Failure to Disclose Industry Funding in NIH Grant Applications May Jeopardize Researchers and the Institution

A recent communication from Dr. Jordan Cohen of the AAMC (full text below) described a case in which a researcher knowingly omitted industry funding information from an NIH grant application. The Courts held both the researcher and the University of Pittsburgh liable under the federal False Claims Act. This Act imposes liability for treble damages against anyone who knowingly submits a false statement to the government in an effort to obtain federal funds.

The Office of Research and Graduate Studies reminds all researchers and staff responsible for preparing federally sponsored research applications of the importance of full and complete disclosure of industry support in these applications.

The AAMC notes that 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 actions.

Memo from AAMC (Association of American Medical Colleges # 01-13)

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

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 times the amount of the grant award. In United States exrel Canteknin 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. Catekin also sued Bluestone and the University under the qui tam provision 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 submissions. 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 (3^rd Cir. 1999).

² Although the legal precedent in Cantekin binds only courts in the 3^rd 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.

Responsible Conduct of Research -
What You Need to Know

The Office of the Vice President for Research invites you to its seventh annual Research Responsibility Program (RRP), a series of information and discussion sessions on responsibility in research. Sessions are free and open to all faculty, students, and staff. The Medical School strongly encourages its members to take advantage of this program. For more information about the RRP, please call the OVPR at 763-1289 or send e-mail to: research.responsibility@umich.edu. All sessions are 5:00-7:00 p.m. on the days indicated.

Introduction to Responsibility in Research

Wednesday, September 12, 2001, at 4448 East Hall
Thursday, September 20, 2001, at F1540 Mott

Conflict of Interest

Monday, January 14, 2002, at 4448 East Hall
Wednesday, January 23, 2002, at G2305 Towsley

Human Participant Protections

Social Sciences:

Wednesday, October 10, 2001, at 6050 Institute for Social Research
Monday, February 18, 2002, at 4448 East Hall

Biomedical Sciences:

Monday, December 3, 2001, at F2305 MCHC
Monday, March 18, 2002, at G2305 Towsley

Authorship

Social Sciences:

Wednesday, October 17, 2001, at 4448 East Hall

Biomedical Sciences:

Tuesday, October 23, 2001, at F1540 Mott

Data Management

Monday, November 5, 2001, at 4448 East Hall
Tuesday, November 13, 2001, at F1540 Mott

Animal Subject Protections

Tuesday, February 5, 2002, at G2305 Towsley

Award Recipient

Anna Mapp, Ph.D., Winner of Burroughs Wellcome Fund Award

The Office of Research and Graduate Studies is pleased to announce that Anna Mapp, Ph.D., Assistant Professor, Medicinal Chemistry, College of Pharmacy, is the recipient of a Burroughs Wellcome Fund New Investigator Award in Toxicological Science.

Dr. Mapp is an outstanding organic chemist with a record of accomplishment in both synthetic organic chemistry and bioorganic chemistry. In her independent career at Michigan, Dr. Mapp proposes to pursue three distinct avenues of research, all of which are aimed at the regulation of gene transcription using the tools of modern synthetic organic chemistry and molecular biology.

Microscope Repair Service

The Office of Research and Graduate Studies is pleased to announce the creation of a new microscope repair service as a collaborative effort between the Department of Cell and Developmental Biology and the Microscopy and Image-analysis Laboratory (MIL). Service will be provided by Ms. Shelley Almburg who has been performing microscope repair and cleaning at the University for over twelve years. Many departments are already familiar with her skills. Service hours will begin October 8, 2001. Shelly can be contacted through MIL at 763-1170 for appointments or contact Chris Edwards at 936-4912.

UMHS Events Calendar

It is always challenging to come up with good ways to alert students, faculty and staff to the many events that occur on the medical campus. There is a limit to how much attention an individual can give to much of the information that is made available to them each and every day. One very helpful site that posts notices on a selection of seminars and events is the University of Michigan Health System Events calendar located at: http://www.academic.med.umich.edu/lassopages/publicevents.lasso

This is a main repository for the advertisement of seminars and events within the University of Michigan health system and the biomedical research community. All departments and units can post their seminars/lectures and events on this calendar. To post an event on this calendar, you submit online at http://www.med.umich.edu/medadmin/events/.

Safety Advisories

Compressed gas cylinder safety tips:

Never transport cylinders loose in any manner
Always transport cylinders secured in a carrier designed for this purpose
Always store cylinders in a designated area, secured upright in a rack or carrier
Never leave cylinders that are not in use unattended in a hall or other area not designated for storage
Never use oil or grease on regulators or fittings

The most sensitive part of a compressed gas cylinder is the valve (located at the top of the cylinder). When improperly handled, the cylinders can be very dangerous, even deadly. If dropped or knocked over in a way that causes damage to the valve, the cylinder can react like a missile. In these situations, cylinders have been known to penetrate concrete walls or spin wildly, damaging anything in their path.

Questions regarding the use, storage and handling of compressed gas cylinders can be directed to the Respiratory Care Department. For the Taubman Center and Cancer Center, call 936-8369 or pager 1559. For the University Hospital and all off-site areas, call 936-5240 or pager 1550.

Funding Opportunities

Doris Duke Clinical Scientist Development Award Program–Internal Deadline October 8, 2001 http://ddcf.aibs.org/medical/index.asp

The Doris Duke Clinical Scientist Development Award Program is designed to help support new investigators with a MD or MD/PhD as they begin their careers in clinical research. The program is limited to investigators doing research in cardiovascular disease, cancer, AIDs, and sickle cell anemia and other blood disorders. The awards are offered to junior faculty and research fellows. Junior faculty are eligible to receive $100,000 per year for five years and fellows are eligible to receive $65,000 per year for five years.

Applicants must have received a MD on or after July 1, 1990. They must have completed two or more years of clinical training and one or more years of a full time research fellowship . Applicants must be working in a US institution but they do not have to be US citizens. Physician-Scientists who are faculty members at the Assistant Professor level or below for three years or less, are eligible to be nominated for this award.

Together the Medical School and the School of Public Health may nominate a total of eight applicants, one applicant at the fellow level and one at the faculty level in each of four disease areas (cardiovascular diseases, cancer, AIDS, and sickle cell anemia and other blood disorders).

The Foundation requests letters of nomination prior to full proposals.

Internal application deadline: October 8, 2001
Foundation Letter of intent deadline: November 8, 2001
Foundation Proposal deadline: December, 12, 2001

For consideration as one of the institutional nominees, submit the following by Oct. 8, 2001:

A 1–2 page research summary
A CV on the nominee
A letter (maximum 2 pages), which includes:

The name of the nominee and the title of the proposed project.
The nominee's title (job status–faculty or fellow), the date that the nominee received his/her MD degree, and for faculty members, the date of his/her first faculty appointment and a statement that this appointment is in an academic track.
A statement indicating whether the project area is cardiovascular diseases, cancer, AIDS, or sickle cell anemia and other blood disorders. It also should indicate the clinical research type e.g. etiology/pathogenesis, a therapeutic intervention, a clinical trial, disease control, epidemiology, or health outcomes.

Please submit all internal applications to the Office of Research and Graduate Studies (Medical School), 4107 Med Sci I, Box 0624 by October 8, 2001. Contact: Denise Swayze, 763-4086 or dswayze@umich.edu

Complete details on the program can be found on the Doris Duke Charitable Foundation web site at: http://ddcf.aibs.org/medical/index.asp, or contact Denise to receive a copy by fax.

The Dana Foundation Clinical Hypotheses in Immuno-imaging Program–Deadline October 22, 2001 http://www.dana.org/grants/health/proposals/immuno.cfm

The Dana Foundation is pleased to announce a call for proposals for its Clinical Hypotheses in Immuno-imaging Program. The Program hopes to promote a better understanding of the cellular and molecular events in immune system functioning through the use of new imaging technologies.

Grants totaling up to $100,000 over three years will be provided. Researchers at U.S. medical schools and schools of public health are eligible to apply. Projects involving collaborations with NIH intramural researchers or industry scientists are acceptable.

Deadline for receipt of preliminary proposals is October 22, 2001. Applicants will be informed within five weeks whether or not they are invited to send in full proposals. Winners will be notified eight weeks following submission of full proposals. Grants will be made with funding starting April 1, 2002.

Please see the Foundation website for complete information and application procedures. http://www.dana.org/grants/health/proposals/immuno.cfm

The Dana Foundation Clinical Hypotheses Program in Imaging
"Using Brain Imaging Innovations to Improve Human Health" - Deadline October 12, 2001

http://www.dana.org/grants/health/proposals/imaging.cfm

The UM Medical School has been invited to submit one proposal for this grant program. Successful applicants will receive grants of up to three years for up to a total of $100,000 for research focusing on developing and testing new uses of brain imaging technologies, creating new approaches to understanding brain processes, and monitoring brain activities or the effects of new therapies. Deadline for submission of a preliminary proposal to the foundation is November 5, 2001. For consideration as the institutional nominee, please e-mail or call Denise Swayze (dswayze@umich.edu), 763-4086) before October 12, 2001.

The McKnight Endowment Fund for Neuroscience

The McKnight Endowment Fund for Neuroscience announces three annual awards to support research designed to bring us closer to accurately diagnosing, preventing and treating diseases of the brain and behavior.

1. McKnight Scholar Awards–Deadline January 2, 2002.

Each year up to six Scholars are awarded $75,000 per year over three years. Funds may be used in any way that will facilitate development of the Scholar's research program, but not for indirect costs. To be eligible, applicants must have the following:

M.D. and/or Ph.D. degree; formal postdoctoral training completed
A record of meritorious research in areas pertinent to the interests of the Endowment Fund
Not more than four years of experience in an independent faculty position
Evidence of a commitment to a career in neuroscience
U.S. citizenship or lawful permanent resident status
U.S.-based sponsoring institution, to which awards will be paid

Applicants may not:

Be employees of the Howard Hughes Medical Institute or scientists within the intramural program of the National Institutes of Health
Apply im more than two rounds of competition
Apply for continued postdoctoral support
Hold tenured positions or their equivalents

Deadline for applications is January 2, 2002. Awards will be announced in May and begin on July 1, 2002.

2. McKnight Technological Innovations in Neuroscience Awards–Deadline December 3, 2001

These awards support scientists working on new and unusual approaches to understanding brain function. Each award provides $100,000 annually for two years. Types of projects may include (but are not limited to):

Monitoring brain activity in awake, behaving animals
Increasing the spatial and temporal resolution of brain imaging methods
Simultaneously measuring the activity of ensembles of neurons
Monitoring synaptic plasticity in developing and living organisms
Delineating changing patterns of gene expression
Developing analytical techniques for multichannel neuronal recording
Introducing genes and controlling gene expression in specific classes of neurons
Unraveling chemical and genetic networks

Deadline for the letter of intent is December 3, 2001. Awards will be announced in late June and begin on August 1, 2002.

3. McKnight Neuroscience of Brain Disorders Awards–Deadline May 3, 2002

These awards support neuroscientists whose research involves solving the problems of neurological and psychiatric diseases. Each award provides $100,000 annually for three years. Types of projects may include (but are not limited to):

Using a model organism to study the function of disease genes
Applying novel technology (imaging, genomics, proteomics) to achieve early diagnosis, or to identify the pathogenesis of a brain disease
Apply principles of gene transfer and stem cell biology to neuro repair and to the recovery from brain disorders
Applying principals of axonal growth to neural repair.

Deadline for the letter of intent is May 3, 2002. Awards are announced in December and begin February 1, 2002.

Please check the Fund's web site for complete information at http://www.mcknight.org/neuroscience/

Ford Foundation Fellowships for Minorities http://www4.nationalacademies.org/pga/fo.nsf

The Ford Foundation announces Fellowships for Minorities to be administered by the National Research Council. The Fellowships are open to U.S. citizens or nationals who are planning a career in teaching and research at the college or university level and are:

Native American Indian
Mexican American/Chicana/Chicano
Alaska Native (Eskimo or Aleut)
Native Pacific Islander (Polynesian or Micronesian)
Black/African American
Puerto Rican The following Fellowships are available:

The following Fellowships are available:

Predoctoral–$16,000 to the fellow, institutional allowance of $7,500 for three years
Dissertation–$24,000 for one year
Postdoctoral–$35,000 for one year, $3,000 travel and relocation allowance, $2,000 cost-of-research allowance, $2,500 employing institution allowance, to be matched by employing institution

Application Deadline Dates:

Predoctoral: November 19, 2001
Dissertation: December 3, 2001
Postdoctoral: January 7, 2002

See website for complete eligibility information and applications at: http://www4.nationalacademies.org/pga/fo.nsf

Sidney Kimmel Foundation for Cancer Research Scholar Award–Deadline December 12, 2001 http://www.kimmel.org/

Sidney Kimmel Foundation for Cancer Research announces its 2002 Kimmel Scholar Award. The Foundation is dedicated to improving basic understanding of cancer biology and developing new methods for the prevention and treatment of cancer. The Foundation supports the research of accomplished young cancer investigators which emphasize "Basic Cancer Research", "The Rapid Translation of Basic Science Concepts Into Potential Therapeutic Applications" and "Clinical Research With Novel or Innovative Treatment Strategies."

The Foundation selects up to ten grant recipients who will receive $100,000 per year for two years. Qualified applicants must hold a M.D., Ph.D. or equivalent graduate degree and perform research in an American nonprofit institution. The Foundation provides five additional awards for physicians engaged in translational science. Eligible applicants include those with M.D. or equivalent degrees who have achieved the rank of Assistant professor on or after July 1997. Applicants must demonstrate a significant personal involvement in the laboratory component of the translational project described.

For complete guidelines and application information, see the Foundation's website at http://www.kimmel.org/

Howard Hughes Medical Institute Predoctoral Fellowships in Biological Sciences 2002 Deadline November 13, 2001 http://www4.nationalacademies.org/pga/fo.nsf

The Howard Hughes Medical Institute will award at least 80 five-year fellowships for full-time study toward a Ph.D. or an Sc.D. degree in the biological sciences. The competition is administered by the National Research Council. The annual stipend is $21,000 for 2002-2003. There is no dependency allowance. In addition, HHMI provides an annual fellow's allowance of $2,500 for health insurance, health-care expenses, books and supplies, journal subscriptions, a computer and computer-related expenses, travel to scientific meetings, professional fees or dues, tuition for special summer courses, secretarial or clerical services relevant to the program of study, or other purposes relevant to a fellow's study. HHMI provides an annual institutional allowance of $13,500 in lieu of tuition and assessed fees.

The fellowships are for students who have completed less than one year of graduate study toward an M.S., a Ph.D., or an Sc.D. degree in the biological sciences. Students who hold or are pursuing medical or dental degrees (M.D., D.O., D.V.M., D.D.S.) may be eligible to apply for fellowship support for study toward a Ph.D. or an Sc.D.

The program is open to both U.S. citizens and foreign citizens. Students with U.S. citizenship may take the fellowship abroad. Non-U.S. citizens must study in the United States. The application deadline is November 13, 2002. Applicants must apply via the Web. The program announcement, instructions, and sample application materials are available at: http://www4.nationalacademies.org/pga/fo.nsf

Seminars

Graduate Program in Immunology Seminar

The Graduate Program in Immunology will sponsor a seminar to be held on Wednesday, October 10, 2001 from 12:00– 1:00 p.m. in room 5623 Med Sci II. The speaker will be David B. Corry, M.D., Assistant Professor of Medicine and Immunology, Baylor College of Medicine. The topic will be "Regulation of Th1/Th2 Effector Switching During Antigen Exposure." For questions on the seminar, contact Ellen Elkin, Immunology Program at 615-4846 or eelkin@umich.edu.

Faculty New Business Creation Seminar

This seminar is for UM faculty who are interested in, or are in the process of launching a company. The seminar will focus on the basics of organizing, launching and building technology companies. Space is limited to 55 guests on a first-come first-serve basis. The course will cover a spectrum of relevant questions which include:

Is this a good time to start a company?
Is there money in the market to finance my idea/company?
How do I write a business plan?
How do I build an appropriate team?
How do I patent my inventions?
How do I license intellectual property from the university?
What are venture capitalists looking for?
What resources are available to me to get started?
What are some of the legal considerations that I should keep in mind?
How and where do I incorporate?
How do I do a deal with financiers?
How do we partner with corporations?

The seminar will be presented by the Business School (Samuel Zell), Robert H. Lurie Institute for Entrepreneurial Studies and the Center for Venture Capital and Private Equity Finance. It will be held on November 2, 2001 from 8:00 a.m.–5:00 p.m. at the Business School Executive Education Center (701 Tappan St.). Contact: Wassim Mourtada, Associate Director, Business School. at 936-3528 or wassim@umich.edu.

Wiesner Symposium IV, "Braving the New World: Benefits and Challenges of Genetic Knowledge"

The Office of the Vice President for Research and the Life Sciences, Values, and Society Project announce the Wiesner Symposium IV, "Braving the New World: Benefits and Challenges of Genetic Knowledge", featuring Dr. Francis Collins,
Director of the National Human Genome Research Institute, as the keynote speaker. Dr. Collins will explore what the recent life science advances in genomics hold for society and research universities.

The symposium will be held Friday, December 7, 2001 from 8:30 AM to 6:00 PM (keynote speaker, other speakers and panel discussions) and Saturday, December 8, 2001 from 8:30 to 12 noon (workshops). It will be held in the Hale Auditorium (room 1115) of the School of Business Administration, located on Hill Street and Tappan. The symposium and workshops are free, but registration is required. More information and on-line registration is available at: http://www.wiesner.research.umich.edu

Cellular and Molecular Therapeutics Seminar Series

The "EGFR Superfamily and Breast Cancer Progression" will be presented by Marc Lippman, M.D., John G. Searle Professor and Chair, Internal Medicine. The seminar will be Monday, October 8, 2001 at 1:00 PM in the MCHC Auditorium (F2305). Contact: Lonna Watts at lwatts@umich.edu or 7-3413.

DRDA Proposal Writing Workshops

Research Proposal Writing:

October 9, 2001, from 8:30 AM-12:00 PM in the Pendleton Room at the Michigan Union. The cost is $10.00

This workshop is geared towards writing proposals for research grants in the physical, social, behavioral and life/health sciences.

Arts, Humanities and Education Grants Workshop:

October 18, 2001, from 8:30-11:30 AM in the Henderson Room at the Michigan League. There is no fee for this workshop.

This workshop will address funding and proposal writing issues for grants in the Arts, Humanities and Education.

For more information, or to register, go to:

http://cgi.research.umich.edu/workshops/workshop_descriptions.taf

October 2001, Vol. 19 No. 5