Dr. Smith has received the approval of the local school system as well as the principal of the school in which the study is to be conducted. She proposes to obtain passive consent from the students’...

Dr. Smith has received the approval of the local school system as well as the principal of the school in which the study is to be conducted. She proposes to obtain passive consent from the students’ parents and to provide the school system with a summary of the outcome of the study.

As an IRB member, evaluate this study from the perspective of

a.            The investigators—what are the important items to consider?

b.            The nature of the study—what are the important aspects of the study design that must be considered?

c.             The research participants—what are the important considerations regarding who they are and how they are recruited?

d.            Confidentiality—what information should be kept confidential, and what can be revealed?

e.            Debriefing—what should these children be told about the study?