A Guide to research ethics

Abstract

A GUIDE TO RESEARCH ETHICS [University] 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 for graduate students, academicians, and professionals. For undergraduate students, proper citation guidelines are outlined in the MLA Handbook for Writers of Research Papers. (5th Edition) Joseph Gibaldi, ed., 1999. A reference article concerning plagiarism: Price AR. Federal Actions against Plagiarism in Research. Journal of Information Ethics, 1996; 5(1):34-51. Another article about plagiarism and the Internet: Eysenbach G. Report of a case of cyberplagiarism--and reflections on detecting and preventing academic misconduct using the Internet. Journal of Medical Internet Research, 2000; 2(1):E4. PEER REVIEW DEFINITION AND IMPORTANCE Peer review is the process in which an author (or authors) submits a written manuscript or article to a journal for publication and the journal editor distributes the article to experts working in the same, or similar, scientific discipline. The experts, otherwise called the reviewers, and the editor then enter the peer review process. The process involves the following: Reviewers and editors read and evaluate the article Reviewers submit their reviews back to the journal editor The journal editor takes all comments, including their own, and communicates this feedback to the original author (or authors) The peer review process seldom proceeds in a straight line. The entire process may involve several rounds of communication between the editor, the reviewers, and the original author (or authors) before an article is fully ready for publication. According to an article on quality peer reviews in the Journal of the American Medical Association, a high quality peer review should evaluate a biomedical article or publication on the following merits: Importance – Does the research impact health and health care? Usefulness – Does the study provide useful scientific information? Relevance – Does the research apply to the journal’s readers and content area of interest? Sound methods – Was the research conducted with sound scientific methods that allowed the researchers to answer their research question? Sound ethics – Was the study conducted ethically ensuring proper protection for human subjects? Were results reported accurately and honestly? Completeness – Is all information relevant to the study included in the article? Accuracy – Is the written product a true reflection of the conduct and results of the research?20 ETHICAL GUIDELINES The two most important ethical concepts in the peer review process are confidentiality and protection of intellectual property. Reviewers should not know the author (or authors) they are reviewing, and the author (or authors) should not be told the names of the reviewers. Only by maintaining strict confidentiality guidelines can the peer review process be truly open and beneficial. Likewise, no person involved in the peer review process – either the editor, reviewers, or other journal staff – can publicly disclose the information in the article or use the information in a submitted article for personal gain. Peer reviewers, in addition to maintaining confidentiality, can be neither conflicted nor political in their review. Conflicts may take the form of financial conflicts with the results, conflicts if the research is too similar to their own research endeavors, and conflicts due to personal relationships with the author (or authors). Political motivations that might interfere with the peer review process include competition to publish with other scientists and inaccurate reviews designed to “punish” a competing colleague or journal.21 Editors may find it difficult to guarantee a conflict-free peer review process, because reviewers must be experts with knowledge unique to the field to which the article pertains. Therefore, many reviewers may find themselves faced with an article concerning research that is very similar to their own. Peer reviewers should disclose all conflicts of interest that may unduly influence their review to the journal editor and disqualify themselves when appropriate. Editors of journals should maintain an open and ethical peer review process, and all submitting authors and readers should be fully aware of a journal’s process of peer review. Editors do retain flexibility in assigning the number of peer reviewers and what to do with the peer review information once completed. One method is for an editor to approach two or three reviewers and then ask an author (or authors) to change the article to satisfy all the reviews. On the other hand, an editor may take all the reviews and consolidate the advice to help guide the author (or authors) when making changes, clarifications, and corrections. Editors must not relinquish too many of their own responsibilities to peer reviewers. The peer review process represents one step in the publishing process and editors need to take full responsibility for their decision to include an article in their journal. This means that editors must review the content and character of a submitted article, using all the criteria listed for reviewers above, and should rely on the reviewers primarily to catch errors that lie outside the editor’s area of expertise and technical understanding.22 Finally, editors should have full and complete freedom over the content of a published journal. They should only include articles that they believe to be honest, accurate, ethical, and scientifically responsible. According to the International Committee of Medical Journal Editors, all editors have: “An obligation to support the concept of editorial freedom and to draw major transgressions of such freedom to the attention of the international medical community.”23 EXAMPLE CASE STUDY Query Dr. Connelly is a faculty member at Springer University. He has been asked to review a publication for a biomedical journal. After receiving the article, he realizes the author is a student working under the guidance of a fellow faculty member in a neighboring department. The faculty member happened to mention the merits of the student at a recent social gathering. Does Dr. Connelly have a reportable conflict of interest? Answer The peer review process relies on a foundation of confidentiality. Dr. Connelly should contact the journal editor and report his belief that the manuscript originated from the university where he is employed. He and the editor should then open a dialogue about how this could potentially effect his participation in the peer review process and how to proceed. UNIVERSITY OF MINNESOTA RESOURCES AND GUIDELINES24 The University of Minnesota’s Board of Regents’ guidelines regarding intellectual property can be found on-line at: http://www1.umn.edu/regents/policies/academic/IntellectualProperty.pdf OTHER RESOURCES AND GUIDELINES The International Committee of Medical Journal Editors website at www.icmje.org has information on the peer review process. CONFLICTS OF INTEREST DEFINITION AND IMPORTANCE Conflicts of interest arise when a person’s (or an organization’s) obligations to a particular research project conflict with their personal interests or obligations. For example, a university researcher who owns stock in XYZ Pharmaceuticals is obligated to report truthful and accurate data, but he might be conflicted if faced with data that would hurt stock prices for XYZ pharmaceuticals. Conflicts of interest are particularly important to examine within the context of biomedical research because research subjects may be particularly vulnerable to harm.25 A researcher should attempt to identify potential conflicts of interest in order to confront those issues before they have a chance to do harm or damage. If conflicts of interest do exist, then the objectivity of the researcher and the integrity of the research results can be questioned by any person throughout the research review process – from the IRB review through the peer review phase. It is therefore imperative to address conflicts of interest up front and discuss how to combat potential lack of objectivity, before the research is called into question.26 ETHICAL GUIDELINES The “Objectivity in Research NIH Guide,” provides guidelines on how investigators receiving grants from the National Institutes of Health (NIH) should handle conflicts of interest. In essence, it suggests that investigators should:27 Disclose to their institution any major or significant financial conflicts of interest that might interfere with their ability to conduct a research project objectively Disclose any such financial conflicts of interest of their spouses or dependent children The Title 42 Code of Regulations (42 CFR 50) section on conflicts of interest contains the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought guidelines, which consist of the following regulations for organizations receiving NIH funding: The organization must have, “a written and enforced administrative process to identify and manage, reduce, or eliminate conflicting financial interests with respect to research projects for which NIH funding is sought;” Before any NIH funds are spent, the organization must inform the Chief Grants Management Officer (CGMO) at the appropriate NIH office of any existing conflicts of interest and indicate that the conflict has been addressed, “by indicating whether the conflict has either been managed, reduced, or eliminated;” The organization has to identify and report any conflicts that arise during the course of NIH funded research; The organization has to comply with NIH requests for information on how an identified conflict of interest has been handled.28 The NIH recommends the following possible actions to help organizations address conflicts of interest: “Public disclosure of significant financial interests; Monitoring of research by independent reviewers; Modification of the research plan; Disqualification from participation in all or a portion of the research funded by PHS; Divestiture of significant financial interests; or Severance of relationships that create actual or potential conflicts.”29 Physician and other health care professional researchers may find themselves facing conflicts of interest in their duties towards research versus their duties towards the health and welfare of their patients. Clinical obligations to patients should always be considered above and beyond the obligations of research. EXAMPLE CASE STUDY Query Dr. Garrath is a gynecological physician and an investigator on a research project for a pharmaceutical company testing a new topical treatment for a sexually transmitted disease that must be administered frequently and can cause itching and irritation. The company is paying her a rate of $2,000 per person enrolled. Does she have a conflict of interest? Answer Yes. Dr. Garrath’s obligation to her patients has the potential to be compromised by her personal interests. While her job is to protect and promote her patients’ welfare and health, at $2,000 per person enrolled, she might be tempted to recruit more people into the study for her personal financial benefit by encouraging her patients to participate and downplaying the side-effects and burdens of participation. Dr. Garrath should very carefully evaluate whether this conflict of interest might impact her patients’ health and welfare and how to solve this potential conflict before agreeing to be an investigator. She should also report this potential conflict to the proper administration authority at the clinical site where she is practicing.30 UNIVERSITY OF MINNESOTA RESOURCES AND GUIDELINES31 The University of Minnesota’s policies on reporting conflicts of interest can be found at: http://www1.umn.edu/regents/policies/academic/ConflictofInterest.pdf. OTHER RESOURCES AND GUIDELINES The Association of American Universities’ (AAU) Report on Individual and Institutional Financial Conflict of Interests provides recommendations and guidelines for members on handling financial conflicts of interest: http://www.aau.edu/research/COI.01.pdf. Federal regulations can be found in the Public Health Service Regulation: Responsibility of Applicants for Promoting Objectivity in Research. Available on-line at: http://grants.nih.gov/grants/guide/notice-files/not95-179.html. DATA MANAGEMENT DEFINITION AND IMPORTANCE Data management, in respect to research ethics, references three issues: 1) the ethical and truthful collection of reliable data; 2) the ownership and responsibility of collected data; and, 3) retaining data and sharing access to collected data with colleagues and the public.32,33 Each issue contributes to the integrity of research and can be easily overlooked by researchers. Oftentimes, researchers will downplay the importance of data management because the details can be time consuming and they assume they can “figure it out” as they go along. It is not adequate research practice to assume issues involved in data collection will work themselves out on their own. Instead, a clear, responsible, ethically sound, and carefully outlined plan for data management is required at the beginning of research to prevent all manners of conflicts and inappropriate research methods. Ethical data collection refers to collecting data in a way that does not harm or injure someone. Harm and injury could range from outright physical injury to harmful disclosure of unprotected confidential health information. In comparison, truthful data collection refers to data that, once collected, are not manipulated or altered in any way that might impact or falsely influence results. Assigning and ensuring responsibility for collecting and maintaining data is one of the most important ethical considerations when conducting a research project. Responsibilities include the following important issues: Oversight of the design of the method of data collection Protecting research subjects from harm Securing and storing data safely to preserve the integrity and privacy of data Delegating work with data to others and responsibility over the work of others Responsible use of data and truthful portrayal of data results In contrast to the fairly straightforward concepts underlying truthful and ethical data collection issues, the issue of data sharing is complicated by personal emotions, motives, obligations, and ownership. Despite its complexities, data sharing is considered to be a hallmark of the scientific community, particularly in academia. NIH describes the importance of data sharing on its website: Data sharing achieves many important goals for the scientific community, such as reinforcing open scientific inquiry, encouraging diversity of analysis and opinion, promoting new research, testing of new or alternative hypotheses and methods of analysis, supporting studies on data collection methods and measurement, facilitating teaching of new researchers, enabling the exploration of topics not envisioned by the initial investigators, and permitting the creation of new data sets by combining data from multiple sources.34 While part of scientific research encourages accuracy and verification of data through data sharing, sometimes data are associated with intellectual property and need to be protected as such. For this reason, whether to retain or share data can be a fine line for researchers who wish to protect their intellectual property, but the line must be properly drawn in order to allow the positive aspects of data sharing to occur while protecting the researcher’s hard work and ingenuity. ETHICAL GUIDELINES The three issues for data management (ethical and truthful data collection, responsibility of collected data, and data sharing) can be addressed by researchers before and during the establishment of a new research project. Researchers must accurately identify answers to the following questions to resolve and address all data management issues in a timely manner: Who is in charge of the data? (This person is usually the principal investigator of the research project and is responsible for data collection design and physical data collection.) How will data be collected? (Will data be collected via phone, mail, personal interview, existing records, secondary sources, etc.?) Will there be identifying information within the data? If yes, why? How will this be rectified? How will data be stored and what privacy and protection issues will result from the method of storage? (Will it be stored electronically, on paper, as raw tissue samples, etc.?) Who will ensure that no data were excluded from the final results and ensure accuracy of result interpretation? How long after the project is over will data be kept? (This will depend on the source of funding and organizational policies.) Protecting intellectual property while at the same time encouraging data sharing is highly important in order to ensure valid and reliable research. In order to identify what is and is not protected as “intellectual property,” the concept must be clearly defined. The University of Minnesota’s Intellectual Property Policy defines intellectual property as: ‘Intellectual Property’ means any invention, discovery, improvement, copyrightable work, integrated circuit mask work, trademark, trade secret, and licensable know-how and related rights. Intellectual property includes, but is not limited to, individual or multimedia works of art or music, records of confidential information generated or maintained by the University, data, texts, instructional materials, tests, bibliographies, research findings, organisms, cells, viruses, DNA sequences, other biological materials, probes, crystallographic coordinates, plant lines, chemical compounds, and theses.* Intellectual property may exist in a written or electronic form, may be raw or derived, and may be in the form Emphasis added. of text, multimedia, computer programs, spreadsheets, formatted fields in records or forms within files, databases, graphics, digital images, video and audio recordings, live video or audio broadcasts, performances, two or three-dimensional works of art, musical compositions, executions of processes, film, film strips, slides, charts, transparencies, other visual/aural aids or CD-ROMS.35 In February of 2003, NIH released guidelines on data sharing. The primary guideline states that all data must be shared and released in a timely manner. The NIH defines timely manner as “no later than acceptance for publication.” In addition, all grant applications to the NIH for grants of at least $500,000 are required to establish a data sharing plan or give an explanation as to why data will not be shared in the proposal (i.e. IRB allowance or institutional restrictions).36 The Health Information Portability and Accountability Act (HIPAA) of 1996 provides detailed guidelines about data sharing and using data containing personal identification information. The HIPAA guidelines protect personal health information and provide legal requirements for all segments of the health care system (including biomedical research) concerning what type of information can be shared, how information should be stored and protected, data coding, and how information is used. Genetic information is an area of particular concern when considering the issues surrounding data management. Due to the wealth of information locked inside the human genome and the potential for using this information to determine a variety of conditions and genetic tendencies, including the potential to identify a person based on his or her genetic information, particular interest has been expressed in protecting the information found in DNA. Careful attention should be paid by researchers when using genetic information due to its sensitive nature. EXAMPLE CASE STUDY Query Joanne is a researcher at George Kent College. She collected data on rural mental health patients and just published an article on her research in a scholarly journal. Joanne plans to independently write a book about her research and develop educational tools that she can sell to professionals. Joanne is partly funded through her college, but most of her research was paid for with a private stipend from a charitable foundation. Joanne is reluctant to publicly disclose her data before her book is finished. Can she hold off on sharing her data until she completes her book? Answer Joanne has published an article on her data and according to NIH policies, she should be prepared to disclose her data at the time of publication. However, Joanne is not funded with NIH dollars. She would have to use her judgment about publishing her data and be prepared to give a strong reason to the editor of the journal (i.e. she is writing a book) as to why she isn’t sharing her data at this time. UNIVERSITY OF MINNESOTA RESOURCES AND GUIDELINES37 The University of Minnesota Intellectual Property Policy: http://www1.umn.edu/usenate/policies/intelproperty.html. The University of Minnesota Code of Conduct: http://www1.umn.edu/regents/policies/academic/Conduct.pdf. University of Minnesota Privacy and Security Project: http://www.ahc.umn.edu/ahc_content/about/privacy/ OTHER RESOURCES AND GUIDELINES NIH Data Sharing website is: http://grants.nih.gov/grants/policy/data_sharing/. For Frequently Asked Questions about data sharing: http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. U.S. Department of Health and Human Services Office for Civil Rights HIPAA final regulations: http://www.hhs.gov/ocr/hipaa/finalreg.html RESEARCH MISCONDUCT DEFINITION AND IMPORTANCE Research misconduct is the process of identifying and reporting unethical or unsound research. The United States’ Office of Scientific and Technology Policy (OSTP) released a new definition of research misconduct that went into effect in December of 2000. OSTP defines misconduct, and its components, as follows: Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism* is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion.38 In addition to defining research misconduct, the federal policy released by OSTP includes guidelines on what must be present in order to find a researcher guilty of committing research misconduct. A finding of research misconduct requires that: There be a significant departure from accepted practices of the relevant research community; and Emphasis (bolded text) added. The misconduct be committed intentionally, or knowingly, or recklessly; and The allegation be proven by a preponderance of evidence.39 Research misconduct can be the result of criminal behavior. For example, making up research data that doesn’t exist and other overt acts of fraud are deliberate and punishable criminal acts. Government regulations and criminal punishments are necessary to prevent these criminal practices. Research misconduct can also be the result of mistaken, negligent, unintentional, lazy, or sloppy research practices. These types of misconduct are usually covered by institutional policies and are punishable at the institutional level. In these instances of research misconduct, the use of outside research evaluators (like the IRB) and the process of peer review helps to maintain and safeguard scientific integrity.40 ETHICAL GUIDELINES Who is responsible for reviewing instances of research misconduct? Any person who knows that research is being conducted unethically should raise his or her concerns to the appropriate authorities, whether that person is involved in the research or not. The first step in this instance may likely be a confidential conversation with the person in charge of research integrity at an institution. Once research misconduct has been identified, all parties involved in the research must take responsibility to resolve the situation, including: the principal investigator, co-investigators, the institution hosting the research, the funding agency, and publishing journal editors, if applicable. While the federal government takes responsibility for research projects funded with federal money, it assigns the primary responsibilities of identifying and investigating research misconduct to the agency or institution hosting the research. When someone is suspected of committing research misconduct, the proper procedure is to first launch an inquiry. If the inquiry reveals a potential research misconduct situation, the second step is to then conduct a full-scale investigation. Finally, the institution uses the information collected during the full-scale investigation to make decisions concerning the presence of misconduct and its severity, and what appropriate corrective action should be taken, if needed.41 What should people do if they are suspected of having committed research misconduct? The Department of Health and Human Services Office of Research Integrity suggests the following procedural guidelines for reporting and investigating research misconduct. While the procedures are not mandatory, nearly all research institutions have adopted very similar procedures to the following: A person suspecting a scientist of research misconduct should report the incident to a research integrity officer who should immediately look into the allegation to assess if it is both: a) research misconduct; and b) within the jurisdiction of the research institution. The person who informs the research integrity officer of suspected misconduct (the whistleblower) should be treated with “fairness and respect” by the research institution and efforts should be made to protect their job and reputation as necessary. The person suspected of research misconduct (the respondent) should be protected and treated with “fairness and respect” by the research institution. The research integrity officer should strive to maintain the confidentiality of both the whistleblower and the respondent. If the misconduct issue is a criminal one or exceeds the jurisdiction of the research institution, the research integrity officer should report the misconduct allegations to the proper authorities or agencies.42 EXAMPLE CASE STUDY Query Marcus and Clay have been working on a research project studying the prevalence of pneumonia in nursing home residents. Marcus learns that while Clay is interviewing research participants, if he does not elicit an answer, he invents one and passes it off as truthful data...