What triggers a COI disclosure to generate for an individual quizlet?

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Researchers need to be aware of real, perceived and potential conflicts of interest that may compromise their independence or objectivity and report them to the REB in their application for research ethics review. For any identified COI, researchers must demonstrate how the conflict can be eliminated, minimized or managed to ensure the ethical conduct of the research.

Pressures to delay or withhold results or to use questionable recruitment strategies are some possible outcomes of COI.

• Interpersonal
Researchers' conflicts of interest may arise from interpersonal relationships (e.g. family, colleagues, or community relationships). If a spouse or family member, colleague or friend stands to benefit from the outcome of a study, the researcher has a conflict of interest that needs to be minimized or managed. For example, a researcher's evaluation of several natural health products includes one that his spouse's company represents.

While it may not be possible to eliminate all conflicts of interest, researchers are expected to identify, minimize or otherwise manage their individual conflicts in a manner that is satisfactory to the REB.

• Dual Roles
Researchers often have dual roles in academic and other professional settings. Having responsibilities as both a researcher and a therapist, a caregiver, a teacher, a consultant, an employer, or other role can lead to conflicts of interest.

To ensure that the trust relationships that go with these responsibilities are safeguarded, researchers need to clearly identify potential conflicts of interest between their roles and plan in advance how to manage COI when it happens.

For example, researchers who are recruiting for a study should either avoid recruiting students who depend on their good will for career advancement, or should have another member of the research team conduct the recruitment and the study itself.

• Financial
A real or perceived financial conflict of interest can destroy trust in researchers and in all of their previous work. Unfortunately, it has been established that financial incentives can distort researchers' judgement in regard to the ethical design and conduct of research.

It is the responsibility of researchers to disclose and document all kinds and amounts of financial incentives (sponsorship, salary, fee per participant, equipment, other resources, gifts, etc.) in their application for REB approval. In addition to identifying all financial COI, researchers must demonstrate in their proposal how they intend to minimize or manage these conflicts.

The REB will examine research budgets and payment provisions as part of their review to ensure that there are no inappropriate payments to be made or other unexplained expenses. For example, if a sponsor of a study is offering large incentives for researchers to recruit quickly, there is a risk to participants of inappropriate inclusion, coercion, or undue influence.

Full disclosure of any financial COI can help researchers and REBs work together to manage real, perceived and potential COI and ensure that research is conducted in accordance with the core principles of TCPS 2.

Example 5 (Conflict of Interest and Compensation Arrangements):

Samantha Snead, a portfolio manager for Thomas Investment Counsel, Inc., specializes in managing public retirement funds and defined benefit pension plan accounts, all of which have long-term investment objectives. A year ago, Snead's employer, in an attempt to motivate and retain key investment professionals, introduced a bonus compensation system that rewards portfolio managers on the basis of quarterly performance relative to their peers and to certain benchmark indices. In an attempt to improve the short-term performance of her accounts, Snead changes her investment strategy and purchases several high-beta stocks for client portfolios. These purchases are seemingly contrary to the clients' investment policy statements. Following their purchase, an officer of Griffin Corporation, one of Snead's pension fund clients, asks why Griffin Corporation's portfolio seems to be dominated by high-beta stocks of companies that often appear among the most actively traded issues. No change in objective or strategy has been recommended by Snead during the year.

Example 6 (Conflict of Interest, Options, and Compensation Arrangements):

Wayland Securities works with small companies doing IPOs or secondary offerings. Typically, these deals are in the US$10 million to US$50 million range, and as a result, the corporate finance fees are quite small. To compensate for the small fees, Wayland Securities usually takes "agent options"—that is, rights (exercisable within a two-year time frame) to acquire up to an additional 10% of the current offering. Following an IPO performed by Wayland for Falk Resources, Ltd., Darcy Hunter, the head of corporate finance at Wayland, is concerned about receiving value for her Falk Resources options. The options are due to expire in one month, and the stock is not doing well. She contacts John Fitzpatrick in the research department of Wayland Securities, reminds him that he is eligible for 30% of these options, and indicates that now would be a good time to give some additional coverage to Falk Resources. Fitzpatrick agrees and immediately issues a favorable report.

At what point he and his study team must submit COI disclosures to comply with the PHS regulation?

What is an example of an institutional COI?

Which is an example of a situation where deferential vulnerability might be a factor?

What is the de minimis threshold for disclosure of any financial interest related to the sponsor or to the research for researchers conducting human subjects research?