april 21, 2015administrators workgroup. 2 agenda introductions announcements / updates (raquel...
TRANSCRIPT
April 21, 2015Administrators Workgroup
2
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
Announcements/Updates
4
Central Pre-award Role
As a follow up to discussions with senior grant administrators, pre-award 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.
Partners Research Management Training Update
Upcoming Training CoursesData Use Agreements
Apr 13th 9AM-12PMASSIST Proposal Submission System
Apr 24th 9AM-11AMJournal Entries in Depth
Apr 27th 9AM-12PMResearch Cores
Apr 27th 1PM-4PMAn Introduction to Research Management
May 4th 9AM-12PMNavigating 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
6
Effort Report Summary – 2015 P1
Pre-Review 32
Certification 33
Post-Review 4
Completed 52
Total 120
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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.
8
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)
HR transactions Susan Negro, HR DirectorTanya Bernabei, HR GeneralistLiz Walker, HR Assistant
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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
InfoEd for Innovation Update
12
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 pre-clinical research and intellectual property
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Tips for PD entry of Innovation agreements
Sponsored Research Agreements (SRA) • 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) • 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.
Revised PI Eligibility Policy
Research Compliance Update
McLean Research Committee
April 1, 2015
Mary MitchellPartners 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 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 studentsSupervision by faculty member w/PI status
Limited to duration of project
New - PI on Partners HealthCare Award 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
- 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
o Intentionalo Knowingo Reckless
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
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
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)
Orient and train new members Provide postdocs/graduate students/technicians with strong
mentoring and support.
References 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.
Acknowledgement Thanks to Allison Moriarty for sharing research misconduct slide decks that
contributed significantly to this presentation.
Questions/Discussion
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