people who volunteer for research funded by the federal government in both this country and abroad are well protected by the federal ethics rules, a group of senior experts has found. But there is room for improvement. The United States needs to do a better job of monitoring human studies, the panel said, and should consider the creation of a compensation system for injured volunteers.
This advice comes from a report released today by the Presidential Commission for the Study of Bioethical issues. He began a probe last year after a historian revealed that in the 1940s, US researchers deliberately exposed more than 1,300 Guatemalans with syphilis and other sexually transmitted diseases to study the effects and possible treatments. President Barack Obama has requested an investigation of the facts that the commission finished in September; he found ethical violations "unreasonable". The president also called for a review of whether the research topics today are adequately protected.
In the decades since the Guatemala study, the United States and other authorities imposed many standards and rules on the use of human subjects, the Panel finds. In the US, the 30-year-old federal Common Rule requires informed consent, an independent ethical evaluation, and minimizing risk. The common rule also applies to the growing share of funded US trials conducted abroad, where most countries now have similar rules. Consequently, "the commission is convinced that what happened in Guatemala in the 1940s could not happen today," said Chairman of the Committee Amy Gutmann, president of University of Pennsylvania, during a Wednesday press conference.
However, in his report of 104 pages (plus notes and appendices), the Commission finds shortcomings in transparency. When his staff asked 18 US agencies identified by the common rule to the list of human studies they support, many could not easily provide the information. Even the National Institutes of Health (NIH) of the base subsidies can not be easily searched only human research. And a federal database of drug trials, ClinicalTrials.gov, leaves many at an early stage (phase I) trials and social science studies and behavior, according to the report, titled "Moral Science: Protection participants in human research subjects. "
Bioethics Committee, which collected 55,000 studies funded by the federal government in 2010, said that federal agencies should be required to make public basic information online about each project, including title the investigator, the location and funding of the study.
Another problem the commission of the flags is the need to address or compensate the wounded volunteers. Most developed countries have remuneration policies but in the US it is said, efforts are "piecemeal." Patients may continue in case of injury, but the resolution can take years. Some organizations their own pay systems for in-house research, pharmaceutical companies usually have insurance the University of Washington is "a wonderful case study," said the vice president James Wagner commission, president of Emory University. : It provides up to $ 10,000 in costs out of pocket and unlimited treatment through its health care system for subjects who claim to need help the United States should consider establishing a national compensation system. for research topics, the commission concludes Although there is a pattern to it. - National it Injury compensation Program vaccines is not the only option "Usually, what works in the US are not. not a uniform centralized system, but a system whereby, for example, the federal government may recommend or require that all the institutions of a certain size to ensure they have provisions for compensation, "said Gutmann. "We want the government to get this right."
Among its 14 recommendations, the Committee is also focusing on the possibility that developers could choose to locate a study in a place for reasons of "disturbing" for example because the regulations are not strong. for this reason, the committee concludes, funding agencies should ensure that the study can be done ethically in a proposed site. at the same time, he said the United States should consider allowing the rules of a foreign country to supplant the common rule when they are equivalent.
the Committee also makes recommendations for an ongoing overhaul of the common rule, including : development of simple shapes, standard informed consent allowing multi-site studies to go through a central ethical review; and to facilitate the examination requirements for studies that present a minimal risk.
The report notes that previous bioethics panel made recommendations for-like example, in 02 the Institute of Medicine urged the institutions necessary to compensate for injured research participants. This time, the Office of the White House science and technology policy and other agencies should issue a response on why or why not the government plans to respond to the opinion of the Committee, the report said.
Last week, Guatemala issued its own report on the review of the 1940 syphilis; he found that nearly 2,100 people had been deliberately exposed to diseases, much more than what had been reported earlier, according to a press report. Guatemalan investigators drew on archived documents that the US bioethics commission has not had access to, says director Valerie Bonham Executive Board. His team is currently reviewing the report, which received Spanish. He plans to fold the findings in a study guide for students about the Guatemala study.
Correction :. This article has been amended to correct a statement suggesting that the report specifically recommends a compensation system along the lines of the National Compensation Program Vaccine Injury
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