Is it A im not sure.?

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the irb are: stated in the human subject protection regulations, but not in the drug or device regulationsincluded in the consent processdetermined by research staffdetermined by the institution in its written policies and procedures

Which of the following statements most accurately describes the requirement for the documentation of minors’ assent to participate in research? parents must approve written documentation. documentation is required unless waived by an irb. to protect minors documentation is always required. federal regulations do not require the documentation of minors’ assent.

Earlier studies were more slanted toward a. the upper class. c. caucasian males. b. teenagers in school. d. caucasian females. select the best answer from the choices provided a b c d