Developmental Milestones/Developments to Date:
Current Assessment/State of the Field:
Walter, Charles, Richards, Edward, P., “Research Misconduct: Catching the Desperados and Restraining the Zealots,” 13 IEEE Engineering in Medicine and Biology Magazine #1, Feb/Mar issue, pg. 142.
- “The current public debate about scientific misconduct received impetus in the early 1980’s when the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, chaired by Congressman John D. Dingell (D-Mich), began its misconduct investigations. According to the Crewdson article, Congressman Dingell demanded that the National Institutes of Health (NIH) root out science fraud. NIH responded by creating the Office of Scientific Integrity (OSI), a sort-of scientific Star Chamber manned by scientists investigating scientific misconduct… One of the first cases to capture the subcommittee’s attention was the NIH-funded research of Dr. John Darsee of Harvard Medical School. According to Congressman Dingell, Dr. Darsee was investigated first by his department chairman and then by a committee of scientists appointed by the Harvard dean. Both reviewed Dr. Darsee’s data and reported no misconduct in Darsee’s published research. Then a committee appointed by NIH investigated and concluded that data for some of Dr. Darsee’s published experiments did not exist.”
- “The definition of ‘misconduct in science’ adopted by the National Academy of Sciences’ Committee on Science and Engineering Public Policy (COSEPUP) is ‘fabrication, falsification, or plagiarism, in proposing, performing, or reporting research’ whether intentional or otherwise. The committee felt that these three ‘cardinal sins’ comprise the crux of misconduct in science and even anointed them with their own abbreviation: FFP.”
- Other categories include: “‘questionable research practices’ which include dishonest and/or sloppy research practices such as sharing authorship of articles with noncontributing collegeagues, accepting honorary authorship of articles, using facilities for private gain or keeping poor research records.”
- “‘other misconduct,’ which includes sexual harassment, rape, embezzlement, murder, extortion, arson, theft, and violations of government regulations…”
American Society for Microbiology, “Proposed Federal Policy on Research Misconduct To Protect the Integrity of the Research Record,” American Society for Microbiology, Dec. 2, 1999.
- Revision suggestions for “the proposed policy on research misconduct published in the Federal Register on October 14, 1999.” “…we suggest that the sections should be restructured…”
Youngner, Julius, “Promoting Research Integrity at the American Society for Microbiology,” Address, Representing The American Society for Microbiology, Apr. 10, 2000.
- “In 1988 the ASM adopted a Code of Ethics… The Code of Ethics continues with an Ethics Review Process… the Publications Board of the ASM oversees the publication of 10 journals that print over 6,000 papers a year. …The ASM’s Public and Scientific Affairs Board maintains a strong Washington presence…”
- “It is instructive that in the 100-year history of the ASM, only one member has been expelled from the Society and that this expulsion occurred in 1998. …In April 1997 Larry Wayne Harris, a member of the ASM, pled guilty to wire fraud in connection with an effort to obtain vials of ”Versinia pestis” (the organism that causes plague) from the American Type Culture Collection. Mr. Harris misrepresented the existence of a laboratory, used the telephone number, address, and EPA approval number of his employers’ laboratory without their knowledge or permission, and misstated the purpose for which he wanted the organism. …In February 1998, Mr. Harris was arrested in Las Vegas, Nevada for suspected possession of anthrax, and was charged by the FBI with violating his parole. At this point, 10 members of the Society formally complained to the President of the ASM the Mr. Harris had violated the Society’s Code of Ethics by making false and misleading statements that made ‘use of microbiology contrary to the welfare of humankind.’ This complaint set into motion the Ethics Review Process of the Society.”
Kwik, Gigi; Fitzgerald, Joe; Inglesby, Thomas V.; O’Toole, Tara, “Biosecurity: Responsible Stewardship of Bioscience in an Age of Catastrophic Terrorism.” Biosecurity and Bioterrorism Volume 1 Number 1, November 1, 2003.
- “Characteristics of an Effective Self-Governance System… …There must be increased awareness of biosecurity and bioterrorism risks among scientists and the scientific leadership… …Security provisions should be organic to the culture and practices of biological research… …Biosecurity must be ‘bottom-up.’… …Biosecurity must include processes or measures for periodic assessment of how well the system is working… …Biosecurity systems should provide the means of making applications and test systems increasingly pervasive and global.”
Department of Health and Human Services, “42 CFR Parts 50 and 93, Public Health Policies on Research Misconduct; Proposed Rule,” Federal Register, April 16, 2004, Vol.69, No. 74.
- “The purpose of this proposed rule is to implement legislative and policy changes that have occurred since the regulation was issued, including the common Federal policies and procedures on research misconduct…”
- “…we have not had clear-cut procedures for research misconduct adjudications. …Accordingly, we believe that adding a hearing regulation applicable only to research misconduct cases is advisable to codify a fair, efficient, and timely process for accused researchers.”
Shenk, Thomas, “ASM Comments on Public Health Service Policies on Research Misconduct,” American Society for Microbiology, June 15, 2004.
- RIN #0940-AA04
- ASM response to the Proposed Rule submitted at 69 Federal Register. “…the ASM submits that recommended decisions be issued by a RIAP and that, upon the request or either party, a scientist or technical expert participate fully as a member of the panel. With the appointment of a Presiding Panel Member, other procedures for expediting a fair and effective hearing may be utilized…”
- “…the PHS proposes that a single Administrative Law Judge (ALJ) appointed from the Departmental Appeals Board (DAB) Administrative Law Judges conduct hearings on allegations of research misconduct and issue a recommended decision for review by the Assisatnt Secretary for Health. This procedure would constitute a substantial modification of the current process through which a Research Integrity Adjuducations Panel (RIAP) consisting of three members conducts a hearing on charges of research misconduct. The ASM submits that hearings on allegations of research misconduct should continue to be conducted before a Research Integrity Adjudications Panel and that, at the request of either party, at least one member of the panel should be a scientist with research experience and knowledgeable in the scientific area focused on in the hearing. …Under the proposed procedure… the expert would play only a consultative role and would not have any right or responsibility to participate in the deliberation concerning, or rendition of, a recommended decision on the allegations.”
Ricks, Delthia, “Reseacher’s Ties Faulted,” Newsday Long Island, July 10, 2004, A2.
- “One week after cholesterol-reducing Crestor was approved last year, a top government researcher published a scientific paper praising the medication, but failed to mention he was a consultant to the drug’s maker…”
Afrasiabi, Kaveh, L., “Iran Sanctions Hit the Wrong Target,” Asia Times, Jan. 25, 2008. http://www.atimes.com/atimes/Middle_East/JA25Ak03.html Last checked Oct. 18, 2009.
- “Indeed, this much is clear by examining the poor logic of renewed attempts to toughen Iran sanctions on the part of the UN Security Council’s five permanent members (the US, Britain, France, Russia and China) plus Germany – the Five plus One – reportedly agreeing in their last meeting in Berlin on Tuesday t odraft a new resolution. … [Which will] impose new travel bans, certain ‘asset freezes’ as well as calls for ‘vigilance’ with respect to the transfer of ‘banned material’ for sensitive nuclear activities, and ‘monitoring’ of the sanctions regime.”
- “The latest draft UN resolution’s provisions for ‘travel bans’ simply lack a sound strategic design, rigorous monitoring and enforcement mechanism and will likely fail to generate international cooperation and compliance.”
- “such UN initiatives will likely backfire on the UN and diminish its standing, particularly among the majority of the world’s population who belong to the Non-Aligned Movement (NAM), given NAM’s solid support of Iran’s nuclear rights.”
- “Resolution 1747, while providing a short list of several scientists and heads of Iran’s Revolutionary Guards Corps as intended targets for a travel ban, [cite omitted] nonetheless opens a loophole by stating ‘except when such travel is for activities directly related to items in certain sub-paragraphs. One such exception deals with religious pilgrimage, another deals with Iran’s non-proliferation sensitive nuclear activities.”
- “There is always the availability of false passports and travel documents and the challenges of effective customs and border monitoring, particularly by Iran’s neighbors. [cite omitted] Then there is a lack of incentives for cooperation by other states, especially those which are critical of the US-led sanctions on Iran and which agree with Iran that these measures have the character of ‘psychological warfare.'”
*”the question arises as to the grounds on which poor scientists who simply follow orders should be penalized, and their freedom to travel curtailed.”
Carey, Benedict, “Researchers Find Bias In Drug Trial Reporting,” New York Times, January 17, 2008, A18.
- “…a team of researchers identified all antidepressant trials submitted to the Food and Drug Administration to win approval from 1987 to 2004. The studies involved 12,564 adult patients testing drugs like Prozac from Eli Lily, Zolofot from Pfizer and Effexor from Wyeth. …They found that 37 of 38 trials that the FDA viewed as having positive results were published in journals. The agency viewed as failed or unconvincing 36 other trials, of which 14 made it to journals.” (Almost all positive results made the journals, less than half negative results did.)
Hakim, D., Peters, J.W. “Scientist for State Police Kills Himself,” The New York Times, May 24, 2008.
- “A State Police scientist hanged himself in his garage Friday, law enforcement officials said, the second time in a little over a week that someone with ties to the agency has killed himself.”
- “Mr. Veeder appeared to have been distressed about an unrelated investigation of evidence handling by the State Police crime lab in Albany, according to a published report. The report, which appeared Friday on the Web site of The Times Union of Albany, said a suicide note written by Mr. Veeder cited his concerns about the investigation.”
- “Lieutenant Miner did confirm, however, that the police had begun an investigation of the lab after recently finishing an audit of its policies and procedures to meet national accreditation requirements. He gave no details of what was learned in the audit that prompted an investigation.”
- “The episode is the latest to weigh on the agency, which is now facing investigations on multiple fronts. Mr. Veeder’s suicide is the third to hit the State Police in less than two months.”
Broder, John M. “Researcher steps down over e-mails; Climatologist leaves post while ‘criminal breach’ of computers is investigated,” The International Herald Tribune, newspaper December 3, 2009.
- “The head of the British research unit at the center of a controversy over the disclosure of thousands of e-mail messages among scientists studying climate change has stepped down pending the outcome of an investigation.”
- “Phil Jones, the director of the Climatic Research Unit at the University of East Anglia in Norwich, England, said that he would leave his post while the university conducted a review of the release of the messages. The university has called the release and publication of the messages a ”criminal breach” of the school’s computer systems.”
- “The e-mail exchanges among several prominent American and British climate-change scientists appear to reveal efforts to keep the work of skeptical scientists out of major journals and the possible hoarding and manipulation of data to overstate the case for human-caused climate change.”
- “Skeptics have seized upon the disclosures to call into question years of efforts to document changes to the climate and its causes. Republicans in the U.S. Congress have begun an investigation into the work of the scientists who sent the messages – many of whom have conducted much of their research with money from the U.S. government – and the scientific and policy decisions that may have flowed from them.”
- “The British university says the messages were illegally obtained by a hacker, who posted them on Web sites of groups critical of the current scientific consensus that human activity has caused dangerous changes to the climate.”
Fanelli, Danielle, “How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data,” Journal: PLoS ONE, May 29, 2009.
- “In surveys asking about the behaviour of colleagues, fabrication, falsification and modification had been observed, on average, by over 14% of respondents, and other questionable practices by up to 72%.”
Pollack, Andrew, “Biotech Company Fires Chief and Others Over Handling of Data,” NYT, Sept. 29, 2009, B2.
- “A biotech company developing what was expected to be a groundbreaking blood test for [detecting] Down Syndrome fired its chief executive, a top research official and three other employees Monday after an investigation into ‘mishandling’ of test data and results.”
- “its investigation concluded that the company had ‘failed to put in place adequate protocols and controls’ for studies… [as reported in a regulatory filing citing] ‘inadequately substantiated claims, inconsistencies and errors’ about the Down syndrome test [that] had been disclosed to investors.”
- “Sequennom’s announcement left many questions unanswered, in particular how exactly the data was ‘mishandled’ and whether what happened was mere sloppiness or outright fraud.”
- “the company could not say more because it was under investigation by the Securities and Excahnge Commission and had been sued by shareholders.”
- “The company’s work drew widespread attention from Wall Street, the medical community and the news media, especially after it reported that in early trial runs the test was virtually perfect in detecting Down syndrome, with no false positives or false negatives.”
Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins, National Research Council of The National Academies, Report Released September 30, 2009. http://www.nap.edu/catalog.php?record_id=12774
- “The Committee was asked to consider the appropriate framework of laboratory security and personnel reliability measures that will optimize benefits, minimize risk, and facilitate the productivity of research.”
- ”Recommendation” 1: “…personnel with access to select agents and toxins should receive training in scientific ethics and dual-use research.”
- ”Recommendation” 2: “… a Biological Select Agents and Toxins Advisory Committee (BSATAC) should be established. … [to]… Promulgate guidance of the Select Agent Program; … Promote harmonization of regulatory policies and practices.”
- ”Recommendation” 3: “The list of select agents and toxins should be stratified in risk groups according to the potential use of the agent as a biothreat agent, …mechanisms for the timely inclusion or removal of an agent oroxin from the list are necessary and should be developed.”
- ”Recommendation” 4: “Because biological agents have an ability to replicate, accountability is best achieved by controlling access to archived stocks and working materials. …[as opposed to] counting the number of vials.”
- ”Recommendation” 5: The appeals process for Security Risk Assessments should be broadened beyond mere checks for factual errors.
- ”Recommendation” 6: “… define minimum cross-agency physical security needs.”
- ”Recommendation” 7: Dedicated funding should support an independent evaluation of the Select agent Program to assess benefits and consequences of the program.
- ”Recommendation” 8: “Inspectors of select agent laboratories should have scientific and laboratory knowledge and experience, as well as appropriate training in conducting inspections specific to BSAT research. Inspector training and practice should be harmonized across federal, state, local, and other agencies.”
- ”Recommendation” 9: A separate category of support should be allocated for BSAT research due to the costs of security.
Bremner, Charles, Sage, Adam, “Hadron Collider physicist Adlene Hicheur charged with terrorism,” TimesOnline, october 13, 2009. http://www.timesonline.co.uk/tol/news/world/europe/article6871774.ece
- “However, his arrest last week has sparked a furious row among France’s anti-terrorist magistrates. Judge Teissier’s critics say that he missed an opportunity to obtain invaluable information about Aqim networks by moving to detain the suspect at an early stage in his investigation. They said that he should have held off and kept the man under surveillance.”
- “Brice Hortefeux, the French Interior Minister, is also being criticised for publicising the arrest. Detractors say that the publicity will have driven the suspect’s contacts underground.”
- “Residents in the suspect’s home town of Vienne, in eastern France, said that his success had made him a role model for young Muslims. ‘They are good boys,’ said one neighbour of the suspect and his brother. ‘They are from a family of six children and from a very moderate Muslim family which is seen as a model of integration.’”
- “The suspect’s brother is reported to have graduated from the University of Paris with a degree in biomechanics.”
- “He was placed under surveillance by French officers last year after US intelligence services intercepted internet messages he allegedly sent to contacts close to al-Qaeda in the Islamic Maghreb (Aqim).”
Harris, Gardiner, “Dissidents at F.D.A. Complain of Inquiry,” The New York Times, newspaper January 28, 2009.
- “Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.”
- “The letter is the latest escalation in a highly unusual internal battle that has been simmering for nearly a year within the agency’s device division. The nine scientists have banded together and charged that agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective.”
- “The scientists complained in May to Dr. Andrew C. von Eschenbach, who was then the F.D.A. commissioner, and the agency began an internal review that continues. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one, which also continues.”
- “It can be a crime for agency employees to reveal documents or information considered confidential by companies seeking agency approval for medical products.”
- “Critics have long bemoaned the agency’s device approval process, which allows most devices to be approved with minimal testing. Manufacturers say the agency is already overly restrictive.”
Overbye, Dennis, “French Investigate Scientist In Formal Terrorism Inquiry,” NYT, A13, Oct. 14, 2009.
- “A French court placed a phycisist working at CERN, the huge research center in Switzerland, under formal investigation on Monday for suspected ‘conspiracy with a terrorist enterprise.”
- “…identified him as Adlene Hicheur, 32, a French particle phycisist born in Algeria … [was] arrested on Thursday in hi home in Vienne, France, on suspicion of having contacts with a member of Al Qaeda in the Islamic Maghreb, a Sunniextremeist group based in ALgeria that has affiliated itself with Osama bin Laden’s terrorist network.”
- “some incriminating evidence was in the form of e-mail messages and other communications obtained at the time of Dr. Hicheur’s arrest.”
- “Dr. Hicheur is part of a 49-member team from the Laboratory for High Energy Physics at the Ecole Polytechnique Federale de Lausanne that is working on one experiment at CERN’s large Hadron Collider, as part of a 700-member international group.”
- “The research [for his Ph.D. from university of Savoie] was done at the Stanford Linear Collider in California, where he worked for several months in 2002 as part of the BaBar collaboration.”
- “In principle, antimatter could be used to make a powerful bomb, because particles and their antiparticles annihilate each other into pure energy on contact.”
- “A spokesman for the technical school in Lausanne characterized Dr. Hicheur’s colleagues as being ‘extremely surprised adn in emotional shock’ at the possibility that he was a suspect.”
Wilson, Duff, “Research Uproar at a Cancer Clinic: Errors at Illinois Center May Signal Failings at Similar Hospitals,” B1 & B7, NYT, Oct. 23, 2009.
- “an outside audit that had found ‘major deficiencies’ in 12 of 29 experiments being overseen by that doctor, potentially endangering patients or skewing the studies’ results.”
- “And if Carle’s problems turn out to any indication, the community centers may not always be adhering to the rigorous protocols of research medicine that the national Cancer Institute expects them to follow. That could call into question the scientific evidence that the community research program amasses.”
- “But some experts in community medicine say that many of the local programs simply fly under the federal government’s radar.”
Sang-Hun, Choe, “Discredited Cloning Expert Is Convicted of Fraud in South Korea,” NYT, A11, Oct, 27, 2009.
- “Hwang Woo-suk, a disgraced cloning expert from South Korea who had claimed major breakthroughs in stem-cell research, was convicted Monday of falsifying his papers and embezzeling government research funds.”
- “His school, Seoul National university, disowned him in 2005, saying that he had fabricated the papers he had published to global acclaim.”
- “Dr. Hwang, a veterinarian by training, became known as an international pioneer in stem-cell research in 2004 when he and his colleagues published a paper in the journal Science claiming that they had created the world’s first cloned human embryos and had extracted stem cells from them.”
Associated Press, “Espionage Suspect Admits Overbilling: Scientist Entered Secret Plea Deal,” USA Today, 6A, Oct. 27, 2009.
- “A former government scientist accused of attempted espionage pleaded guilty to overbilling NASA and the Department of Defense more than $265,000 for contracting work.”
- “Seperately, Nozette was arrested last week and accused of trying to sell classified information on U.S. defense secrets to an undercover FBI agent posing as an Israeli intelligence operative.”
Madigan, Nick, “Ex-UM Researcher Whose Fiancee Died is Indicted,” Baltimore Sun, 5, Oct. 27, 2009.
- “A Baltimore grand jury indicted a former University of Maryland School of Medicine researcher Monday on 14 drug-related counts.”
- “McCracken was charged by police after the Sept. 27 death of his 29-year-old fiancee, Carrie John, a fellow doctoral lab researcher at Maryland. [According to McCracken]…she injected herself with … a fluid containing the narcotic buprenorphine. … McCracken also possessed with intent to distribute the stimulant methlphenidate and the anti-anxiety drug clonazepam. …McCracken is no longer employed by Maryland.”
Normile, Dennise, “Hwang Convicted But Dodges Jail; Stem Cell Research Has Moved On,” Science Magazine, Vol. 326. no. 5953, pp. 650 – 651. October 30, 2009.
- “…stem cell scientist Woo Suk Hwang was handed a 2-year suspended prison sentence on 26 October for embezzlement and bioethics law violations.”
- “Hwang’s results didn’t hold up. On 29 December, an investigative committee at SNU found the 2005 paper fraudulent and on 10 January 2006 concluded that the 2004 paper was bogus as well.”
- “Scientific journals now examine papers more closely. Science, for instance, now routinely screens all images in accepted papers…” (Note that “Science” is that magazine writing this article)
Associated Press, “Pfizer drug studies fudged, report says” NBC News. Last checked 11/11/2009 http://www.nbcnews.com/id/33867108/ns/health-health_care/t/pfizer-drug-studies-fudged-report-says/
- “Studies indicated the drugs worked better than internal documents showed”
- “Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often fudged, indicating the medicine worked better than internal company documents showed.”
- “Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report ‘one of the most ethically disturbing papers I’ve read in some time’ and ‘an indication that people have been playing fast and loose with studies,’ particularly industry ones.”
Clavert, Scott, “Researcher did not die of overdose autopsy says: Allergic reaction, not bupe, killed UM pharmacologist,” Baltimore Sun, P. 1, Nov. 13, 2009.
- “University of Maryland pharmacologist Carrie John died from an allergic reaction and not because she injected a seemingly tainted batch of the narcotic buprenorphine.”
- “The [autopsy] results suggest that McCracken, 33, might have unwittingly bought phony narcotics.”
- “Her death stunned the school, where the two postdoctoral fellows did brain research and she studied drug abuse.”
- “He [McCracken] said he and and John soaked a 2 mg pill in water, filtered it, then filled two syringes with the solution.”
- “The couple met as graduate students at Wake Forest University. …Before that he was at the University of Pittsburgh. he is no longer at Maryland.”