220 likes | 379 Views
Origins of RRI at ORI. 1999Chris Pascal / Larry Rhoades request $1M for RRIHHS (NIH source of funds) approvesMary Scheetz, ORI program officernow Cynthia Ricard <Cynthia.Ricard@hhs.gov> Contract to study of RRI literatureContacted researchers for adviceJuly 1999, contact N. Steneck regarding
E N D
1. Trends and Updates: Research on Research Integrity Nicholas H. Steneck, PhD
University of Michigan
2009 ORI RRI Conference:
THE CONFERENCE CENTER NIAGARA FALLS, NY
May 15-17, 2009
2. Origins of RRI at ORI 1999
Chris Pascal / Larry Rhoades request $1M for RRI
HHS (NIH source of funds) approves
Mary Scheetz, ORI program officer
now Cynthia Ricard <Cynthia.Ricard@hhs.gov>
Contract to study of RRI literature
Contacted researchers for advice
July 1999, contact N. Steneck regarding four projects:
November advisory committee meeting
National RRI Conference
RRI program
RRI Literature review
3. ORI justification (Pascal 2000) Since its establishment in 1992, the Office of Research Integrity (ORI) has conducted several studies on research misconduct and research integrity in an attempt to develop a knowledge base on important issues, such as the impact of misconduct allegations on exonerated scientists, the experience of whistleblowers in the aftermath of making allegations, the research guidelines adopted by medical schools, and the causes of research misconduct.
Over time, it became apparent to ORI that a more comprehensive, coordinated effort in collaboration with extramural research scholars was needed to develop the science base on research integrity issues. This recognition led to development of this "Research Conference on Research Integrity" and the related "Research on Research Integrity" program announcement jointly issued by ORI and the National Institute of Neurological Disorders and Stroke (RFA: NS-01-008).
4. Planning Committee Ruth Fischbach, Ph.D., M.P.E., National Institutes of Health
Mark Frankel, Ph.D., American Association for the Advancement of Science
Paul Friedman, M.D., UC, San Diego
Edward Hackett, Ph.D., Arizona State University
Stanley Korenman, University of California, San Diego
Francis Macrina, Ph.D., Virginia Commonwealth University
Barry Markovsky, Ph.D. University of Iowa
Kathleen Montgomery, Ph.D., UC, Riverside
John Perhonis, Ph.D., National Science Foundation
Drummond Rennie, M.D., F.R.C.P., F.A.C.P., UC, San Francisco
Allan Shipp, M.H.A., Association of American Medical Colleges
Peter Yeager, Ph.D., Boston University
5. Major events RRI (& RCR) Conferences
November 2000, Bethesda MD (Marriott)
November 2002, Potomac MD (Bolger Conference Center)
November 2004, San Diego CA (Paradise Point Resort)
UC San Diego School of Medicine
December 2006, Tampa FL (Safety Harbor Resort)
University of South Florida College of Medicine
April 2007, St. Louis MO (Washington University)
Washington University in St. Louis School of Medicine
May 2009, Niagara Falls NY (Conference Center)
Roswell Park Cancer Institute
RRI Program, December 15, 2000, deadline, 1st round
ORI does not have granting authority
Early 2000 explored administration options
6. May NIH presentation, IC Directors
7. Closing slides NINDS agreed to be 1st co-sponsor
8. RRI Program History 2001, RO1, two-year, $100,000/year, direct cost
2004, three-year, $250,000/year direct cost
Most proposals received
Lowest percentage of proposal funded
2005, two-year, $175,00
9. Funding rate average = 18%
10. Source of funds / totals
11. ORI / Other funding (60% / 40%)
12. Primary focus, all proposals
13. Areas: Proposed / Funded
14. RRI apart from ORI NIH funds training and research ethics, not RRI
Ethics = bioethics, not research ethics/integrity
RCR funded through training grants
RRI can be considered but few applications
NSF broad array of programs
STS –> EVS, HPS, SSS, and SPS
Research ethics training (REU, IGERT, etc.)
Peer Review Congresses
Research on peer review and biomedical publication
Peer generated and supported; no funding
15. NSF vs. NIH, RCR education ORI/NIH RCR Enhancement Initiative (2002)
Budget
National planning and coordination effort ($1.1m),
Institutional Support Program ($11.5m), and
Instructional Enhancement Program ($6.1m).
Approved by NIH Director in 2004, never implemented
National Science Foundation, research ethics
2001-2009, 328 “research ethics” awards
$270,616,429.00 total funding
Most to support instructional development
No special attention to or coordination of RRI
16. Global interest in RRI? Some interest in Europe:
Early pioneer, Croatia, now joined by other countries
European Science Foundation has RRI committee
Just getting organized
UK RIO has considered, but not yet undertaken
No support from European Commission
China is supporting some RRI
Developing an instrument to assess integrity
Has investigated plagiarism
Elsewhere, support for RRI is scattered
17. Observations: Professional development RRI has become a recognized field of research
Established researchers anxious to pursue
Peers have reviewed and endorsed proposals
Funding agencies provide some support
Literature and professional community has emerged
Influences on professional development of RRI
FUNDING ~ interest grows/declines with support
Funding mechanism ~ RO1 vs. R22
External events
Human subjects concerns
Conflict of interest
18. Observations: Tensions Researcher-funder conflict
Researchers interested in broad (basic) studies
Funders interested in IC-specific (applied) topics
Research-policymaker conflict
Researchers interested in broader (basic) studies
Policy makers want studies that are relevant to policy making
Professional apathy / hostility
RRI is “important” but low priority
…
RRI is conspiracy to undermine science
19. RRI track record (ORI & other) Misconduct “worldview” 1970s
Serious misconduct is rare
Self-regulation keeps in check
Misconduct is difficult to detect
Misconduct cannot be prevented
Apart from misconduct, standards are high
RRI has cast doubt on all five assumptions
FFP ~ 0.1–>1.0%; QRP ~ 5% –> 50%
Self-regulation has serious shortcomings
Better self-regulation would prevent FFP / QRP
Research integrity can be improved (considerably)
20. Challenge ~ demonstrating relevance 2006 Study (NEJM)
Early detection study
CT scan vs. X-ray
With CT scan, 80% of cases could be cured
March 28, 2008 NY Times*
Did not report study partly funded by tobacco company
Vector Group (Liggett) —>$$$—> Foundation for Lung Cancer:
Foundation listed in NEJM article, along with 31 additional funding sources
Did not report held patents on CT-scan-related technology
Impact/profit: 48M former smokers / 40M current smokers (US)
Others involved as members of Foundation for … Early Detection
Dean & Vice-Chair Board of Overseers, Weill Cornell Medical College
Controversial cases get attention
21. Comparison to careful RRI study Gorman, Evaluation & Program Planning (2007)
study of National Registry of Effective & Promising Programs for drug and alcohol use prevention
78% of published evaluations had developer as an author
Developers had a significant financial interest in outcomes
Evaluation in one program had serious methodological flaws
Texas spent $35M on one questioned program in 2007
Why is this story not national headline news?
COI –> wasted funds and probably loss of life
Conclusion: future of RRI depends on relevance
Need more studies of impacts (economic / human)
RRI community must become proactive