Federal privacy rules can impede studies

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.

University of Michigan researchers documented similar barriers in a recent issue of the Archives of Internal Medicine.

They found that the new-at-the-time privacy requirements impeded their ability to recruit patients who had received cardiac care to participate in follow-up surveys used to measure quality improvement at the medical center. The new hurdles also required additional staff hours, adding about 15% to 20% to the cost of the study, said Kim Eagle, MD, a professor of internal medicine at the Medical School.

"If you take a very strict interpretation of the privacy act and you require a written consent from the patient even to receive a phone call at six months, then it drastically changes our ability to study how patients do over time," Dr. Eagle said.

Frustration abounds

So far, there are only a few published reports like these, but many researchers are experiencing similar problems, said David Korn, MD, senior vice president in the Division of Biomedical and Health Sciences Research at the Assn. of American Medical Colleges.

"They are very, very frustrated and unhappy, and this was ... 100% predictable during the evolution of the HIPAA rule," he said.

In an AAMC survey conducted last year, a majority of investigators and other members of the research community reported problems with the implementation of the privacy rule. Respondents reported that the requirements hindered recruitment and access to patient records. They also were concerned that patients who participated were more confused than reassured by the additional consent requirements and that, overall, the privacy rule introduced new participation biases.

"The complexity of the authorization form intimidates some potential participants," one respondent said. "My concern is that by not including those people in the study, we are not including a true cross section of the population."

Those and other findings were presented in March 2004 to the Secretary's Advisory Committee on Human Research Protections, a Dept. of Health and Human Services-sponsored panel of outside experts. In September, the committee sent a letter to the HHS secretary complaining about the problems and recommending modifications and clarifications to the rule.

Although the department is still formulating a response to the panel's letter, officials did take into account such concerns in crafting the final rule, said a spokeswoman for the Office of Civil Rights, the HHS branch responsible for overseeing the privacy rule.

The regulatory process is ongoing, she said. "Our goal is to ensure that the rule strikes the appropriate balance of enabling important research to continue, while still respecting the important privacy interests at stake. If we conclude that some clarifications or changes to the rule are necessary to properly effectuate that balance, we will take appropriate action."

Getting the hang of it

Even without movement from HHS, many institutions seem to be struggling less with following the letter of the rule while reducing barriers for researchers working with human subjects.

"At first, our institutional review board was quite reluctant to release any information ... but as time has passed, it's not that they're not cautious any more, not to say that, but there has been a growing understanding of what is and is not allowed under HIPAA," said Amit Khera, MD, MSc, assistant professor at the University of Texas Southwestern Medical Center.

"The good part, and I think this is what was intended, is it does make us all pause before we try to use patient information for whatever reason," he said.

The rule has reinforced the ability of institutional review boards to protect patients' privacy, said Richard Doolittle, MD, director of medical sciences at Rochester Institute of Technology and chair of the school's IRB.

"A lot of people have groused and complained about it, but it has definitely benefited patients," he said.

Many of the early problems that researchers faced were due mainly to overzealous interpretation of the rule, but there is still dramatic variation from institution to institution, Dr. Ness said.

For some small medical centers and even hospitals, HIPAA was the straw that broke the camel's back, she said.

The introduction of a series of federal regulations over the past 10 years has made research increasingly onerous to conduct in the United States, Dr. Ness said. More and more clinical trials are moving overseas, she added.

"I think this is all the worse for American medicine."