Hopkins Asks Patients to Waive Privacy Rights to Facilitate Research Recruiting – AP/ ABC

Tue, 8 Jul 2003

In the 19th century doctors robbed graves to obtain cadavers for medical training purposes. Today, medical researchers are far more ambitious– they seek backdoor access to living patients for medical experiments.

A news report on ABC (below) notes that Johns Hopkins University researchers seek blanket approval to obtain a waiver from federal patient privacy law requirements ( known as HIPPA). The researchers want to have ready access to patient rosters for research recruitment purposes.

“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…” One can foresee a coercive climate in which patients would be pressured to sign blanket consent. Such an environment is contrary to the foremost legal and human right to “voluntary, informed, consent.”

This is but another illustration of a culture of entitlement within which medical researchers seem to operate. In a letter to the Department of Health and Human services, a Hopkins official disingenuously claimed the Hopkins proposal “for a blanket approval form is preferable to the confusing maze of rules applicable to recruitment for clinical trials.”

Given that federal investigations continue to find widespread noncompliance with medical research ethics–most notably violations of informed consent-the demand for waiver from privacy rights by an institution that repeatedly violated federal research regulations, is the height of arrogance. Hopefully, the Office of Civil Rights which administers compliance with HIPPA, and which accepts complaints about HIPPA violations will consider Hopkins request in the context of the institution’s documented human / civil rights violations. For example, a lung inhalation experiment that killed a volunteer; a nonconsensual cancer trial in India; a lead paint poison experiment conducted on children. The latter outraged the Maryland Court of Appeals whose landmark 2001 decision severely chastised the institution.

Most recently, Johns Hopkins and the other participating institutions in the ARDSNetwork, were found to have enrolled patients into fatally flawed clinical trials without legally valid informed consent. See: http://ohrp.osophs.dhhs.gov/detrm_letrs/YR03/jul03a.pdf

Documents available on the AHRP website: www.ahrp.org including press coverage, OHRP letters of determination, links to the Maryland Court decision, and AHRP’s amicus curiae brief.

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http://www.wjla.com/news/stories/0703/93771.html
ABC
Hopkins Asks Patients to Waive Certain Privacy Rights
Posted – July 07, 2003 10:42am

Baltimore, Md. (AP) – Johns Hopkins Medicine wants to ask all its patients to waive certain privacy rights, so researchers can look through their medical records to find people they can ask to take part in clinical trials.

The university called the proposal a straightforward attempt to balance patients’ rights under a new medical privacy law with researchers’ need 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

But privacy advocates say the proposal is too 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.

For example, they can look at patient records if a university oversight panel determines it is impractical to ask permission first. Hopkins and the University of Maryland, Baltimore use this method – though Maryland says it does so sparingly.

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.

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