CITI SPD

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Determined by the institution in its written policies and procedures

An example of an institutional COI is:

An industry sponsor pays for the construction of a new research laboratory at the organization

Researchers must report potential unanticipated problems that involve risks to others directly to:

Institutional Review Board (IRB)

A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.

No later than the time of proposal submission

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

What is the term for management controls that are built in to a research study (for example, independent data analysis)?

Inherent controls

The COI management plan aims to:

Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?

No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHHS regulations, should the researcher report this event to the IRB?

No, this does not need to be reported since it is unrelated to participation in the study.

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?

Promptly

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

Researcher

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:

Disclose their potential COI and may answer questions, but recuse themselves from voting

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

There may be bias by the peer reviewer as to the area of research

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk