October 26

University of Washington Violated Federal Protections for Human Research Subjects

University of Washington Violated Federal Protections for Human Research Subjects

Thu, 21 Apr 2005

A major research scandal reveals that the University of Washington in Seattle is in gross systemic violations of federal research regulations. Experiments that were conducted on vulnerable populations – including, pregnant women, neonates, children, prisoners–should never have been approved, according to the federal Office of Human Research Protections.

This is the seventh time in four years that this University has been caught and admonished.

The News Tribune (Tacoma) reports:
“Documents released Tuesday raise the possibility that the school might in some cases have completely bypassed laws and regulations meant to keep people in studies safe, including children.”

“The federal Office for Human Research Protections… has demanded that the school turn over additional files for review.

Based on a random review of about 70 experiments, the office has concluded the university approved studies that should not have been approved.”

“There is no way to tell if recent oversight lapses harmed people.”

The current culture at major research institutions is such that they have become repeat offenders violating federal protective barriers that were adopted following the disclosure in the 1970s of the now, infamous experiments that were conducted at Tuskegee and Willowbrook.

The federal regulations under 45 CFR 46 were supposed to ensure that Tuskegee, Willowbrook and their ilk would not ever be repeated–but as has been demonstrated time and time again, the most prestigious academic institutions violate those regulations with impunity–the proof is in the rate of recidivism.

The problem is simple: there is very little incentive to do it right. The federal regulations lack an important element without which there is a lawless disregard for safety standards. Under the current regulations there are no penalties for non-compliance with safety standards in medical research. In the absence of meaningful penalties–including criminal penalties–powerful institutions, such as the University of Washington, thumb their nose in the knowledge that

Yet, instead of addressing the failure of the system–relying as it does on local institutional review boards (IRBs)–to protect vulnerable research subjects, the government has turned its focus on tinkering with the federal regulations to accommodate violators.

An advisory committee appointed by the Secretary of Health and Human Services (SACHRP) is currently in the process of weakening existing safeguards that are codified in the federal regulations under 45 CFR 46. Although the SACHRP committee would have you believe that they are “adding protections,” the committee is in fact, charged with reducing “the regulatory burden” – which is a code for demolishing the protective barriers.

The committee’s recommendations would become the standard applied by the research gatekeepers across the nation–an estimated 8,000 IRBs. So, the committee’s loosening of protections is not just an academic exercise.

The AHRP was in attendance and presented a reality check in both oral and written statements at the April 18 SACHRP meeting at which time the committee voted to adopt new interpretations of the federal children’s protections (Part D). Of particular concern was the committee’s effort to stretch the interpretation of Section 46.406–which was meant to protect children from exploitation and exposure to risk and discomfort in medical experiments that are not designed to offer them a direct benefit. That means that healthy children who have no need of medical interventions should NOT be used as guinea pigs.

Any research proposal that seeks to use healthy children in non-therapeutic experiments that (by definition) offer them no benefit, must be sent to the Secretary of HHS who must convene a special panel of experts and provide an opportunity for public oversight and comment.

The SACHRP recommendations–which were formulated with the object of reducing “regulatory burden”–would, in fact, expand the use of children in non-therapeutic experiments that would expose them to risks of harm.

AHRP posed the following question to the SACHRP panel:
1. Under the SACHRP proposed Subpart D changed interpretations, would a non-therapeutic lead exposure experiment such as the (now infamous) experiment conducted–with approval by the Johns Hopkins IRB–on young African-American toddlers, be approvable under any risk category provided under the regualtions?

See AHRP statement

Contact: Vera Hassner Sharav

Tacoma, WA – Tuesday, April 19, 2005

Safety practices at UW criticized
Feds warn the school it could lose hundreds of millions in research funds
M. ALEXANDER OTTO; The News Tribune
Last updated: April 19th, 2005 12:51 PM (PDT)

The University of Washington has been cited by the federal government for significant problems in how it oversees safety in its human research programs, which involve hundreds of thousands of people in thousands of studies worldwide.

The school must tell the government by April 28 how it will fix the problems or risk losing hundreds of million of dollars the federal government gives the school each year to study medical, social and other problems.

It also must stop some projects the government found were not properly supervised unless doing so would put subjects at risk.

“We are not going to fight these findings,” said Craig Hogan, the UW’s vice provost for research, who oversees human research at the school. “We see this as constructive criticism. We are going to act on it.”

The school has been cited six times in the past four years for safety concerns, and some of the new concerns echo past ones.

But this is the first time regulators found school-wide problems. Previous investigations focused on individual studies.

There is no way to tell if recent oversight lapses harmed people.

Inspectors from the federal Office for Human Research Protections – which polices federally funded human experiments – visited the school in late February on a routine check, randomly pulling records for about 70 experiments.

They found studies not properly reviewed for safety, trials not checked on time to make sure people were doing OK, a breach of privacy in an HIV study, poor record keeping and inadequate written safety policies.

Five of the 15 pages of the April 1 report are blank, having been redacted by the federal government for reasons that are not clear.

Whatever they contain was of such concern that the report was sent directly to UW President Mark A. Emmert, instead of Hogan, which would have been the usual practice, the federal office said.

Hogan would not release the redacted pages to The News Tribune. Many of the problems the government revealed stem from how UW’s research safety boards – which must sign off on experiments – sometimes approve studies they have concerns about without always following-up to make sure the concerns are addressed.

In a 2003 experiment, for example, a safety board did not make sure premature infants got enough iron in their diets, although there was concern they might not.

“It was inappropriate to grant approval,” the federal report said. In December, a safety board approved a study on HIV patients without ensuring they would get medications to control the infection.

It doesn’t mean the patients didn’t receive the medications or the babies didn’t get the iron, just that the research protection office determined it wasn’t adequately checked.

At other times, safety boards – known in the research community as institutional review boards, or IRBs – recorded concerns about subject consent and ending a study if drugs proved toxic, but the studies proceeded anyway.

Federal law requires such matters be addressed beforehand. “UW IRBs often seem reluctant to defer approval of a study,” the federal office noted.

Hogan said contingency approvals would stop.

According to the April 1 report, regulators also found “little evidence” that UW follows federal rules for experiments on prisoners, who, like children, have special research safeguards because they are particularly vulnerable to exploitation.

Hogan said the redacted section, in part, raises concerns about researchers contesting safety board decisions, another practice he said will stop.

Based on information available elsewhere, the redacted pages might also touch on whether people are made fully aware of what they are signing up for in UW studies and on changes made to experiments without safety board approval.

The safety office said the school should create a manual for its researchers on how to comply with basic safety rules.

Past citations involved experiments on Alzheimer’s disease patients and people near death due to lung failure, among others. In those cases, too, the school was cited for not doing enough to keep people safe and for not letting them or their caretakers know what they were in for.

In each case, the school addressed the problems.

Hogan said the UW would make the necessary changes this time, too, and soon. “What we’re are looking at is a bunch of procedural stuff we can fix. We want to get it right.”

The school was already planning to change “a lot of polices and procedures,” he said.

The UW will soon be inspected by an independent group for research safety accreditation, a growing but still not universal trend among research institutions.

The research protection office is hopeful the UW will improve, too. Despite the criticism, the April 1 report commends the school on its “enthusiastic and sincere concern for, and commitment to, the protect of human subjects.”

Study safety has in recent years become a major concern in the medical community following several highly publicized deaths, including that of 18-year-old Jesse Gelsinger, whose 1999 death in a poorly supervised University of Pennsylvania gene therapy experiment focused national attention on problems in human research.

Considering signing up for a study?

Get all the information you can before agreeing to participate in a research study.

Ask if will you at least get the standard treatment if you participate, if not the experimental one? What will you be required to do? Is the doctor making money by signing you up?

The Bureau of National Affairs, a news company in Washington D.C., has pulled together what you need to know, along with tips on how to find trials and other important information, at www.bna.com/medicalresearch/#2

M. Alexander Otto: 253-597-8616

Originally published: April 19th, 2005 12:01 AM (PDT)

Tacoma, WA – Thursday, April 21, 2005
Feds find more cause for concern with UW
M. ALEXANDER OTTO; The News Tribune
Last updated: April 20th, 2005 12:01 AM (PDT)

The federal government is concerned there could be additional serious safety problems at the University of Washington’s human research program beyond those already confirmed in an April 1 inspection report.

Documents released Tuesday raise the possibility that the school might in some cases have completely bypassed laws and regulations meant to keep people in studies safe, including children.

The federal Office for Human Research Protections – which polices federally funded human research – has demanded that the school turn over additional files for review.

Based on a random review of about 70 experiments, the office has concluded the university approved studies that should not have been approved.

The concerns about additional problems are contained in the five pages originally redacted from the 15-page report, but released Tuesday by the university in response to a request from The News Tribune made under state public disclosure laws.

The federal office is concerned some members of the boards charged with keeping research at the school safe “appear to lack a detailed understating of the specific requirements of (federal) regulations for the protection of human subjects,” the office said.

The April 1 report is the seventh time in four years the federal government has found safety problems with human research at the University of Washington.

Safety oversight at the school “will never be perfect,” said Craig Hogan, the UW’s vice provost for research, who oversees human experiments there. The program is just too big and complex, he said, and the potential for human error too great.

“But we are committed to making it the best we can,” Hogan said, adding that the report “is useful feedback” and that improvements are being made.

The university, one of the world’s leading research institutions, conducts thousands of studies on hundreds of thousands of people worldwide.

Experiments run the gamut from virtually harmless interviews to potentially dangerous research on new surgical techniques.

The federal government and industry give the school hundreds of millions of dollars annually to run the studies, and UW scientists recruit for subjects on the radio, in newspapers and elsewhere.

The federal research office is concerned safety board members might not always have been told of some studies and that scientists might not have followed federal rules when running an experiment without participants’ full knowledge and consent.

It is also worried that consent documents combine explanations of purpose and possible benefits in such a way that could mislead people to think they will benefit from an experiment and thus entice them to sign up, when in most cases people do not benefit from their participation in research.

In addition, the research protection office said “documents reveal little evidence” that the school follows the law when running experiments on children, for whom there are extra safeguards.

“Please respond,” federal inspectors said repeatedly in the April 1 report.

As they have previously, university officials maintain the school has largely been doing the right things to keep people safe, but actions have not been sufficiently documented.

But one area that does need change, Hogan conceded, are policies that undermine the power of school research safety boards – dubbed “institutional review boards,” or IRBs – to control what studies go forward and how.

Until now, UW policy allowed researchers to appeal IRB decisions. Also, Hogan himself switched a neurology experiment from one review board to another in March after the scientist complained about the first board.

“OHRP is concerned Dr. Hogan undermined the independence of the IRBs,” the office said.

Hogan said review board appeals and “IRB shopping,” as it’s called in the research community, will end.

Laws to keep people in studies safe have evolved in the United States in response to research atrocities, including Nazi war crimes, syphilis experiments on poor black men and the infamous Willowbrook experiment, in which retarded children at a state school in New York were infected with hepatitis in the 1950s and 1960s to see how it progressed.

More recently, several deaths at major research universities have heightened scrutiny, including that of 24-year-old Ellen Roche, killed at Johns Hopkins University in Baltimore in 2001 when she was accidently given a lung poison to inhale in an asthma study.

The federal research protection office temporarily shut down human research at Johns Hopkins after a subsequent investigation revealed widespread, basic safety problems.

M. Alexander Otto: 253-597-8616

Originally published: April 20th, 2005 12:01 AM (PDT)

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