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Downloaded from ajpadvan.physiology.org on July 20, 2010 Dale J. Benos, Jorge Fabres, John Farmer, Jessica P. Gutierrez, Kristin Hennessy, David Kosek, Joo Hyoung Lee, Dragos Olteanu, Tara Russell, Faheem Shaikh and Kai Wang Advan Physiol Educ 29:59-74, 2005. doi:10.1152/advan.00056.2004 You might find this additional information useful... This article cites 25 articles, 14 of which you can access free at: http://ajpadvan.physiology.Org/cgi/content/full/29/2/59#BIBL This article has been cited by 3 other HighWire hosted articles: Plagiarism*: Avoiding the Peril in Scientific Writing L. Cicutto Chest, February 1, 2008; 133 (2): 579-581. [Full Text] [PDF] The ups and downs of peer review D. J. Benos, E. Bashari, J. M. Chaves, A. Gaggar, N. Kapoor, M. LaFrance, R. Mans, D. Mayhew, S. McGowan, A. Polter, Y. Qadri, S. Sarfare, K. Schultz, R. Splittgerber, J. Stephenson, C. Tower, R. G. Walton and A. Zotov Advan Physiol Educ, June 1, 2007; 31 (2): 145-152. [Abstract] [Full Text] [PDF] Ethical Considerations in the Interpretation and Communication of Clinical Trial Results D. Coultas Proceedings of the ATS, May 1, 2007; 4 (2): 194-199. [Abstract] [Full Text] [PDF] Medline items on this article's topics can be found at http://highwire.stanford.edu/lists/artbytopic.dtl on the following topics: Religious Studies .. Ethics Sociology .. Responsibility Medicine .. Competing Interests / Conflicts of Interest Medicine .. Authorship Political Science .. Welfare Physiology .. Humans Updated information and services including high-resolution figures, can be found at: http://ajpadvan.physiology.org/cgi/content/full/29/2Z59 Additional material and information about Advances in Physiology Education can be found at: http://www.the-aps.org/publications/advan This information is current as of July 20, 2010 . Advances in Physiology Education is dedicated to the improvement of teaching and learning physiology, both in specialized courses and in the broader context of general biology education. It is published four times a year in March, June, September and December by the American Physiological Society, 9650 Rockville Pike, Bethesda MD 20814-3991. Copyright 2005 by the American Physiological Society. ISSN: 1043-4046, ESSN: 1522-1229. Visit our website at http://www.the-aps.org/. Adv Physiol Educ 29: 59-74, 2005; doi:10.1152/advan.00056.2004. Staying Current Ethics and scientific publication Dale J. Benos,1 Jorge Fabres,2 John Farmer,1 Jessica P. Gutierrez,1 Kristin Hennessy,1 David Kosek,1 Joo Hyoung Lee,1 Dragos Olteanu,1 Tara Russell,1 Faheem Shaikh,1 and Kai Wang1 1Departments of Physiology and Biophysics and 2Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama Submitted 15 October 2004; accepted in final form 27 January 2005 Downloaded from ajpadvan.physiology.org on July 20, 2010 Benos, Dale J., Jorge Fabres, John Farmer, Jessica P. Gutier rez, Kristin Hennessy, David Kosek, Joo Hyoung Lee, Dragos Olteanu, Tara Russell, Faheem Shaikh, and Kai Wang. Ethics and scientific publication. Adv Physiol Educ 29: 59-74, 2005; doi:10.1152/advan.00056.2004.--This article summarizes the major categories of ethical violations encountered during submission, re view, and publication of scientific articles. We discuss data fabrication and falsification, plagiarism, redundant and duplicate publication, conflict of interest, authorship, animal and human welfare, and re viewer responsibility. In each section, pertinent historical background and citation of relevant regulations and statutes are provided. Further more, a specific case(s) derived from actual situations is(are) pre sented. These cases were chosen to highlight the complexities that investigators and journals must face when dealing with ethical issues. A series of discussion questions follow each case. It is our hope that by increasing education and awareness of ethical matters relevant to scientific investigation and publication, deviations from appropriate conduct will be reduced. plagiarism; redundant; falsification; conflict of interest; fabrication refer the reader to more in-depth literature on these important matters (42-44, 53). We conclude with a discussion of re viewer rights and responsibilities. In each section, we compile pertinent current regulations, include source documentation, and present a specific case or cases relating to the topic. These cases were modified from actual situations that have arisen during reviews of manuscripts submitted to the American Journal of Physiology, the Journal ofApplied Physiology, and the Journal of Neurophysiology over the past decade. Each case is followed by a series of discussion questions. It is our hope that both investigators and students will use this article as an educational and reference tool. The council of Science Editors (previously known as the council of Biology Editors) has published a book dealing with ethical policies in scientific publications (9). The reader is also referred to the committee on Publication Ethics (COPE) and World Association of Med ical Editors web pages for other specific cases, and for a discussion of ethics as it relates to publication (16, 78). publication of a research article represents the final stage of a scientific project. It is the culmination of many months and sometimes years of meticulous planning, execution, and anal yses of hundreds of experiments. In many cases, the funds supporting the project were derived from public monies. There is, therefore, the expectation that the work be conducted and reported honestly, objectively, and fairly. Yet, sometimes de viations from this ideal occur. Ethical breaches can be inten tional, such as data fabrication, or can arise simply out of ignorance, e.g., inappropriate anesthetic use in animal experi mentation. Nonetheless, in legal parlance, ignorance is not and cannot be an excuse. Thus it is incumbent on every investigator to be cognizant of all the ethical requirements for conducting scientific studies. Moreover, a scientist needs to develop a strong sense of ethical responsibility to apply at every stage of scientific inquiry. Straying from an ethical course during the conduct of an investigation undoubtedly manifests itself during the publication phase. The purpose of this article is to provide a comprehensive discussion of ethical problems encountered during the publi cation process. We discuss common ethical breaches such as data fabrication and falsification, plagiarism, and redundant and duplicate publication. We discuss ethical issues that can arise because of conflict of interest, author conflicts, and human experimentation. We also present a brief discussion of animal welfare concerns, but because of the breadth, complex ities, and controversies of animal experimentation issues, we Address for reprint requests and other correspondence: D. J. Benos, Dept. of Physiology and Biophysics, Univ. of Alabama at Birmingham, MCLM 704, 1918 Univ. Boulevard, Birmingham, AL 35294-0005 (e-mail: benos@physiology.uab.edu). SCIENTIFIC MISCONDUCT: WHAT'S THE PROBLEM? The current Federal definition of scientific misconduct (and one that is used by most universities and publishers) is ".. .fab rication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results..." (73). Fabrication is defined as recording or presenting (in any for mat) fictitious data. Falsification is manipulating data or ex perimental procedures to produce a desired outcome or to avoid a complicating or inexplicable result. Plagiarism is using someone else's words, ideas, or results without attribution. In order for an action to be considered misconduct, it must be a ".. .serious deviation from accepted practices..." of the rele vant research community, have been ". . .committed intention ally, or knowingly, or recklessly...", and it must be ".. .proven by a preponderance of evidence..." (73). Research misconduct does not include legitimate differences of opinion. While it is always difficult to legislate appropriate standards of behavior, it was the intent and responsibility of the Federal Government to ensure that publicly funded research is above reproach. The first two regulations covering human and animal experimentation that were enacted by Congress were the 1974 National Research Act (PL 99-158) and the Animal Welfare Act (PL 89-544, 1986). The issue of scientific misconduct in the United States attained public awareness in the 1980s with the emergence of several episodes of scientific improprieties (29, 31, 58, 60, 61, 71, 74). At the same time Congress became concerned that both the National Institutes of Health (NIH) and universities were not responding adequately to these charges and allega tions. Consequently, Congress in 1985 passed the Health Re search Extension Act (30, 50). This act, specifically section 493, required institutions seeking federal research funding 1043-4046/05 $8.00 Copyright 2005 The American Physiological Society 59 Downloaded from ajpadvan.physiology.org on July 20, 2010 Staying Current 60 ETHICS AND SCIENTIFIC PUBLICATION grants to establish an administrative process to deal with scientific misconduct in a formal way. This legislation under went revision and was entitled, Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science (54FR 32446) when it was ratified into the Federal Register August 8, 1989. The regula tion was codified in the Code of Federal Regulations (CFR) at 42 CFR Part 50 Subpart A.1 In essence, an institution must have procedures in operation that designate an individual or individuals to assess allegations of misconduct, to conduct inquiries and formal investigations of allegations, a person designated to adjudicate the findings of the inquiry and inves tigative committees, and a mechanism for reporting to the Office of Research Integrity (ORI). Before 1986, the funding agencies themselves (or, in the case of NIH, the individual institutes) were responsible for performing the regulatory functions established by the afore mentioned CFR. After that time, the NIH Institutional Liaison Office received and responded to allegations of scientific mis conduct. In 1989, the Public Health Service (PHS) created the Office of Scientific Integrity located within the NIH Director's office and the Office of Scientific Integrity Review located within the Office of the Assistant Secretary for Health (73). In June of 1993, the NIH Revitalization Act was signed by President Bill Clinton establishing the ORI as an independent entity within the Department of Health & Human Services (73). The ORI is located within the Office of the Secretary of Health & Human Services in the Office of Public Health & Science, which is run by the Assistant Secretary for Health (73). One of the more serious sanctions that a journal can impose on its authors is to inform his/her home institution of a publication infraction. Once an institution is informed, it is required by statute to begin an inquiry into the matter, if that allegation involves Federal funding (42CFR Part 50; Ref. 59). If NIH funding or animal or clinical trials are involved, these may be frozen or suspended until a resolution is achieved. Regardless of outcome, the process is quite stressful and unpleasant for the accused. In addition, the scientists who serve on institutional investigational committees also pay a price. These scientists lose time from their research, are not compen sated for this service, and potentially incur the wrath of their colleagues, not to mention possible civil lawsuits (27). Never theless, it is a scientist's duty to serve on such boards. Because science is a profession, it is essential that scientists themselves self-evaluate and establish policies and procedures to selfregulate and correct any wrongdoing. Only in this way will public trust in the enterprise be maintained. 1 The CFR is a compilation of all the regulations issued by all of the agencies of the United States Federal Government. The United States Code (USC) is the compilation of all permanent laws of the United States. Laws and regulations are different. Only Congress can enact laws. Federal agencies issue regulations to enforce and ensure compliance with laws. The USC is published every 6 yr by the Office of the Law Revision Counsel of the United States House of Representatives. The CFR is amended as needed. These agency-approved amendments, or proposed amendments, appear in the Federal Register, which is published daily. The Federal Register also publishes notices of the Federal agencies, executive orders, and other executive branch documents. Federal regulations may have the force of law and can be enforced by the government agencies but are not laws themselves. Regulations can only be developed by agencies if laws permit them to do so, i.e., there is an enabling statute. All three of these publications can be accessed and searched from the web site of the United States Government Printing Office (www.gpoaccess.gov). Once an accusation of scientific misconduct has occurred, normally reposited directly to the university's Research Integ rity Officer, the allegation is assessed to determine whether it warrants an inquiry. If so, then an inquiry committee is estab lished to decide whether the allegation has substance and whether an investigation is warranted (56). It is possible that the inquiry could lead to an investigation, which is the formal development of a factual record, and the examination of that record leading to dismissal of the case or to a recommendation for a finding of research misconduct or other appropriate remedies (56). If the parties are judged guilty of scientific misconduct by the investigation committee, then adjudication occurs, usually by a high-ranking university official such as the provost or president, during which recommendations are re viewed and appropriate corrective or punitive actions deter mined (56). This discussion applies only to federally funded research, but most universities have procedures in place to deal with any allegations of misconduct. The final legal definition of scientific misconduct was pub lished in the Federal Register on December 6, 2000 (22), although proposed changes to this definition are being consid ered (22). These proposed changes include 1) changing the terminology, i.e., "scientific" misconduct would become "re search" misconduct; 2) expanding misconduct to include both grant and contract research; 3) expanding the scope of plagia rism to encompass activities related to funding requests and scientific publications; 4) use the term "performing" instead of "conducting" research, which would expand misconduct to encompass reviewing of research; 5) replacing the term "seri ous deviation" from accepted practices to "significant depar ture"; and 6) dropping the phrase "other practices." As indi cated above, extramural institutions and intramural programs have primary responsibility for responding to allegations of scientific misconduct. The Office of the Inspector General conducts initial fact-finding inquiries in cases of scientific misconduct, whereas the ORI provides investigational over sight and has discretionary ruling power. All extramural insti tutions requesting federal PHS funding must provide training in the responsible conduct of research to employees, faculty, students, and postdoctoral students (39). In addition, training must be provided to those who contribute work to PHS-funded projects, even if the institution does not receive PHS funding. Between 1974 and 1981, only 12 cases of alleged scientific misconduct in the United States were reported (60). However, recent years have seen an exponential increase in alleged cases (Fig. 1; Ref. 57). This increase in reporting alleged scientific misconduct to ORI paralleled the same increase in alleged scientific and publication improprieties seen in many biomed ical journals, including those of the American Physiological Society (APS). For example, Fig. 2 shows the yearly increase in ethical cases handled by the publications program of the APS between 1996 and 2004. Over this time span, on average 30 new cases per year were opened. It is important to empha size that this number still represents only a small fraction of the total number of manuscripts that flow through the system. Nonetheless, even one incident is too many. The cost of such ethical issues is high to both the authors and the journal and to biomedical science in general. The nature of the ethical problems reported to the ORI is evenly distributed among fabrication, falsification, and plagia rism. For example, for the 103 new allegations of scientific Advances in Physiology Education VOL 29 JUNE 2005 Downloaded from ajpadvan.physiology.org on July 20, 2010 ETHICS AND SCIENTIFIC PUBLICATION Staying Current 61 180 # of Allegations 160 140 120 100 80 60 40 20 0 1996 1997 1998 1999 2000 2001 2002 Fig. 1. Total number of new allegations of scientific misconduct reported to Office of Research Integrity (ORI) (Data obtained from Ref. 60). misconduct reported to the ORI in 2000, 24 involved falsifi cations of data, 37 involved data fabrication, 19 involved plagiarisms, and 23 were in other categories (59). For the APS journals between 1996 and 2004, redundant publication (i.e., attempts to republish data that have already been published) was the most frequent (24%) infraction (see Fig. 3). It is important for authors and reviewers alike to be aware of what constitutes misconduct in publication. In this way, the sanctity of the process can be preserved, and authors can be spared much anguish. Honesty, objectivity, and fairness are the virtues essential for conducting, reporting, and evaluating research. In this way, our scientific colleagues, the paying public, our appointed and elected government officials and members of Congress, and most importantly, we as individual scientists can be assured that the products of our labors are true and beyond reproach. shifting disease management program, the impact on a patient could be life threatening at the worst or, at a minimum, psychologically devastating. It is obvious from the reports of ORI that the falsification/ fabrication of data is rising. Each member of the scientific community must ensure that he/she faithfully and accurately obtains, represents, and reports experimental data. It is only in this way that the integrity of the scientific enterprise can be maintained. Case study. A manuscript has been submitted to a journal. After being sent out for peer review, one of the reviewers contacted the editor and said that she had reviewed the manu script previously for another journal. What concerned her about the manuscript was that, in the submission to the other journal, a time course experiment was shown in which intra cellular calcium was measured by fura-2. The external solution was said to be NaCl in the original submission. However, the identical figure is in this manuscript, only with the external solution being stated to contain LiCl. In the reviewer's original review, she had made the major comment that the experiment should be rerun with LiCl. What should be done? Questions for discussion: 1. How would you go about checking whether or not this author actually had rerun the experiment? 2. How would you ensure that all authors knew of the ethical breach, if that was determined to be the case? 3. What sanctions would you, as a member of a publications committee, suggest for these authors if they were deemed guilty? 4. Would your recommendation apply to all of the authors, or only to those who knew of the ethical misconduct? 5. What about the integrity of the reviewer? In order for the reviewer to remember such experimental detail, it is likely that he/she retained a copy of the original confidential submission, an action contraindicated by most journals. DATA FABRICATION AND FALSIFICATION PLAGIARISM Data fabrication and falsification are perhaps the most ob vious and egregious examples of scientific misconduct. Falsi fication or fabrication of data represented over half of the new allegations reported to the ORI in 2002 (57). According to the ORI, "Falsification of data encompasses fabrication, to decep tive selective reporting of findings and omission of conflicting data, or willful suppression and/or distortion of data." (55). This can include anything from throwing out an unwanted piece of data to just making it up. Data falsification is prob lematic for many reasons. First and foremost, it dilutes the integrity of other scientific research, both from that author(s) and from others in the field. Second, if left undiscovered, it could waste other researcher's time and energies attempting to replicate or build on the data presented in a falsified paper. Third, it jeopardizes the public trust in the scientific enterprise. Data falsification/fabrication can have consequences more disastrous than these. The Alliance for Human Research Pro tection points out that ".. .scientific misconduct is a big prob lem undermining the integrity of the scientific literature. Data falsification leads others to erroneous conclusions that may have adverse consequences for patients in clinical research and clinical practice." (69). If an investigator were to falsify find ings on a potentially new clinical therapy or a paradigm- The ORI estimates ~25% of the total allegations it has received concern plagiarism (45). A surprising number of 1996 1997 1998 1999 2000 2001 2002 2003 2004 Fig. 2. Total number (expressed as a percentage of total yearly submissions) of ethical cases handled by the publications program of the American Physi ological Society (APS). Advances in Physiology Education VOL 29 JUNE 2005 Staying Current 62 ETHICS AND SCIENTIFIC PUBLICATION Other (reviewer bias, submission irregularities) Fig. 3. Distribution of ethical issues in APS publications (1996 through March 2004). Downloaded from ajpadvan.physiology.org on July 20, 2010 plagiarism allegations turn out to be misunderstandings of exactly what constitutes plagiarism or proper citation proce dure (45). Dr. Mark Wiser of Tulane University (New Orleans, LA) has suggested applying five criteria to evaluate the seri ousness of plagiarism allegations (45). These five criteria are 1) What was the extent of the plagiarism? 2) Was the intent malicious? 3) Has the author previously engaged in plagia rism? 4) What is the position and training of the author? and 5) Was the source material original or did the plagiarism occur from notes? The ORI considers plagiarism as ".. .the theft or misappro priation of intellectual property..." or ".. .the substantial un attributed textual copying of another's work. The theft or misappropriation of intellectual property includes the unautho rized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review. Sub stantial unattributed textual copying of another's work means the unattributed verbatim or nearly verbatim copying of sen tences or paragraphs which materially mislead the ordinary reader regarding the contributions of the author." (60). The current trend in the regulatory procedural scheme of dealing with plagiarism is not uniform among scientific jour nals. Obviously, education of graduate students, postdoctoral fellows, and faculty is necessary to instill a set standard of scientific research conduct. Dr. Miguel Roig, St. Johns Uni versity (New York, NY), has proffered a sound and thorough set of guidelines dealing with the finer points of plagiarism and writing practices that may not pass ethical muster (68). These guidelines include 1) always acknowledge explicitly the orig inator of ideas and the contribution of another, regardless of whether it was paraphrased, summarized, or used directly; 2) any verbatim text taken from another author must be enclosed in quotation marks (68); 3) when paraphrasing, make sure you understand completely the text and use your own words; and 4) provide a reference when you are not sure that the fact or idea you are using is common knowledge. There are a number of different computer programs avail able to detect commonality of language between different written works (see Ref. 33). These programs do not detect identity of ideas, only of language. Yet, duplication of words and phrases, however brief, may be indicative of plagiarism (34). The cost of plagiarism can be high for all the parties involved in the initiation, investigation, appeal, and resolution of the allegation. Obviously, in a reputation-driven field such as the biological sciences, even the allegation of plagiarism can seriously damage a scientist's career. A recent example of plagiarism and its associated cost was published in Nature, in January of 2004 (29). Yung Park, a visiting materials scientist at Cambridge University (Cambridge, United Kingdom) pub lished eight plagiarized articles between 1997 and 2001. A disturbing anecdote is that of these eight papers, four were retracted from the journals, but the remaining four were not (29). Fortunately, the total number of plagiarism incidents in the United States is low compared with the total number of peer-reviewed journal submissions, but reports of plagiarism have increased every year since 1998 (27). This fact may reflect increased reviewer and editorial vigilance, increased misconduct, or both. Whatever the reason, it is important that students, fellows, and faculty understand precisely what con stitutes plagiarism and how to reference items and statements appropriately. Case study 1. A scientist has submitted a manuscript to a journal for publication. Three reviewers reviewed the manu script. One reviewer claims plagiarism has occurred and cites three examples of paragraphs in the submitted paper that have been copied verbatim or substantively from other works. The journal editor rejects the manuscript for other reasons, but fails to mention in his cover letter to the manu script author the alleged plagiarism. In fact, the editor encour ages the author to revise and resubmit his manuscript else where. A coauthor, on reading the reviews, immediately con tacts her departmental chair and journal editor about this incident, and states that indeed the cited examples were pla giarized, unknown to her, because they were added to the final version (which she did not see just before submission). What should be done? Advances in Physiology Education VOL 29 JUNE 2005 Downloaded from ajpadvan.physiology.org on July 20, 2010 Staying Current 66 ETHICS AND SCIENTIFIC PUBLICATION interest in a company. Even if they divested all financial ties to industry, there would still be a two-year hiatus from writing review articles about research involving companies from which support was received. This prohibition has recently been re scinded primarily because of the difficulty of finding authors that were completely free of industry ties (6, 54). Under the final rule on "Objectivity in Research" in the CFR, investigators are required to disclose a listing of "signif icant financial interests" that would reasonably appear to in fluence the research proposed for funding by the PHS. "Finan cial interest" means anything of monetary value, including, but not limited to, the following: 1) salary or other payments for services (consulting fees or honoraria); 2) equity interests (stocks, stock options, or other ownership interests); and 3) intellectual property rights (patents, copyrights, and royalties from such rights). Davidoff et al. (18) wrote a concise sum mary of conflict of interest policies for clinical journals. An investigator's financial interest in an external entity is considered to be "significant" and must be disclosed if it exceeds either one of the following: 1) $10,000 per annum for any combination of salary, payments for services, equity, and income from intellectual property rights; or 2) 5% ownership interest. Examples of how financial conflicts of interest might be addressed include 1) public disclosure of significant financial interests; 2) monitoring of research by independent reviewers; 3) modification of the research plan; 4) disqualification from participation in all or a portion of the research funded by PHS; 5) divestiture of significant financial interests; or 6) severance of relationships that create actual or potential conflicts. Under a renewed effort to address the issue, it has been recommended recently by a Blue Ribbon Panel that reviewed the current NIH conflict of interest policies that employees in a position to influence the financial interests of an outside entity such as a current or possible future recipient of an NIH grant or contract should neither receive financial benefits from that organization nor have significant financial interests in it (48). From our perspective, the rule of thumb to follow is this: it is better to disclose a potential conflict than not. In this way, information is available to the reader so that he/she can better judge whether the author's objectivity has been compromised. The fact that an author disclosed such information sends a positive message that he/she has nothing to hide. We also think that a $10,000 per year threshold for reporting is too high and too rigid. Perhaps an additional $9,000 check for consulting work may not influence unduly an independently wealthy scientist, but an extra $1,000 (or maybe even $100) to a graduate student, a newly appointed assistant professor, or even a full professor may make a significant difference in their income. Case study 1. A paper has been submitted to a journal, and after two rounds of thorough scientific review, is accepted for publication. Just hours before web posting of this manuscript, the editor received a panicked call from the communicating author who said that a problem had arisen. A major drug company that had sponsored the research disputed the authors' right to submit the manuscript because the authors and the company signed a contract specifically stating that the com pany must agree with the contents of the manuscript before submission. The company did not agree with the authors' conclusions. The company made it clear to the authors that it was prepared to bring legal action against them and the journal if the paper was not immediately withdrawn. What should be done? Questions for discussion: 1. Is it appropriate for the drug company to bring legal action against the authors and the journal? 2. In case the drug company disagrees with the content of the paper and exercises its legal right to prevent the paper from being published, would it be justified to hold back informa tion from the scientific community and the general public, given that the editors of the journal have deemed the contents of the paper novel, significant, and hence publish able? 3. Who should bear responsibility for such miscommunication between the authors and the sponsoring agency? 4. What should a journal's stance be on industry-sponsored research? 5. Should findings of sponsored research always be viewed with distrust as being biased towards the funding agency? Case study 2. The Director of Publications receives a letter from an irate reader complaining that the journal did not publish a financial disclosure from an author of a review article that was published 6 mo earlier. At the time, the journal did not have a policy on conflict of interest that covered review articles. This reader was not dissuaded by any argument. He/she continued to write, demanding that ". . .an honest dis closure of competing financial interest..." of the authors be acknowledged in print. The author's response was that this individual had been harassing him over this issue for years, mainly because of a personal scientific vendetta. The author has, in the past, freely disclosed his finances if asked, but feels in this case that it is not appropriate, given the policies of the journal at the time. What should be done? Questions for discussion: 1. Should the journal publish a retrospective disclosure? 2. What are appropriate journal policies concerning conflict of interest disclosures? AUTHORSHIP ISSUES Being an author on a scientific manuscript is a privilege and one of the more satisfying experiences of a scientist. Not only does being an author signify a personal contribution to knowl edge thus imparting respect and pride, but it is also used as a measure for promotions and tenure. These aspects, however, are only half of the authorship equation. Being the author of a scientific manuscript also entails responsibility. It is this amal gam of credit and responsibility that forms the precious foun dation for the esteemed moniker of "author." Every scientist has his/her own conception of what is re quired to be an author. However, often these ideas differ among participants in a research project. Disputes and person ality conflicts can arise during an investigation that may cause discord and disagreement over who qualifies for authorship. There are general guidelines put forth by entities such as the NIH and The Council of Science Editors. But, as helpful as they are, they are just guidelines. These helpful guidelines appear definitive, but, like a smoky advertisement written from a vapor trail of a plane, they can quickly fade into bits of Advances in Physiology Education VOL 29 JUNE 2005 Downloaded from ajpadvan.physiology.org on July 20, 2010 Staying Current 70 ETHICS AND SCIENTIFIC PUBLICATION have been promulgated to guide investigators in the resolution of ethical issues surrounding their studies. All institutions receiving funds from DHHS to conduct or support research with human subjects are subject to regulatory requirements outlined in The Belmont Report. Respect for Persons is the first of the three principles stipulated by the Belmont Report. It states that individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection (21). An au tonomous person is one who is capable of deliberation about personal goals and can rationally make decisions for him/ herself. Those who lack this capacity require protection. The next basic principle, Beneficence, relies on the re searcher to "do no harm." In other words, the study must maximize the possible benefits while minimizing all possible health risks (21). Persons should be treated in an ethical manner by respecting their decisions and protecting them from danger. Investigators are thereby charged with making efforts to secure the well-being of research subjects. Third, the Belmont Report outlines Justice. Consideration of this principle resulted from the common practice in the 1800s and early 1900s of using the poor, the mentally deficient, or prisoners as research subjects, while affording the benefits of such research to the privileged. Therefore, scientists are re quired to evaluate whether their selection of research subjects has been made because of ".. .their easy availability, their compromised position, or their manipulability..." (21). More over, the benefits that derive from the research must be dis tributed to all persons regardless of class so that justice prevails. The DHHS states that the application of these three basic principles entails certain requirements. First, subjects must give informed consent before participating in a study. Before the beginning of any experimentation, the subject is to be informed of the research procedure and its purpose, the risks and anticipated benefits of the study, and alternative proce dures, if any. The subject should also be allowed the opportu nity to ask questions as well as be given the freedom to withdraw without prejudice or fear of reprisal at any time from the research. Additional information concerning subject/inves tigator liability, the subject screening process, etc., has also to be delineated. In some cases, it may be necessary to provide subjects with incomplete disclosure of the research. This is permissible only if incomplete disclosure is truly necessary to accomplish the goals of the study, there are no undisclosed risks to the subjects, and there is an appropriate process for debriefing subjects and distribution of results (21). It is also important to convey all information in an organized fashion, and to take time to relieve any confusion a subject may have concerning the study. When all necessary information is provided and the subject understands the benefits and drawbacks of the study, it becomes the subject's responsibility whether or not to give voluntary consent. Voluntary consent refers to a positive re sponse toward partaking in a study that has not been coerced or influenced in any manner. All human subject protocols, includ ing the actual informed consent document, must be reviewed and approved by a duly established Institutional Review Board (IRB). A requirement of publication in any of the APS journals is an explicit statement in the manuscript that such approval was obtained. Before the commencement of any study, it is important to consider the target groups of subjects that will be included in the experimental process. Based on the experimental outline and intended benefits of the experiment, some populations may be unnecessary for inclusion, whereas others may be integral to the investigation. Of course, the inclusion of children and others considered not to be autonomous require special con sideration and protection. The use or exclusion of one popu lation over another must be accompanied by proper reasoning and be agreed on by the investigator's IRB. In 1981, the regulations outlined by the Belmont Report were added to the CFR at Title 45, Part 46 (76). This particular portion of the CFR defines basic DHHS policy concerning the protection of human subjects; and as stated, "Applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable to such research" (24). The CFR, like the Declaration of Helsinki, is continually critiqued and upgraded to maintain relevance to current scientific research. Exemptions from this policy are those that can be seen as the least physically and psychologically invasive of studies con ducted on human subjects. Research conducted in established or commonly accepted educational settings; studies involving the use of educational tests; research involving the collection or study of existing data, records, etc., taste and food quality evaluations and consumer acceptance; and the assessment of public benefit or studies aimed at causing beneficial changes to preexisting programs are all excluded from CFR 45.46 (24). However, these types of studies are subject to separate guide lines also found under the umbrella of the CFR. Importantly, the regulations outlined in the CFR have no effect on any local, state, or foreign laws or guidelines established to provide further protection of human subjects in scientific research (80). Use of these materials and protocols, including surveys, still require IRB approval. Well-established outlets of scientific research such as the American Journal ofPhysiology, and the New England Journal of Medicine require that the research described in their publi cations adhere to the standards outlined by the Declaration of Helsinki and CFR Title 45, Part 46. Documented approval by an IRB, IACUC, or equivalent oversight committee is also a requirement for publication. Those submissions that do not contain such documentation are to be refused by reviewers. In the end, it still falls on the shoulders of those conducting human research to exhibit integrity, dignity, and justice to ensure that proper care is given to all who offer themselves to advance our understanding of the disease process. Case study. During the review of a manuscript, one reviewer noticed that human cardiac tissue was obtained for microarray analysis from a patient during, according to the authors, a standard catheterization procedure used for diagnosis of a specific cardiac myopathy. The authors also stated in the manuscript that informed consent was obtained, and the entire study was reviewed and approved by their institution's IRB. However, the reviewer, who was a cardiologist, stated categor ically that this procedure is not used for diagnosis; the condi tion is so well defined that its diagnosis is made by less invasive means. The authors' institution is in a European country. What should be done? 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