My name is Julius Youngner and I am speaking today on behalf of the American Society for Microbiology (ASM). We are the largest life science society in the world with over 40,000 members who are involved in basic, applied and clinical research areas. The membership of the Society is quite diverse: 55 percent of the members are employed by academic institutions, 23 percent work for industry, 18 percent carry out clinical/medical activities, and 4 percent work for a government agency, either state or federal. The ASM holds two major scientific meetings each year. In one meeting, over 2,000 papers are presented on developments in the microbiological sciences. The other meeting, the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), is the largest meeting on infectious diseases in the world.
The material I present today was developed by the ASM Ethics Committee, which I chair. This committee has the responsibility of helping ASM formulate policies and procedures on issues of scientific misconduct and assisting in the development of educational materials on this subject for use by ASM members. My comments also were reviewed by the ASM's Public and Scientific Affairs Board (PSAB), which guides the Society in the area of public policy, and by ASM's Publications Board, which is responsible for the publication of 10 journals that printed over 6,000 articles last year.
The ASM is concerned with issues of research integrity at several levels: a Code of Ethics for society members; editorial oversight of ethical issues involved in publications; involvement in ethical issues and controversies at a national level by the Public and Scientific Affairs Board; and the use of meetings and publications to inform and educate members about research integrity. I would like to make some comments about each of these activities.
Code of Ethics
In 1988, the ASM adopted a Code of Ethics that is now being revised in keeping with the realities of the 21st century. The Code of Ethics begins with a section titled "Ethics Standards for Society Members." This section presents a set of general principles to guide members. These principles relate to the dignity of the profession; the advancement of human welfare; standards for dealing with employers, associates and students; the responsibilities of sharing research results; and the maintenance and expansion of professional skills and knowledge. This section is followed by a list of Rules of Conduct that deals with such topics as the definition of scientific misconduct; the avoidance of conflicts of interest and abuse of privileged positions; and the responsibility of members to report breaches of the Rules of Conduct.
The Code of Ethics continues with an Ethics Review Process that presents in detail the responses of the Society to charges of scientific or ethical misconduct by a member. It is important to note that if a charge is brought against a member, where appropriate, it is recommended that the academic or other institution that employs the member should make the investigation and resolve the issues. If the allegations are within the scope of responsibility of the ASM, the process mandates several discrete steps. These steps include a complaint signed by at least five members of the ASM; the response of the accused to the accusation; the appointment of an investigative panel that examines the evidence and presents a report to the Ethics Committee. Based on this report, the Ethics Committee decides if an ethical violation has occurred and makes a recommendation to the President of the Society for action. If a violation has taken place and a penalty is imposed, there is a Right of Appeal available to the accused and a process for judging such an appeal. In all stages of adjudication there are two mandatory conditions: first, strict confidentiality must be maintained and, second, the accused must be afforded due process.
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. The case may be indicative of the times in which we live. Here are a few of the details. 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 Yersinia 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. The Federal District Judge sentenced Mr. Harris to 18 months of probation and 200 hours of community service. This was not the end of the matter. 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 that 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. The President of the Society appointed an Investigative Panel which examined the validity of the allegations against Mr. Harris, in this case the court proceedings that terminated in the felony conviction. The Investigative Panel gave Mr. Harris notice of the charges against him and offered him the opportunity to respond to these allegations. He did not send any reply. After reviewing all the evidence, the Investigative Panel found the conduct of Mr. Harris to be repugnant to the Code of Ethics of the Society and recommended to the Ethics Committee that Mr. Harris be expelled from Membership. The Ethics Committee reviewed the report and voted unanimously that Mr. Harris be expelled from the ASM. In July 1998, the President of the ASM informed Mr. Harris of his expulsion from the ASM. It is worth noting that the Ethics Review Process proved to be a set of rules and procedures that worked in practice and protected the due process rights of the accused.
As was stated earlier, the Publications Board of the ASM oversees the publication of 10 journals that print over 6,000 papers a year. It is not surprising that this activity of the ASM would be the source of most of the ethical problems with which the Society has to deal. In acknowledgment of the increasing number of ethical issues and violations of publishing policy brought to the attention of ASM journal editors, a Publications Board ad hoc panel on scientific integrity was appointed in 1992. The panel was instructed to review policies, to recommend changes for matters pertaining to publications, and to formulate guidelines for implementation by the Publications Board. The panel's report and recommendations, issued in 1993, were revised and upgraded in 1994, and again in 1999. The policies that have evolved are contained in a document titled, "ASM Editorial Policies/Ethics: Procedures and Guidelines" that was formulated specifically to deal with editorial policies dealing with ethical issues that affect ASM journals.
Each of the 10 ASM publications presents in its pages a detailed Instruction to Authors. In addition to describing the mandatory procedures for form of submission and style of presentation, the instructions require the authors to guarantee certain conditions are met, among them ethical concerns. First, the authors must guarantee that the manuscript or one with substantially the same content, was not published previously, is not being considered elsewhere, and was not rejected on scientific grounds by another ASM journal.
Second, by publishing in an ASM journal, the authors agree that any plasmids, viruses, and living materials such as microbial strains and cell lines newly described are available from a national collection or will be made available in a timely fashion and at a reasonable cost to members of the scientific community for noncommercial purposes.
Third, all co-authors must have made a substantial contribution to the overall design and execution of the experiments. ASM considers all authors responsible for the entire paper.
Fourth, all authors are expected to disclose any commercial affiliations as well as consultancies, stock or equity interests, and patenting-licensing arrangements that could be considered to pose a conflict of interest regarding the submitted article.
Fifth, in order to protect anonymity when clinical studies are involved, isolates derived from patients are not to be identified by using the patient's initials or hospital unit numbers.
Sixth, it is expected that newly assigned GenBank accession numbers for nucleotide and/or amino acid sequence data will be included in the original manuscript and that the data will be released to the public by the time the manuscript is published.
What happens if these conditions are not met? The instructions state that, "Failure to comply with the policies…may result in a letter of reprimand, a suspension of publishing privileges in ASM journals, and/or notification of the authors' institutions."
What are the problems that are encountered most frequently? They are authorship disputes, duplicate submissions or publications, not making materials available to other scientists after manuscripts are published, plagiarism, lack of proper citation of the work of others, copyright violation, and fraud.
When there are authorship disputes, the authors are encouraged to settle the matter themselves. If an authorship dispute arises after publication, the journal will not intervene. The authors should resolve the dispute. The journal will publish an Author's Correction if required. In case the authors cannot agree on an authorship issue post-publication, the chair of the publication Board can be requested to adjudicate the matter. The authors' institutions are not involved or informed of these problems.
In case of a proven violation of what can be called "strain availability" rules, one or more of the authors may be barred from publishing in any ASM journal for up to five years. Again, the authors' institutions are not involved or informed by ASM.
Plagiarism is a more serious problem. When the work of others is plagiarized, the authors are sent a letter of reprimand and can be barred from publishing in any ASM journal for up to five years. An Authors' Correction or Retraction is required, and the authors' institutions may be informed of these actions.
When self-plagiarism occurs, that is, when an author publishes in a non-ASM journal material from his own article without attribution to the ASM journal, a letter of reprimand is prepared and sent to the authors by the Journals Department. The authors are asked to publish a Correction/Erratum in the non-ASM journal so that appropriate attribution may be given to the ASM journal article. In the reverse situation, when material was first published in a non-ASM journal and subsequently published without attribution in an ASM journal, a letter of reprimand is sent to the authors, an Author's Correction or Retraction is printed, and the publisher of the non-ASM journal is informed. In this instance, the authors' institutions may be informed of the actions taken by the ASM.
Duplicate submissions or duplicate publications in non-ASM journals results in a letter of reprimand to the authors or debarment from all ASM journals for a period up to five years. In addition to a Retraction or Notice of Duplicate Publication in the ASM journal, the authors' institutions are informed of actions taken by ASM.
The penalties for fabrication or falsification are more severe. Publication of a Retraction is mandatory. In addition, one or more of the authors will be barred from publishing in any ASM journal for a length of time to be determined on a case-by-case basis. One or more of the authors will be barred from serving as editor, editorial board member, or ad hoc reviewer for any ASM journal for a period to be determined. Also, the following courses of action may be considered: an author may be barred from receiving ASM privileges and awards; barred from chairing or organizing meeting sessions or programs; and removed from ASM membership by the Ethics Review Process. The Society may decide to publish the charges and findings in the ASM NEWS. A report of the actions by ASM will be forwarded to the authors' institutions as well as to the Office of Research Integrity of the DHHS, or the Inspector General of the NSF, if federal funds are involved. It should be noted that in cases of alleged falsification or fabrication, ASM will not render a decision regarding penalties until an authorized investigative body, such as the responsible institution, employer, or government agency releases the results of its investigation.
The Publications Board also issues a set of Principles and Policies for Editors and Reviewers. The most serious ethical offense that can occur is a breach of confidentiality. If the investigative process finds that a breach of confidentiality has occurred, the editor or editorial board member is sent a letter of reprimand or removed from editorial responsibilities. If such a removal is carried out, the editor or reviewer cannot be appointed to either position with any ASM journal for up to five years, and may be barred from reviewing on an ad hoc basis for any ASM journal for a similar period. The individual's institution or employer is not necessarily involved or informed.
Public and Scientific Affairs Board (PSAB)
The ASM's Public and Scientific Affairs Board maintains a strong Washington presence and is routinely called on to provide timely, objective information on science issues to Congress, the Executive Branch, federal agencies, and the public. In matters dealing with research integrity, the PSAB has taken an active role in commenting on the development of legislation and federal regulations dealing with this issue. The PSAB took an active role in commenting on the NIH Authorization Bill that created the Office of Scientific Integrity. In 1995, the PSAB prepared a critique of the Ryan Commission Report to the Secretary of DHHS titled "Integrity and Misconduct in Research" and on the implementation proposals by the Raub Committee that followed in 1996. In November 1999 the chair of the ASM Ethics Committee (now a component of the PSAB) presented comments on the "Proposed Federal Policy on Research Misconduct To Protect the Integrity of the Research Record." that appeared in the Federal Register on October 14, 1999. This meeting was sponsored by the National Academy of Sciences and provided an opportunity for scientific societies, various government agencies, and the scientific community to comment on the definitions and procedures developed by the Office of Science and Technology Policy (OSTP).
The PSAB has also utilized the ASM General Meetings to sponsor sessions on topics such as conflict of interest policy, the responsibilities of research mentors, and ethical issues for reviewers of scientific manuscripts. The PSAB and the Ethics Committee will continue to organize sessions on timely subjects dealing with scientific integrity issues at annual meetings that are attended by a large percentage of the 42,000 members of the ASM.
American Academy of Microbiology (AAM)
The AAM is an arm of the ASM that elects to membership those microbiologists with outstanding accomplishments. The Academy sponsors colloquia conducted by experts, which focus on issues that have broad implications for society and provide information to scientists, government agencies, industry, and the public. Such a meeting that dealt with an ethical issue was held in 1995. The subject discussed by 12 experts was "Dynamic Issues in Scientific Integrity: Collaborative Research." The report of this meeting which was widely circulated, considered issues such as defining contributions, defining authorship, the responsibilities of the individual researcher in collaborative relationships, defining intellectual property ownership, defining accountability, and monitoring collaborative efforts. The report was intended to be of maximum use to scientists and to instructors in defining, refining, and developing their courses in scientific integrity. In addition, the information presented was meant to assist the lay public in understanding the complexity of the issues surrounding collaborative scientific research.
The ASM also has made a significant contribution to education in the area of ethical behavior in a research setting by publishing a textbook by Dr. Francis Macrina entitled "Scientific Integrity: An Introductory Text with Cases." This text, now in its second edition, is widely used by research institutions that have initiated formal courses dealing with this subject.
The many details of the role of the ASM in scientific integrity issues that I have described to you recognize the boundaries of responsibility of one major scientific organization. Our efforts are, and should be, limited to those matters in our purview. Beyond our efforts are those of universities, research institutes, industry, and government agencies that are employers and overseers of the research activities that go on in their organizations. It is imperative that each of these entities have in place procedures and practices that assure fair and diligent investigation while safeguarding the due process rights of the accused and the confidentiality that is necessary to a fair outcome.
I thank the organizers of this meeting for providing me with the opportunity to present the role of the American Society for Microbiology in promoting research integrity.