Reporting, Assessing & Managing Personal Financial Conflicts

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.” • “… 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.

Acting Responsibly & With Integrity • Is a characteristic of QUALITY Researchers and QUALITY Research/Scholarship

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

“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!

Conflicting Interests • Active and responsible professionals often have conflicting interests • Researchers/scholars have professional duties & are personally responsible for conducting themselves with 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

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

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

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 College of Engineering

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.

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.

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.

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.

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 College of Engineering

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

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

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) College of Engineering

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

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.

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 Engineering

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 Engineering

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 Engineering

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 Engineering

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 Engineering

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 Engineering

For Questions & More Information • Terry May / Brian Mattes • Faculty Conflict of Interest Officer • 408 W. Circle Dr., Room 105DPhone: 517-884-7000Fax: 432-9555Email: fcoiio@msu.edu College of Engineering

Reporting, Assessing & Managing Personal Financial Conflicts