Research with Human Subjects
When evaluating risks of harm IRBs must determine that: Correct Ans-isks are reasonable in relation
to anticipated benefits.
According to the criteria for IRB approval, when considering equitable treatment of subjects, special care
must be taken with which of the following populations? Correct Ans-prisoners
Which statement is correct about informed consent? Correct Ans-It requires disclosure of any
benefits to the subject or to others that may reasonably be expected
Comment
The informed consent document, regardless of the research topic, must always include the following:
Correct Ans-A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained.
A graduate student in Communications intends to write her thesis, as part of a federally-funded study, on
the effect of print versus televised media on people's daily lives. The researcher wishes to conduct the
study in a local prison because of limited resources for subject recruitment. The subjects will be asked
for 15 minutes of their time. The questionnaire appears innocuous and the risks appear to be minimal.
The IRB should: Correct Ans-Not approve this project because the research question could be
answered without the participation of prisoners.
A researcher wishes to conduct a study on the relationship between paternal care giving (that is, the
care the prisoner subjects received as children from their fathers) and incarceration, using a short 15-
minute survey. Which category applies to this research? Correct Ans-Study of the possible causes,
effects, and processes of incarceration, and of criminal behavior, provided that the study presents no
more than minimal risk and no more than inconvenience to the subjects (Category i)
Comment
Providing parents information about a study, in lieu of active parental permission, is allowed when:
Correct Ans-An IRB has approved a waiver of the requirement for parental permission