Question: As part of the consent process, the federal regulations require researchers to:

A) Provide potential subjects with information at the appropriate reading comprehension level.

B) Describe penalties that may be imposed for non-participation.

C) Recommend that potential subjects discuss their decision to participate with family members.

D) Provide a list of the IRB members who reviewed the protocol.

The correct answer is:

Federal regulations require researchers to ensure that potential research subjects are provided with clear and understandable information about the study, including risks, benefits, and procedures, in a way that matches their reading comprehension level. This is essential for informed consent, which ensures participants fully understand what they are agreeing to. The other options (describing penalties for non-participation, recommending discussions with family, and providing a list of IRB members) are not federally required elements of the informed consent process.