This week's headlines
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In an 10-page letter co-written by a former official with the Office for Human Research Protections, Public Citizen has asked HHS Secretary Kathleen Sebelius to “direct” OHRP staff to review their determinations that an NIH-funded, multicenter study of an immunosuppressant in individuals as young as six with newly diagnosed diabetes complies with federal regulations, and to “direct the Secretary’s Advisory Committee on Human Research Protections [SACHRP] to conduct an in-depth evaluation of (a) OHRP’s implementation and enforcement” of Subpart D “and (b) the effectiveness of OHRP’s compliance oversight program.” Subpart D of the Common Rule contains additional protections for children; the study was approved to enroll people from ages six to 45. The letter, dated Jan. 9, was sent by Michael Carome, former associate director for regulatory affairs at OHRP and current deputy director of Public Citizen’s Health Research Group, and Sidney Wolfe, its director.
Carome and Wolfe had previously submitted two complaint letters to OHRP about the study, which also falls under FDA regulations, and requested OHRP conduct an oversight review of all sites. In a Nov. 28 letter, OHRP asked for a corrective action plan from one site, the University of Minnesota, to correct the failure of consent documents to address gastrointestinal disorders as a possible side effect of canakinumab, the drug in the study, but said it found unsubstantiated other allegations of noncompliance with HHS regulations. One issue was redacted (RRC 12/13/12). Carome and Wolfe maintained in their letter that OHRP’s determination regarding the study is “dangerously lax” and “reflects a continuing trend spanning several years during which the leadership of OHRP has failed to effectively implement the regulations for the protection of human subjects and has taken stances that place greater priority on protecting the interests of the HHS agencies, research institutions, and investigators than protecting the rights and welfare of human subjects.”
An HHS spokesperson said OHRP “cannot comment on cases that are currently under review.” SACHRP chair Jeffrey Botkin, professor of pediatrics and medical ethics and associate vice president for research at the University of Utah, tells RRC he does not “think SACHRP is best suited to conduct critical assessments of OHRP enforcement activities,” based on its charter and other issues, but said that members “would respond to a request by the secretary to address these issues and presumably would do so in collaboration with OHRP.” The number of determination letters OHRP issues — one measure of its enforcement activities — has dropped precipitously since the tenure of OHRP Director Jerry Menikoff began in 2008, causing some to question OHRP’s commitment to enforcement (RRC 3/11, p.1). SACHRP’s two previous chairs before Botkin assumed the post in October 2012 both expressed concerns about whether declining funding and staffing for both OHRP and SACHRP have hampered their ability to fulfill their responsibilities (RRC 11/12, p. 1).
HHS has published a proposed rule, with a 60-day comment period, that would amend its federal acquisition regulation (FAR) supplement to address patent and data rights of the government and inventors. “The purpose of this proposed rule is to ensure that providers of proprietary material(s) to the government will retain all their preexisting rights to their material(s), and rights to any inventions made under a contract or subcontract (at all tiers), when a determination of exceptional circumstances has been executed,” states the notice in the Jan. 10 Federal Register. Such determinations are made “under certain circumstances, in order to ensure that pharmaceutical companies, academia, and others will collaborate with HHS in identifying, testing, developing, and commercializing new drugs, therapeutics, diagnostics, prognostics and prophylactic measures affecting human health,” HHS said. The proposed rule amends 48 CFR parts 327 and 352 and “applies to all federal contractors and subcontractors at all tiers as applicable, regardless of size or business ownership.”
Buried in a 26-page list of court cases it considered hearing, the Supreme Court of the United States (SCOTUS) indicated on Jan. 7 it denied certiorari to Sherley v. Sebelius, leaving in place the District of Columbia District Court's August 2012 ruling that federal funding of human embryonic stem cell research is legal. Following word of the denial, NIH Director Francis Collins said he was “very pleased.” In a statement posted on NIH’s website, Collins said the decision “enables NIH to continue conducting and funding stem cell research, following the strict ethical guidelines put in place in 2009. Patients and their families who look forward to new therapies to replace cells lost by disease or injury, or who may benefit from new drugs identified by screening using stem cells, should be reassured that NIH will continue supporting this promising research.” Two days later under an entry titled, “Why We’re So Excited About Stem Cells,” Collins posted an image of induced pluripotent stem cells on his blog and wrote about their use in research on Parkinson’s disease. An advocacy group also praised the court’s decision not to review the case, saying it was a “major victory for scientifically and ethically responsible innovative research.”
Organization Files Scientific Integrity Complaint Against Dept. of Interior on Behalf of Seven Biologists
A move to reassign all seven biologists who comprise a branch of the Bureau of Reclamation in the Department of Interior (DOI) and a decision to disallow publication of their research constitute misconduct under the department’s scientific integrity policy, alleges a complaint filed by Public Employees for Environmental Responsibility (PEER), an environmental group. PEER previously represented the bureau’s first-ever scientific integrity officer who helped draft DOI’s policy and later filed a similar complaint after he was removed (RRC 8/16/12). The scientists are part of the Fisheries Resource Branch in the bureau’s Klamath Basin Area Office in Oregon. In his Jan. 7 letter to DOI’s Office of the Executive Secretariat and Regulatory Affairs, PEER President Jeff Ruch said the biologists were told the branch would be eliminated in November in response to their activities, including research that showed more fish than previously believed to exist in a certain area and a study that found tributaries that are not under the control of the bureau are more important to coho salmon preservation efforts than a major river that is. Ruch said suppressed findings were simply deemed “controversial” and that the biologists were targeted for removal due to “political or interagency ‘problems’” with the biologists’ findings, “not the quality, integrity or value” of their research.
Following an international summit last summer on “animal rights extremism,” the Federation of American Societies for Experimental Biology (FASEB) plans to send a letter to “administrative officials at universities, research institutes, and pharmaceutical companies” in the United States to “introduce the problem of animal rights extremism, describe the major recommendations that emerged from the meeting, and invite an exchange of ideas related to the topic of animal rights extremism,” according to an executive summary of the June meeting. A similar letter will be sent to international stakeholders. The summary terms animal rights extremism “an active terrorist movement,” as well as a “serious impediment to the progress of biomedical research and a worldwide concern.” Also included in the summary is an overview of recommendations developed at the meeting that address “three key areas: 1) engaging the public on the benefits of animal research; 2) optimizing international and external communication strategies; and 3) preparing for threats and/or acts” of animal rights extremism.
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