CDC: Overseas Ethics Lapse Reported

      Yesterday's Cleveland Plain Dealer reported that the Centers for Disease Control and Prevention has failed to abide by tough rules protecting research subjects in studies it sponsored overseas. Based on its review of CDC records and interviews with key officials, the newspaper reported: "On nearly every inhabited continent, the U.S. government has fashioned scientific partnerships with foreign officials and undertaken scores of medical research projects without obtaining basic agreements to avoid human rights abuses," as required under federal law. Agreements to protect research subjects "were missing in all 96 research projects" sponsored by the CDC overseas over the past decade. J. Thomas Puglisi, the director of human subjects protections at the NIH's Office for Protection from Research Risks, said the CDC's revelation "demonstrated that a handful of controversial CDC experiments on foreign mothers with HIV were not isolated incidents." The Plain Dealer reported that a "recent report to a presidential advisory commission described OPRR, the enforcer of the rules, as virtually powerless, especially when it comes to the CDC." The report stated that the OPRR "is too 'small and weak' to compel the CDC to correct problems."

Rules Need Not Apply?
      The Plain Dealer further reported that "CDC officials in recent months have been arguing that U.S. ethical rules ought not to apply in many of the very nations where the agency failed to adhere to the regulations." CDC scientists also make the argument "that in countries where no better care is available, scientists need not live up to U.S. standards of care." Marjorie Speers, CDC deputy associate director for science, asserted, "We shouldn't be dictating a code of ethics for other countries. Telling them how things should be done is often viewed as imperialistic." Nevertheless, the Plain Dealer noted that the NIH has in place "more than 700 assurances" for protecting research subjects "in more than 110 countries" where it sponsors research. Speers contended that no research subjects were harmed in CDC-sponsored studies. "What was missing was the procedural requirement to have this written assurance, a document where an institution is saying we will follow ethical principles and abide by the rules," she said (Epstein/Sloat, 11/8).