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The Ethical Responsibilities of Academic Research Institutions and Funders to Safeguard the Integrity

of ResearchZubin Master, PhD

MedicRes 2015, 5th World Congress on “Good Medical Research”October 19, 2015

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Outline• Describe the current environment of biomedical and behavioral research in the US

• Outcome: Pressure, Burnout, Cutting Corners

• Solutions: What can NIH and Universities/ Colleges do?

• Case Study: Stem Cell Research

• Argue: hypercompetitive environment causing counternormative behavior

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U.S. Biomedical Science Environment (I)

• NIH needs to make efforts to better understand the entry, growth, and exit rate of scientists

• The current U.S. biomedical science workforce diverges from typical rules of labor economics where there is a weak link between supply and demand

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U.S. Biomedical Science Environment II

“A central flaw is the long-held assumption that the enterprise will constantly expand. As a result, there is now a severe imbalance between the dollars available for research and the still-growing scientific community in the United States. This imbalance has created a hypercompetitive atmosphere in which scientific productivity is reduced and promising careers are threatened.”

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Biomedical Workforce Working Grp Data

PDF

Faculty

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SHE Doctorate Holders Employed in Academia

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Success of New Research Project Grants

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

25.0% 25.0%24.0%

20.0%

18.0%

16.0%

19.0% 19.0%18.0% 18.0%

15.1% 14.9% 14.3%15.5%

29.0%

27.0%

24.0%

21.0%

18.0%

15.0%16.0%

17.0%

14.0%15.0%

12.9%14.1% 13.5% 14.0%

33.0% 33.0%

29.0%

24.0%

22.0%

19.0%

24.0%

22.0%

19.0% 19.0% 19.1%19.9%

16.4% 16.8%

Perc

ent

Succ

ess o

f New

RPG

NIH Doubling

R03R01R21

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Average Age of 1st Time R01s in Medical Schools

1980

201342yrs

37yrs

http://nexus.od.nih.gov/all/2012/02/13/age-distribution-of-nih-principal-investigators-and-medical-school-faculty/

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Biomedical Science Today• Low success of NIH grants

• Pressure from institutions to secure funds “soft-money” positions

+• Insufficient resources

Limited Rewards of Science

• Few tenure/track jobs

• Longer post-docs

• Secrecy

Counter-Normative & Hypercompetitive Environment/Behavior

• Self-interestedness• Limits creativity, originality,

risk taking

• Cut corners, rush into print, disaggregate findings

• Irreproducible results

• Excessive demands on scientists’ time

• Burnout, stress, job dissatisfaction

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Incongruity of Scientific Norms

Norms (Classic) Counternorms

Norm>Counternorm

Norm>Counternorm

Norm<Counternorm

Norm<Counternorm

Pressure

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Burnout and Pressure to PublishPerformed an online survey of medical scientists (N=437) in Netherlands

•24% have signs of burnout

•39% finds it affects the credibility of research•54% judged pressure to be excessive

This may account for honorary and other

unethical authorship practices

•15% admitted to having fabricated, falsified, plagiarized or manipulated data•72% rated pressure to publish as “too high”

(N=315 Flemish biomedical scientists)

•26% judge publication pressure to have “sickening effect on medical science”

Is integrity a problem?

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Illustration by David Zinn in ORI Intro to RCR (2007)

Fabrication, Falsification & Plagiarism = ~4% (Pupovac & Fanelli, 2014 Sci Eng Ethics; Fanelli, 2009 PLoS One)

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Steen RG. J Med Ethics, 2011

Retractions & Misconduct

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Fang et al. 2012, PNAS

Reasons for Retracted Articles

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What happens to scientists?

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Surveyed 112 stem cell scientists (~10% response rate) reported that 55% felt stem cell research was put under more intense scrutiny than other areas of biomedical science.

http://www.newscientist.com/article/dn25281-stem-cell-scientists-reveal-unethical-work-pressures.html#.VYfs0k3bKUl

Felt pressure from peers or superiors to falsify or augment data or do anything unethical

3% 92%

Reported doing or knowing someone who falsified or augmented data that ended up in publication

4% 90%

Felt pressure to submit a paper for publication they believed was incomplete or contained unverified information

16% 80%

NoYesNo

Answer

(2014)

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• Fabricated the data in both 2004 & 2005 studies• Claimed to have derived patient specific iPSCs, differentiate into cardiac muscle and transplant into patients with terminal heart failure• Had questionable methods• Possible plagiarism of methods• Placed coauthors on papers without notifying them• Claimed to have ongoing affiliation with Harvard & MGH

Cytometry Contour Plots

Alla Katsnelson Nature 2013

Supplementary Figure S3b in retracted paper (Mayack et al. Nature, 2010, 463:495-500)

Figure 6c from earlier paper (Mayack & Wagers, Blood 2008, 112:519-31)

• Former post-doc (Mayack) in Amy Wagers’ lab may have had duplicated images and was sanctioned by U.S. ORI to receive supervision if she receives funding support

Mayack Wagers

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• Haruko Obokata claimed to have converted mouse cells into pluripotent state with exposure to stress and RIKEN committee concluded that Obokata committed misconduct

• Yoshiki Sasai deputy director of Center for Developmental Biology (CDB) was found to hold “heavy responsibility”

• CDB leaders were accused for hyping science and a final recommendation was made to dismantle CDB

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NIH & Research Funders

Universities, Colleges& Research Centers

Bad-Apples & the Responsibilityof Institutions

• Too often are scientists dismissed for cases of misconduct while institutions remain virtually blameless

• Institutions have a moral responsibility to promote research integrity

What can institutions do?

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• NIH should determine how to many early career scientists should be supported in a given year

• Increasing budget is not the only answer

• Figure out how to share resources between senior scientists and junior/mid-career scientists

Early Career Reviewer/Early Stage Investigators

Emeritus Grants

• Develop policy/programs to support for mid-career scientists

• Limit number of students on research grant support

Incoming OutgoingIncoming Outgoing

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• Renegotiate indirect costs, but avoid alienating universities. Likely everyone will take a hit

Indirect Costs• $5.7 billion in indirect costs (2013)• Negotiated rates 103% to Boston Biomed Res Inst• Japan has flat rate of 30%• Top 10 Earners received $1.1 billion in indirects

• Incorporate other factors e.g., measures of research integrity climate, proportion of PhDs working in field

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• Research on research integrity is funded by smaller federal agencies

• NIH should also fund research on research integrity as it relates to biomedical and behavioral science

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• Assess institutional integrity climate: SOuRCe

• Create staff scientist positions/limit soft money positions

• Decouple labor from training function by limiting grant-based doctoral students• Offer incentives to mentor junior faculty

• Broaden existing career options for PhD students and fellows

• Promote culture of responsible conduct of research through continuous education (not just 1 shot online deal), ombudsperson/consultant

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Take Home Messages• Institutions bear responsibility for

research misbehavior/misconduct and should be held accountable

• Universities/colleges & funders can decouple labor/learning, have more permanent positions, assess their environment, & promote RCR education

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Acknowledgements/Disclaimer

• MedicReS Organizers

• Artists/organizations for the their images

• Brian Martinson is a co-creator of SOuRCe

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zubin@zubsplace.com