May 2001

R&SP Honors JoAnn Pipkin for the R&SP Communicator Name
In JoAnn's own words, "When we were first asked to think of a name for the newsletter and how the newsletter was to be used to communicate with our research clients, I just thought R&SP Communicator was appropriate. I think the newsletter will be a great tool for our office to communicate with other offices we deal with on a daily basis." Well said, JoAnn! The R&SP Communicator is a prime example of technology being utilized to keep the IUPUI research community informed.

As the Administrative Secretary for the Research and Sponsered Programs office, one of JoAnn's daily tasks involves providing information and service to the many research clients that contact R&SP for assistance. JoAnn is a native of St. Louis, MO. She has lived in Indy for twenty-three years. JoAnn and husband Mike, will celebrate their 25th anniversary this year. They have three sons. Jeff graduated from Franklin College May 19 and was married May 26. Matt and Tim are both IUPUI students. One down, two to go!

IRB-05 Established for IUPUI Biomedical
The deadlines (Documents must be received in Research & Sponsored Programs no later than 12:00 noon) for IRB-05 are:
Monday, July 9, 2001
Monday, August 13, 2001
Monday, September 10, 2001
Monday, October 8, 2001
Monday, November 5, 2001

Faculty Council Approves Test Requirement
R&SP offers faculty, staff, and students several options to fulfill the Protection of Human Subjects in Research education:

Departing IUPUI?
It is the responsibility of the principal investigator to notify the Research and Sponsored Programs office prior to leaving the University to amend or close out their study:

Researchers and Institutions May be Liable in Whistleblower Lawsuits

American Association of Medical Colleges
March 6, 2001
Memorandum # 01-13

Association members should be aware that when a researcher fails to disclose sources of industry support in an application for a federal grant, both the researcher and the grantee institution may be held liable for damages of up to three time[s] the amount of the grant award. In United States ex rel Cantekin v. Univ. of Pittsburgh,1 a case in which a researcher knowingly omitted industry funding information from an NIH grant application, the U.S. Court of Appeals for the Third Circuit held both the researcher and the institution liable under the federal False Claims Act.2

The False Claims Act, the government's most powerful weapon against civil fraud, imposes liability for treble damages against anyone who knowingly submits a false statement to the government in an effort to obtain federal funds. The qui tam provisions of the False Claims Act, 31 U.S.C. § 3730(b), allow a private individual to bring a false claim suit on the government's behalf. The statute is deliberately structured to encourage such third party lawsuits, by enabling the "whistleblower" or qui tam plaintiff in a successful false claims suit to share in any damages awarded to the government.

Cantekin arose from a disagreement between two University of Pittsburgh Medical School researchers, Dr. Erdem Cantekin and Dr. Charles Bluestone. Cantekin questioned Bluestone's interpretation of several industry-funded studies, and the dispute escalated to the point where Cantekin alleged research misconduct. Cantekin also sued Bluestone and the University under the qui tam provisions of the False Claims Act, claiming that Bluestone, the recipient of millions of dollars in both federal and industry support, had made an illegal false claim by failing to disclose his industry funding in NIH grant applications.

Bluestone challenged Cantekin's right to bring a whistleblower suit based upon a grant application, but on appeal the Third Circuit reversed a decision by the lower court and determined that Cantekin could indeed sue Bluestone and the University on the government's behalf over Bluestone's failure to meet the NIH disclosure requirements. The Third Circuit accepted Cantekin's argument that complete information about sources and amounts of industry sponsorship is material to the NIH review of grant applicants' potential conflicts of interest. The Third Circuit also confirmed that under the False Claims Act Cantekin need not prove that Bluestone intended to defraud the government, but instead need merely show that Bluestone was aware of a material omission in the grant application.

AAMC Recommendation
Association members should remind their faculty and affiliated researchers of the importance of full and complete disclosure of industry support in NIH grant applications. The Cantekin case is significant for its formal legal recognition of whistleblower claims arising from incomplete information about sources of research support in grant submission. Because whistleblowers have a financial incentive to pursue false claims lawsuits, this decision increases the likelihood that whistleblowers who allege research misconduct will scrutinize grant applications for any misstatements or omissions that may form the basis for legal action.

Association members should consult their legal counsel for further advice concerning liability under the False Claims Act.

1 192 F.3d 402 (3rd Cir 1999).

2 Although the legal precedent in Cantekin binds only courts in the 3rd Circuit (i.e., courts in Delaware, New Jersey, Pennsylvania, and the Virgin Islands), other courts could adopt the Third Circuit's reasoning when ruling upon a similar matter.

21st Century Research and Technology Fund Reauthorized
The awards to IU researchers have totaled over $8 million to date. The only changes to the Fund made by the legislature were to add additional members to the board to enhance the "economic development" orientation of the awards. This means that, while it has always been the case that projects that included the direct participation of industrial partners have been favored, it is expected that this will be even more important in the future.

The deadlines for proposals for the next two rounds of funding will be September 15, 2001 and June 1, 2002. After allowing for commitments to existing multiyear projects, the Fund expects to award approximately $21 million each time. For further information about the fund and to view the revised RFP, go to their web site at: http://www.21fund.org/.

To:	Council of Deans Council of Academic Societies Council of Teaching Hospitals and Health Systems
From:	Jordan J. Cohen, M.D.
Subject:	Researchers and Their Institutions May be Liable in Whistleblower Lawsuits for Failure to Disclose Industry Funding in NIH Grant Applications


Volume I, Issue 2 May, 2001	Research and Sponsored Programs


Research and Sponsored Programs UN 618 General - 274-8285 Research Compliance - 274-8289 Sponsored Program Development - 278-0249

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