Question

if a researcher determines that his/her study poses no more than minimal risk as defined in 45 cfr 46, there is no need for the protocol to have irb review and approval.

Answer 1

False. A good researcher would leave no stone unturned. He or she must make sure there are no errors. The slightest error would lead to ruin a difficult research project. Better to err on the side of caution to ensure that no mistakes are made.