In a New Atlantis column, Tevi Troy explores a proposal to change the federal rules covering human research involving human subjects.
The Obama administration has long claimed that it will seek to reduce unnecessary regulation. But even so, the proposed rules for human subjects research would in some areas add new regulations. One proposed change would greatly expand the domain of the rules themselves, so that they would apply to all studies conducted at institutions that receive funding from medically-related federal agencies. So for example, as noted in another Times article, “if a university gets financing from the National Institutes of Health, then even a study at that university paid for by a drug company would be covered by the rules.” But the Food and Drug Administration already has jurisdiction over drug company research used to get drugs approved, so this new rule would just add another bureaucratic hurdle to what is already a lengthy process.
Another new rule requires a patient’s written consent for the research use of his or her tissue samples, also known as biospecimens. This rule could reduce the number of biospecimens available to researchers; securing consent is better done when the sample is originally collected, and so better left between patients and hospitals.
And another proposed new rule will likely send chills down the spines of researchers who are used to dealing with the federal government: “To strengthen the enforcement mechanisms … we are considering providing for periodic random retrospective audits, and additional enforcement tools.”
