Secrecy in Scientific Research

1. Secrecy in Scientific Research David B. Resnik, PhD, JD National Institute for Environmental Health Sciences National Institutes of Health This research was supported by the intramural program of the NIEHS/NIH. The ideas and opinions do not represent the views of the NIEHS/NIH.

2. Whereas every lie stands in need of justification, all secrets do not. Secrecy may accompany the most innocent as well as the most lethal acts; it is needed for human survival yet it enhances every form of abuse. The same is true of efforts to uncover and invade secrets. --Sissela Bok, Secrets (1983), xv

3. Secrecy vs. openness in science is a perennial issue Secrecy in science can be good or bad Need to look at reasons for secrecy Secrecy in science

4. Historical background • Openness has not always been part of the ethos of science. • Applied science/technology: trade secrets, guilds, “tricks of the trade,” “secret recipes.” • 1449 King Henry VI issues the first known patent to John of Utynam for method for making stained glass. • 1641 Massachusetts Bay Colony issues the first Colonial patent for a method for making salt. • 1787 US Constitution gives Congress the power to grant patents • 1790 US Patent Act Patent Bargain = disclosure in exchange for the ability to control and commercialize a product or process

5. Historical background • Leonardo Da Vinci (1452-1519) wrote in mirror writing to prevent his ideas from being stolen. Other scientists and mathematicians, including Isaac Newton (1643-1727), were worried about the same problem. • 1450 printing press—Gutenberg. • 1665 Philosophical Transactions of the Royal Society of London; 1700s/1800s more journals and peer review established. • Rapid communication, openness and sharing of information. Publication bargain = disclosure in exchange for priority, credit

6. Charles Darwin (1809-1882) Voyage of the Beagle (1831-36) Formulates and gathers evidence for his theory of evolution by natural selection; only shares his ideas with a few people Receives and publishes paper with Alfred Russell Wallace (1858) Publishes Origin of Species (1859) Historical background

7. Historical background • 1765 Scientist James Watt and Industrialist Matthew Bolton collaborate to develop and patent the steam engine • 1850s Modern industrial laboratory emerges in Germany for the production of synthetic dyes • 1900-1930s private investment in R & D far exceeds publish investment • 1941 Manhattan Project • 1957-1985 public investment in R & D grows steadily • 1985-present private investment in R & D outpaces public investment • 2006 Private investment in R & D = 60% of total R & D spending in US

8. Openness in Science “Share data, results, ideas, tools, and resources. Be open to criticism and new ideas,” Shamoo and Resnik, Responsible Conduct of Research (2003), p. 20.” “It is widely agreed that research data should be shared, but deciding when and with whom raises questions that are difficult to answer,” Steneck Introduction to Responsible Conduct of Research (2004), p. 95. “The ideal of openness—i.e. the idea that scientific information should be accessible to interested parties—is strongly supported throughout the scientific community,” Munthe and Welin, Science and Engineering Ethics 2,4 (1996): 412.

9. Justifications for openness • Collaboration: sharing enhances efficiency, takes advantage of division of labor • Collegiality: sharing enhances trust, comradeship • Confirmation: sharing is necessary for criticism, validation • Creativity: sharing ideas stimulates thought • Accountability: secrecy makes it easier to get away with corruption, abuse, irresponsibility

10. Legal requirements • Most granting agencies have data sharing policies • The NIH requires extramural and intramural researchers to share data, reagents, cell lines, and transgenic animals in a timely fashion following completion of research. • Sharing can occur through publication, placement of data on public websites, by answering specific requests…

11. Legal requirements • Most granting agencies have data sharing policies • The NIH requires extramural and intramural researchers to share data, reagents, cell lines, and transgenic animals in a timely fashion following completion of research. • Sharing can occur through publication, placement of data on public websites, by answering specific requests… • Exceptions: data may be kept secret to protect confidential information about human subjects or data developed as parts of a cooperative research and development agreement (CRADA) with a private company.

12. Legal requirements • The Freedom of Information Act (FOIA) • All documents created by or for the federal government are public documents. • The public can request access to these documents. • Fees can be charged for copying costs, etc. • Numerous exceptions: business secrets, classified information, personnel information, medical information, attorney-client information, information about human subjects… • Once a study the is funded by the federal government is completed, interested parties can obtain the data via a FOIA request, unless an exception applies.

13. There are many different reasons not data, results, ideas, tools, and resources in science. Some reasons are good ones; others are not. They can create ethical/legal dilemmas in research. Challenges to openness

14. Priority/credit • Sharing data prior to publication can endanger priority/credit. Most researchers are reluctant to do this (justifiably so). • What about after publication? You should share data, but there are still some problem areas: databases, reagents, transgenic animals

15. Priority/credit Dr. D, an epidemiologist, has spent 10 years conducting a long-term study of a population. He has now completed his research and is planning to publish six or more papers from the database. He has published one paper. He now receives a request to share the entire database. What should he do? A) Share; B) Don’t share; C) Share on the condition that he is named on author on papers resulting from the database?

16. Inconvenience • It can take time, money, and personnel to share data. • Making and shipping copies of documents. • Making, storing, and shipping reagents, cell lines, and transgenic animals. • Who pays for this? Who has time to do this? • One solution: contract with a private company, license them to share the materials, upon request, for a fee…

17. Another reason to not share (and not publish) is that the research may be preliminary, rough, unpolished, not validated. Sharing can harm your reputation or the public, e.g. Darwin, Cold Fusion. Interim data in clinical trials is usually not shared not shared with researchers or research subjects but it analyzed by a data and safety monitoring board. Preliminary work

18. Breaking News • The Ohio State Supreme court ruled that Ohio State University did not have to release training materials related to animal research to Physicians to Committee for Responsible Medicine. The court held that these materials were research-related intellectual property, not subject to Ohio public disclosure laws, because they had not been publicly released, published or patented. • State ex. rel. Physicians Commt. for Responsible Medicine vs. Ohio State Univ. Bd. Of Trustees, 108 Ohio St. 3d 288, 2006 Ohio 903.

19. Peer review • Confidentiality is one of the most important ethical principles of peer review; without it, the system wouldn’t work, because people would not be able to trust that their work would not be stolen. • Unfortunately, confidentiality in peer review is sometimes breached and reviewers do steal ideas. • To foil would be thieves, some researchers intentionally omit important details when they submit their manuscripts.

20. Protecting human subjects • Scientists are required by laws and regulations to strip clinical research data of information that can identify particular individuals, such as name, address, etc. unless the subjects have waived their rights to confidentiality. • Sometimes useful demographic data, such as sex or county of residence, must be removed to protect confidentiality, because the data could be used to identify an individual. Removing the data may interfere with the usefulness of the research.

21. Secrecy is important in hiring, promotion, and tenure decisions Sexual harassment investigations Research misconduct investigations Grievances Other legal/ethical inquiries Personnel matters

22. Politics • Sometimes researchers may refuse to share data to avoid political harassment or controversies. • Example: animal rights group attempts to find out project being conducted at a scientist’s lab so that it sabotage the research or stage a protest.

23. Intellectual property • For research that may lead to patentable inventions, publication or disclosure can invalidate the patent or allow others to steal one’s ideas. • Secrecy is the best policy to avoid having one’s patent invalidated or idea stolen. • Intellectual property plays a key role in industrial research and increasingly academic research. • Companies assert that they own all the inventions developed by their employees. Universities also now claim ownership of inventions developed by faculty.

24. Intellectual property • Argument for patents: promotes innovation and discovery by providing incentives to inventors and investors. Also encourages disclosure through the patent application (which becomes a public document) as opposed to trade secrecy. • Can patents undermine innovation? Licensing problems, transaction costs, blocking patents, research exemptions, abuses of the patent system… • These problems require additional empirical research…

25. Business/trade secrets • Trade secrecy protects proprietary business information, such as intellectual property but also research data. • Merck sponsored a post-marketing study of its drug Vioxx. In 2000, the study, known as VIGOR, showed that there were cardiovascular problems associated with Vioxx in 2000. • Merck reported the results of the VIGOR study to the FDA but did not publish these results or inform doctors. • In 2002, the FDA changed the warnings on Vioxx’s label to include cardiovascular risks. • In 2004, Merck took Vioxx of the market and lawsuits ensued. • In 2005, the APPROVE study, not sponsored by Merck, was published. It showed that people taking Vioxx for 18 months have double the risk of stroke.

26. Business/trade secrets • In 2004, the State of New York sued GlaxoSmithKlein for fraud, alleging that it withheld data showing that its drug Paxil increases the risk of suicide in adolescents. • In 1995, Boots Pharmaceuticals tried to prevent Betty Dong from publishing a paper showing that its hypothyroidism drug is more safe or effective than competing drugs. Boots, which sponsored Dong’s research, threatened to sue Dong for violating her confidentiality agreement. • In 1998, Apotex took legal action against Nancy Olivieri and tried to get her fired for warning patients and doctors about risks (high iron levels in the liver) associated with its drug deferiprone, which she had been studying. Apotex sponsored her research.

27. Classified research is sponsored or co-opted by the military or national security agencies. Examples: Manhattan Project, research on stealth technology, etc. Academic, basic science research is not classified, it can be published without prior approval by the government (e.g. declassification). National/international security

28. National/international security • There is a consensus that you should not divulge classified information because disclosure can harm individuals and society. • However, some have claimed that a greater harm results from keeping classified information secret. • For example, following WWII some US scientists leaked nuclear secrets to the Soviet Union to ensure military parity between the two powers. • Mordachai Vanunu was found guilty of treason for exposing Israel’s secret nuclear weapons program.

29. Over the years, non-military research has threatened national and international security. 1940-60s: nuclear science and technology 1960s-1990s: encryption science and technology. 21st century: biotechnology, biomedicine bioterrorism National/international security Anthrax attacks in 2001

30. National/international security • 2001, Jackson et al published a paper in J Virology on how to increase the virulence of a mousepox virus. • 2002, Rosengard et al published a paper in PNAS on how to overcome the human immune system’s defense against smallpox. • 2002, Cell et all published a paper in Science on how make a polio virus from mail-order materials. • Congressional leaders held hearings on the publication of these papers. • 2005, Wein and Liu published a paper in PNAS on how terrorists could attack the milk supply with botulism and how to prevent an attack, over objections from the Department of Health and Human Services.

31. National/international security Potentially Dangerous Additional Review Classified Secret Not classified Open How should scientists and society deal with this grey zone? Who should make decisions about potentially dangerous research? What criteria should be used?

32. Currently, these decisions are left to researchers and editors of scientific journals. Decisions are complicated by the fact that almost all research in biotechnology and biomedicine has a dual use. Research on the virulence of pathogens can be used to make a bioweapon or to treat diseases or defend against bioweapons. National/international security

33. National/international security • Professional organizations could provide guidance, establish committees. • Should the government get involved in these decisions? • Perhaps, in an advisory capacity, but strong government involvement would raise significant free speech issues in the US or create cumbersome regulatory burdens in some areas of research. • Government advisory committees could be modeled on FDA drug review panels and include representatives from government, academia, and industry from various disciplines, e.g. microbiology, genomics, pathology, medicine, social studies, international studies, political science, ethics, law.

34. National/international security A National Research Council report identified 7 types of dangerous research*: • Demonstrate how to render a vaccine ineffective • Confer resistance to therapeutically antibiotics • Enhance the virulence of a pathogen or render a nonpathogen virulent • Alter the host range of a pathogen • Enable the evasion of diagnostic/detection modalities • Enable the weaponization of a biological agent or toxin NRC, Biotechnology research in an age of terrorism. Washington: National Academy of Sciences, 2003.

35. National/international security • But there are really many types of dangerous research. Just use your imagination: • Research on how to infect the milk, food, or water supply; • Research on how to disrupt the internet and telecommunications • Research on the vulnerability of nuclear power plants • Research on structural flaws in skyscrapers, bridges, tunnels, sports stadiums • Research on how to evade security measures

36. National/international security Some options for addressing risky research: • Publish/disseminate the whole study in a well known journal • Publish/disseminate only part of the study • Publish/disseminate to a small audience • “Bury” the study in an obscure journal • Don’t publish • Classify the research

37. National/international security Some factors to consider for choosing options for addressing risky research: • Interests of terrorists in the research • Risks of disseminating the information (probability, magnitude, reversibility, preventability of various harms) • Benefits of disseminating the information • Ability to control the information

38. National/international security • Publication/dissemination favored when: 1. Interests of terrorists in the research are minimal or non-existent; 2. Risks of dissemination are low; 3. Benefits of dissemination are high; 4. The information is difficult to control in any case. Example: research how bacteria become resistant to antibiotics. • Publication/dissemination not favored when: 1. Interests of terrorists in the research are significant or high; 2. Risks of dissemination are high; 3. Benefits of dissemination are low; 4. The information is not difficult to control. Example: research on weaponizing anthrax.

39. Conclusion • Openness is now one of academic science’s most important ethical norms but this was not always the case. • There is a perennial tension between openness and secrecy in all forms of science. • Even though openness is important in academic science, there are many different reasons to keep secrets in academic science. • Openness is not one of the most important norms in industrial or military science. Science conducted in these settings often operates under a cloak of secrecy.