RCRResponsible Conduct of

Research

Presentation Material Credit

On Being a Scientist: A Guide to Responsible Conduct in Research, Third Edition, The National Academies

Michael Kalichman, Director, UC San Diego Research Ethics Program

Organized for SURF-IT by Said Shokair, UCI UROP Director

Re-organized for ICS Honors Program by Rick Lathrop, ICS-HP Director

RCR Training Requirement

To comply with the requirements of the federal America COMPETES (America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science) Act, all undergraduate and graduate students, and postdoctoral scholars supported by National Science Foundation funds must complete a course in the Responsible Conduct of Research.

The most basic basics

• Three deadly sins of research misconduct:– Fabrication

– Falsification

– Plagiarism

• The most basic basics are quite simple:– Don’t lie

– Don’t cheat

– Don’t steal

• Complex cases require thought and judgment.– Communication and Professionalism are key.

Researchers’ Obligations & Responsibilities

Obligations

To honor the trust that their colleagues place in them To themselves To act in ways that serve the public

Responsibilities

Research: Data, Bias, Regulations, Misconduct Researchers: Communication, Dissemination, Credit,

Mentoring Society: Research Focus, Public Understanding, Public

Policy.

RCR Training Topics Advising and Mentoring The Treatment of Data Mistakes and Negligence Research Misconduct Responding to Suspected Violations of Professional

Standards Human Participants and Animal Subjects in Research Laboratory Safety in Research Sharing of Research Results Authorship and the Allocation of Credit Intellectual Property Competing Interests, Commitments, and Values The Researcher in Society

Advising & MentoringCase Study

Joseph came back from a brief summer vacation convinced that he would be able to finish up his Ph.D. in one more semester. Though he had not discussed the status of his thesis with his adviser or any other member of his thesis committee since the spring, he was sure they would agree that he could finish up quickly. In fact, he had already begun drawing up a list of companies to which he planned to apply for a research position.

However, when his research adviser heard about his plans, she immediately objected. She told him that the measurements he had made were not going to be enough to satisfy his dissertation committee. She said that he should plan to spend at least two more semesters on campus doing additional measurements and finishing his dissertation.

Joseph had always had a good working relationship with his adviser, and her advice had been very helpful in the past. Plus, he knew that he would need a good recommendation from her to get the jobs that he wanted. But he couldn’t help but wonder if her advice this time might be self-serving, since her own research would benefit greatly from the additional set of measurements.

Advising & MentoringCase Study -- Questions

TRUE or FALSE: If Joseph’s adviser indeed wants him to perform the additional measurements solely to benefit her research, this violates a basic principle of mentoring.

TRUE. “The main role of an adviser or mentor is to help a researcher move along a productive and successful career trajectory (On Being a Scientist, pg. 4).” Mentors and advisers should model a high standard of conduct.

TRUE or FALSE: The responsibility for Joseph’s problem lies with the adviser, who should have been clearer in expressing her expectations.

FALSE. Clarifying expectations is jointly the responsibility of the adviser and the student.

The Treatment of Data -- Case StudyDeborah, a third-year graduate student, and Kamala, a postdoctoral fellow, have made a series of

measurements on a new experimental semiconductor material using an expensive neutron test at a national laboratory. When they return to their own laboratory and examine the data, a newly proposed mathematical explanation of the semiconductor’s behavior predicts results indicated by a curve.

During the measurements at the national laboratory, Deborah and Kamala observed electrical power fluctuations that they could not control or predict were affecting their detector. They suspect the fluctuations affected some of their measurements, but they don’t know which ones.

When Deborah and Kamala begin to write up their results to present at a lab meeting, which they know will be the first step in preparing a publication, Kamala suggests dropping two anomalous data points near the horizontal axis from the graph they are preparing. She says that due to their deviation from the theoretical curve, the low data points were obviously caused by the power fluctuations. Furthermore, the deviations were outside the expected error bars calculated for the remaining data points.

Deborah is concerned that dropping the two points could be seen as manipulating the data. She and Kamala could not be sure that any of their data points, if any, were affected by the power fluctuations. They also did not know if the theoretical prediction was valid. She wants to do a separate analysis that includes the points and discuss the issue in the lab meeting. But Kamala says that if they include the data points in their talk, others will think the issue important enough to discuss in a draft paper, which will make it harder to get the paper published. Instead, she and Deborah should use their professional judgment to drop the points now.

The Treatment of DataCase Study Questions

TRUE or FALSE: Kamala is justified in wanting to drop the two data points under these circumstances.

FALSE. In the absence of criteria for identifying outliers at the beginning of the study it is inappropriate to drop data points to improve the results. If those manipulated results were published they would affect the research record and if incorrect, impede the progress of science.

TRUE or FALSE: If the data points are dropped over Deborah’s objections and she is an author on the resulting paper, she still shares responsibility for the data alteration.

TRUE. Each author is responsible for the entire publication. Increasingly, however, publications require information about each author’s contribution. With complex multidisciplinary studies, the responsibility for the paper’s integrity may be split among disciplines. In such a case, each author or group of authors are responsible for data from their contributed portion of a publication.

Mistakes and Negligence -- Case Study

Two young faculty members—Marie, an epidemiologist in the medical school, and Yuan, a statistician in the mathematics department—have published two well-received papers about the spread of infections in populations. As Yuan is working on the simulation he has created to model infections, he realizes that a coding error has led to incorrect results that were published in the two papers. He sees, with great relief, that correcting the error does not change the average time it takes for an infection to spread. But the correct model exhibits greater uncertainty in its results, making predictions about the spread of an infection less definite.

When he discusses the problem with Marie, she argues against sending corrections to the journals where the two earlier articles were published. “Both papers will be seen as suspect if we do that, and the changes don’t affect the main conclusions in the papers anyway,” she says. Their next paper will contain results based on the corrected model, and Yuan can post the corrected model on his Web page.

Mistakes and NegligenceCase Study Questions

TRUE or FALSE: Because correcting the error in the earlier model did not change the interpretation of data in the two published manuscripts, the authors are under no obligation to correct the published record.

FALSE. Researchers are obligated to be as accurate as possible in the conduct of their research, including analysis of their data, in order not to mislead subsequent researchers and those who will use the research. Therefore, it would be negligent of the authors not to correct the published record. They should send a corrigendum (note explaining an author’s error) to the editors of the journals of the previously published papers containing the erroneous model.

TRUE or FALSE: In correcting the model of infections, Yuan must keep a record of all references to the coding error in the original model.

TRUE. To fulfill your responsibility to maintain the integrity of the research record, “[m]istakes in other documents that are part of the scientific record – including research proposals, laboratory records, progress reports, abstracts, theses, and internal reports – should be corrected in a way that maintains the integrity of the original record and at the same time keeps other researchers from building on the erroneous results reported in the original.”

Research Misconduct -- Case Study

Vijay, who has just finished his first year of graduate school, is applying to the National Science Foundation for a predoctoral fellowship. His work in a lab where he did a rotation project was later carried on successfully by others, and it appears that a manuscript will be prepared for publication by the end of the summer. However, the fellowship application deadline is June 1, and Vijay decides it would be advantageous to list a publication as “submitted” rather than “in progress.” Without consulting the faculty member or other colleagues involved, Vijay makes up a title and author list for a “submitted” paper and cites it in his application.

After the application has been mailed, a lab member sees it and goes to the faculty member to ask about the “submitted” manuscript. Vijay admits to fabricating the submission of the paper but explains his actions by saying that he thought the practice was not uncommon in science. The faculty members in Vijay’s department demand that he withdraw his grant proposal and dismiss him from the graduate program.

Research MisconductCase Study Questions

TRUE or FALSE: Vijay’s lie regarding his publication record is a minor offense and should not be viewed as research misconduct.

FALSE. Contrary to Vijay’s excuse, padding one’s publication record is a “significant departure from accepted practices.” This is a serious breach of ethical standards.

TRUE or FALSE: Vijay’s lie was potentially harmful to the scientific community.

TRUE. According to On Being a Scientist, “When researchers intentionally deceive their colleagues by falsifying information … they are violating fundamental research standards and basic societal values (pg. 17).” The consequence of Vijay’s actions is an erosion of his colleagues’ trust in him and their trust in the validity of research in general. Since science is based on trust and the pursuit of truth; anyone who intentionally fabricates information is behaving counter to the expectations and rules of the scientific community.

Human Subjects -- Case Study

For his dissertation project in psychology, Antonio is studying new approaches to strengthen memory. He can apply these techniques to create interactive Web-based instructional modules. He plans to test these modules with students in a general psychology course for which he is a teaching assistant. He expects that student volunteers who use the modules will subsequently perform better on examinations than other students. He hopes to publish the results in a conference proceedings on research in learning, because he plans to apply for an academic position after he completes the doctorate.

Human SubjectsCase Study Question

TRUE or FALSE: Testing new educational approaches is what teachers normally do to help students learn, therefore it is not research and it is not necessary to apply for IRB* approval.

FALSE. Antonio is conducting human research. He is not trying to enhance the memory of the whole class but rather of those who volunteered. He intends to submit the results to the professional literature. Thesis or dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval. He may not begin his research until he has received approval from the IRB. The IRB must also approve the informed consent form that will describe the experiment to potential volunteers.

*IRB = Institutional Review Board; must approve all human experiments. Title 45 CFR (Code of Federal Regulations) Part 46, National Research Act of 1974. ---Wikipedia

Human Subjects -- Additional Questions TRUE or FALSE: Research involving human participants is permitted only when there is a possibility of direct benefit

to the participants.

FALSE. Assessing the risk to benefit ratio is one of the main functions of the IRB. However, the benefits of the research may be indirect benefits to society, not just direct benefits to the research participants. However, the benefits of conducting the research must outweigh the risks to the participants.

TRUE or FALSE: To ensure that a potential research participant can freely decide whether to join a study or not, investigators must provide them with information that fully describes the purpose of the study, its scientific and operational details, and its potential risks and benefits to the individual and/or society as a whole, so that an informed decision can be made about whether to participate.

TRUE. The informed consent process involves giving a potential research participant adequate information concerning the study, providing adequate opportunity for the participant to consider all options, responding to their questions, ensuring that the participant has comprehended this information, obtaining their voluntary agreement to participate and, continuing to provide information as the subject or situation requires. To be effective, the process should provide ample opportunity for the investigator and the participant to exchange information and ask questions. Thus, the informed consent document must be in simple language with limited technical jargon, 8th to 10th grade level, and in the primary language of the participant. Furthermore, incentives to participate should not be so high that they add a level of undue influence or the appearance of coercion.

TRUE or FALSE: Investigators have considerable leeway in deciding which studies require IRB approval and which do not.

FALSE. Federal regulations and UC policies and guidance outline the circumstances for which IRB approval or certified exemption is required on your campus. Investigators have no leeway. Your institution’s human research protection program and its IRB have final authority for determining whether a proposed activity constitutes human subjects research.

Animal Subjects -- Case Study

Hua is doing a postdoctoral fellowship in a laboratory that studies cancer treatment. In the experiment she is overseeing, a cancer-prone strain of mice is allowed to develop visible tumors and then receives experimental drugs to observe the effects on the tumors.

Hua notices that the tumors are interfering with the ability of some of the mice to eat and drink. She also notices that some of the mice are weaker and more emaciated than the others, which she suspects is a consequence of their feeding difficulties. The protocol for the experiment states that the mice will be treated only if they exhibit obvious signs of pain or discomfort.

When she mentions her concerns to another postdoctoral fellow, he suggests not raising the issue with the rest of the lab. The mice will be euthanized as soon as possible after the experiment is over, and their nutritional status probably has little or no effect on the drug treatment. Furthermore, if it proved necessary to change the experimental protocol, the previous work would be invalidated and the Institutional Animal Care and Use Committee would need to be notified.

Animal SubjectsCase Study Question

TRUE or FALSE: As a postdoctoral fellow, Hua should know that animal research requires minimizing the pain and suffering of the animals. She has already noted more discomfort than anticipated and she is obligated to request a protocol addendum to assist the mice in some way.

TRUE. As with human experimentation, everyone involved in animal experimentation has an individual ethical responsibility to maximize benefit and minimize risk. The experiment may have been compromised already. Hua and her colleagues should go to the Institutional Animal Care and Use Committee with a modified protocol.

Laboratory Safety in Research -- Case Study

Kenan, a first year graduate student who is eager to start his research in a chemistry department, discusses his experimental protocols with his research advisor, which involve the use of hazardous chemicals and radiation. They had a productive discussion on the experiments, the potential impact of this research, and the need to obtain preliminary results to support a grant proposal application. The research advisor asked a postdoctoral researcher to provide Kenan with all the required information on laboratory safety training courses and materials safety data sheet (MSDS) so that he can be properly trained before he conducts the experiments. The postdoctoral researcher gave all the information to Kenan but told him that there is no time to wait for all the training courses to take place before they start the experiments. The postdoctoral researcher said to Kenan, “Don’t worry, I will show you how everything works and I will be your buddy when you are doing the experiments so you will be safe.”

Laboratory Safety in ResearchCase Study Questions

TRUE or FALSE: You are required to read the Materials Safety Data Sheet (MSDS) only if you foresee that you will come in direct contact with a particular chemical.

FALSE. Researchers are required to know the properties and potential hazards of all chemicals, biological, radiological, and any other materials, including physical hazards that they will work with or are in their work environment. The researchers have a right to know, keep current training records, and are responsible for safe work practices and procedures through implementation of hazard controls and appropriate surveillance in conducting research.

TRUE or FALSE: When in doubt, a researcher should consult the Environment(al) Health & Safety (EH&S) office on campus to obtain information on all forms of hazards, guidelines, and compliance on laboratory safety.

TRUE. In addition to chemical and radiation, there are many other forms of hazards that all researchers must be aware of and be trained to respond to before initiating any work in the laboratory. Your campus’s Office of Environment(al) Health & Safety is your primary resource for guidance regarding laboratory safety. For information that goes beyond the campus’s guidelines and for reviewing specific safety-related programs, more information can be found through the appropriate federal and state agencies: OSHA (federal) and Cal-OSHA (state).

Sharing of Research Results -- Case Study

Andre, a young assistant professor, and two graduate students have been working on a series of related experiments for the past several years. Now it is time to write up the experiments for publication, but the students and Andre must first make an important decision. They could write a single paper with one first author that would describe the experiments in a comprehensive manner, or they could write two shorter, less-complete papers so that each student could be a first author.

Andre favors the first option, arguing that a single publication in a more visible journal would better suit all of their purposes. This alternative also would help Andre, who faces a tenure decision in two years. Andre’s students, on the other hand, strongly suggest that two papers be prepared. They argue that one paper encompassing all the results would be too long and complex. They also say that a single paper might damage their career opportunities because they would not be able to point to a paper on which they were first authors.

Sharing of Research ResultsCase Study Question

TRUE or FALSE: Andre should have decided early on that there would be only one paper stemming from this collaborative research, pending the determination of the first author.

FALSE. Research is dynamic and fun, in part, because the answers are not always predictable. This is one of those situations in which the determination of whether there should be one or more papers cannot be made in advance.

Authorship & Allocation of Credit -- Case Study

Robert has been working in a large engineering company for three years following his postdoctoral fellowship. Using computer simulations, he has developed a method to constrain the turbulent mixing that occurs near the walls of a tokomak fusion reactor. He has written a paper for Physical Review and has submitted it to the head of his research group for review. The head of the group says that the paper is fine but that, as the supervisor of the research, he needs to be included as an author of the paper. Yet Robert knows that his supervisor did not make any direct intellectual contribution to the paper.

Authorship & Allocation of CreditCase Study Question

TRUE or FALSE: Supervisors have an automatic right to be named as co-authors on articles written by members of their research group.

FALSE. Increasingly journals outline specific guidelines about assigning authorship credit. In general, those named as authors should have made substantial contributions to the concept and design, acquisition, analysis and/or interpretation of data, to drafting or revising the article, and should provide final approval of the article. This is true in both industry and academia.

Intellectual Property -- Questions TRUE or FALSE: Trainees (graduate students, post-docs and undergraduates) participating in work that leads to a

patentable invention or idea do not have the right to share in any profits derived from exploitation of that idea.

FALSE. Under UC Patent Policy, all UC employees, including faculty and staff, who are inventors of UC-owned inventions share in the financial awards associated with licensed intellectual property. Inventors who are not employees, such as undergraduate students, may also share in any financial return derived from licensing if they have assigned their rights in the invention to the University. “Inventorship” has a strict legal meaning under the laws and regulations of the U.S. patent system. Those who have made conceptual contributions to an invention are legal inventors in the United States. Patents that do not correctly identify all legal inventors or omit proper inventors are defective and may be invalid.

TRUE or FALSE: Publishers of research results generally require authors to transfer copyright privileges to them when an article is accepted for publication.

TRUE. Most publishers require that an author assign their copyright rights to the publishing journal in order to protect the publisher from unapproved replication of articles in reviews and compilations, etc.; however, some journals are now publishing under an open source format and do not require assignment of the author’s copyright, but these are fairly rare. Investigators can negotiate with Publishers for other copyright ownership models, but many publishers are reluctant to give up ownership of the copyright.

TRUE or FALSE: Even if the research is funded through an investigator’s institution, she/he owns the intellectual property and can personally patent it.

FALSE. Under UC Policy, University employees who make an invention with University funds or resources, including funds received through the University, are required by the terms of their employment to disclose and assign their interest in inventions to the University. At some campuses, the Office of Intellectual Property manages and controls the process for seeking patent protection of University-owned inventions at the University’s expense.

Competing Interests, Commitments & Values Case Study

Sandra was excited about being accepted as a graduate student in the laboratory of Dr. Frederick, a leading scholar in her field, and she embarked on her assigned research project eagerly. But after a few months she began to have misgivings. Though a part of Dr. Frederick’s work was supported by federal grants, the project on which she was working was totally supported by a grant from a single company. She had asked Dr. Frederick about this before coming to his lab, and he had assured her that he did not think that the company’s support would conflict with her education. But the more Sandra worked on the project, the more it seemed skewed toward questions important to the company. For instance, there were so many experiments she needed to carry out for the company’s research that she was unable to explore some of the interesting basic questions raised by her work or to develop her own ideas in other areas. Although she was learning a lot, she worried that her ability to publish her work would be limited and that she would not have a coherent dissertation. Also, she had heard from some of the other graduate students doing company-sponsored work that they had signed confidentiality statements agreeing not to discuss their work with others, which made it difficult to get advice. Dr. Frederick and the company’s researchers were very excited about her results, but she wondered whether the situation was the best for her.

Competing Interests, Commitments & Values Case Study Question

TRUE or FALSE: Since Sandra had not made any confidentiality agreements with the Company she is free to discuss her research with anyone and the Company could not delay completion of her thesis or publication of her results.

FALSE. Since Sandra had not made any confidentiality agreements with the Company she is free to discuss her research with anyone and the Company could not delay completion of her thesis or publication of her results.

Researcher in SocietyStudy Questions

TRUE or FALSE: Our society depends on research studies to provide evidence for policy making so researchers are often required to explain and defend their results. In doing so they may become advocates for one side of a scientific controversy with political implications. That advocacy, no matter how firmly grounded, necessarily detracts from their reputation as scientists.

FALSE. It’s critically important to defend one’s work in relation to professional colleagues. It is sometimes hard to be heard and to be believed, but if one is objective about the results and believes in them, then their defense is essential. Some scientists believe that their role is to produce the facts and conclusions and leave it up others to make the political decisions about the implication of those facts in shaping policy. Today, leading scientists can enhance their reputations by being called on to interpret their work for the public and for legislators.

TRUE or FALSE: The values of honesty, fairness, collegiality and openness have been critical assets in the establishment of the scientific enterprise as a principal source of information, innovation and productivity to this technology-driven world.

TRUE. And they will only become more important over time.

Thank You!For more information, please contact:

Said M. Shokair, Director

Undergraduate Research Opportunities Program

Division of Undergraduate Education

Student Services II, Suite 2300

University of California

Irvine, CA 92697-5685

Phone: (949) 824-4189

Fax: (949) 824-1607

E-mail: shokair@uci.edu or urop@uci.edu

URL: www.urop.uci.edu