Privacy rules hinder research, survey says -- and Boston researchers agree

Regulations to protect patient privacy make it more difficult to conduct medical research, a national study reports, findings that don't surprise Boston researchers who say the rules slow the pace of their work, place a burden on the patients they seek to protect and may discourage them from participating in clinical trials.

Two-thirds of the scientists who answered a survey on privacy rules imposed under the Health Insurance Portability and Accountability Act said the law had a "substantial negative influence" on human health research, according to the article in tomorrow's Journal of the American Medical Association.

"HIPAA regulations have hindered more than they have helped," Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital, said in an interview. She was not involved in the study. "They have had a chilling effect on researchers and epidemiologists."

Even though patients give their permission to researchers who want to open their medical files, different hospitals and doctors' offices interpret privacy rules in different ways, meaning researchers have to tailor the process to each provider, Dr. Andrew Chan, a colon cancer clinician and researcher at Massachusetts General Hospital, said in an interview. That means researchers have to go through many more steps, from making the initial contact with a patient to following up on the information they give.

He also thinks adding privacy forms to already lengthy consent forms may deter patients from joining clinical trials.

"We've seen a drop-off in individuals being willing to participate. I think this is a big part of it," he said.

Dr. James Hudson of McLean Hospital is both a researcher and a member of the hospital's Institutional Review Board, the body that must approve research protocols before clinical trials can begin. Like Manson and Chan, he stressed the importance of protecting patient privacy and confidentiality.

"HIPAA adds red tape without affording any substantive additional protections for participants," he said in an e-mail interview. "All of our informed consent forms now have several pages of additional required and difficult-to-comprehend language that serves only to inform participants of privacy protections that are less comprehensive than those that are already in place."

"The net effect of HIPAA has been to increase the burden of conducting research, without any appreciable gain in safety," Hudson said.