A Guide to research ethics

A GUIDE TO RESEARCH ETHICS UNIVERSITY OF MINNESOTA CENTER FOR BIOETHICS 2003 TABLE OF CONTENTS BACKGROUND AND DEFINITIONPage 3 RESEARCH ETHICS ISSUES AuthorshipPage 8 PlagiarismPage 11 Peer reviewPage 15 Conflicts of interestPage 19 Data managementPage 22 Research misconductPage 27 Research with animalsPage 31 Research with human subjectsPage 35 GLOSSARY OF CLINICAL TRIAL TERMSPage 43 REFERENCESPage 51 RESEARCH ETHICS: BACKGROUND AND DEFINITION Definition Research ethics provides guidelines for the responsible conduct of biomedical research. In addition, research ethics educates and monitors scientists conducting research to ensure a high ethical standard. Brief history The birth of modern research ethics began with a desire to protect human subjects involved in research projects. The first attempt to craft regulations began during the Doctors Trial of 1946-1947. The Doctors Trial was a segment of the Nuremberg Trials for Nazi war criminals (see photo*). In the Doctors Trial, 23 German Nazi physicians were accused of conducting abhorrent and torturous “experiments” with concentration camp inmates. The accused physicians tortured, brutalized, crippled, and murdered thousands of victims in the name of research. Some of their experiments involved gathering scientific information about the limits of the human body by exposing victims to extreme temperatures and altitudes. The most gruesome and destructive experiments tested how quickly a human could be euthanatized in order to carry out the Nazi racial purification policies most efficiently. Photo of the Nuremberg Palace of Justice Photo by: Thomas J. Dodd Papers, Dodd Research Center, University Libraries, University of Connecticut To prosecute the accused Nazi doctors for the atrocities they committed, a list of ethical guidelines for the conduct of research – the Nuremberg Code – were developed. * Thomas J. Dodd Papers website. http://www.lib.uconn.edu/DoddCenter/ASC/dodphot1.htm. Accessed 2/05/03. The Nuremberg Code consisted of ten basic ethical principles that the accused violated.1 The 10 guidelines were as follows: Research participants must voluntarily consent to research participation Research aims should contribute to the good of society Research must be based on sound theory and prior animal testing Research must avoid unnecessary physical and mental suffering No research projects can go forward where serious injury and/or death are potential outcomes The degree of risk taken with research participants cannot exceed anticipated benefits of results Proper environment and protection for participants is necessary Experiments can be conducted only by scientifically qualified persons Human subjects must be allowed to discontinue their participation at any time Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death The Nuremberg Guidelines paved the way for the next major initiative designed to promote responsible research with human subjects, the Helsinki Declaration. The Helsinki Declaration was developed by the World Medical Association and has been revised and updated periodically since 1964, with the last update occurring in 2000.2 The document lays out basic ethical principles for conducting biomedical research and specifies guidelines for research conducted either by a physician, in conjunction with medical care, or within a clinical setting. The Helsinki Declaration contains all the basic ethical elements specified in the Nuremberg Code but then advances further guidelines specifically designed to address the unique vulnerabilities of human subjects solicited to participate in clinical research projects. The unique principles developed within the Helsinki Declaration include: The necessity of using an independent investigator to review potential research projects Employing a medically qualified person to supervise the research and assume responsibility for the health and welfare of human subjects The importance of preserving the accuracy of research results Suggestions on how to obtain informed consent from research participants Rules concerning research with children and mentally incompetent persons Evaluating and using experimental treatments on patients The importance of determining which medical situations and conditions are appropriate and safe for research Following the Helsinki Declaration, the next set of research ethics guidelines came out in the Belmont Report of 1979 from the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report outlines: The ethical principles for research with human subjects Boundaries between medical practice and research The concepts of respect for persons, beneficence, and justice Applications of these principles in informed consent (respect for persons), assessing risks and benefits (beneficence), and subject selection (justice)3 The Nuremberg, Helsinki, and Belmont guidelines provided the foundation of more ethically uniform research to which stringent rules and consequences for violation were attached. Governmental laws and regulations concerning the responsible conduct of research have since been developed for research that involves both human and animal subjects. The Animal Welfare Act provides guidelines and regulations for research with animals. It goes into detail about sale, licensure, facilities, transport, and other care instructions. For research with human subjects Title 45, Part 46 from the Code of Federal Regulations (45 CFR 46): The Protection of Human Subjects Regulations outlines the purpose and policies of Institutional Review Board (IRB) oversight and approval, informed consent, and protections and policies for research with children, pregnant women, fetuses, prisoners, and mentally incompetent individuals. Currently, the focus of research ethics lies in the education of researchers regarding the ethical principles behind regulations as well as the oversight and review of current and potential research projects. The field has expanded from providing protections for human subjects to including ethical guidelines that encompass all parts of research from research design to the truthful reporting of results. There are several avenues for people who wish to seek education on basic ethical principles, and avenues for education on how to comply with policies at the institutional, state, and national levels. The University of Minnesota’s Center for Bioethics (www.bioethics.umn.edu) and many other universities and professional associations around the country continually offer education for researchers and scientists on ethical research issues. Curriculum is available in frequently offered conferences, classroom settings, and on-line (www.research.umn.edu/curriculum). Why study research ethics? Knowing what constitutes ethical research is important for all people who conduct research projects or use and apply the results from research findings. All researchers should be familiar with the basic ethical principles and have up-to-date knowledge about policies and procedures designed to ensure the safety of research subjects and to prevent sloppy or irresponsible research, because ignorance of policies designed to protect research subjects is not considered a viable excuse for ethically questionable projects. Therefore, the duty lies with the researcher to seek out and fully understand the policies and theories designed to guarantee upstanding research practices. Research is a public trust that must be ethically conducted, trustworthy, and socially responsible if the results are to be valuable. All parts of a research project – from the project design to submission of the results for peer review – have to be upstanding in order to be considered ethical. When even one part of a research project is questionable or conducted unethically, the integrity of the entire project is called into question. AUTHORSHIP DEFINITION AND IMPORTANCE Authorship is the process of deciding whose names belong on a research paper. In many cases, research evolves from collaboration and assistance between experts and colleagues. Some of this assistance will require acknowledgement and some will require joint authorship.4 Responsible authorship practices are an important part of research. Reporting and analyzing results is the key to applying research findings to the real world. Despite its vital role, authorship remains a murky and vague area for many scientists who frequently run into difficulty when deciding which colleagues should be listed as authors or co- authors, and which colleagues should instead receive acknowledgement. Despite the challenges, researchers should familiarize themselves with proper authorship practices in order to protect their work and ideas while also preventing research fraud. ETHICAL GUIDELINES Each person listed as an author on an article should have significantly contributed to both the research and writing. In addition, all listed authors must be prepared to accept full responsibility for the content of the research article. The International Committee of Medical Journal Editors (ICMJE) is the recognized international expert organization when it comes to guidelines regarding biomedical research authorship. Their website (www.icmje.org) lists all requirements for authorship, which are quoted as follows: Authorship credit should be based only on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Conditions 1, 2, and 3 must all be met. Acquisition of funding, the collection of data, or general supervision of the research group, by themselves, do not justify authorship.5 According to the ICMJE, colleagues who are part of a research group or team but do not meet the conditions above should NOT be listed as authors. They should instead receive acknowledgement at the end of the manuscript, with a brief description of their contribution if appropriate. In order to acknowledge a contributing colleague, the colleague must consent to the acknowledgement, lest they seem to be endorsing research or conclusions drawn from research for which they are not responsible.6 All the contributing co-authors of an article must jointly decide the order of the listing of names. The first person listed should be the person most closely involved with the research.7 The authors should then decide the order of the remaining authors in accordance with the criteria of the publishing journal, and be prepared to answer questions about why the order is as it appears. “Can I be a co-author?” “Sure! But only if you… Contributed substantially to the research, AND… Wrote or revised all or part of the manuscript, AND… Approved the final version of the entire article.” ~ Guidelines from the ICMJE website at www.icmje.org EXAMPLE CASE STUDY Query Jamal is a graduate student working under the supervision of professor, Dr. Kerry. Dr. Kerry is conducting research on tooth decay and has gathered data from hundreds of dental patients. Jamal uses Dr. Kerry’s data to analyze a research question that he came up with on his own about tooth enamel erosion. His question is his own idea, but is still based on what he learned about tooth and enamel decay under Dr. Kerry. Jamal’s friend, Darcie, helped Jamal design a statistical computer program for data analysis, but did not contribute in any other way to the research. When writing up his results, Dr. Kerry helped Jamal write the methods section of his manuscript and reviewed his final results and conclusions, as well as the final draft of the entire manuscript. How should authorship be decided in this case? Answer Jamal should be listed first as the primary author because he is most closely involved in the research project. Dr. Kerry should be listed second as co-author because she meets the ICJME requirements of authorship. Darcie does not meet the criteria for authorship, but she should be acknowledged for her contribution if she so consents. UNIVERSITY OF MINNESOTA RESOURCES AND GUIDELINES8 University of Minnesota Code of Conduct for researchers (Section 2, Subdivisions 4 and 5) available online at: http://www1.umn.edu/regents/policies/academic/Conduct.html University of Minnesota Publication of Investigation Results: http://www1.umn.edu/regents/policies/administrative/PublicationofResults.html On-line curriculum on authorship issues by Mark Dworkin available at: www.research.umn.edu/ethics. Click on “curriculum,” then “authorship”. OTHER RESOURCES AND GUIDELINES The International Committee of Medical Journal Editors has a variety of helpful hints on a range of research ethics topics, including authorship. www.icmje.org. The following article suggests how to organize authorship when research is conducted in more than one institution. Barker A. Powell RA. Authorship. Guidelines exist on ownership of data and authorship in multicentre collaborations. British Medical Journal, 1997; 314(7086):1046. PLAGIARISM DEFINITION AND IMPORTANCE Plagiarism is the act of passing off somebody else’s ideas, thoughts, pictures, theories, words, or stories as your own. If a researcher plagiarizes the work of others,they are bringing into question the integrity, ethics, and trustworthiness of the sum total of his or her research.9 In addition, plagiarism is both an illegal act and punishable, considered to be on the same level as stealing from the author that which he or she originally created. Plagiarism takes many forms. On one end of the spectrum are people who intentionally take a passage word-for-word, put it in their own work, and do not properly credit the original author. The other end consists of unintentional (or simply lazy) paraphrased and fragmented texts the author has pieced together from several works without properly citing the original sources.10,11 No part of the spectrum of potential plagiaristic acts are tolerated by the scientific community, and research manuscripts will be rejected by publishers if they contain any form of plagiarism – including unintentional plagiarism. ETHICAL GUIDELINES The Indiana University website provides the following advice to avoid plagiarism. A researcher preparing a written manuscript should cite the original source if he or she: “Quotes another person’s actual words, either oral or written; Paraphrases another person’s words, either oral or written; Uses another person’s idea, opinion, or theory; or Borrows facts, statistics, or other illustrative material, unless the information is common knowledge.”12 The rules of plagiarism typically apply to graphics, text, and other visuals from all traditional forms of publication and include modern forms of publications as well, in particular the World Wide Web. If a substantial amount of another person’s graphics or text will be lifted from a web page, an author should ask permission to use the material from the original author or website host.13 Most researchers certainly try not to plagiarize. However, it isn’t always easy because people often consult a variety of sources of information for their research and end up mixing it in with their own background knowledge.14 To avoid unintentional or accidental plagiarizing of another person’s work, use the following tips from the Northwestern University website: Cite all ideas and information that is not your own and/or is not common knowledge, Always use quotation marks if you are using someone else’s words, At the beginning of a paraphrased section, show that what comes next is someone else’s original idea (example: these bullet points start out by saying the information originated with Northwestern University), At the end of a paraphrased section, place the proper citation.15 Redundant publications constitute a special type of plagiarism. The ICMJE defines redundant publication as follows: “Redundant or duplicate publication is publication of a paper that overlaps substantially with one already published.”16 The ICMJE further points out that resubmitting a manuscript to a journal when it has already been published elsewhere violates, “international copyright laws, ethical conduct, and cost-effective use of resources.” Articles that have been published already should not be either resubmitted under another title, or resubmitted with only minor changes to the text unless it is clearly stated that it is a resubmitted article.17 EXAMPLE CASE STUDY Query Belinda is publishing her first article that builds on the research of a similar project she did three years prior with her colleague, Isaiah. In Belinda’s current article she has placed a graph from the article she and Isaiah co-authored about their previous research. Isaiah created the original graph. Does Belinda have to site the previous article? Answer Yes. Belinda is using the ideas of another person(s). Even though the graph came from an article she herself worked on, she should appropriately cite the prior publication to show that: a) the data and results depicted in the graph are not new and have been previously published; and, b) the idea originated with another entity (in this instance the other entity is the research team of Belinda and Isaiah). UNIVERSITY OF MINNESOTA RESOURCES AND GUIDELINES18 The University of Minnesota does not condone plagiarism. Plagiarism violates university policy and is not tolerated. For guidelines and Code of Conduct information, try the University of Minnesota’s Office of Vice President of Research’s website at www.research.umn.edu. OTHER RESOURCES AND GUIDELINES The website www.plagiarism.org has been recommended by some researchers as a way to improve the quality of peer reviewed research publications. The website has a database of publications and can be used to detect plagiarism in a submitted manuscript.19 The International Committee of Medical Journal Editors’ website at www.icmje.org has resources on plagiarism and other ethical research issues, including how to reference all types of literature. Proper citation and referencing procedures can be obtained from the Modern Language Association’s guidebook, MLA Style Manual and Guide to Scholarly Publishing. (2nd Edition) Joseph Gibaldi, ed., 1998. This guidebook is f