ADARUQ ConferenceADARUQ Conference

October 18, 2006October 18, 2006

Timothy L. Quigg, Associate Chair of Computer ScienceTimothy L. Quigg, Associate Chair of Computer Science

University of North Carolina at Chapel HillUniversity of North Carolina at Chapel Hill

Overview of Current Overview of Current Research Administration Issues Research Administration Issues

in the United Statesin the United States

(Compared with Quebec!)

Research

Management

Influences on Development of Influences on Development of U.S. Approach to Conducting and U.S. Approach to Conducting and

Managing ResearchManaging Research

History of External Support

Research System

Key Cultural Values

General Trends in

Management

Increasing Funding

Complexity

OutlineOutline

Money

Staffing (Central-Departmental)

Compliance – Unified Institutional Response• Misconduct in Science

• Human Subject Testing

• Intellectual Property Management

• Technology Transfer

• Conflict of Interest (Individual-Institutional)

Current State of Research Current State of Research Administration in the United StatesAdministration in the United States

“In the real world, Research Administrators strive to provide quality support to the research enterprise while following all of the applicable policies and rules. It’s not always as easy as it sounds!”

Department Chair

Sponsored Programs Office

Purchasing Office

Funding Agencies

Dean’s Office Students

OutlineOutline

Money

Staffing (Central-Departmental)

History & Projections of U.S. History & Projections of U.S. Research FundingResearch Funding

Increase in National R&D Funding

Increase in Federal Health Funding

R&D at Colleges Increasing

Most of Increase is in Life Science

Conclusions - NationalConclusions - National

Funding increased significantly over last 50 years

Health funding increased

NIH tripling

Flattening in next 5 years

Awards in Millions at UNC-CH

$0

$100

$200

$300

$400

$500

$600

$700

Trends of Federally Sponsored Trends of Federally Sponsored Awards at UNC-CHAwards at UNC-CH

60

65

70

75

80

85

90

95

Federal Funding

Federal Fundingtrend

% o

f Fed

eral

Fu

nd

ing

Sponsored awards vs state Sponsored awards vs state appropriations at UNC-CHappropriations at UNC-CH

$0

$50

$100

$150

$200

$250

$300

$350

$400

$450

$500

$550

$600

1978 1981 1984 1987 1990 1993 1996 1999 2003 2006

(in Millions)

State Appropriations

Sponsored Research Awards

2006 Funding by School2006 Funding by School

Other schools

Education

College of Arts & Sciences

10%

Medicine49%

All other units22%

Social Work

Dentistry

Pharmacy

Nursing

Public Health10%

2006 Funding by Source2006 Funding by Source

Other Government

3%

Industry4%

Other Non-Profit9%

Foundations7%

State of North Carolina

5%

Federal72%

Research Dollars vs Staffing at UNC-CHResearch Dollars vs Staffing at UNC-CH

$0

$100

$200

$300

$400

$500

$600

$700

RESEARCH DOLLARS

(in Millions)

0

20

40

60

80

100

OSR STAFFING

ResearchDollarsStaffing

Conclusions: UNC-Chapel HillConclusions: UNC-Chapel Hill

From zero to $600M in 45 years % from federal sources decreasing Sponsored research exceeds state

appropriations Staff size constant Need for new paradigms

• Central – department cooperation

• Delegation of responsibility

OutlineOutline

Money

Staffing (Central-Departmental)

Compliance – Unified Institutional Response• Misconduct in Science

• Human Subject Testing

• Intellectual Property Management

• Technology Transfer

• Conflict of Interest (Individual-Institutional)

“The only ethical principle which has made science possible is that

the truth shall be told all the time…”

C.P. Snow “The Search” 1959C.P. Snow “The Search” 1959 Quoted in “Honor in Science”Quoted in “Honor in Science”

““The right to search for truth The right to search for truth

implies also a duty; implies also a duty;

one must not conceal any partone must not conceal any part

of what one has of what one has

recognized to be true.”recognized to be true.”

- Albert EinsteinAlbert Einstein

Scientific Fraud and Misconduct Scientific Fraud and Misconduct Frequency Over the Past 10 YearsFrequency Over the Past 10 Years

Institutional Compliance is:Institutional Compliance is:

A commitment to obey federal and state laws and sponsor policies, and follow internal policies and procedures

An ongoing operational program to prevent, detect, and correct wrongdoing

A system of internal control and procedures to evaluate operational practices, minimize legal and business risk and implement corrective action

Expectations of high standards of conduct in science:• Protection of human and animal research subjects

• Proper fiscal management of public funds

• Proper use and disposal of hazardous materials

• Adherence to scientific method to produce valid knowledge

Federal Definition - Federal Definition - Research Misconduct:Research Misconduct:

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results. Research misconduct does not include honest error or differences of opinion.

Fabrication: making up data or results and recording or reporting them

Falsification: manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record

Plagiarism: the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

WhistleblowersWhistleblowers

A good faith allegation is made with the honest belief that research misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation

Qui Tam provisions of the Qui Tam provisions of the False Claims ActFalse Claims Act

Allows private parties to sue entities and individuals that have submitted false claims to the federal government

Can receive a portion of the settlement if the government receives a monetary agreement with the defendant

Recent SettlementsRecent Settlements

Revealed via Qui Tam (Whistleblower):

University 1- $5.5 M (Feb, 2003)

University 2 - $2.6 M (Feb, 2004)

University 3- $3.4 M (Apr, 2005)

University 4- $4.4 M (Jun, 2005)

Revealed via voluntary disclosure:

University 5- $2.4 M (June 2004)

All involved overstatement of effort on NIH grants

Human Subject Testing:Human Subject Testing:Tuskegee Syphilis ExperimentsTuskegee Syphilis Experiments

From 1932 to 1972, the US Public Health Service conducted an experiment in Macon County, Alabama, to determine the natural course of untreated latent syphilis in black males. Treatment was withheld even after the onset of penicillin therapies became commonplace around 1940.

Recent CasesRecent Cases Jesse Gelsinger Case (University of

Pennsylvania, Institute for Gene Therapy) – September 1999

An 18 year old volunteer in a gene therapy clinical trial for Ornithine Transcarbamylase (OTC) Deficiency, died four days after being injected with corrective genetic material. It was determined that the death was research-related.

The university held equity in the company developing the drug, and the lead doctor held one-third of its shares of stock

Conflicts of Interest Conflicts of Interest It’s About Public TrustIt’s About Public Trust

“Is the situation likely to interfere or appear to interfere with the independent judgment one is supposed to show as a professional performing official duties?

Conflicts of InterestConflicts of InterestFinancial Ties between ResearchersFinancial Ties between Researchers

and Industryand Industry Grants and Contracts

Consultants

Advisory Boards

Speaker’s Bureaus

Patent/Royalty Arrangements

Expensive Gifts/Trips

Equity Interest

It’s About Public Trust

Longstanding interest in objectivity in research and financial conflict of interest.

Key Question: “Is the situation likely to interfere or appear to interfere with the independent judgment one is supposed to show as a professional performing official duties?”

Conflict of InterestConflict of Interest

It must also require that those financial disclosures are updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained.

Institutional policy must ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF or NIH.

Conflict of InterestConflict of Interest

Technology Transfer: Technology Transfer: Bayh-Dole ActBayh-Dole Act

Enacted December 1980; tech transfer born

Encouraged universities and research institutions to collaborate with industry, to commercialize successes

Institutions may elect to retain IP title Institutions must file patents if

ownership is desired Government retains nonexclusive license

plus march-in rights Preference provided to small businesses

Research EthicsResearch EthicsConclusionsConclusions

Science is a community of trust. When this trust is violated, it tends to be on the front page of the paper.

You cannot teach ethics, but you can watch for it

Conflicts of interest and commitment are natural. They cannot be eliminated, but they can (and should) be managed.