CITI IRB Populations and Unanticipated Problems

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

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

A physician recruiting his patients

Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of

Medical Vulnerability

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

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of

Economic vulnerability

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

Institutional Review Board (IRB)

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Is there a power differential between researchers and subjects?

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.

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

Pregnant women, prisoners, children

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