News Briefs
OHRP seeks comments on foreign research
The federal Office for Human Research Protections (OHRP) is seeking public comment through May 24 on recommendations regarding the use of human subjects protection procedures of foreign countries in overseas research.
A workgroup of the Department of Health and Human Services (HHS) looked at criteria the department might use to implement the authority in 45 CFR 46.101(h), allowing "procedures normally followed in the foreign countries to protect human subjects . . . (when they) . . . afford protections that are at least equivalent to those provided in" the HHS regulations.
When this finding is made, HHS "may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in" the HHS regulations.
Public comment is being sought on the recommended criteria for making decisions about whether to approve such substitutions.
The comment period runs through May 24. A copy of the notice can be accessed at www.hhs.gov/ohrp/international/EquivProtectNotice.pdf, and the full workgroup report at www.hhs.gov/ ohrp/international/EPWGReport2003.pdf. An appendix to the report is at www.hhs.gov/ohrp/international/EPGWFramework.pdf.
Researchers unknowingly used real anthrax in tests
Researchers at a hospital in California found that a benign biological surrogate they were working with actually contained anthrax spores.
On June 9, 2004, the California Department of Health Services (CDHS) was notified of possible inadvertent exposure to Bacillus anthracis spores at Children’s Hospital Oakland Research Institute (CHORI), where workers were evaluating the immune response of mice to B. anthracis.
Hospital researchers had injected 10 mice with a suspension believed to contain nonviable vegetative cells of B. anthracis Ames strain. The suspension was centrifuged and drawn into syringes on an open bench in the laboratory. The mice were injected in a separate animal-handling facility at CHORI. By May 30, all of the injected animals had unexpectedly died. The carcasses were removed from the cages, placed into a plastic biohazard bag, and frozen. The bedding was discarded as standard animal waste. The cages were sanitized in an automated washer.
A sample of the original suspension was cultured and grew nonhemolytic gram-positive rods consistent with B. anthracis. Because staff believed they were working with inactive organisms, they had performed these activities on an open bench, and appropriate personal protective equipment (PPE) was not used consistently until after the deaths of a second group of mice.
Twelve people were involved in either the lab or its animal-handling facilities. Three had direct contact with the bacterial suspensions, cultures, or infected animals. Although at low risk for inhalation of B. anthracis spores, to further reduce their risk, the three workers with direct contact were recommended for post-exposure chemoprophylaxis for prevention of inhalational anthrax (i.e., either ciprofloxacin 500 mg or doxycycline 100 mg, orally twice daily for 60 days).
The nine people who worked in the lab or animal-handling facility but who did not have direct contact were offered the same chemoprophylaxis regimen. Eight of the 12 potentially exposed people opted to take chemoprophylaxis, including the three for whom the regimen was recommended. None of the potentially exposed people had symptoms consistent with anthrax.
One theory is that the heat-killing procedures used by the contractor might have been lethal to vegetative cells, but anthrax spores survived. Regardless, inactivated suspensions of B. anthracis should be cultured both at the preparing lab before shipment and at the research lab several days before use to ensure sterility, the CDC added. Such procedures would increase the probability of detecting even a small number of viable B. anthracis spores.
CHORI staff did not perform sterility testing on the suspension received in March 2004. "Research laboratory workers should assume that all inactivated B. anthracis suspension materials are infectious until inactivation is adequately confirmed," the CDC wrote in an advisory.
The federal Office for Human Research Protections (OHRP) is seeking public comment through May 24 on recommendations regarding the use of human subjects protection procedures of foreign countries in overseas research.Subscribe Now for Access
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