This past summer, I went to India to volunteer at a hospital and to try and help them with their self-identified problem with tuberculosis. There was considerable debate as to whether or not IRB approval was necessary—my infectious disease colleagues felt it was not, as it was part of a public health initiative and the "research" was no different than that conducted every day in public health departments. The social science types at the U.S. university I was working with all insisted we obtain IRB approval, a time-consuming and, in some settings, expensive process. (Many IRBs levy an administrative charge of $1-2,000 per study). And the folks in India could have cared less, nor did they understand the fuss, as there is next to no patient privacy in their crowded facility, nor was it culturally relevant. All they wanted was help caring for their patients.
Stone does not relate what happened next: whether she did, in fact, seek IRB approval, and--if so--what level review she received or what kinds of restrictions she faced.
Ultimately, Stone blames not the social science types but flaws in the regulations and laws, especially HIPAA, which she blames for "failing to provide any protection for clinical research subjects [while] increasing research costs and probably reducing participation . . ." She hopes "that reason will prevail, and the HIPAA rules will be eliminated for clinical research."