The rule mandates that all underlying data from studies be made available to any and all researchers in the interests of transparency. But while transparency is generally a laudable goal, the rule may be used to throw out older studies for which data is no longer available and newer studies with data that can’t be shared because of patient privacy issues, says Renee Salas, MD, MPH, MS, the lead author on an opinion piece published in Annals of Internal Medicine, Jan. 28.1
Dr. Salas, an emergency medicine physician at the Massachusetts General Hospital and a researcher with the Harvard Global Health Institute, Boston, tells Reuters Health the new rule would be “turning the existing system on its head.”
“Instead of being automatically considered, a study that uses protected health information or human subjects cannot be considered except on a case by case basis,” Dr. Salas says.
If the rule is passed, the data used in studies must be made available to anyone who wants to “independently validate the research,” Salas says. “But to do that would erode patient confidentiality, which we as researchers have a mandate to protect.”
Many studies, for example, don’t include participants’ names, but do include information about where they liv—which is necessary if a researcher is trying to discern possible health hazards due to pollution. If the data is made available with the patient addresses, that would violate confidentiality. But if researchers don’t know how far people live from a potential source of pollution, they won’t be able to connect symptoms with the environmental hazard.
The researchers point to the example of the Harvard Six Cities Study, which determined that fine particle pollution in the air was strongly and consistently linked to an increased risk of death. That study “was fundamental to the EPA’s implementation of the Clean Air Act, and the evidence is clear: the stringent air regulations improved health and saved lives,” Salas and her colleagues wrote. “Although the Six Cities Study has been heralded as transparent, high quality science, the proposed rule would have excluded it from the EPA’s consideration.”
Beyond that, Dr. Salas says, many of the EPA’s regulatory decisions have been based on decades-old studies for which the raw data are no longer available.