The only circumstance in which an investigator can deviate from the protocol without prior IRB approval is for emergency reasons. The investigator has primary responsibility for conducting the study, supervising all personnel, and for protecting the rights, safety and welfare of the research subjects participating in their project. Research that is exempt from federal regulations may require review by someone other than the investigator to verify exempt status. Women of childbearing potential may be routinely excluded from participating in research. Retaliation against a 'whistleblower' may be construed as an act of misconduct.
Investigators bear the ultimate responsibility for the safety and welfare of their human subjects.
The following items are considered during IRB review of a study. The two drugs being studied are both marketed products, and both are known to cause heart palpitations when prescribed alone. There are no other cardiovascular side effects listed for these drugs. The study design requires that the subjects start an exercise plan for two weeks prior to being randomized to the study drugs. A 65 year old man whom you enrolled with consent has a heart attack on the second day of the exercise plan.