Group 2: Social-Behavioral-Educational (Non-HPD) Researchers CITI Training

Your informed consent form must describe _______.

All foreseeable risks and discomforts. Per the federal regulations, the informed consent form must describe all foreseeable risks and discomforts.

Which type of IRB review does not require an IRB approval but does require a determination by an IRB member or an IRB designee (such as experienced staff person)?

Exempt Exempt research is human subjects research that is "exempt" from the Common Rule provisions. Per federal guidance, the recommendation is that researchers should not be able to self-determine whether a study qualifies for exemption. Therefore, an IRB, or its designee, generally reviews and determines whether a study is exempt. Expedited and convened reviews both require IRB approval.

A graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?

Not Human Subjects This study would qualify as not human subjects because the data that the student is collecting does not meet the definition of human subjects research. She is not collecting any information about the store owners and her study seeks to find information about the items in the store.

Which of the following studies would need IRB approval?

Studies collecting data about living individuals. If a study intends to collect data or information about a living individual, you must obtain IRB review and approval.