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HIPAA Privacy Rule Thwarts Clinical Research Recruitment |
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HIPAA Privacy Rule Thwarts Clinical Research Recruitment
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.
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