Question

Seven of 100 research subjects voluntarily withdrew from a study. Which action by the author of the study is most appropriate?

a. The loss of any research subjects should be included in the study's abstract.

b. If the loss of participants does not impact the integrity of the study, it is not necessary to report it.

c. The discussion of the sample studied should include any subjects who did not complete the study as planned.

d. If the loss of participants is less than 10%, disclosure is not needed.

Answer 1

The most appropriate action by the author of the study would be option C - The discussion of sample studied should include any subjects who did not complete the study as planned.

OHRP recommends that investigators and IRB's consider whether and how the withdrawl of a subject from the research study should be documented.For example, in biomedical research involving more than minimal risk, it may be appropriate to document the instance of subject's withdrawl. On the other hand, for the longitudinal studies,involving large number of subjects, attrition of subjects over time is common so documenting each withdrawl of a subject may not be useful.

But in this question, it is mentioned that only 100 subjects are involved in the research study, so documentation of withdrawl of the subjects is important.