Federal privacy rules can impede studies

Requirements make it more difficult to find study participants, researchers say.

By Joel B. Finkelstein, AMNews staff. July 11, 2005.

Washington -- More than two years after federal privacy standards went into effect, clinical researchers are still experiencing a range of barriers that have slowed down or even stymied their studies.

Since April 14, 2003, the privacy rule mandated by the Health Insurance Portability and Accountability Act has imposed written patient consent requirements that have made it more difficult for physicians and other scientists to recruit study participants, researchers say.

"The HIPAA rule came as yet another major hurdle in terms of doing population-based research. For the treating clinician, ... this has slowed down the accrual of the evidence base that we rely upon," said Roberta Ness, MD, MPH, professor and chair of the Dept. of Epidemiology at the University of Pittsburgh Graduate School of Public Health.

The institution's lawyers and research review board initially held that researchers would need patients' written consent before they could look at their medical records or even call to ask them to participate in studies. That essentially cut off the researchers' access to patients and their records, putting all epidemiological studies on hold for a year and a half, she said.

"The only way to do research at our institution at that point in time was to work through the individual physician," Dr. Ness said. "Now, as you can imagine, no treating clinician has the time for screening for everybody else's protocols."

In an editorial published earlier this year in the Annals of Epidemiology, Dr. Ness described the problems she faced in conducting the second part of a two-phase study on the causes of preeclampsia after the implementation of the HIPAA rule. Recruitment for the second phase was half of what it was in the first.