Joint Commission on Accreditation of Healthcare Orgs & NCQA
Fri, 9 Sep 2005
After much hand wringing following public disclosrure that the current IRB (institutional review board) research review and approval process is so inadequate and unreliable, the (then) outgoing Secretary of Health and Human Services, Donna Shalala, acknowledged in 2000 that the research protection system was dysfunctional and in need of major reform. An initiative by concerned IRB bioethicists provided a venue for raising IRB standards and oversight through accreditation.
Below is a press release by The Joint Commission on Accreditation of Healthcare Organizations and the National Committee for Quality Assurance disolving the Partnership for Human Research Protection, Inc. PHRP chair, Mary Faith Marshall conceded: “The need for critical improvements in protection for participants in research remains strong. Unfortunately, there is not, as yet, enough demand for a rigorous oversight program like the one offered by PHRP from either the public or private sector.”
This well intentioned effort from within the research community failed dismally. Of the estimated 4,000 IRBs (some speculate, 8,000) only nine have met accreditation standards.
Since accreditation is not mandatory, the research establishment thumbed its nose and dug in its heels when it rejected voluntary accreditation along with the higher standards of performance for which IRBs would be held accountable. IRBs are the sole authorized gatekeepers entrusted by law to review and oversee research involving humans. But IRBs provide only cursory review and little if any oversight. Thus, the safety of human subjects is in jeopardy–consider, only 9 research institutions thought enough about the safety of those who serve as test subjects, to meet accreditation standards.
The rejection of voluntary accreditation is one more demonstration of a culture that arrogantly puts business interests above the safety concerns. For example, the latest fast breaking expose akin to the infamous Tuskegee syphilis experiment whose disclosure led to the creation of the IRB system, are a series of Phase I and II experiments conducted on infants and children in foster care who were the test subjects of AIDS drug, vaccine, and drug/vaccine combinations. At a NYS hearing by two state Assembly committees, on Sept 8, about this case, AHRP presented testimony accompanied by documents–peer reviewed published reports. These reports reveal that: “the incidence of transmission of [HIV] from an infected mother to her offspring is estimated to be in the range of 5%–40%.” Yet, infants who were “HIV-UNINFECTED” were enrolled in experimental Phase I vaccine trials. It is hard to claim that the risk / benefit ratio was favorable for the babies who were exposed to experimental vaccines in the earliest stages of testing.
Such evidence refutes the repeated claim by those who approved the experiments that the children were “sick with HIV-AIDS.”
The current safeguards are on paper only. There is no safety net, no effective oversight system to prevent ethical corner cutting, or the approval of highest risk experiments with an unfavorable risk / benefit ratio–and there is no enforcement mechanism. The current IRB system of research review lacks consistency, professionalism, standards, and accountability:
The system is in desperate need of radical reform to avert preventable harm. Without mandatory independent checks and balances unsuspecting patients and volunteers are all too often put at unjustifiable risks of harm.
The research community’s refusal to adopt minimalist accreditation standards –much as hospitals are obliged to accept healthcare accreditation standards make them eligible for Medicaid, Medicare and third party insurance payments–serves as a strong signal to Congress that it should take action.
The American public deserves corrective legislation that would protect it from flawed experimentation that results in preventable deaths that are concealed for years–e.g., the COX 2 inhibitors. Congress needs to mandate accreditation for all institutions that receive any government funds or that any clinical research leading to FDA licensure of new drugs and medical devices.
Contact: Vera Hassner Sharav
Joint Commission and NCQA to Discontinue Partnership for Human Research Protection, Inc.
FOR IMMEDIATE RELEASE: August 31, 2005
OAKBROOK TERRACE, Ill. and WASHINGTON, D.C.- The Joint Commission on Accreditation of Healthcare Organizations and National Committee for Quality Assurance (NCQA) today announced that they have jointly decided to dissolve the Partnership for Human Research Protection, Inc. (PHRP), effective November 15, 2005.
Although the Joint Commission and NCQA continue to believe that an in-depth examination of the protections provided for human research subjects participating in clinical trials – such as a comprehensive accreditation review – is one of the best ways to ensure safety, government regulators, pharmaceutical companies and other stakeholders do not yet demand this level of public accountability.
“The need for critical improvements in protection for participants in research remains strong,” says Mary Faith Marshall, PHRP Board Chair. “Unfortunately, there is not, as yet, enough demand for a rigorous oversight program like the one offered by PHRP from either the public or private sector.”
The number of organizations accredited to date is nine. The Joint Commission and NCQA will continue to provide support to these organizations for the duration of their accreditation over the next three years.
“These organizations deserve special praise for their commitment to the safety of studies conducted at or reviewed by their facilities,” says Marshall.
The PHRP program was established in January 2003 to provide a national set of standards and a voluntary oversight process for making certain that processes are in place to inform and protect the thousands of volunteer human subjects who participate in clinical trials and other research activities every year. The rapid expansion of medical research, drug trials and other studies involving human subjects has increased demand to ensure that studies’ risks and benefits are thoroughly weighed, that volunteers are properly informed, that adverse events are carefully monitored, and that research risks are minimized.
For more information, please contact:
Charlene D. Hill (630-792-5175)
Barry Scholl (202-955-5197)