Investigator external interest (coi) disclosure forms are processed by quizlet

A participant in a study assessing the effect of relaxation techniques on overall mood has come to you with feelings of depression. The study began two weeks ago, but the participant has reported feeling depressed for the last several months. Because your team has defined a study-specific adverse event reporting plan, you know that depressive thoughts are a possibility for participants. How would you classify this event?

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What is COI disclosure?
Who is considered an investigator under the FCOI regulation quizlet?
What position is responsible for overseeing the conflict of interest process?
What are the two basic types of COI?

a. Related, expected, non-serious

b. Unrelated, unexpected, non-serious

c. Related, unexpected, serious

d. Unrelated, expected, non-serious

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

a. Obtains, uses, studies, analyzes, or generates identifiable private information

b. Obtains, uses, studies, analyzes, or generates identifiable public information

c. Observes public behavior

d. Obtains, uses, studies, analyzes, or generates de-identified private information

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections

a. Children, prisoners, and terminally ill

b. Pregnant women, prisoners, and mentally disabled

c. Pregnant women, prisoners, children -

d. Prisoners, children, and elderly

Financial Accounting

4th EditionDon Herrmann, J. David Spiceland, Wayne Thomas

1,097 solutions

Intermediate Accounting

14th EditionDonald E. Kieso, Jerry J. Weygandt, Terry D. Warfield

1,471 solutions

Accounting: What the Numbers Mean

9th EditionDaniel F Viele, David H Marshall, Wayne W McManus

345 solutions

Fundamentals of Financial Management

14th EditionEugene F. Brigham, Joel F Houston

845 solutions

When an Investigator fails to comply with the Institution's FCOI policy or the management plan, the Institution shall within 120 days:
a) complete a retrospective review of the Investigator's activities and the NIH-funded research project to determine any bias in the design, conduct or reporting of research;
b) document the retrospective review consistent with the regulation; and
c) document the Institution's determination as to whether any NIH-funded research, or portion thereof, conducted during the period of time of the Investigator's non-compliance with the Institution's FCOI policy or a FCOI management plan, was biased in the design, conduct, or reporting of such research.
If bias is found, the Institution shall notify the NIH promptly and submit a mitigation report to the NIH that shall address the following:
- impact of the bias on the research project and
- the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias.
Thereafter, the Institution shall submit FCOI reports annually, in accordance with the regulation. Depending on the nature of the FCOI, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the NIH-funded research project between the date that the FCOI is identified and the completion of the Institution's independent retrospective review, in accordance with 42 CFR 50.605(a)(3) and 42 CFR 50.605(b)(3).

In addition, if the NIH determines that one of its funded clinical research projects whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator with a FCOI that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

Applicable to each Institution that is applying for or receives, NIH research funding by means of a grant or cooperative agreement and, through the implementation of the regulation by the Institution, to each Investigator who is planning to participate in, or is participating in, such research.
Does not apply to Phase I SBIR or STTR applications. For FCOI only, the regulation covers the Investigator's spouse and dependent children.
Also applies to few cases where an individual, rather than an Institution, is applying for or receives NIH research funding. In those cases, the NIH will make case-by-case determinations on the steps an Institution or an Investigator must take, consistent with the regulation, to provide a reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from a FCOI of the individual.

What is COI disclosure?

A research COI disclosure refers to the description of a person's financial interests which is submitted to OSU's Research COI Program for review and determination.

Who is considered an investigator under the FCOI regulation quizlet?

In the regulation at 42 CFR 50.603, "Investigator" is defined as the Project Director or Principal Investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, including persons who are ...

What position is responsible for overseeing the conflict of interest process?

Conflict of Interest Officer (COIO) means the institutional official responsible for implementing procedures governing the disclosure, review and management of conflicts of interest in accordance with the research provisions of the University of Iowa Operations Manual, serving as a resource for faculty and staff for ...

What are the two basic types of COI?

COI can be individual or institutional: Individual COI arise from relationships established by the individual. Types of individual COI include financial, professional, and intellectual COIs; Institutional COI arise from relationships established by the individual's institution, and of which that individual is aware.