Just Sign on the Dotted Line?

Medical research studies with human subjects are essential to develop lifesaving drugs and medical devices. The medical community needs volunteers—both healthy individuals and those with the disease or condition being investigated—for such studies. The subject’s in- formed consent is key to ensuring that participation is voluntary.

Government regulations set forth requirements for obtaining informed consent to enroll in medical research. But the regulations don’t specifically address everything, leaving unsettled areas that complicate the researcher’s duty to ensure that volunteers receive complete information.