1. Does the current regulatory U.S. scheme regarding human participant research effectively achieve the regulatory goals for such research, laid out in this Module's lecture?
2. Should the Institutional Review Board (IRB) have approved the research protocol described below? Explain your reasoning, including your analysis regarding informed consent.

A study was conducted of the prevalence of cocaine use among low-income, mainly African-American patients seen at an inner-city hospital clinic. One goal of the study was to determine the validity of self-reported cocaine use in this population. Researchers asked clinic patients to participate in a study of STDs in return for $10. Informed consent was obtained from participants for the STD study via a form written at a 12^th grade reading level. However, consent was not received for the undisclosed study of the prevalence of cocaine use and the validity of self-reported information about cocaine use. Participants were told that their urine would be tested for STDs, but were unaware that it also would or could be tested for cocaine metabolites. Among male participants, 39% tested positive for cocaine metabolites in their urine, but 72% of the positive men denied any illicit drug use in the recent past.