A46-year-old man is currently enrolled in a phase iii study of a drug for severe diabetic neuropathy. while the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. the investigator should do which of the following?
a. irb review, or similar process, may be required since generally investigators are not able to exempt their own research
b. an organization's irb, "privacy board", "privacy officer", or "security officer," depending on the particular issue and the requirements of the hipaa regulation