judge F. Dennis Saylor also ordered Floyd to pay restitution in the amount of $3 million.

A federal judge in Boston sentenced Charles Adams today to 48 months in prison for tax evasion, conspiring to defraud the United States and obstructing the Internal Revenue Service (IRS), the Justice Department and IRS announced. U.S. District Judge F. Dennis Saylor also ordered Adams to pay restitution in the amount of $401,000.

The Residential Mortgage Backed Securities Working Group members today announced their first legal action since the working group formation earlier this year.

A federal judge in Boston sentenced Gary Alcock today to 14 months in prison for tax evasion, for conspiring to defraud the United States, and for willfully failing to file tax returns, the Justice Department and Internal Revenue Service (IRS) announced. U.S. District Judge F. Dennis Saylor also ordered Gary Alcock to pay restitution in the amount of $515,518. Alcock pleaded guilty to the charges on Dec. 9, 2011, and provided substantial assistance to the government in prosecuting the case against the remaining defendants, which Judge Saylor cited, among other factors, as a basis for a reduced sentence.

An indictment was unsealed today in Fort Pierce, Fla., charging Joseph Rizzuti with one count of corruptly endeavoring to obstruct the Internal Revenue Service (IRS) and four counts of wire fraud, the Justice Department and the IRS announced. The indictment was returned by a grand jury on Nov. 29, 2012.

A federal grand jury in Trenton, N.J., returned an indictment charging David Moleski with 14 counts of mail fraud, one count of wire fraud, one count of corruptly impeding the due administration of the Internal Revenue laws and three counts of filing false claims for tax refunds, the Justice Department and the Internal Revenue Service (IRS) announced today.

Thomas William Quintin, 65, formerly of Denver, pleaded guilty to one count of conspiracy to defraud the United States with respect to claims, and one count of misuse of a Social Security number, before U.S. District Court Judge R. Brooke Jackson.

Eric Majette, 52, a tax return preparer and owner and operator of the Berrisford Group, located in Somerville, N.J., pleaded guilty today to corruptly endeavoring to obstruct and impede the Internal Revenue laws and to preparing a false tax return.

The Justice Department announced that late yesterday a federal court in San Francisco entered an order authorizing the Internal Revenue Service to serve a John Doe summons seeking information about U.S. taxpayers who may hold offshore accounts at Canadian Imperial Bank of Commerce FirstCaribbean International Bank.

The Justice Department today unveiled a plan calling for sweeping changes to advance crime victims’ rights and services in the 21st century.

The Justice Department and the Internal Revenue Service (IRS) announced today that Richard R. Whatley, a former owner of Alliance Staffing Management Inc. (ASM), was sentenced to 51 months in prison today for willfully failing to account for and pay over employment taxes.

The Justice Department announced today the unsealing of a superseding indictment returned by a federal grand jury in Sacramento, Calif., charging Teresa Marie Marty, Charles Tingler and Victoria Tingler, all of Placerville, Calif., with conspiracy to defraud the United States and filing multi-million dollar liens against government officials.

A licensed psychiatrist employed by the Department of Veterans Affairs (VA) pleaded guilty today to health care fraud for falsely billing Medicare for home medical treatment to Medicare beneficiaries and agreed to forfeit more than $1.2 million in illegal profits.

Assistant Attorney General for the Tax Division Kathryn Keneally and U.S. Attorney Melinda Haag for the Northern District of California announced that Noemi Rubio Baez, of Salinas, Calif., pleaded guilty to conspiracy to file false claims for tax refunds with the Internal Revenue Service (IRS) and to aggravated identity theft.

Five Banks Directed to Produce Records for Accounts at Zurcher Kantonalbank, The Bank of N.T. Butterfield & Son Limited and Affiliates

Attorney General Eric Holder today announced the first public hearing of a new task force to examine the impact of exposure to violence on American Indian and Alaska Native children. Joining President Obama and other officials at the Department of the Interior for the White House Tribal Nations Conference, Attorney General Holder shared the announcement with leaders from the 566 federally recognized tribes and emphasized the Justice Department’s long-standing collaboration with leaders in American Indian and Alaska Native communities to improve public safety.

Robert Eldon Robertson and his wife Esther Lynne Robertson of Manteca, Calif., were indicted on charges of filing two false claims for federal tax refunds, filing liens against the former Internal Revenue Service (IRS) commissioner and impeding the administration of federal tax laws, the Justice Department and IRS announced today.

Attorney General Eric Holder and Acting Department of Homeland Security (DHS) Secretary Rand Beers today hosted an EU/U.S. Justice and Home Affairs Ministerial with their counterparts in the European Union: Lithuanian Minister of Justice Juozas Bernatonis and Lithuanian Vice Minister of Interior Elvinas Jankevicius representing the Lithuanian Presidency of the Council of the EU; Greek Minister of Justice, Transparency and Human Rights Charalampos Athanasiou representing the incoming Greek Presidency of the EU; and European Commission Vice President Viviane Reding and Commissioner Cecilia Malmström representing the EU Commission.

Chairman Carper, Ranking Member Coburn, and distinguished Members of the Committee: Thank you for the opportunity to appear before the Committee today to discuss the Department of Justice’s work regarding virtual currencies.

"Thank you for the opportunity to appear before the Committee today to discuss the Department of Justice’s work regarding virtual currencies. I am honored to represent the Department at this hearing and to describe for you our approach to virtual currencies"

Gary Mach, of Palm Desert, Calif., was sentenced to 16 months in prison, two months of house arrest, and 18 months of probation and ordered to pay $270,725 in restitution to the Internal Revenue Service (IRS), the Justice Department and IRS announced today.

The Attorney General’s Advisory Committee of the Task Force on American Indian/Alaska Native Children Exposed to Violence held its first public hearing today in Bismarck, N.D., convening tribal researchers, advocates and local community members to discuss domestic violence and child physical and sexual abuse in Indian Country.

The Tax Division of the Department of Justice today strongly encouraged Swiss banks that want to seek non-prosecution agreements to resolve past cross-border criminal tax violations to submit letters of intent by the Dec. 31, 2013 deadline required by the Program for Non-Prosecution Agreements or Non-Target Letters for Swiss Banks.

The U.S. Department of Justice and the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) today announced appointments to a newly created National Commission on Forensic Science.

The Justice Department’s Civil Rights Division and the U.S. Attorney’s Office for the Southern District of Indiana announced the filing of a nine count federal indictment this afternoon against Jerry Mitchell, aka Tre da Great, age 24, of Indianapolis.

Abdelhamid M. Horany, 58, of Denver, pleaded guilty today before U.S. District Judge R. Brooke Jackson in federal court in Denver to one count of tax evasion related to his 2007 individual income taxes, announced the Justice Department and the Internal Revenue Service.

Since 2009, the Department has publicly charged 73 account holders and 35 professionals with violations arising from their offshore banking activities, and 72 individuals have pled guilty or were convicted at trial. Just as importantly our enforcement efforts have driven over 43,000 taxpayers with secret offshore accounts to identify themselves to the IRS, disclose their offshore accounts, and to pay a total of over $6 billion in back taxes, penalties and interest. And that number is growing.

A licensed psychiatrist formerly employed by the Department of Veterans Affairs (VA) was sentenced today to serve 18 months in prison for falsely claiming to provide at-home services to Medicare beneficiaries.

Romano Pisciotti, an Italian national, was extradited from Germany on a charge of participating in a conspiracy to suppress and eliminate competition by rigging bids, fixing prices and allocating market shares for sales of marine hose sold in the United States and elsewhere.

“For 27 years, Gina Talamona has been a tremendous asset to the Department of Justice and an exceptionally dedicated public servant. She’s been the backbone of our dedicated Office of Public Affairs team, providing leadership and sound guidance to Attorneys General and other leaders from administrations of both parties."

Attorney General Eric Holder, Deputy Attorney General James Cole, Assistant Attorney General for the Tax Division Kathryn Keneally and IRS Commissioner John Koskinen will hold a press conference to announce a major law enforcement action.

We recognize the Committee’s interest in this matter. We share that interest and are conducting a thorough and complete investigation and analysis of the allegations of targeting by the IRS. While I know you are frustrated by the fact that I cannot at this time disclose any specifics about the investigation, I do pledge to you that when our investigation is completed, we will provide Congress with detailed information about the facts we uncovered and the conclusions we reached in this matter

A federal jury returned guilty verdicts today against former Virginia Governor Robert F. McDonnell and former First Lady of Virginia Maureen G. McDonnell for participating in a scheme to violate federal public corruption laws.

Chairman Carper, Ranking Member Coburn and distinguished members of the committee, thank you for inviting me to speak with you today about the Department of Justice’s role in supporting state, local and tribal law enforcement agencies.

Business leaders from the Asia-Pacific region called for APEC leadership and cooperation to combat the grave challenges to health and economies posed by the COVID-19 pandemic.

When I was a teenager, my grandfather would invite my new boyfriends to run short, pointless errands with him, just so he could watch them drive. He said he could tell a lot about a boy’s character simply by observing his actions behind the wheel. Did he stay under the speed limit? Did he use his signal when he was switching lanes? Did he slow down when children were playing near the road? If so, it was a good sign that the boy was generally a careful and attentive fellow. If not, it was an early indication of reckless tendencies, and I would do well to be on my guard.

What does this have to do with PI oversight?



As Sponsors and CROs, you’re sometimes forced to make site selection decisions based on a limited set of criteria that you deem to be – hope to be – reflective of the site as a whole. In a short space of time, you need to assess a PI’s commitment to study oversight. On what should your pre-study “test drive” focus to help you gauge the level of care and attention a prospective PI will devote to your study?

We have some suggestions.


Assessing Attention to Detail
Any GCP-compliant site can produce a set of current CVs, job descriptions, and training records; they’re essential documents. But the most attentive sites are able to show you more than a collection of records during your pre-study visit with them. These sites keep a complete, organized set of uniform records and can describe their tight system for maintaining it. All documents for each staff member are found in dedicated tabs inside a records binder, or are equally well-organized in an electronic records system. All CVs are in a standard format so Sponsors can easily compare qualifications across individuals. Every document is current; CVs are up to date, and there’s a system in place to track which medical licenses are expiring when. Training records are comprehensive and include training on GCP regulations, site SOPs, and EMRs.

This is not sexy stuff. That’s why it’s a good indicator of PI oversight.  A site that is disciplined enough to keep such tight control over its personnel records is likely to carry that control into all aspects of trial execution.

Assessing Commitment to Protocol Compliance
During site initiation visits, Sponsor/CRO staff is on site to conduct protocol training; all study sites start off the same in this respect. But protocol amendments are inevitable, and sometimes – though nobody’s happy about it – frequent. You need assurances that a site’s response to each amendment will be swift, well-coordinated, and deliberate. Ask the prospective PI, “What procedures does your site follow for managing protocol amendments?”

The A answer:
“When a protocol amendment arrives, we convene a special team meeting to review the changes and discuss their effects. For example, if additional safety tests are required, the team discusses who shall be delegated to perform them? Do we have adequate time scheduled into the visit for any additional procedures the amendment requires? How will I be demonstrating oversight of any new test results? Once we’ve asked and answered these kinds of questions, we document attendance at the meeting, record assignments of delegated duties, and publish meeting minutes.”

The F answer:
“I email the amendment out to my team. I assume they’re all adults and know how to read.” (#TrueStory)

Just Ask
After reviewing essential documents and protocol amendment procedures, you should ask about other PI oversight mechanisms the site has in place. A good prospective site might tell you the PI holds biweekly meetings to review the items raised during monitoring visits. A PI may block out time at regular intervals to review adverse events and other study documents, and sign off on labs. A PI who values staff excellence may actively encourage and support Study Coordinator certification; some may even require it after an initial period of employment. In the past, we’ve worked with sites that have established internal Quality Control procedures, some maintain CAPA programs, and others conduct mock inspections.

There’s a wide variety of responses that can give you confidence a prospective PI is committed to running your study in a constant state of control. Whatever oversight measures are discussed, remember to ask how they will be documented, so during the study you’ll be able to verify that each activity is being consistently carried out.

Epilogue
After running an errand with a boy I met at college, my grandfather happily reported back to me, “He didn’t roll through a single stop sign coming down Green Hill Road. He’s all right, that one.”

My grandfather, a retired police detective for the city of Pittsburgh, knew how to read a person. That boy and I celebrated our 30th anniversary last month.

I was a child bride.

If you found this article helpful, you might also like:
Anticipating Tensions Between Clinical Care and Study Protocol
Avoiding Protocol Deviations

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