Human Subjects News Archive
Here you will find information, stories, or policies previously highlighted in the Recent News section of the OEP Research Involving Human Subjects homepage.
- "Patient Zero” of Aids Epidemic Exonerated. The New York Times (10/29, McNeil, Subscription Publication, 13.42M) reports that genetic sequencing of blood samples from the 1970s has exonerated “Patient Zero” of the Aids epidemic, “French Canadian flight attendant named Gaétan Dugas.” Dugas’s was identified as person who introduced AIDS into the US by journalist Randy Shilts, who also died from AIDS. However, analysis shows that “the strain infecting [Dugas] had circulated among gay men in New York for several years before he arrived here in 1974.” According to the Times, Dugas “did not introduce the virus to North America; he was a victim before he was a vector.” His case, however, “raises a moral question: Is it right to hunt down the first case in any outbreak, to find every Patient Zero?” The Times notes that it is this search that “has become a regular feature of health journalism.”
- Secret World War II Chemical Experiments Tested Troops By Race. Edwards was one of 60,000 enlisted men enrolled in a once-secret government program — formally declassified in 1993 — to test mustard gas and other chemical agents on American troops. But there was a specific reason he was chosen: Edwards is African-American. While the Pentagon admitted decades ago that it used American troops as test subjects in experiments with mustard gas, until now, officials have never spoken about the tests that grouped subjects by race. Japanese-American, African-American and Puerto Rican troops were used as test subjects. NPR breaks a two-part story of mustard gas testing on US military members based on race. Part II of the story focuses on the broken promises of treatment by the VA. Click here to read Part I and Part II.
- NIH to Begin Testing Zika Vaccine in Humans. The Washington Post (8/3, Dennis, 9.18M) reports NIH officials announced on Wednesday that they will begin clinical testing of a Zika vaccine in human trials. The initial trial will “involve at least 80 volunteers between ages 18 and 35 at three locations around the United States,” including the NIH Clinical Center in Bethesda. In a statement, National Institute of Allergy and Infectious Diseases director Anthony Fauci said, “A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative.” In a previous interview with The Washington Post, Fauci said that government researchers had leveraged research on the West Nile and dengue viruses to “quickly create vaccine candidates that target Zika, which currently has no cure or effective treatment.” If the early results are successful, researchers “hope to begin a larger-scale trial in Zika-affected countries in early 2017.”
- This Doctor Breaks Down Language and Cultural Barriers to Health Care. The Washington Post (9/6, Kelly, 10.14M) “To Your Health” blog profiles Dr. Eliseo Pérez-Stable, the director of the National Institute on Minority Health and Health Disparities (NIMHD), and his continuing efforts to break down cultural and language barriers that prevent people from accessing healthcare. The article explains that Dr. Pérez-Stable experienced such barriers firsthand while growing up as an immigrant from Cuba in the Miami area and later learned more about the prevalence of such experiences in the Latino community while doing research at the University of California at San Francisco.
- More on the Precision Medicine Initiative (PMI) Majority of People Would Give Personal Information to Precision Medicine Database. Modern Healthcare (8/18, Castellucci, Subscription Publication, 235K) reports the majority of Americans support the Precision Medicine Initiative Cohort Program and would be willing to participate, according to a new survey conducted by market research firm GfK and published in Plos One. The article explains that the program aims to improve medicine by gathering genetic information, medical histories, and EHRs from over 1 million people and the National Institutes of Health has already awarded almost $55 million in grants to begin recruiting people to participate.
Additional Sources. Fierce Healthcare (8/18, Dvorak, 147K) reports the survey found that almost 80% of Americans support the program and a majority said they would “definitely” or “probably” take part in it. NIH’s deputy director for science, outreach, and policy Kathy L. Hudson said the survey results are “extremely promising.”
Politico (8/18, Geller, 1.95M) adds the survey was supported by the NIH and the results were based on the responses of around 2,600 people.
Analytics, Data Science and EHRS in the New Age. In a nearly 4,000 word article, Healthcare IT News (8/15, Andrews, 1K) reports on how “the rapid advancement of precision medicine” is “continually outstripping” the pace of change in EHRs. The article reports that EHRs are essentially the same as they were in 2004 when the Office of the National Coordinator for Health Information Technology launched the interoperability initiative, but medicine has changed a lot since then. The Office of the National Coordinator for Health IT’s deputy national coordinator Jon White said, “The overarching problem with interoperability is that there is no common data model – not only between vendors, but between instances of a particular vendor. There really needs to be a standard data model for healthcare.”
Spotlight on Zika in US
Zika hits Miami: Nation's first local outbreak, health officials confirm. The Centers for Disease Control and Prevention confirmed certain Zika cases in Miami were the first in the continental US to demonstrate the local transmission of the virus. All three network newscasts provided nearly 11 minutes of coverage combined and led with the story, while print and online sources also provide extensive reporting on the announcement. Coverage highlighted the implications of the spread of the Zika virus in the US and suggested that the news will increase pressure on Congress to act on the President’s funding request to fight the disease.
In a nearly 1,700-word article, the Miami Herald (7/29, Chang, 762K) reported that “four people in South Florida – two in Miami-Dade County and two in Broward – have been infected by local mosquitoes, according to Florida Gov. Rick Scott, whose announcement triggered a wave of response from public health agencies and elected officials.” CDC Director Tom Frieden said the agency is not currently advising against travel to Miami, asserting that these cases appear to be “isolated” and an example of what “may be occasional clusters in the United States,” but not the beginning of “widespread transmission.”
On ABC World News Tonight (7/29, lead story, 2:25, Llamas, 14.63M), correspondent Eva Pilgrim added that health officials have tested around 19,000 mosquitoes from the neighborhood, but none have so far tested positive for the virus. Reuters (7/29, Fagenson) said that “many” local residents “viewed the arrival of Zika in Miami as all but inevitable, given the region’s large numbers of tourists and its sweaty summer mosquito season.” On ABC World News Tonight (7/29, story 2, 1:05, Llamas, 14.63M), chief medical editor Dr. Richard Besser praised the CDC for not imposing travel restrictions on Miami, calling the decision “a responsible move,” given the lack of “a widespread outbreak across Miami.”
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told NBC Nightly News (7/29, lead story, 2:25, Holt, 16.61M) correspondent Kerry Sanders he thinks “we’re going to see more” incidents of locally transmitted cases and posited, “The critical issue is how do you respond to that?” The Hill (7/29, Sullivan, 884K) added that Fauci “said at an event at the Bipartisan Policy Center Friday that he thinks ‘very aggressive mosquito abatement’ will prevent the virus from becoming ‘sustained’ in the continental United States.”
- Heat on White House to Scrap Redo of Human Research Rules. On its website, the NPR (6/29, 2.27M) “Shots” blog reports that the National Academies of Sciences, Engineering and Medicine released a 238-page report criticizing the changes that HHS proposed to the “Common Rule,” which regulates research involving human subjects.
Additional Sources. STAT (6/29, Scott) reports that the National Academies called for the NIH to withdraw its proposed changes. Several groups, including the American Association for Cancer Research, have criticized the proposed changes as vague.
Science Magazine (6/29, Malakoff, 411K) also covers the story explaining that the proposed rules in question were made by the NIH. A committee from the National Academies sent a report to NIH telling the agency to abandon their current proposal to update the rules in question, and wait for federal lawmakers to create a new commission to study the matter.
Fatal French Clinical Trial Was Legal But Made Several Errors, Investigation Finds. NPR (5/3, Bichell, 2.27M) reports an independent investigation into the French clinical trial that led to the death of a 49 year old man earlier this year concluded that the drug trial “followed the rules and was perfectly legal but suffered from missteps.” The inquiry found that the trial participants were given “extremely high doses of the drug – about 40 times the amount that they expected was needed to quell pain.” The researchers also “ignored the fact that one participant was hospitalized and proceeded to give another high dose to five more people.” Finally, “the drug hadn’t shown much promise for treating pain, but the company decided to test it in humans anyway.”
- A Notice of Proposed Rulemaking (NPRM) for the Federal Policy for the Protection of Human Subjects was released on September 9, 2015 by the Office of the Federal Register. A brief summary of the proposed changes can be accessed at the following HHS website: http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html
Preliminary Guidance Related to Informed Consent for Research on Dried Blood Sports Obtained Through Newborn Screening. NIH has published a Guide Notice (NOT-OD-15-127) describing the implementation of new research requirements contained in the Newborn Screening Saves Lives Reauthoriztion Act. This legislation designates federally funded research using newborn dried blood spots collected on or acter March 18, 2015 as non-exempt human subjects research for which parental permission must have been obtained. Implementation questions should be directed to Dr. Tina Urv and NICHD.