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Research Ethics Workshop

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1 Research Ethics Workshop
“In general terms, responsible conduct in research is simply good citizenship applied to professional life” Office of Research Integrity, Introduction to the Responsible Conduct of Research; Accessed October 1, 2010. RCR (responsible conduct of research), rather than research ethics, is the term preferred by the U.S. Federal government, including the National Institutes of Health and the National Science Foundation.

2 Research Ethics Training
Federal government requires certain people to have certain training, but knowing the “Rules of Research” is good for everyone. Missouri State University would like to recognize those who have achieved certain levels of training. Co-curricular transcript “recognition” This workshop = 2 hr Additional hours this month for: IRB workshop (Tues Nov 9, 4:00 - 5:00, PSU 315) = 1 hr IACUC workshop (Thurs Nov 11, 4:00 - 5:00, PSU 315) = 1 hr More details to come on earning this “recognition”

3 Presentation Outline What is Research Ethics? (aka, Responsible Conduct of Research, aka, Research Integrity) Research Misconduct Conflict of Interest Authorship and Publication Intellectual Property Technology Transfer Data Collection & Data Management Data Ownership & Data Sharing Mentor/Trainee Relationship Peer Review Export Control Human and vertebrate research (covered elsewhere)

4 Introduction A review by Knechtle SJ, published in the PhilosTrans R Soc Lond B Biol Sci, 2001, May 29;356(1409):681-9, entitled ‘Treatment with immunotoxin,’ cites 4 publications from the Thomas Laboratory. Not only were these papers cited, but the reviewer seemed impressed by the Thomas work. All 4 papers were later retracted because of false claims. What does this do to the credibility of other papers from this research lab? What does this do to the credibility of Knechtle & his paper? What does this do to the field of immunotoxicology? Case study showing Data manipulation and falsification. Knechtle SJ, published in the PhilosTrans R Soc Lond B Biol Sci, 2001, May 29;356(1409):681-9, entitled ‘Treatment with immunotoxin” – Office of Research Integrity, 2009 Annual Institutional Report on Misconduct Activities; Vol 18, No. 1, Page 3; December 2009

5 Research Ethics “.. is a kind of applied or practical ethics, meaning that it attempts to resolve not merely general issues but also specific problems that arise in the conduct of research. Its goal is to determine the moral acceptability and appropriateness of specific conduct and to establish the actions that moral agents ought to take in particular situation. Research ethics is therefore not merely theoretical. It aims to establish practical moral norms and standards for the conduct of research.” Peach, Lucianda (1995) “ An Introduction to Ethical Theory,” Research Ethics: Cases and Materials,

6 In general terms, “research ethics” is simply good citizenship applied to professional life.
Four basic tenants HONESTY — conveying information truthfully and honoring commitments, ACCURACY — reporting findings precisely and taking care to avoid errors, EFFICIENCY — using resources wisely and avoiding waste, OBJECTIVITY — letting the facts speak for themselves and avoiding improper bias.

7 Ten most important things to know about Research Ethics
Ten most important things to know about Research Ethics Be Honest Be Fair Do no harm Know and Follow the Rules Bad rules should be changed, not broken Be a good citizen When in doubt, ask questions Listen to the still small voice of your conscience, especially when it’s being overwhelmed by the cacophony of stress If you suspect unethical behavior, proceed cautiously Be honest – Honesty implies more than avoiding falsehoods; it requires telling the truth to the best of your ability and being candid. Candor sometimes requires revealing embarrassing or complicated details that your would rather leave out or gloss over. Be honest with yourself. Self-deception is a real peril of research. Be fair - Fairness applies to everyone – your students, your teachers, your co-workers, the humans or non-human animals who are the subjects of your research, your funding agency, the researchers who will build on your work – everyone. Give to each what is her or his due; accept only what is your due. Do no harm. In research, as in medical practice and in life, it is often impossible to do no harm whatever, but that does not negate the importance of stating this principle in its strongest form. We should all strive to do no harm, even if the best we can actually accomplish is to do no net harm – that is, to do no harm that isn’t counterbalanced by a comparable good. Do good research. Good research is useful, interesting, or important, and well-designed – ideally, elegant. The moral implications of your choice of a research topic and the adequacy of your research design increase as the cost of your research increases. The cost of your research can be measured in your time and the time of others, in money (especially public funds), in human or non-human animal suffering, and in other resources. Know and follow the rules. The rules of research include the conventions and customary practices of your particular field, as well as the policies, regulations, laws, etc., that cover your work, including the rules of your lab, department, university, field of study, city, state, country, and so on. Rules are almost always written in response to actual transgressions, which is sobering when you consider the vast number of rules. Bad rules should be changed, not broken. If you don’t like or agree with a rule, don’t break it – change it. Rules are made for reasons; changing one only requires convincing the right people that there’s good reason to change it. Making the effort might convince you that it’s actually a good rule. Or you might succeed in changing it. Be a good citizen. Pull your weight. Be a responsible peer reviewer. Do your part to help shape the culture, climate, priorities, and direction of research. When in doubt, ask questions. Missouri State University has a designated Research Integrity Officer (RIO), who is located in the office of the Vice President for Research and Economic Development. It should always be safe to get in touch with the RIO. Listen to the still, small voice of your conscience, especially when it’s being overwhelmed by the cacophony of stress. If you ever think, “I can get away with this because no one will ever know the difference,” or, “no one will ever find out,” or “I don’t have any choice” – stop. These are red flags from your conscience, and you are almost certainly contemplating doing something unethical. Before you act, ask yourself what will happen if you don’t do it. Does the world come to an end? Do you die? Probably not. Then imagine that the unethical act you are tempted to do is impossible, for whatever reason, and think of three other actions you can take. One of them is bound to be ethical. It might not be as easy as the unethical course of action, but once you’ve identified it you can find the courage to follow through on it.3 If you suspect unethical behavior, proceed cautiously. If you ever see someone acting in a way that you think is unethical, don’t jump to conclusions. Treat it as a scientific question – gather data, observe carefully, and keep notes. Gathering data might include asking the person to clarify what’s going on. You do have a responsibility to report misconduct, but you also have a responsibility (to yourself, to the person you suspect, and everyone else who might be implicated) to have a clear idea of what’s really going on.

8 Your Responsibilities
Your Responsibilities In order to function effectively and make appropriate ethical decisions, faculty and administrative staff need to develop the skills to: 1. identify when situations present ethical conflicts, 2. reason among possible courses of action, and 3. effectively implement their best solution to the problem. We all function in an environment governed by regulations and policies, which we must abide by within a core of ethical principles.

9 Research Misconduct Federal Policy
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 differences of opinion.

10 University Policies must . . . .
Establish definitions of “misconduct” Outline procedures for reporting and investigation misconduct Provide protection for whistle-blowers Without these, studies can get out of hand

11 Researcher Obligations
Researcher Obligations As researchers, there are three sets of obligations, namely: To honor the trust that their colleagues place in them (researchers trust their colleagues to have used appropriate analytic and statistical techniques in gathering of data) To have an obligation to themselves, and To act in ways that serve the public (including the university and its stakeholders). Taken from the book, “On Being a Scientist”, Guide to Responsible Conduct of Research The scientific enterprise is built on a foundation of trust, between society and researchers and their institution. Researchers HAVE committed misconduct in science Researchers ARE penalized, including research debarment

12 Research misconduct has understandably received considerable public attention. Researchers who act dishonestly waste public funds, harm the research record, distort the research process, undermine public trust, and can even adversely impact public health and safety. Judged on the basis of the number of confirmed cases, misconduct apparently is not common in research. Over the last decade, PHS and NSF combined have averaged 20 to 30 misconduct findings a year. < 1 case for every 10,000 researchers. However, two important cautions need to be kept in mind: 1. Underreporting is to be expected, as it is in criminal and other types of inappropriate behavior. 2. the responsibility to avoid misconduct in research is a minimum standard for the responsible conduct of research.

13 Real Cases: NSF Research Misconduct Investigations
In the most serious case of student misconduct NSF has ever investigated, a graduate student at a Washington university admitted he falsified and fabricated NSF-funded research data in four manuscripts, three of which were published. NSF received the allegation following the university’s inquiry. During the investigation, the student admitted he falsified and fabricated the data because of “a combination of lack of motivation, laziness and a lack of interest in the work (especially experiments).” The university’s investigation committee found that a preponderance of the evidence proved that the subject intentionally fabricated and falsified data. The university made a finding of research misconduct, dismissed the student from the university, and revoked his master’s degree. The university also encouraged the removal of the publications from the co-authors’ websites, retraction of the affected publications, and education of the university community about scientific misconduct. NSF sent the subject a letter of reprimand; debarred him for 3 years, required both certifications and assurances for 3 years following debarment, and barred the subject from serving as an NSF reviewer for 3 years.

14 Real Cases: NSF Research Misconduct Investigations
A Pennsylvania university notified NSF it was conducting an investigation into an allegation of data falsification. The investigation focused on a figure in a paper, whose lead author was a post-doctoral researcher (the subject) working in an NSF-supported PI’s laboratory. When the questionable figure was initially brought to the PI’s attention, she asked the subject to provide the raw data for review. The subject provided neither the raw data nor a suitable explanation. Subsequently, the PI asked the subject to leave her group and asked another researcher to review the subject’s lab computer files related to the figure. None of the data files on the lab computer supported the data depicted in the figure. NSF took the following actions: sent a letter of reprimand to the subject; debarred the subject for 2 years; required certifications from the subject and his supervisor for 2 years after the debarment that submissions to NSF are in compliance with NSF’s research misconduct policy; required the subject to provide proof of the retraction of the published paper; and required the subject to attend an ethics class and provide a copy of the training material.

15 Conflicts of Interest “A situation in which an individual has one or more significant financial interest that have the potential for tainting the conduct or reporting of the work conducted under a sponsored project.” Administrator University Business

16 Researcher Resigns! In January of 2009, Dr. Charles Nemeroff, chair of Psychiatry at Emory resigned after a University investigation determined he had failed to communicate with Emory officials about $800,000 in income he had received from a pharmaceutical company. He now works at another university. Questions: Why was he obligated to tell his employer? Is receiving money a bad thing in this case?


18 Researcher Conflicts Researchers’ motivation:
Researcher Conflicts Researchers’ motivation: Advances knowledge, Leads to discoveries that will benefit individuals and society, Furthers professional advancement, and/or Results in personal gain and satisfaction. Conflicts of Interest cannot and need not be avoided. However, in three crucial areas, special steps are needed to assure that conflicts do not interfere with the responsible conduct of research : Financial gain Work commitments Intellectual and personal matters

19 Federal Policies These policies require research institutions to establish administrative procedures for: reporting significant conflicts before any research is undertaken; managing, reducing, or eliminating significant financial conflicts of interest; providing subsequent information on how the conflicts were handled. Significant financial conflict is defined as: additional earnings in excess of $10,000 a year, or equity interests in excess of 5 percent in an entity that stands to benefit from the research. The financial interests of all immediate family members are included in these figures.

20 Other Policies Missouri State University:
Other Policies Missouri State University: Researchers must also be aware of our conflict-of-interest policy to find out when and what they are required to report. “The key to handling potential conflicts is to fully disclose significant financial interests and, if a conflict of interest is identified, to participate in the development and implementation of an appropriate management plan ” University disciplinary processes Federal government sanctions Criminal sanctions or civil liability Professional and journal policies: A number of professional societies have issued reports or made -recommendations on appropriate ways to handle conflicts of interest.

21 Conflicts of Commitment
Conflicts of Commitment Conflicts of commitment arise from situations that place competing demands on researchers’ time and loyalties. Care needs to be taken to assure that these commitments do not inappropriately interfere with one another. These range from: Allocation of time Relationships with students Use of Resources Disclosure of Affiliations Representing outside entities See

22 Time allocation At a minimum, these rules require that researchers:
Time allocation At a minimum, these rules require that researchers: Honor time commitments they have made, such as devoting a specified percentage of time to a grant or contract; Refrain from charging two sources of funding for the same time; Seek advice if they are unsure whether a particular commitment of time is allowed under an institution’s or the Federal Government’s policies.

23 Relationship with Students
Relationship with Students Academic researchers involved in start-up ventures often have opportunities to hire students. As mentors, they have a primary obligation to help students develop into independent researchers. Should an individual who is both the researcher’s student and employee be advised to develop a promising idea that could lead to an independent career or to work on a more routine problem that will benefit the start-up company? Situations such as these create conflicts and should be avoided or appropriately managed.

24 Use of Resources Equipment and supplies purchased with public funds can easily be used to advance private research interests. The equipment can be used for other university work since this is allowed by the government. But it cannot be used for a personal project without permission. In addition, equipment and supplies cannot be used for research that is explicitly prohibited by the Federal government, such as stem cell research using lines not authorized by the government’s policy

25 Disclosure It is widely agreed that outside affiliations that create conflicts of interest should be listed on academic publications, but should researchers list their academic affiliations on other publications? Researchers must be careful to separate their academic or institutional work from their private work. They should not inappropriately use their institutional research affiliation to advance their private interests by implying, for example, that private work has the support of their research institution if it does not.

26 Outside Entities The results researchers commercialize in private ventures, such as drugs used in a university hospital, a software program used in an accounting office, or a consultation service for employees, might be used by their primary employer Each employer in this case presumably wants the best deal on the goods and services, whereas the researcher is also interested in personal profits, creating a conflict of commitment.

27 Personal & Intellectual Conflicts
Personal & Intellectual Conflicts Researchers are also expected to avoid bias in proposing, conducting, reporting, and reviewing research. They therefore should be careful to avoid making judgments or presenting conclusions based solely on personal opinion or affiliations rather than on scientific evidence. Researchers generally should not serve as reviewers for grants and publications submitted by close colleagues and students. If a researcher holds strong personal views on the importance of a particular area of research or set of research findings, those views should be disclosed so that others can take them into consideration when judging the researcher’s statements.

28 Reporting If a researcher has a significant conflict of interest, as defined by Federal, state, institutional, journal, or other policies, it must be reported and managed or eliminated. Options for managing conflicts of interest include: requiring full disclosure of all interests so that others are aware of potential conflicts and can act accordingly; monitoring the research or checking research results for accuracy and objectivity; or removing the person with the conflict from crucial steps in the research process, such as the interpretation of data or participating in a particular review decision.


30 Case Study: Conflict of Interest
Early in his undergraduate education, Dr. Sam M. decided to dedicate his studies to finding a cure for a psychological disorder that seemed to run in his family. As a biology major, he pursued independent research projects and worked long hours as a lab assistant. He then enrolled in a psychopharmacology PhD program in and is now completing a 3-year postdoc in the neurosciences. During his postdoc, he worked on a promising compound he first discovered during his graduate years. His work has gone well and he feels the time is right to explore clinical applications. University of Michigan, Peerrs learning

31 As Sam weighs the options of an academic versus an industry job, he begins to wonder about who owns or will own the useful applications of his work, if and when there are any. Will it be owned by: His graduate institution, where he first worked on the promising compound? His postdoc institution, where he refined his ideas? His future academic or industry employer? Himself, based on his hard work and innovative ideas? Society, which funded parts of his education and most of his research? Who has a legitimate interest in Sam’s work and when do his own personal financial interests create conflict of interest?

32 Other Questions for Discussion
Other Questions for Discussion Should researchers be allowed/encouraged to profit personally from their research apart from their normal compensation? What are appropriate mechanisms for managing financial conflicts of interest? What are appropriate mechanisms for protecting students from a mentor’s conflict of commitment? What are appropriate mechanisms for managing intellectual and personal conflicts of interest?

33 Authorship and Publication
Researchers share the results of their works with colleagues and the public in a variety of ways. These range from: Laboratory meetings, Workshops, In seminars, and At professional meetings. Whether structured or informal, controlled or free ranging, responsible publication in research should ideally meet some minimum standards, such as: a full and fair description of the work undertaken, an accurate report of the results, and an honest and open assessment of the findings.

34 Authorship The names that appear at the beginning of a paper serve one important purpose. They let others know who conducted the research and should get credit for it. Consequently, the authors listed on papers should fairly and accurately represent the person or persons responsible for the work in question. Contribution Importance Corresponding/primary author

35 Contribution Authorship is generally limited to individuals who make significant contributions to the work that is reported. This includes anyone who: Instrumental in obtaining funding for the project was intimately involved in the conception and design of the research, assumed responsibility for data collection, analysis, and interpretation, participated in drafting the publication, and approved the final version of the publication.

36 Importance Authors are usually listed in their order of importance, with the designation first or last author carrying special weight, although practices again vary by discipline. Academic institutions usually will not promote researchers to the rank of tenured faculty until they have been listed as first or last author on one or more papers. Some journals have specific rules for listing authors; others do not, again placing most of the responsibility for this decision on the authors themselves

37 Corresponding/primary author
Many journals now require one author, called the corresponding or primary author, to assume responsibility for all aspects of a publication, including: the accuracy of the data, the names listed as authors (all deserve authorship and no one has been neglected), approval of the final draft by all authors, and handling all correspondence and responding to inquiries.

38 Avoid These Practices Honorary Authorship - Listing undeserving authors on publications. Salami publication - Dividing one significant piece of research into a number of small experiments, simply to increase the number of publications. Duplicate publication - Publishing the same information a second time without acknowledging the first publication. Premature public statements - research results should be made public only after they have been carefully reviewed and properly prepared for publication. “honorary” authorship, is widely condemned and in the extreme considered by some to constitute a form of research misconduct. However, common agreement notwithstanding, honorary authorship is a significant problem in research publication today (see articles by Drenth and Flanagin, Additional Reading). Researchers are listed on publications because they: are the chair of the department or program in which the research was conducted, provided funding for the research, are the leading researcher in the area, provided reagents, or served as a mentor to the primary author.  Salami publication. - This practice may distort the value of the work by increasing the number of studies that appear to support it. It also wastes valuable time and resources. Before an article is published it is reviewed, edited, and in one form or another prepared for publication.

39 Case Study - Methodology
Katherine, a postdoc in Dr. Susan B.’s laboratory, has just had a manuscript accepted for publication in a prestigious research journal, conditional on a few important changes. Most importantly, the editor has requested that she significantly shorten the methods section to save space. If she makes the requested changes, other researchers may not be able to replicate her work. Asked about the situation, Dr. B. recommends that Katherine go ahead with the changes. After all, if other researchers want more information they can always get in touch. She remains concerned that an inadequate explanation of her methods could lead other researchers to waste time and valuable research dollars attempting to replicate her work. Should Katherine make the requested changes? Should she be concerned about providing inadequate information to colleagues? How can Katherine get definitive answers to these and other questions about the responsible conduct of research?

40 Intellectual Property
Data Acquisition, Management, Sharing, and Ownership University faculty and staff are engaged in many new media in their teaching and research, usually requiring special resources from the university. Examples are software for teaching, web sites, and databases for reference or research. Ownership and licensing issues differ with these kinds of Intellectual Property compared with books

41 Case Study: Intellectual Property
Professor Martha E. teaches a Business class about stock market dynamics. To help her students learn the material, she developed a set of software tools that mimic stock market forces. A student can manipulate the forces, observe the reactions, and learn the dynamics. An outside software vendor learns about Martha’s stock-market tools and offers to license the rights to market them commercially. Question: Is Professor E. legally in a position to pursue the financial venture without involving the university?

42 Ruling The university owns software created by faculty related to their employment. There are a few exceptions, like code snippets within printed texts. Missouri State is reviewing its IP Policy: The new policy clarifies that money provided from competitive, internal MSU Faculty Grants would not have to be paid back before gaining royalties, either in patents or copyright. The new policy allows that under some circumstances a staff member might be the creator and thus inventor or holder of copyright. Includes a larger scope of what is “normal use” or not significant use of University resources for the decision of ownership. Includes a science lab as part of “not significant use” Includes kilns and other things of art production. Allows online course development as the property of the creator, but University retains ongoing right to use materials. Separates Creation of Intellectual property policy from use of copyrighted Material policy. See It is the responsibility of the faculty to disclose the invention to the university via the Office of Sponsored Research and Programs. No one owns ideas such as those described in journal articles and books; only the specific application of ideas can be protected and many be developed and licensed in ways that may generate revenue.

43 Technology Transfer Technology transfer is the process of Exchange or sharing of knowledge, skills, processes, or technologies across different organizations into new products, processes, applications, materials or services. [Referenced from NSF; ; October 6, 2010] By starting the process at this point, the PI and the office of Sponsored Research and Programs (OSRP) can access the possible viability of effectively transferring University technologies to the market so as to generate benefits for the University, the community, and the general public. This process can cover: Disclosure Facilitation Patenting and Other Protections Licensing Legal Support, and Decision Support

44 Data Management The central role of proper data management in the realm of Research Integrity: Maintaining data security, integrity Destruction of Data Sharing Data Mentoring, Data Oversight and Misconduct Presenting data in Research and Grants Ownership of, control of, and access to data Proper recording of research data

45 Relationship to Other Issues
Relationship to Other Issues Data/Sharing: Collaboration/Competition Intellectual Property Research Data Export Controls Mentoring Maintaining data security, integrity Destruction of Data Sharing Data Mentoring, Data Oversight and Misconduct Presenting data in Research and Grants Ownership of, control of, and access to data Proper recording of research data Authorship Integrity

46 Data Management Policies
Definition of research data Distinctions between ownership, control, and access to data Standards for keeping laboratory notebooks and research journals Standards for maintaining data, including perishable data, such as biological samples Data retention periods and destruction of data Standards for mentoring new investigators regarding data Standards for sharing data Standards for presenting data (including images) in publications and grant applications

47 Control of Data Who are the responsible parties? Laboratory Manager
Control of Data Who are the responsible parties? Laboratory Manager Principal Investigator Department Head University Responsibilities: Authority Control Safeguard Access to data Institutions should explicitly delegate control of research data to the laboratory director or principal investigator, except in extraordinary circumstances. The PI should have authority and responsibility to control, safeguard, and determine access to the data. Responsibility for Data Control

48 Questionable Research Practices Involving Data
Questionable Research Practices Involving Data Failure to retain research data; Failure to document agreements over ownership of data; Maintaining inadequate research records; Refusing reasonable access to unique research materials for data; Misrepresenting speculations as fact or releasing preliminary research results, without sufficient data to allow critical review; Inadequate supervision or exploitation of subordinates; Using inappropriate statistics to enhance significance of research findings.

49 Questionable Research Practices Involving Data
Questionable Research Practices Involving Data Selecting and reporting data to improve the “appearance” of the data or to increase its significance Failure to disclose or manage conflict of interest that may result in biasing the interpretation and reporting of data Suppression of negative data that may result in needless repetition of studies Lack of laboratory notebook retention policies

50 Case Study Case Study: Data Ownership
Betty. came to Dr. T’s lab as a post-doc after completing her Ph.D. at a leading university. Dr. T accepted her because of her ability in isolating and manipulating proteins in complex structures. Dr. T. has some grant support that will cover much of Betty’s stipend for three years. Under Dr. T’s intellectual leadership they complete some basic research that promises intellectual property development. They file a patent application. University of Michigan, Peerrs learning Question: Who has the intellectual ownership?

51 Case Study – answer Ruling
Both have intellectual ownership, but Dr. T. retains primary project management and supervisory role. The university has legal ownership based on access to and retention of research data.

52 Case Study Case Study: data ownership (part 2)
A major chemical corporation expressed interest in funding further research. Dr. T. and Betty agree that she is ready to become an independent investigator and she obtains a job in industry with Dr. T’s blessings. They discuss future collaboration. Betty’s new company is pushing her to start soon and she begins clearing out her office. Dr. T is away that day as she removes computer files, biological specimens that should be left in the lab, even some belonging to others. She dismisses the other researchers’ concern, and packs her note books, journals, computer discs and specimens, and departs. During the time of the research, the university did not have a university intellectual policy agreement and no subsidiary agreement signed by Betty. University of Michigan, Peerrs learning Questions: Who has the ownership of data and how long should they be retained? Can they university sue or file criminal charges?

53 Case Study – answer Ruling
Because the university did not have a sign subsidiary agreement or intellectual policy clearly showing who owned the data, it would be limited in filing federal charges and even criminal charges would be difficult because of a lack of signed documents. The most the university can do is to charge here with larceny and have her pay a fine. Financial records, supporting documents, statistical records, and all other records pertinent to an award [including research data] shall be retained for a period of three years from the date of submission of the final expenditure report or, for awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual report, as authorized by the Federal awarding agency. (OMB Circular A-110)

54 Final Thoughts on Intellectual Property
Technological Advances in scientific instrumentation, computing, data storage, makes responsible data management more and more complicated. Both as a matter of law, federal policy and practical necessity, institutions should assert the ownership of research data. [the institution is the legal party to federal sponsored grants and is responsible to safeguard, retain and provide access to data.] OMB Circular A-110 Public Law (1998) The Shelby Law

55 Mentor/Trainee Responsibilities
The term “trainee” is used in this section to refer to anyone learning to be a researcher under an established researcher’s supervision. This includes principally graduate students and postdoctoral fellows (post-docs), but may also include undergraduate and high school students working on research projects or junior research faculty, research scientists, and research staff. ORI: Introduction to Responsible Conduct of Research; Mentor/Trainee Responsibilities, Chapter 7, Page 103

56 Real Cases: NSF Research Misconduct Investigations
A New York university professor plagiarized a substantial amount of text from multiple sources into a proposal submitted to NSF, and into two research publications acknowledging NSF support. The professor claimed that his students and post-doctoral research associate provided the plagiarized texts to him in their research progress reports. A university investigation concluded that these individuals did not provide the text, and determined that the professor had also plagiarized text into a previously submitted NSF proposal, and into three internal university proposals. We recommended that NSF make a finding of research misconduct; debar the subject from receiving federal funds for a period of two years; prohibit the subject from serving as a reviewer of NSF proposals for the same two-year period; and require, for a period of two years after the debarment period, that the subject submit assurances by a responsible official of his employer that any proposals or reports submitted by the subject to NSF do not contain plagiarized material. We also recommended that NSF require the professor to complete an ethics training course.

57 Mentor-Trainee relationship
The essential elements of a productive mentor-trainee relationship are difficult to codify into rules or guidelines, leaving most of the decisions about responsible mentoring to the individuals involved. Common sense suggests that good mentoring should begin with: A clear understanding of mutual responsibilities, A commitment to maintain a productive and supportive research environment, Proper supervision and review, and An understanding that the main purpose of the relationship is to prepare trainees to become successful researchers. Knowing the importance of personal commitments, researchers should carefully consider what responsibilities they have to trainees before they take on the essential task of training new researchers. Trainees, in turn, should be we aware of their responsibilities to mentors before accepting a position in a laboratory or program.

58 Sample Agreement To: New & Used Graduate Students in the Laboratory of Last Resorts From: Director Major Dread Subject: General Rules Welcome to our laboratory. As you know, research in this laboratory is funded by grants from NIH, NSF, DoD, ED, and other agencies. The projects so funded have specific aims and a detailed research plan stated in the grant applications. Departure from these aims and plans requires re-application for the grant funds. We would do this only if the original ideas prove early to be without merit. Therefore, students in the laboratory are not free to pursue ideas and activities of their own design, unless these fit the aims and research plan of the project that supports them. In accepting this fact you are surrendering a significant amount of intellectual freedom. It is important that you understand what you will gain here and what you will give up. Please be certain that the mutual agreement stated below is acceptable to you. This memo, while partly tongue in cheek, also clearly states the realities of graduate student life in most research labs. Students are provided the resources to complete their education and begin their careers, but they give up a great deal of autonomy. However, rather than receiving an explicit memo from "Director Drake," most entering graduate students learn the conventions and expectations of life in the lab from older students, post docs, and through their own experience. Being clear about expectations of subordinates and fair apportioning of work and credit are important ethical responsibilities of lab directors. Director "Dread" illustrates an approach to how clarity can be accomplished.

59 I agree to provide . . . 1). Your tuition and a stipend to live on.
3). Excellent laboratory facilities, including all necessary computers, instruments, equipment, tools, supplies, and desk space. 4). Superior research training. 5). Thesis idea and guidance. 6). A long-term commitment to your career goals.

60 . . . you agree that I may 1). Set your daily work schedule.
2). Determine your research. 3). Personally present your work whenever and wherever I deem appropriate. 4). Decide what and when to publish. 5). Decide the authorship and order of names on all publications. 6). Determine your readiness for PhD qualifying, preliminary, and final examinations. 7). Approve your committee membership. 8). Have exclusive ownership of your data -- before and after you leave the laboratory. 9). Restrict your lunches to the usual banana and an occasional tuna sandwich.

61 Mutual Expectations Mentors need to know (a written agreement is preferred) that a trainee will: Do assigned work in a conscientious way, Respect the authority of others working in the research setting, Follow research regulations and research protocols, Live by agreements established for authorship and ownership. Mentors invest time and resources in trainees. Trainees should respect this time and use resources responsibly, keeping their mentors informed about changing research interests or other circumstances that could affect their work.

62 Trainees need to know How much time they will be expected to spend on their mentor’s research; The criteria that will be used for judging performance and form the basis of letters of recommendation; How responsibilities are shared or divided in the research setting; Standard operating procedures, such as the way data are recorded and interpreted; How credit is assigned, that is, how authorship and ownership are established. Clarifying these issues early in a mentor-trainee relationship can prevent problems from arising later

63 Common Mentor/Trainee Ethical Problems
The mentor is too focused on his/her own research agenda to consider whether trainees are having appropriate educational experiences; Research problems seem to be distributed in an unfair or arbitrary manner within the research group; Ground rules are not articulated for communicating and sharing data; Policies are not clear for the assignment of credit and authorship; Mentor fails to follow funder, institutional or professional expectations or otherwise acts in ethically prohibited or ethically questionable ways in carrying out the work; Mentor and trainee disagree regarding the ownership of data, the timing of presentation or publication, or about the accuracy or interpretation of what is to be reported. Mentors are dependent upon their trainees to carry out their research plans, keep appropriate records, produce and leave the documentation necessary for publication and other use of the trainer's documented work and results. This extraordinary level of mutual dependence coupled with the power disparity that exists in the mentor/trainee relationship creates the potential for abuse and exploitation by both.

64 Trainee Supervision and Review
Proper supervision of a trainee takes time. In one way or another, a mentor needs to: Assure proper instruction in research methods, Foster the intellectual development of the trainee, Impart an understanding of responsible research practices, Routinely check to make sure the trainee develops into a responsible researcher. Mentors do not need to check all aspects of a trainee’s work directly. In large laboratories, postdocs often supervise graduate students and laboratory technicians might teach specific laboratory skills. Training in the responsible use of animals is often done through an animal care program. However, the ultimate responsibility for training rests with the mentor.

65 Mentors should review work done under their supervision carefully enough to assure that it’s well done and accurate. This can be accomplished by: Reviewing laboratory notebooks and other compilations of data; Reading manuscripts prepared by trainees carefully to assure that they are accurate, well-reasoned, and give proper credit to others; Meeting with trainees on a regular basis to keep in touch with the work they are doing; and Encouraging trainees to present and discuss data at laboratory meetings. Proper supervision and review play an important role in quality control. Trainees can make mistakes. Some have deliberately falsified or fabricated data. Some of this responsibility can be delegated to others, but as with all other matters regarding training, the mentor should assume ultimate responsibility.

66 Case Study: Mentoring Ethics
Dr. Elizabeth Sterling has a federal grant to develop an enzymatic method of isolating the epithelial cells that line the pancreatic duct. She’s been working on this project for about a year and must submit a progress report on the study. With the assistance of Jim Wong, a Ph.D. candidate in her lab, she is poring over photographs of isolated epithelial cells that she might include in the report. To Jim’s eye, the photographs are of approximately equal contrast and quality, but some suggest more than others a greater yield of cells. Readouts from the automated cell counter, however, indicate that the yields have been fairly consistent. Dr. Sterling instructs Jim to gather up four specific photos out of the ten that they have produced. These four photos will be included in the report, which Jim will help prepare. The photos, which Dr. Sterling says she has selected for their aesthetic quality, also happen to be the most supportive of the cell counter results. In the report, the photos will serve to illustrate the effectiveness and yield of Dr. Sterling’s technique. Used with permission of Association of American Medical Colleges. Case drawn from Teaching the Responsible Conduct of Research Through Case Study Approach: A Handbook for Instructors, Stanley G. Korenman and Allan C. Shipp, Eds., 1994.

67 Case Study Questions What are some appropriate criteria for selecting photographic material to illustrate research results? What criteria might be inappropriate? How do Dr. Sterling’s responsibilities change when she involves a trainee in this project? In aiding Dr. Sterling in the manner described above, to what extent is Jim responsible for the integrity and content of the annual report? If Jim is uncomfortable with Dr. Sterling’s request, how might he respond? Other materials on Mentorship;

68 “evaluation by colleagues with similar knowledge and experience”
Peer Review Peer Review --- Copy --- Hmm.. You know? This procedure would sure speed up my inquiries…. “evaluation by colleagues with similar knowledge and experience” Peer Review is the evaluation by colleagues with similar knowledge and experience - is an essential component of research and the self-regulation of professions.

69 Evaluation by Colleagues
Many important decisions about research depend on advice from peers, including: Which projects to fund (grant reviews), Which research findings to publish (manuscript reviews), Which scholars to hire and promote (personnel reviews), and Which research is reliable (literature reviews and expert testimony). The average person does not have the knowledge and experience needed to assess the quality and importance of research. Peers do.

70 Case Study: Publication & Peer Review
Mary, a computer science professor, is asked by a journal editor to review and comment on a manuscript submitted by John, a faculty member at another institution. Upon reading the paper, Mary is struck by how useful the novel technique described by John would be in speeding up the data processing stage in her own computer simulation study. Incorporating John’s technique would allow Mary to complete her research project in just two weeks, rather than the 12 weeks projected. Mary decided to go ahead and use the author’s technique University of Michigan, Peerrs learning Question: What harm will that do? After all, the technique is quite useful and the paper will be published soon anyway. 70

71 Ruling Even though the reviewer, Mary, did not or will not claim the author’s technique as her own, by writing it in a paper or presenting it at a conference, she nevertheless appropriated to herself someone else’s intellectual property and used it to her own advantage without the permission of the true owner. Mary abused one of the important tenets of the review process, namely that reviewers will keep the contents of the manuscripts confidential and will not use that information to give them an unfair advantage. Question 2: What should Mary have done?

72 Solution It is reasonable for Mary to continue using the older techniques until the new one is published. However, if the results of Mary’s research holds out the promise of significant benefits to society, Mary may have some moral obligation to seek permission to use the new technique. Normally this is not a proper option, as reviews are generally confidential and under the supervision of the editor. She could ask the editor to contact the author to seek for permission. Continue using the old technique until the new technique is published? Contact author and ask permission? Ask editor for assistance to contact author? 72

73 Ethics of Peer Review For peer review to work, it must be:
Timely (even though uncompensated and with short deadlines), Thorough (appropriate? important? flawed?) Constructive, Free from personal bias, Respectful of the need for confidentiality. The quality of the decisions made in each case depends heavily on the quality of peer review. Peer review can make or break professional careers and directly influence public policy. The fate of entire research programs, health initiatives, or environmental and safety regulations can rest on peer assessment of proposed or completed research projects. Researchers who serve as peer reviewers should be mindful of the public as well as the professional consequences of their evaluations and exercise special care when making these evaluations.

74 Thorough Assessment Assessing whether the research methods are appropriate; Checking calculations and/or confirming the logic of important arguments; Making sure the conclusions are supported by the evidence presented; Confirming that the relevant literature has been consulted and cited; Assessing whether the researcher has the tools to complete the study. Peers who are asked to make judgments about the quality of a proposed or completed project must do their best to determine whether the work they have been asked to review is internally consistent and conforms to the practices of their field of research. Some parts of an application or manuscript can be checked fairly easily. Are the calculations correct? Is the method that has been used or proposed appropriate? Do the reported results support the conclusions? Other parts are more difficult to confirm. Have the data been accurately recorded and reported? Were the experiments run? Did the subjects give consent? Do the articles cited in the references and bibliography contain the information they are said to contain?

75 Judging Importance Assuming a researcher could carry out a proposed research project, is it important to conduct this project? Are these research results important enough to publish? Has a researcher made important contributions to a field of study? Is this evidence important enough to be used in setting policy? In addition to quality, peer reviewers are also asked to make judgments about the importance of proposed or published research. Along with quality, judgments about importance essentially determine which research is funded or published and which researchers are hired and relied upon for advice. Peer reviewers do not always make judgments about importance with an open mind. Studies have shown that they can be swayed by: the stature of the researcher who conducted the research or the institution at which the research was conducted; country of origin; a preference for one research method over another, e.g., a clinical versus a laboratory approach; and the outcome of the studies under review.

76 Assist in Finding Problems
Careless mistakes made in reporting data and/or listing citations; The deliberate fabrication and falsification of data; Improper use of material by others (plagiarism); Inaccurate reporting of conflicts of interest, contributors/authors; and The failure to mention important prior work, either by others or by the researcher submitting a paper for publication. At the very least, peer reviewers should be expected to assess whether the manuscript or proposal under review makes sense and conforms to accepted practices, based on the information presented. In addition, it is not reasonable to expect reviewers to check every reference and detail. The fact remains, however, that peer reviewers frequently miss problems that might have been detected had the reviewer checked a little more carefully.

77 Confidentiality It is not acceptable to do any of the following without getting permission: Ask students or anyone else to conduct a review you were asked to do; Use an idea or information contained in a grant proposal or unpublished manuscript before it becomes publicly available; Discuss grant proposals or manuscripts you are reviewing with colleagues in your department or at a professional meeting; Retain a copy of the reviewed material (generally manuscripts and grant proposals should be shredded or returned after the review is complete); and Discuss personnel and hiring decisions with colleagues who are not part of the review process. During grant and manuscript reviews, confidentiality helps protect ideas before they are funded or published. In personnel reviews, confidentiality is important to protect personal privacy. Peer reviewers have an obligation to preserve confidentiality during the review process if they have been asked to do so. While this obligation might seem obvious, it can be compromised in some seemingly harmless and other more harmful ways. It may also be tempting to use information in a grant application or manuscript to speedup your own research, but until it has been made public, confidential information is not available for use, even to reviewers. If you are not comfortable protecting confidential information, then do not agree to be a peer reviewer.

78 Questions for discussion
What should researchers or students do if a colleague or mentor asks them to take a look at a manuscript they have not been authorized to review? What information contained in a manuscript or proposal should reviewers be expected to check? Should peer review be anonymous? How can researchers who sit on committees that advise on research directions separate their own interests from the best interests of the field they are helping shape? What would happen if the public lost confidence in peer review and looked for other mechanisms to judge the quality and importance of research?

79 Export Control Export controls are based on:
(a) the nature of the item or activity, (b) the country involved in the transaction, (c) the person receiving or ultimately using the item or service (d) the end-use to which the item or service will be put. U.S. export controls serve the following purposes: (a) to control any potential military application; (b) to protect U.S. trade/economic interests; (c) to control the exposure of controlled technologies, materials and information to foreign nationals and foreign countries; and (d) to prevent the proliferation of weapons of mass destruction.

80 Sources Other Resources
University of Michigan; Office of Research Integrity, (ORI); Indiana University, Poynter Center for the Study of Ethics and American Institutions; National Institutes of Health, (NIH); Other Resources

81 Missouri State University Office of Research Compliance
The Office of Research Compliance (ORC) assists Missouri State University faculty, staff, and students to assure proper conduct of research.  These regulations [that we follow] protect research subjects, researchers, and the research conducted at the university.  The ORC provides coordination, oversight, and education in the areas of animal care and use, biosafety, conflict of interest, export control, human subjects research, intellectual property, radiation safety, responsible conduct of research, and technology transfer. ORC homepage: Responsible Conduct of Research:

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