Transcript Slide 1

April 21, 2015Administrators
Workgroup
Agenda
 Introductions
 Announcements / Updates (Raquel Espinosa)
 HR transactions (Sue Negro, Tanya Bernabei, Liz Walker)
 Innovation PD roll-out (Raquel Espinosa)
 Revised PI Eligibility Policy (Raquel Espinosa)
 Q & A – All
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Announcements/Updates
Central Pre-award Role
As a follow up to discussions with senior grant administrators, preaward support will be moving to Partners Research Management.
While Research Management is recruiting for the pre-award
administrator position, we will continue using “RSS” (Research
Support Services).
These services are offered by Partners Research Management by
assignment of seasoned staff that are knowledgeable, know the
systems and are signing officials on behalf of McLean.
For purposes of preparing for pre-award volume ahead, please create
InfoEd shells in advance to ensure RSS can prioritize as needed.
We thank you for your support while we work through this
transition.
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Partners Research Management Training Update
Upcoming Training Courses
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Data Use Agreements
Apr 13th 9AM-12PM
ASSIST Proposal Submission System
Apr 24th 9AM-11AM
Journal Entries in Depth
Apr 27th 9AM-12PM
Research Cores
Apr 27th 1PM-4PM
An Introduction to Research Management
May 4th 9AM-12PM
Navigating International Collaborations
May 4th 1PM-4PM
Visit Research Management’s Course Catalog for course descriptions and handouts.
Register for courses through PeopleSoft Self-Service.
Instructions can be found at the bottom of the RM Course Catalog Home Page.
RADG/BRISC/DRAW Training Update
April 2015
Effort Report Summary – 2015 P1
Pre-Review
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Certification
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Post-Review
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Completed
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Total
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McL FY15 Provisional
Fringe Benefit Rates
• New FY15 McL Fringe Benefit rates have been
submitted to DHHS for approval.
• When the new rate agreement has been issued, a
more complete update will be given.
• Until then the provisional fringe benefit rates below will
be charged to all research grants.
• Current Rate agreement is still dated September 13,
2012.
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NIH Closeout Deliverables
• NIH FAQ’s: http://grants.nih.gov/grants/closeout/faq_grants_closeout.htm
• How to find grants that require closeout (IPF # 1876801):
https://public.era.nih.gov/chl/public/search/gpc.era
• All reports required for closeout must be submitted no later than 120 days
after the project end date
Final reports:
• Financial Report must be submitted through the eRA Commons (Research
Finance)
• Final Progress Report submitted through eRA Commons (PI)
• Final Invention Statement submitted through the eRA Commons (PI and
notify Research Administration)
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HR transactions
Susan Negro, HR Director
Tanya Bernabei, HR Generalist
Liz Walker, HR Assistant
Discussion with the group
Next steps:
- HR plans to join the DRAW in upcoming
months to discuss HR transactions and how
to modify current processes based on past
experience and needs
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InfoEd for Innovation Update
Innovation PD roll-out
• Go Live date: April 20, 2015!!!!!
• Effective immediately on April 20, all requests for these
agreements must be initiated through PD
 The following Innovation agreements will be handled
through InfoEd
a. Sponsored Research Agreements (SRA)
b. Material Transfer Agreements (MTA)
c. Confidentiality Agreements (CDA) for discussion of preclinical research and intellectual property
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Tips for PD entry of Innovation agreements
Sponsored Research Agreements (SRA)
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PI Questionnaire embedded in PD process
Must submit scope of work and budget, approved by the sponsor
PD provides links to contact list w/ Innovation Associate for each chief code
SRAs are automatically routed through the chief
If the scope of work involves use of or transfer of human tissue, IRB approval
will be required prior to final signatures
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Continuation- Tips for PD entry of Innovation
agreements
Material Transfer Agreements (MTA)
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PD will ask if material is being received or sent
PI Questionnaire embedded in PD process
PD provides links to contact list with TAG Associate for each chief code
IRB approval required for transfer of human tissue, clinical data
Confidentiality Agreements (CDA/NDA)
• Initiation of one-way in, one-way out and mutual CDAs
• PI Questionnaire embedded in PD process
• PD provides links to contact list with TAG Associate for each chief code
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Innovation PD: Important Notes
• Invention Disclosures – no change to the process
• Effective April 20, all links to PI questionnaires for MTAs,
CDAs and SRAs will be removed from Innovation website
and Research Navigator, with instructions to submit through
InfoEd (links provided)
• Status updates for SRAs, MTAs and CDAs will be available
by logging into the proposal in InfoEd.
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Revised PI Eligibility Policy
Research Compliance Update
McLean Research Committee
April 1, 2015
Mary Mitchell
Partners Research Compliance
Agenda
 Partners PI Eligibility Policy Revisions
 Research Compliance & Scientific Integrity
 Partners Policy on Handling Allegations of Research Misconduct
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Policy Overview
 Effective date: 4/15/15
 Applies
 BWH, MGH, IHP, McLean & Spaulding
 New: Partners
 Principally Paid – New – no less than 50% from
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Hospital/institute funds
HMS endowment funds
Harvard endowment or other funds
PHS funds
Sponsored research funds
HHMI
 Hold or in process of obtaining hospital/faculty appointment
 New: Professor in Residence
Policy Overview – continued
 New Requirements
 Training, skills & expertise for project direction determined by Chief.
 Able to provide regulatory oversight & meet sponsor and institutional
requirements.
 Chief certification PI meets eligibility criteria.
 “Non-employee” or “person of interest” – ineligible to serve as P.I
Policy Overview - continued
 No change
 No delegation of PI responsibilities
 Limitation of authority – cannot bind institution
 Continued eligibility contingent on
 Good financial stewardship
 Compliance with federal, sponsor, & Partners/hospitals
requirements
 PI status may be revoked by Chief or SVP
Exceptions
 Nurse/other health professions
 Postdoctoral fellows/graduate students
Supervision by faculty member w/PI status
 Limited to duration of project
 New - PI on Partners HealthCare Award
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System-wide research
PHS CAO and SVP approval
Meet all PI requirements
Other professional may be granted PI status
New - Change in Employment
 Expectation departing PI
 Transfers grants to new institution.
 New PI appointed
 Request an exception
 Include justification & oversight plan
 Chief & SVP approval required prior to departure
 PI responsibilities
 Obtain regulatory approvals at new institution & Partners
 Work w/offices to execute agreements w/new institution
 IP, data transfer/sharing, publication rights
 Work w/Research Management on sponsor approval
New – Employment Reduced to Less Than 50%
 Submit request 30 days in advance
 How effort will be adjusted
 How oversight will be maintained
 If reduction based on primary appointment at new institution,
explanation of how duties will be split between institutions.
 Chief & SVP approval required prior to reduction
 PI responsibilities
 Obtain regulatory approvals at new institution & Partners
 Work w/offices to execute agreements w/new institution
 IP, data transfer/sharing, publication rights
 Work w/Research Management on sponsor approval
Remaining Provisions
 No change
 Resources/space commitments
 New
 Policy limited to sponsored research projects
 Summary of PI responsibilities – Attachment B
Research Compliance & Scientific Integrity
The right to search for truth implies also a duty; one must
not conceal any part of what one has recognized to be true.
Albert Einstein
A not-so-far-fetched scenario
 A postdoc meets with her PI to review her data in PowerPoint
format which she has compiled into publication-quality figures
using Photoshop. One of the figures she shares with her PI
includes data derived from an experiment generated under
different experimental conditions than those shown in her
figure labels. This figure has never been inserted into a draft
manuscript, published or otherwise presented outside the
meeting with her PI.
Is this research misconduct?
Research Misconduct Defined
 Research misconduct (as defined by 42 CFR Part 93)
 Falsification
 Making up results and reporting them
 Fabrication
 Manipulating research materials, data, or processes; or
manipulating data such that the research is not
accurately represented in the record
 Plagiarism
 Appropriation of another person’s ideas, results, or
words without giving that person appropriate credit)
Research Misconduct: What it is, what it isn’t.
 Falsification
 Fabrication
 Plagiarism
 Significant departure from
accepted research practice
 Proven by a preponderance of
the evidence
o Intentional
o Knowing
o Reckless
- Not an honest error
- Not a difference of scientific opinion
- Not non-compliance related to human
subjects or animal subjects
- Not misuse of research funds
Office of Research Integrity, 42 CFR, Sec. 93.104
Process & Key Players
Research Integrity
Officer (RIO)
• Shelly Greenfield
Complainant
•Journals
•Anonymous
•Collaborator
•Postdoc, student
•Received from ORI
•Retraction Watch
Respondent
•Anyone performing,
proposing, reporting
•Can be multiple
respondents in a given
matter
•All levels of appointment
can and have been
respondents
Office of Research
Integrity
•Jurisdiction over PHS
funded work
•Informed when review
reaches Investigation
•Waits for institutional
finding before own
review
Costs of Misconduct
 Direct costs associated with handling research misconduct cases at the
institutional level in the US exceed $110 million annually1
 Estimated $525,000 per case1
 Institutional reputation
 Investigator reputation
 Retraction of publications
 Loss of employment
 Debarment
 Jail time
 Dr. Scott Rueben – Tufts
 Dr. Eric Pohlman – University of Vermont
 Dr. Luk van Parijs - MIT
 Repayment of sponsored funds
 Loss of public trust
 Greater federal oversight/scrutiny of research/grant activities.
1Michalek
et al. (2010)
Not Just an Academic Issue
 A 2011 article in The Journal of Medical Ethics reviewed ~200
papers that were retracted due to questionable data  the
published research was tied to 28,000 patients, 6,573 of
whom received treatment based on the research presented
in the retracted papers (Steen, 2011).
Evolving Academic Research Environment
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Junior faculty at increased risk
Increase in foreign-born researchers
Mentoring increasingly challenging
Data storage and presentation processes
changing
Academic Appointment Level
 Early and mid-career researchers account for 2/3 of research misconduct
findings (Martinson et al., 2005)
 Pressure to obtain external funding and federal research dollars to support
one’s salary positively correlated with reports of serious misconduct
(Martinson et al., 2009)
 Professional stressors - being overworked & pressure to complete
experiments/produce data with insufficient time allotted - correlated with
research misconduct (Davis et al., 2007)
Foreign-born Investigators: Vulnerabilities
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Differing cultural norms (Davis, 2003)
Lack of English proficiency (Xiguang & Lei, 1996)
Fear of asking for help (Davis, Riske-Morris and Diaz, 2007)
Lack of Responsible Conduct of Research training/oversight in
country of origin (Okonta and Rossouw, 2012)
Mentoring
 62% of mentors had not established procedural standards
(Wright et al., 2008)
 73% had not reviewed the raw data generated by their trainees
(Wright et al., 2008)
 “Improvement in the quality of mentoring in training programs”
is the path to reducing misconduct at any given institution
(Kornfeld, 2012)
Research Integrity: What Not To Do
 Fail to review raw data prior to publication; accept summary data or
prepared tables or graphs instead.
 Demand significant results on Friday to meet a publication or grant deadline
on a project where expected results have not been achieved over several
months.
 Hire a new postdoc who comes highly recommended but leave him or her
without guidance or supervision.
 Tell your lab members to ask question but don’t make yourself available
because you are too busy.
 Tell your lab tech what results you expect from the experiment and that you
need the results right away.
Research Integrity: What You Should Do
 Report all allegations to your RIO
 Establish Data Management Plan (DMP)
 Project description
 Roles & responsibilities of each member of group
 Form of data collected: imagines, lab values, measurements, electronics
files, written records, combination of the above
 Special considerations: PHI? Limited data set
 Security: How will you protect from theft? Disaster retrieval?
 Data sharing
 Storage – long term & short term
Research Integrity: What You Should Do
 Establish and maintain critical record keeping
 Notebooks
 Common language: English
 An accurate reflect of process
 Legible and understandable by others
 All experiments recorded not just those that work
 Primary data kept in or adjacent to notebook
 Mice breeding and housing and reagent sources recorded
 Reagent location recorded
 Date/PI initial/witness
 Electronic files
 Keep original files of primary data in a secure location –
not shared
 Ensure systems have audit trail functionality (versioning)
References
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Davis, M.S., Riske-Morris, M., Diaz, S.R. (207). Casual Factors Implicated in Research Misconduct:
Evidence from ORI Case Files. Science and Engineering Ethics, 13, 395-414.
Fang, F. C., Steen, R.G., & Casadevall, A. (2012). Misconduct accounts for the majority of retracted
scientific publications. Proceedings of the National Academy of Sciences, 109(42), 17028-17033.
Kornfeld, D.S. (2012). Perspective: Research Misconduct: the search for a remedy. Academic Medicine,
87(7), 877-882.
Martinson, B.C., Anderson, M., & de Vries, R. (2005). Scientists behaving badly. Nature, 435, 737-738.
Michalek, A.M., Hutson, A.D., Wicher, C.P., and Trump, D.L. (2010). The Costs and Underappreciated
Consequences of Research Misconduct: A Case Study. PLoS Med, 7(8).
Martinson, B.C., Crain, A.L., Anderson, M.S., & de Vries, R. (2009). Institutions’ Expectations for
Researchers’ Self-Funding, Federal Grant Holding, and Private Industry Involvement: Manifold Drivers of
Self-Interest and Researcher Behavior. Academic Medicine, 84(11): 1491-1499.
Okonta, P. & Rossouw, T. (2012). Prevalence of Scientific Misconduct among a group of Researchers in
Nigeria. Developing World Bioethics.
Wright, D.E., Titus, S.L., & Cornelison, J.B. (2008). Mentoring and Research Misconduct: An Analysis of
Research Mentoring in Closed ORI Cases. Science and Engineering Ethics, 15, 323-336.
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Acknowledgement
 Thanks to Allison Moriarty for sharing research misconduct slide decks that
contributed significantly to this presentation.
Questions/Discussion
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QUESTIONS?
Contact: Raquel Espinosa
[email protected]
617-855-2868
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