{"id":8139,"date":"2016-06-29T12:32:00","date_gmt":"2016-06-29T20:32:00","guid":{"rendered":"http:\/\/associatednews.info\/content\/heat-on-white-house-to-scrap-redo-of-human-research-rules\/"},"modified":"2016-06-29T12:32:00","modified_gmt":"2016-06-29T20:32:00","slug":"heat-on-white-house-to-scrap-redo-of-human-research-rules","status":"publish","type":"post","link":"https:\/\/associatednews.info\/content\/heat-on-white-house-to-scrap-redo-of-human-research-rules\/","title":{"rendered":"Heat On White House To Scrap Redo Of Human Research Rules"},"content":{"rendered":"

By Rob Stein<\/a><\/span> <\/p>\n

\"HeLa<\/a><\/div>\n
\n
<\/div>\n
\n
\n

HeLa cells, commonly used in research, were derived from cervical cancer cells taken in 1951 from Henrietta Lacks without her permission. Science Source<\/a><\/strong> hide caption<\/strong><\/p>\n<\/div>\n

toggle caption<\/strong> Science Source<\/a><\/span><\/div>\n<\/div>\n

An influential federal panel has taken the unusual step of telling the Obama administration to withdraw a controversial proposal to revise regulations that protect people who volunteer for medical research.<\/p>\n

The proposal is “marred by omissions, the absence of essential elements, and a lack of clarity,” according to the National Academies of Sciences, Engineering and Medicine. The conclusions are part of a 283-page report<\/a> released Wednesday.<\/p>\n

The regulations are known collectively as the Common Rule. They were put in place decades ago to make sure medical experiments are conducted ethically.<\/p>\n

But the rules haven’t been updated in nearly a quarter century. So last year the Department of Health and Human Services proposed<\/a> a major revision.<\/p>\n

But the proposal prompted a wide range of criticism<\/a>. Some argued the revisions were too vague, complex and confusing. Others attacked specific changes.<\/p>\n

One especially contentious requirement would oblige scientists to obtain explicit consent from patients before using their blood or tissue for research.<\/p>\n

The requirement aims to prevent a repeat of what happened to Henrietta Lacks<\/a>. She was an African-American woman who died of cervical cancer in 1951. Tumor cells taken from her were used without her consent to produce a research cell line that has been kept alive in labs around the world ever since.<\/p>\n

But many researchers feared the new requirement would create unnecessary red tape and significantly hinder important research.<\/p>\n

The academies report appears to agree. It concludes that “much of this research does not involve physical risk to participants; rather, risks are limited to the more remote possibility of informational harm resulting from the inadvertent release of confidential information.”<\/p>\n

The report recommends that the proposal be withdrawn. Instead, it says the president should appoint an independent national commission<\/a> modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical And Behavioral Research to essentially start from scratch in revising the regulations.<\/p>\n

HHS says it is reviewing the report, along with more than 2,100 public comments on the proposed revision.<\/p>\n

Let’s block ads!<\/a><\/strong> (Why?)<\/a><\/p>\n

Source:: http:\/\/www.npr.org\/sections\/health-shots\/2016\/06\/29\/483896501\/heat-on-white-house-to-scrap-rewrite-of-human-research-rules?utm_medium=RSS&utm_campaign=healthcare<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\"HeLa<\/a><\/div>\n
\n
<\/div>\n
\n
\n

HeLa cells, commonly used in research, were derived from cervical cancer cells taken in 1951 from Henrietta Lacks without her permission. Science Source<\/a><\/strong> hide caption<\/strong><\/p>\n<\/div>\n

toggle caption<\/strong> Science Source<\/a><\/span><\/div>\n<\/div>\n

An influential federal panel has taken the unusual step of telling the Obama administration to withdraw a controversial proposal to revise regulations that protect people who volunteer for medical research.<\/p>\n

The proposal is “marred by omissions, the absence of essential elements, and a lack of clarity,” according to the National Academies of Sciences, Engineering and Medicine. The conclusions are part of a 283-page report<\/a> released Wednesday.<\/p>\n

The regulations are known collectively as the Common Rule. They were put in place decades ago to make sure medical experiments are conducted ethically.<\/p>\n

But the rules haven’t been updated in nearly a quarter century. So last year the Department of Health and Human Services proposed<\/a> a major revision.<\/p>\n

But the proposal prompted a wide range of criticism<\/a>. Some argued the revisions were too vague, complex and confusing. Others attacked specific changes.<\/p>\n

One especially contentious requirement would oblige scientists to obtain explicit consent from patients before using their blood or tissue for research.<\/p>\n

The requirement aims to prevent a repeat of what happened to Henrietta Lacks<\/a>. She was an African-American woman who died of cervical cancer in 1951. Tumor cells taken from her were used without her consent to produce a research cell line that has been kept alive in labs around the world ever since.<\/p>\n

But many researchers feared the new requirement would create unnecessary red tape and significantly hinder important research.<\/p>\n

The academies report appears to agree. It concludes that “much of this research does not involve physical risk to participants; rather, risks are limited to the more remote possibility of informational harm resulting from the inadvertent release of confidential information.”<\/p>\n

The report recommends that the proposal be withdrawn. Instead, it says the president should appoint an independent national commission<\/a> modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical And Behavioral Research to essentially start from scratch in revising the regulations.<\/p>\n

HHS says it is reviewing the report, along with more than 2,100 public comments on the proposed revision.<\/p>\n

Let’s block ads!<\/a><\/strong> (Why?)<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-8139","post","type-post","status-publish","format-standard","hentry","category-health"],"_links":{"self":[{"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/posts\/8139","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/comments?post=8139"}],"version-history":[{"count":0,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/posts\/8139\/revisions"}],"wp:attachment":[{"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/media?parent=8139"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/categories?post=8139"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/associatednews.info\/content\/wp-json\/wp\/v2\/tags?post=8139"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}