Feb. 15, 2005 — Since the federal government's sweeping medical privacy rule went into effect two years ago, the additional paperwork required of academic institutions to obtain patients' consent to participate in clinical research trials has caused enrollment to plummet by as much as 50% at one institution and confusion among many others, a new editorial concludes.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) included a major provision that required covered entities (hospitals, physicians, health plans, and other entities that handle patient information) to obtain confidentiality documentation from researchers before disclosing health data. This section of the law, which took effect as part of the overall medical privacy law in April 2003, was intended to ensure that patients' protected health information (PHI) would not be inappropriately disclosed or used during the course of a research trial.

But a lack of guidance by the U.S. Department of Health and Human Services (HHS) about how to interpret this provision and the resulting variability in approaches by research institutions "could not have been what was intended by the law and is not optimal for balancing the need for confidentiality and research progress," said Roberta B. Ness, MD, MPH, chairman of the Department of Epidemiology at the University of Pittsburgh Medical Center in Pennsylvania. "To put out the rules without guidance has resulted in a lack of clarity," she told Medscape in an interview.

Writing in the February issue of the Annals of Epidemiology, Dr. Ness describes the before-and-after effect of HIPAA's rules governing medical research as it applied to patient recruitment in a single-institution, prospective study to determine the cause of preeclampsia.

In the pre-HIPAA phase of the study, called the Pregnancy Exposures and Preeclampsia Program Project (PEPP I), 2,892 women were recruited in 55 months, for an average of 12.4 women per week. The study was renewed in early 2002, but recruitment was shut down for four months while the maternity hospital at which the study was conducted decided how to comply with upcoming medical privacy laws.

Between April and September 2003, recruitment into the study took place under new rules that disallowed all waivers of HIPAA medical record review, according to Dr. Ness. (Waivers allowing an institution to use or disclose PHI for research purposes can be granted if specific conditions are met, according to the privacy rule).

Under that restriction, "the only medical records PEPP II staff could review to determine potential eligibility were for women who had enrolled into a research registry," Dr. Ness writes. "Only about 10% of women enrolled into the registry, presumably because only a clinical staff was authorized to initiate registry enrollment."

Shortly afterward, the hospital's institutional review board allowed applications for a waiver so that researchers could review medical records and flag those that represented potentially eligible subjects, as had been done before HIPAA. Recruitment was further hindered because health provider consent was required before the clinical research staff could approach potential research subjects, and when the maternity hospital merged with the University of Pittsburgh in June 2004.

After HIPAA took effect, the average recruitment rate for participation in PEPP II was 2.5 women per week without a waiver, 5.7 women per week with a waiver, and 3.3 women per week since retraction of the HIPAA waiver, according to Dr. Ness.

"[R]ecruitment with a HIPAA waiver, as compared to pre-HIPAA, decreased by half; and recruitment without a HIPAA waiver fell by half again as compared to with a waiver," Dr. Ness writes. "We cannot identify other systematic explanations for these trends other than the obvious: local interpretation of the HIPAA regulations had a negative effect on the pace of our research."

The slowdown in Pittsburgh's ability to recruit additional subjects into the preeclampsia study has put the program "way behind where we should be," said Dr. Ness. "I have a long career of running prospective studies, and we have never been this far behind on a study at this juncture."

Many research institutions report being in a similar situation, Dr. Ness notes in the editorial. Nearly three quarters (72%) of the 331 U.S. investigators polled by the Association of American Medical Colleges reported that HIPAA was having an adverse effect on clinical research during the first six months after its implementation. Negative effects on patient recruitment, data access, and data acquisition were cited by more than 68% of the respondents.

An HHS advisory committee has proposed modifications to HIPAA that would better coordinate the rule's requirements with those of the Common Rule, a federal law that protects human research subjects, Dr. Ness writes. "We can only hope that the new Secretary for Health and Human Services will adopt these modifications," she concludes.