Due Process Vetting

Status Brief

Developmental Milestones/Developments to Date:

Current Assessment/State of the Field:



Summary of Due Process Vetting via Congressional Research Service:

Janet Knezo “’Sensitive But Unclassified’ Information and Other Controls: Policy and Options for Scientific and Technical Information,CRS Report for Congress, Page CRS-43.  Updated December 29, 2006.  http://www.fas.org/sgp/crs/secrecy/RL33303.pdf

  1. “Brian J. Gorman proposed a risk-based alternative approach for prepublication peer review. He called for a risk-based process called ‘Due Process Vetting System’(DPVS) together with “… a Risk Assessment Scale [RAS] and a Least Restrictive Classification System for the communication, assessment, and disposition of sensitive life science research in a manner consistent with national security interests.”(FN 184)
  2. “The process would be overseen by a new agency called the Biologic Regulatory Commission, modeled after the Nuclear Regulatory Commission. The vetting process would be triggered at the request of an author or peer reviewer if an article attained a predetermined score on the RAS set by the BRC. “The RAS surveys opinions of informed reviewers including the author of the article, the author’s Institutional Review Board or Institutional Biosafety Committee (IBC), and finally the journal interested in publishing the article.” (FN 185)
  3. ”The DPVS would safeguard highrisk articles by providing the government with a mechanism to identify “potentially dangerous articles before they reach the presses,”(FN 186) would avoid the “deleterious effects of censorship,” (FN 187) and would make articles available only to a “select  academy of biodefense researchers after the authors, the publishing journal and others, reach a consensus with the government through cooperative vetting of the article in question.”188 Gorman proposed expanding the academy to a qualified body of world scientists, an approach he said is superior to the ASM model and ad hoc approaches undertaken by the majority of U.S. biosciences journals.” (FN 189)


Power point briefing for the Committee on Scientific Communication and National Security http://sites.nationalacademies.org/PGA/CSCANS/PGA_046410 is available on Scribd at http://www.scribd.com/doc/54955505/Gorman-National-Academies-CSCANS-30-October-2006 , or http://www.towson.edu/sociology/Popup/documents/Gorman_National_Academies_CSCANS_30_October_2006_000.ppt


The Due Process Vetting Article: “Balancing National Security and Open Science: A proposal for Due Process Vetting” [pdf], Yale Journal of Law and Technology (2005) available at http://yjolt.research.yale.edu/files/gorman-7-YJOLT-491.pdf


Editors, “Scientists Brace for Media Storm Around Controversial Flu Studies,” Science Insider, November 23, 2011.  Available at http://news.sciencemag.org/scienceinsider/2011/11/scientists-brace-for-media-storm.html
Last checked 12/5/11

  1. ”The virus is an H5N1 avian influenza strain that has been genetically altered and is now easily transmissible between ferrets, the animals that most closely mimic the human response to flu. Scientists believe it’s likely that the pathogen, if it emerged in nature or were released, would trigger an influenza pandemic, quite possibly with many millions of deaths.”
  2. ”The other study—also on H5N1, and with comparable results—was done by a team led by virologist Yoshihiro Kawaoka at the University of Wisconsin, Madison, and the University of Tokyo, several scientists told ScienceInsider.”
  3. ”Both studies have been submitted for publication, and both are currently under review by the U.S. National Science Advisory Board for Biosecurity (NSABB), which on a few previous occasions has been asked by scientists or journals to review papers that caused worries.”
  4. ”NSABB chair Paul Keim, a microbial geneticist, says he cannot discuss specific studies but confirms that the board has “worked very hard and very intensely for several weeks on studies about H5N1 transmissibility in mammals.”
  5. ”’I can’t think of another pathogenic organism that is as scary as this one,’ adds Keim, who has worked on anthrax for many years. ‘I don’t think anthrax is scary at all compared to this.’”
  6. ”’This work should never have been done,’ says Richard Ebright, a molecular biologist at Rutgers University in Piscataway, New Jersey, and the Howard Hughes Medical Institute who has a strong interest in biosecurity issues.”
  7. ”Those stories describe how Fouchier initially tried to make the virus more transmissible by making specific changes to its genome, using a process called reverse genetics; when that failed, he passed the virus from one ferret to another multiple times, a low-tech and time-honored method of making a pathogen adapt to a new host.”
  8. ”Fouchier says he consulted widely within the Netherlands before submitting his manuscript for publication. The U.S. National Institutes of Health (NIH), which funded the work, has agreed to the publication, says Fouchier, including officials at the National Institute of Allergy and Infectious Diseases. (NIH declined to answer questions for this story.)”
  9. ”Osterholm says he can’t discuss details of the papers because he’s an NSABB member. But he says it should be possible to omit certain key details from controversial papers and make them available to people who really need to know.”
  10. ”Even Ebright, however, says he’s against efforts to ban the publication of the studies now that they have been done.”
  11. ”’The researchers “have the full support of the influenza community,’ Osterholm says, because there are potential benefits for public health. For instance, the results show that those downplaying the risks of an H5N1 pandemic should think again, he says.”

Open Science, Classified, Due Process Vetting, Flu, Dual Use, NSABB, Anthrax, Pandemic, Zoonotic


Connor, Steve, “Experts condemn plans to lift ban on research into deadly H5N1 birdflu virus,” The Independent, July 27, 2012. http://www.independent.co.uk/news/science/experts-condemn-plans-to-lift-ban-on-research-into-deadly-h5n1-birdflu-virus-7982081.html# last checked July 31, 2012

  1. ”The moratorium on deliberately creating highly infectious strains of H5N1 was supposed to last 60 days but has continued for six months.”
  2. ”This weekend, influenza scientists will meet in New York in the hope of lifting the ban and allowing the work to continue.”
  3. ”’The moratorium should be continued until a broader, dispassionate, international discussion can be held to carefully consider the risks and benefits,” said David Relman, professor of infectious diseases at Stanford University in California. ‘The consequences of misuse or accidental release are potentially catastrophic on the global human and animal populations. Scientists have a deep moral and ethical responsibility to back off…it should not be decided by a group of flu researchers,’ said Dr Relman, who also sits on the US National Science Advisory Board for Biosecurity.”
  4. ”The meeting in New York is being organised by the US National Institute of Allergy and Infectious Diseases whose director, Tony Fauci, has gone on record as saying that he would like to ‘expedite as quickly as possible the lifting of the moratorium’.”
  5. ”Richard Roberts, a Nobel prize-winning molecular biologist and expert in genetic engineering, said the moratorium should continue and that many experts are privately appalled that there are plans to lift it but are afraid of speaking out over fears that it might affect their funding from the NIH.”
  6. ”Stanley Plotkin, a world authority on vaccines at the University of Pennsylvania, has written to Dr Fauci urging him to continue the moratorium. He said that creating a strain of H5N1 virus that is airborne transmissible would be like creating anthrax bacteria that could be easily spread from one person to another.”
  7. ”Professor Berg said that lifting the moratorium is ‘a bit ludicrous’ given that there is no scientific rationale to support an end to the voluntary research ban. ‘There should be a serious review and evaluation of the concerns that led to the moratorium and a scientifically rigorous analysis of why the concerns can be managed before the moratorium could be lifted,’ Professor Berg said.”
  8. ”’Stanley Falkow, Professor Emeritus of Microbiology and Immunology and Medicine, Stanford University: ‘I agree that the moratorium ought to be continued. My reasoning is that the moratorium is essential until such time as there is a dispassionate international meeting to address the issues brought to the fore by the H5N1 “affair”. In my judgment there has been a lack of leadership by the scientific community in dealing with this issue. The majority of statements from scientific leaders recently were often self-serving remarks and communications to journals from either biased virologists or those promoting doom and gloom. What was needed was a plan for a way forward based on the premise that H5N1 was simply an acute exacerbation of a long smouldering problem that was diagnosed in the Fink report a decade ago but still not treated appropriately for over a decade. In contrast, I believe the behaviour of the scientists in the face of the recombinant DNA discovery in terms of their initiative and responsibility was admirable and this kind of leadership has been notably missing now. Of course, that was over 35 years ago and while there are certainly parallels between the implications for public health and society from the discovery of recombinant DNA technology and similar implications for dual use research, it is a different time and a different world. However, the social responsibility of a scientist remains the same regardless of the time.’”

Open Science, Flu, Due Process Vetting, Dual Use, Information Policy, NSABB, Oversight, Lab Safety


Roos, Robert, “Fauci Urges Continuing Pause on Risky H5N1 Studies,” CIDRAP News, July 31, 2012. Available at http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/news/jul3112fauci.html last checked August 1, 2012.

  1. ”The head of the US agency that funds much influenza research today called on scientists to continue their voluntary moratorium on certain kinds of potentially hazardous H5N1 research, saying they need to better address public concerns about the studies, according to news reports from a flu meeting in New York City.”
  2. “’I strongly recommend that you continue this voluntary moratorium until you can have this open and transparent process addressing the fundamental principles,’ said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), as quoted in reports by Nature and National Public Radio (NPR).”
  3. ”According to the Nature story, Fauci spent a half hour at today’s meeting explaining his reasoning and the process now under way to develop a government policy on “dual-use research of concern” (DURC), meaning studies that could be deliberately used to do harm. He said several federal agencies are involved in developing the policy, which would govern how researchers and institutions must report on DURC and address the risks involved.”
  4. ”This policy would include the formation of a ‘government-wide agency’ assigned to develop and implement guidelines for federally funded researchers in a way that involves input from all interested parties, including the public, scientists in other fields, and the global community, Nature reported. Fauci said he hoped that the agency could be in place by the end of the summer, but he was careful not to promise, saying, ‘I don’t control it.’”
  5. ”Ron Fouchier, PhD, of Erasmus Medical Center in the Netherlands, lead author of the more contentious of the two H5N1 studies, called for ending the research pause, according to NPR. He argued that the original conditions for imposing the moratorium have now been met, including time for review of the biosafety requirements for such experiments.”

Open Science, Flu, Due Process Vetting, Dual Use, Information Policy, NSABB, Oversight, Lab Safety