Hopkins seeks patient waiver of privacy rule--errors fixed

[Dave Farber <dave () farber net>]

http://www.sunspot.net/news/local/bal-md.privacy06jul06.story

Hopkins seeks patient waiver of privacy rule

Proposal would allow researchers to see files to recruit for clinical
trials; Plan needs government approval; Opponents call request too broad,
and say it would create confusion
By Julie Bell
Sun Staff
July 6, 2003

Johns Hopkins Medicine <http://www.jhu.edu/www/medicine>  wants to ask all
its patients to waive certain privacy rights so researchers can comb through
their medical records, hunting for people they can invite to enroll in
clinical trials. 

The university called its proposal, which is subject to federal approval, a
straightforward attempt to balance patients' rights under a new medical
privacy law with researchers' need to find volunteers for human tests of
drugs and devices. 

"If we [could say], 'You're here at Johns Hopkins, can we call you about any
study at Johns Hopkins?' that's what we want to do," said Joanne Pollak, a
Hopkins Medicine vice president and general counsel.

But privacy advocates say the Hopkins proposal is overly broad and could
confuse patients at a vulnerable time in their lives.

If the U.S. Department of Health and Human Services approves, Hopkins will
ask every incoming patient to sign a form granting researchers blanket
approval to look at their records. Patients who decline still would be
treated, but their records would be tagged so that researchers could not
review them without explicit permission.

The Hopkins proposal comes as researchers nationwide grapple with finding
patients for clinical trials without running afoul of the Health Insurance
Portability and Accountability Act, which took effect April 14.

Researchers openly recruit test subjects by advertising or by asking
physicians to refer their patients. But they have also found subjects by
combing hospital records without patients' knowledge -- a practice the new
law allows under special circumstances.

They may, for example, look at patient records if a university oversight
panel determines it is impractical to ask permission first. Hopkins and the
University of Maryland, Baltimore
<http://www.sunspot.net/templates/misc/'http://www.sunspot.net/entertainment
/visitor/college/bal-hl-umb.story>  use this method -- though Maryland says
it does so sparingly.

At Duke University, researchers are merely required to notify an oversight
panel before looking at inpatient medical records.

The new privacy regulations are a critical part of the accountability act,
which Congress enacted in 1996 to allow patients to switch jobs without
losing health insurance. The law allows doctors, hospitals and insurers to
share medical information needed for treatment and billing but generally
gives patients control over other uses.

So far, Health and Human Services has received about 600 complaints alleging
violations of the privacy law, department spokesman Bill Pierce said.

In a May 20 letter to federal privacy policy official Susan McAndrew, Pollak
said Hopkins believes that its proposal for a blanket approval form is
preferable to "the confusing maze of rules applicable to recruitment for
clinical trials." 

It also would prevent situations in which patients are unnerved by
researchers who want to recruit them for a trial based on medical conditions
they thought were private.

"People are offended," Pollak said of the current practice. But some worry
that Hopkins' solution would add to the confusing load of paperwork patients
must review before they're treated, leading them to sign without realizing
what the form permits.

"You're going to ask patients at a very vulnerable time to waive their
rights," said Mark Rothstein, director of the Institute for Bioethics,
Health Policy and Law at the University of Louisville.

Others say Hopkins' request is overly broad, violating the spirit of a law
designed to limit disclosure of medical information and inform patients of
exactly who gets their health information and why.

The proposed form seems to be saying, "We're asking permission to look at
your entire file for whatever study we're thinking about doing," said
Katharina Kopp, program manager for the Health Privacy Project, a
Washington-based nonprofit organization that backed passage of the privacy
law. "We don't want to stop research, ... but the authorization is way too
broad." 

Still, Kopp said Hopkins' intentions are good because "they're trying to
raise awareness and get authorization upfront."

Joy Pritts, an assistant research professor at Georgetown University's
Health Policy Institute, agreed, saying that Hopkins' form goes beyond what
the privacy rule requires. "From a patient's perspective, clearly they would
prefer to be contacted in advance," she said.

But Kathy Schaefer of Baltimore, who once volunteered for a Hopkins clinical
trial involving osteoporosis, isn't impressed with the proposal. She said
she prefers other methods of recruiting clinical trial volunteers, such as
asking doctors to refer their patients.

Even if she did sign a blanket waiver form, she said, "I would find it
intrusive. I really would."

Copyright © 2003, The Baltimore Sun <http://www.sunspot.net/>


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