reporting, assessing & managing personal financial conflicts
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Reporting, Assessing & Managing Personal Financial Conflicts. Promoting Objectivity and Minimizing Bias in Research -- February 18, 2014--. Obligations of Researchers / Scholars. “… researchers have an obligation to honor the trust that their colleagues place in them.” - PowerPoint PPT PresentationTRANSCRIPT
Research & Scholarly Integrity
Reporting, Assessing & Managing Personal Financial Conflicts
Promoting Objectivity and Minimizing Bias in
Research-- February 18, 2014--
Research & Scholarly Integrity
Obligations of Researchers / Scholars
“… researchers have an obligation to honor the trust that their colleagues place in them.”
“… researchers have an obligation to themselves.”
“… researchers have an obligation to act in ways that serve the public.” 2009. On Being a Scientist: A Guide to
Responsible Conduct in Research: The National Academies Press, Third Edition. p2.
Research & Scholarly Integrity
Acting Responsibly & With Integrity Is a characteristic of QUALITY
Researchers and QUALITY Research/Scholarship
Research & Scholarly Integrity
One goal of “Quality Research” is to minimize incorrect, misleading, irrelevant, or irreproducible results
Possible reasons: Inappropriate study populations Incorrect sample sizes Use of inadequate or imprecise sampling
techniques Careless data collection and recording practices Inappropriate analysis techniques Incorrect or un-calibrated measuring devices Others???
All of the above can be influenced by Personal Bias
Research & Scholarly Integrity
“Bias” [Wikipedia, accessed on February 16, 2010]
“… a term used to describe a tendency or preference towards a particular perspective, ideology or result, when the tendency interferes with the ability to be impartial, unprejudiced, or objective. In other words, bias is generally seen as a 'one-sided' perspective.
… It is used to describe an attitude, judgment, or behavior that is influenced by a prejudice.”
Bias can be unconscious or conscious in awareness.”
Factors or reasons leading to bias should be understood and managed – It is irresponsible to ignore them!
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Research & Scholarly Integrity
Conflicting Interests Active and responsible professionals
often have conflicting interests Researchers/scholars have professional
duties & are personally responsible for conducting themselves with integrity
Research & Scholarly Integrity
Conflicting Interests Reducing, managing and/or eliminating
conflicting interests is part of being a responsible Research institution Researcher/scholar
students, postdoctoral scholars, staff & faculty alike
Research & Scholarly Integrity
A Conflict of Interest A situation where a person
is trusted to act based on impartial and unbiased professional decisions
has personal interests that could influence or “bias" professional actions objectivity of professional judgments and
actions might be questioned
Research & Scholarly Integrity
Important Considerations Student, Postdoctoral, Trainee, Support / Academic Staff
involvement Involvement of research on Human Subjects Impact on MSU Activities
Restrictions on release of findings Independent agreement restricting MSU Rights Public trust concerning use of Research Results
Impact on an Outside Entity manufacture or commercialize related device, drug,
procedure, service or product Purchase / lease of a product or service Affected by the project
Peer Review and Professional Referrals
College of EngineeringResearch & Scholarly Integrity
Purpose of Sponsor Requirements & MSU’s Policy
To promote objectivity in research and scholarship To ensure there is no reasonable
expectation that the design, conduct, or reporting of research and other scholarly projects will be biased by any personal financial interest of an Investigator that might appear to conflict with their university obligations
Research & Scholarly Integrity
Types of Interests (see Epigeum RI) Personal (e.g., relationships, religious,
political) Personal interests might include
commitment to spend time with family/friends, and your goals in life. Family obligations could conflict with the need to spend long hours in the laboratory or library. Be careful not to confuse personal desires with
personal obligations. Whatever your level, you should be clear about how your personal interests will affect your professional obligations.
Research & Scholarly Integrity
Types of Interests (see Epigeum RI) Professional (e.g., promotion, tenure, fame,
recognition) Professional interests might include getting a job or
research grants, promotion, publication, serving on committees or becoming a research leader. Pursuit of your own professional interests could hinder that
of others, so you should openly and clearly communicate the impact of your professional efforts on others. For example, an advisor should report that a pending research proposal deadline might delay review of a draft paper by a graduate student or postdoctoral researcher. Support for research funding should always be acknowledged and sometimes reported as a conflicting interest if it is by a private entity.
Research & Scholarly Integrity
Types of Interests (see Epigeum RI) Scholarly (e.g., ideology, belief, social good)
Examples might include a unique discovery, a particular research method you favor, or a particular research theory or school of thought. Preference for one kind of technique may conflict with the requirement to review fairly an article or grant proposal from a researcher proposing a competing technique. Scholarly interests are similar to professional interests.
However, the conflicting motivation relates to such things as restricting the sharing of data, not crediting the importance of conflicting areas of research, or not fairly reviewing the work/results of competing researchers. You should disclose scholarly interests before you agree to review articles or sit on review panels.
Research & Scholarly Integrity
Types of Interests (see Epigeum RI) Financial
Examples might include direct financial support for your research, extra financial payments such as consulting fees, royalties, profits from commercializing your ideas, direct financial rewards for being a successful researcher, such as payments for publication in prestigious journals, or financial benefits received by your direct family members as a result of your research activities. The financial relationship of researchers with outside entities is an area of ongoing concern. While institutions occasionally have policies regulating the interests
noted above, Federal funders (e.g. the National Institutes of Health and the National Science Foundation) and Federal regulatory agencies (e.g. the Food and Drug Administration) require institutions to assess, manage and/or eliminate conflicting financial interests. Disclosure to the institution and others (especially journals) is a key component of ensuring transparency as an indicator of research integrity.
College of EngineeringResearch & Scholarly Integrity
FCOI Policy Faculty are required to disclose a Conflict of Interest
related to a particular situation or transaction when the conflict first arises
NSF / PHS Investigators are required to disclose Significant Financial Interests (SFIs) related to their Institutional Responsibilities as a whole. It is the responsibility of Delegated Institutional Officials to
determine if a relate SFI is a Financial Conflict of Interest (FCOI)
In 2015, ALL academic appointees and all support staff assisting as investigators will be required to complete an Annual Disclosure as NSF / PHS Investigators are now required to do
Research & Scholarly Integrity
Must be Disclosed Personal (self & family) financial
interests related to MSU Responsibilities Salary (non-MSU), consulting fees, royalties
or other payments Ownership interests Intellectual property rights based on a
University license Unvalued stock options or other options for
ownership in a company
Research & Scholarly Integrity
Must be Disclosed Personal (self & family) financial
interests related to MSU Responsibilities Service on a governing / advisory board, or
as a general partner of a company paid or unpaid
Service as a trustee for, or having a beneficial interest from, a trust or estate
Indebtedness to or from an entity Gifts of goods, property, or services
greater than $250
College of EngineeringResearch & Scholarly Integrity
Significant Financial Interests The Policy requires that Significant Financial Interests be disclosed
by private organization or entity when you: Receive income or payments of any kind (> $5,000 annually) Own greater than 1% of a single outside entity or have ownership
interests (e.g., stock) Serve as a trustee for a trust or estate, or have a beneficial interest in a
trust or estate Are indebted to or have provided a loan Have intellectual property rights or which generate income of any value Have unvalued options for stock or ownership of any value in a private
company Serve on a governing or advisory board, or in a fiduciary or managerial
role, for, or as a general partner with or without pay Receive gifts -- goods, property, or services, like transportation, resort or
hotel accommodations, or other recreational or personal amenities (greater than $250 when combined)
Research & Scholarly Integrity
Managing Risks from Personal Interests
Protect the integrity of the data and the research process
Protect the interests of early-career scholars who contribute to the research
Protect people who consent to be the subjects of research
Research & Scholarly Integrity
Risks are greatest When:
The value of an investigator’s financial interest could be affected by the outcome of the research; or
The value of the entity in which an investigator’s financial interest is held could be affected by the outcome of the research.
College of EngineeringResearch & Scholarly Integrity
Investigator Compliance To comply with the Policy, you must know which
personal Significant Financial Interests (personal Significant Financial Interest) must be Disclosed. Significant Financial Interest means a financial interest
(anything of monetary value, whether or not the value is ascertainable ) consisting of one or more of various types of financial interests when aggregated over the previous twelve months exceeds $5,000 (or other specified limits).
SFIs include not only your personal interests, but also financial interests held with or by your immediate family (spouse, domestic partner, dependent child(ren), and other dependents) and with or by any legal entity that you or your family owns or controls.
College of EngineeringResearch & Scholarly Integrity
Investigator Compliance Investigator refers to the Principal Investigator(s), Project
Director(s), Senior/Key Personnel, and any other person, regardless of title or position, who is deemed responsible for the design, conduct, or reporting of research, including Investigators working for subgrantees, contractors, consortium participants, collaborators, or consultants.
Disclose means to provide requested information about the nature of personal SFIs to MSU through a web portal.
Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of MSU, which include research, teaching/education, outreach, and service activities, both within and outside the University, in the general area of expertise for which the Investigator is appointed.
College of EngineeringResearch & Scholarly Integrity
Additions for PHS Investigators SFI (Investigator & immediate family) also includes
payments for seminars, lectures, service on committees or review panels, or other educational activities by: Non-profit organizations (e.g., the American Cancer
Society or the Association of American Medical Colleges); Research institutes not affiliated with an institution of
higher education. Foreign governments at all levels; Foreign institutions of higher education; Foreign academic teaching hospitals and medical
centers; and Foreign research institutes.
College of EngineeringResearch & Scholarly Integrity
Additions for PHS Investigators PHS Investigators (they alone)
must also disclose (and update within 30 days) Reimbursed or Sponsored Travel by trip (dates/duration; destination; purpose). Reimbursed or Sponsored Travel means travel expenses
reimbursed or paid on behalf of the Investigator related to their institutional responsibilities by: Non-profit organizations (e.g., the American Cancer Society or the
Association of American Medical Colleges); Research institutes not affiliated with an institution of higher
education; Foreign governments at all levels; Foreign institutions of higher education; Foreign academic teaching hospitals and medical centers; and Foreign research institutes.
College of EngineeringResearch & Scholarly Integrity
PHS Requirements - MSU Must … Determine whether an Investigator’s SFI is related to
research/scholarly activities and, if so related, whether the SFI is a Financial Conflict of Interest (FCOI). A Financial Conflict of Interest exists when MSU, through its
designated official(s), reasonably determines that a SFI could directly and significantly affect the design, conduct, or reporting of a research/scholarly project.
Develop and implement management plans, as needed, to manage SFIs and FCOIs for MSU Investigators and Subrecipient Investigators, if necessary Manage means taking action to address a conflicting interest
to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
College of EngineeringResearch & Scholarly Integrity
Disclosure Portal Through the OSP/CGA web site at http:\\osp.msu.edu
under CONFLICT OF INTEREST
Training module emphasizes the details of this process After August 24, proposals will not be submitted if this is
not completed by Investigators
College of EngineeringResearch & Scholarly Integrity
For Questions & More Information Terry May / Brian Mattes
Faculty Conflict of Interest Officer 408 W. Circle Dr., Room 105D
Phone: 517-884-7000Fax: 432-9555Email: [email protected]