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?
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
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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.