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SiteMap A Federally Mandated C ompliance Education Program July 1, 2008 Volume 8, No. 7 Making the right choices in research with re- forming, or reviewing research, or in reporting gard to research integrity and ethics is essential research results." But "the definition of miscon- for many reasons. The following article, Research duct varies from university to university, and from Integrity: Making the Right Choices is very en- country to country," Steneck says. And though lightening and contains excellent information for they may not rise to the level of `misconduct,' everyone who participants in any way in scientific there are some less serious research sins that research. should also be avoided, and often these come Research Integrity: from merely cutting corners or getting sloppy. Making the Right Choices Serious or not, scientific misbehavior is far more common than most people realize, according Author: Elisabeth Pain to a 2002 survey of 3,600 mid-career scientists United Kingdom, January 4, 2008 and 4,160 postdocs whose research was supported by the National Institutes of Health (NIH). 33% of When the US Department of Health and Hu- respondents � 38% of mid-career scientists and man Services, the European Science Foundation 28% of early-career scientists � admitted sanc- (ESF), the European Commission and Portuguese tionable misbehavior in the previous 3 years, Ministry of Science, Technology, and Higher including falsifying or fabricating data, not dis- Education, the International Council of Science closing conflicts of interest, using others' ideas (ICSU), NATO, the European Molecular Biology without credit, and failing to present data that Organization (EMBO), and the UK Research contradict one's previously published research. Integrity Office and Committee on Publication Scientific misbehavior "always has been a Ethics (COPE) join forces to tackle an issue, you problem, but [it is] today in particular," says know it's a big one. The first world conference on Ulrike Beisiegel, chair of the German Research research integrity, which took place in Lisbon last Foundation's (DFG) ombudsmen committee and September under the auspices of these organiza- director of the Institute of Molecular Cell Biology tions, set an unequivocal tone: Researchers are at the University of Hamburg. "We have so many human, and there is more scientific misbehavior more researchers and not that many more posi- in scientific labs than makes headlines. tions. It's a very tight competition which is put- For early-career researchers, it's a minefield. ting a lot of pressure" on researchers. Scientists "There will be temptations" � and pressures � "who see competition as a major factor in their to misbehave, says Nicholas Steneck, Emeritus environment are more likely to misbehave..., Professor of history at the University of Michigan including engaging in misconduct," says Melissa in Ann Arbor and co-organizer of the Lisbon Anderson, associate professor of higher education conference on behalf of the U.S. Department of at the University of Minnesota in Minneapolis, a Health and Human Services Office of Research co-author of the 2002 survey. Integrity (ORI). Young scientists who succumb to A recent study of ORI's investigations of cases those pressures may see their careers derailed. But of plagiarism, falsification, or fabrication in the even those who don't succumb can be brought biomedical and behavioral sciences in the United down by scientific misconduct. Sitting idly by � States suggests that postdocs and graduate stu- or, alternatively, speaking out � as others in the dents are especially vulnerable to temptations. lab commit research sins can sink the careers even Some fraction of these researchers are likely to of those who do nothing wrong. It's hard to know respond by lowering standards or cutting corners what to do. to meet their deadlines and obligations if "they Pressures and temptations don't know how to answer demands on their The U.S. Office of Science and Technology time," says Elizabeth Heitman, associate professor Policy defines research misconduct as "fabrica- of medical ethics at the Center for Biomedical tion, falsification, or plagiarism in proposing, per- Ethics and Society at Vanderbilt University, Tennessee. Worse, they're likely to experience "Students ... can say, for example, ... `I have pressure from supervisors and advisors "to clean never seen this procedure, can you explain to me up results," or to publish them too quickly in an how it works?'" Heitman says. If your questions effort to beat the competition, Anderson says. are systematically evaded or the results still can't Choose your poison be reproduced, you may have a problem. Just But while early-career scientists may be under don't jump to conclusions too quickly. greater pressure to misbehave, they're also the Once you're convinced that misconduct has most likely to do something about it when they occurred, find help. A young scientist "shouldn't see other people doing it. Of the 60-or-so cases try to take on an issue like that alone. He or she the DFG ombudsman handles each year, Beisiegel needs to talk to another faculty member or super- says, about two-thirds are initiated by early-career visor or maybe there is someone in the institution scientists. Young scientists, she believes, are less ... willing to have a confidential conversation likely to look the other way. "Old professors have about what may be happening," Anderson says. In gentlemen's agreements on what to do ... or not, countries and institutions where they exist, the not always according to the best scientific ombudsman is usually the right person to ap- practices," she says. proach. Those unfortunate enough to witness miscon- Once you've reported your suspicions to the duct face difficult decisions. Expose wrongdoing right people, they should help you deal with them. and your lab may be shut down or have its "Find out what the options are, and work with funding withdrawn. Your research may be stalled someone who you think will take the matter and your graduation may be delayed. You could seriously," Anderson says. If they don't, what even lose your job. Even if the guilty party then? Young scientists "have a responsibility to survives the accusation, the young researcher who bear witness, but institutions and public univer- rats him out is likely to take a fall. All this is sities shouldn't expect students to go out on their bound to take a toll on your mental and physical own and be the whistleblower. They can't be a wellbeing. canary in a coalmine," Heitman adds. Many whistleblowers manage to put their Playing it safe careers back on track, but others leave science and For the most part, landing in a research en- a few suffer permanent damage. "They are very vironment with shoddy ethics is just bad luck. frustrated and are turning into these people who "It's very difficult to know in advance. If you are very unhappy and blame others," Beisiegel look at the worst cases of scientific misconduct, says. The alternative � choosing not to expose the people involved are very productive, charis- wrongdoing � is hardly a more promising option. matic, brilliant ... They are the kind of people who In addition to a heavy weight on your conscience, will attract young scientists," Anderson says. you may have to share the frying pan with your Still, you can tweak the odds in your favor. supervisor if the misconduct is discovered. Before committing to a new place, visit and talk "It's a terrible position for a young scientist to people there. While "no one is going to admit because you are caught between blowing the to pressures to engage in questionable practices," whistle with all the consequences for your own asking people privately "whether they'd choose to career, or being [associated with] fraudulent come back again [and whether] they'd choose research, which can also destroy your career," their current PI again" may yield some indirect Anderson says. insight, Heitman says. Beisiegel also recommends What should you do? checking the publication record of the lab: be "The integrity of research is everyone's re- wary of those that publish at lightening speed or sponsibility," Steneck says. "If you see something rarely mention Ph.D. students and postdocs as that you don't think is right, all professionals have contributors. a responsibility to raise their concerns." Needless to say, it's not always the PI's fault. But if you proceed, proceed with great care. Early-career scientists need to learn to hold Before blaming anyone, make sure you under- themselves to high ethical standards. "If someone stand what's going on and that what you have were watching over [your] shoulders, would you seen violates specific scientific, professional, or do anything differently? ... Don't cut corners. ethical standards. If you keep having problems Don't try to make your findings better than they repeating experiments done previously in your lab really are," Anderson says. "It's not only being and you suspect the results have been falsified, honest to others but particularly to yourself as start by asking how the original work was done. very often you are driven by your hypothesis and 2    you get a slightly unreal picture of what you are Equipment data quality is a continuous process doing. Look carefully at the data," says Beisiegel. designed to assure that a piece of equipment Ultimately, "know yourself and what your produces consistent and reliable data. temptations are," Heitman says. If it is not written down ..... This of course requires knowing the ethical it did not happen........ rules. "I would recommend ... [that young scien- Marilyn M. Marshall, SpM, RQAP-GLP tists] spend time looking at the professional codes Office of the Vice President for Research in their area of research," Steneck says. Check the 621-1469 (p), 621-1429 (f) guidelines and protocols at your university, read the publication rules for the journals you want to publish in, attend meetings and courses on the Radiation Control responsible conduct of research, and talk to trusted senior confidants. "Young people ... need IRPA Conference Information to talk to their mentors and other supervisors and find out how they've learned to cope with these IRPA 12 � Buenos Aires, Argentina pressures" without compromising their integrity, October 19-24, 2008 Anderson says. 13th Annual Congress of the International Radiation Protection Agency (IRPA) "Many researchers think that [research integ- rity] is something they don't really have to think The Congress motto is: about," Steneck says. But "there are a couple of "Strengthening radiation protection worldwide." reasons why one should take it seriously. One is You may also view the conference web site at: self-interest: If you are not aware of the rules, you http://www.irpa12.org.ar/index.php. can make mistakes and these ... could come back Registration and fees: to haunt you." But there are collective reasons, http://www.irpa12.org.ar/index.php. too, for taking research integrity seriously. It is in For more information, please use the following "our interest to maintain ... a good reputation. email address: secretariat@irpa12.org.ar. That's not a given." Losing the public's trust could have political repercussions and mean less funding and freedom for researchers in the future. Source: http://sciencecareers.sciencemag.org/career_develo pment/previous_issues/articles/2008_01_04/caredit News from HIPAA............ _a0800001 Hospital Workers Break UNIVERSITY OF ARIZONA HIPAA Privacy Law RESEARCH SUPPORT SERVICES GROUP A hospital in Laramie, Wyo., is reminding its (RSSG) staff that federal law prohibits them from looking at even their own medical records, after several employees came forward in the wake of several firings and suspensions, and admitted peeking at Good Laboratory Practices (GLP) their own records. Ensuring Equipment Data Quality In the past month, Ivinson Memorial Hospital has terminated one employee, suspended two To ensure equipment data quality there is an others and reprimanded four for violating HIPAA, expectation of a collection of documented the Associated Press (AP) reported. evidence that an instrument performs suitably for its intended purpose which includes the Those employees who were reprimanded also process of qualification, implementation and on looked at medical records other than their own, going use of the equipment. but several employees have since come forward saying they had looked at their own records, the Documentation Laramie Boomerang newspaper reported. � SOP's and Policies "You can"t look at your own records or any � Checklists family member records unless there is a clinical � Maintenance Records need to do so," said Nick Braccino, interim CEO � Calibration of the hospital. "If you are doing so just because � Quality Checks they are there and you have a private interest, you 3  are violating HIPAA regulations and patient older desktop server based program is also being confidentiality." replaced by a much more powerful and useful No employees who looked only at their own package. Another reason eSirius is being imple- patient records will be fired, Braccino told the AP mented at this time is to proactively anticipate news service. the rise in animal populations, protocols, compli- The employees looked at their own records ance reporting, animal requisitions, breeding with harmless intent, said hospital board of trustee colony cage cards and invoices in the near future member Shelbie Bershinsky. "I've been in health with the opening of the BIO-5 research facility. care 19 years and I, until today, I didn't think there Who will use eSirius and to what purpose? was anything wrong with me looking at my Principal Investigators and members of their records," she said. "I now know that I shouldn't staff who submit protocols and/or animal do that." requisitions, or who would need to have access Board of trustee member Dan Baccari also to invoices and account management tools will pointed out that employees are allowed to view have access to eSirius. their own information under certain conditions. eSirius will be used by the IACUC office staff "There is an appropriate process for employees to and IACUC members for protocol management, inquire about their medical or financial informa- facility inspections and compliance; by the UAC tion," Baccari told the AP. Directors office for AAALAC, USDA and Source: http://health-care-it.advanceweb.com/ OLAW reporting and compliance; by UAC general/hipaa/hipaanewslist.aspx#2 Husbandry Purchasing and Bar Code staff for Jeniece Poole, Privacy Officer animal ordering, breeding colony support and Office of the Vice President for Research animal census; by UAC Business Support staff jpoole@email.arizona.edu for invoicing and account management; and by University of Arizona � UAC Management staff for facility manage- Animal Care ment. What are the advantages to the Research community? eSirius is a powerful management tool that allows the PI and their approved staff quick and easy access to their protocols, animal requisitions Quality Care for Research Animals and all associated processes via a password protected homepage. (Census and invoicing to eSirius is Coming! by: Andi Mitchell come at a later date) All protocols, amendments and animal orders University Animal Care, in conjunction with are entered directly into eSirius by the PI and the UofA Institutional Animal Care and Use their staff, reducing paper usage, processing time Committee (IACUC), is in the beginning stages and increasing efficiency. of implementing an online research information Electronic alerts are created by eSirius and management software package called eSirius posted on the homepage to notify a PI when: which encompasses the submission, review, and approval of protocol applications and amend- � A protocol has been submitted to the ments, animal requisitions, account management, IACUC and later when the protocol is invoicing, and census management in a secure approved. environment. The current software (Sirius) used � A protocol has reached 80% of the by University Animal Care is an older product approved number of animals used. and unfortunately is no longer supported by the � It is time to complete an annual report for software company (NTM). Even though the a protocol current software has worked well in the past, � A protocol is expiring. UAC Business Services is concerned about � A protocol amendment as been submitted future issues occurring that could possibly to the IACUC and later when it is jeopardize the business operations of Animal approved. Care. A good comparison to make for this � An animal order has been submitted and change in software programs is the move from later placed by UAC staff. DOS to Windows based applications pre-2K. Just � An animal order has been waitlisted by as DOS was no longer supported, Sirius as the the vendor 4 � Animals have been received. How will existing data be entered into Invoicing and census alerts to come in the eSirius from Sirius? future! Data, including current protocols and active Where do we stand in the implementation personnel, will be transferred from the old system process? (Sirius) to eSirius electronically by NTM AFTER process testing and customization has been com- Currently the protocol application and IACUC pleted and before going "live." screens are being customized to meet the needs of the IACUC office staff and its members. Protocol How soon will I be able to use eSirius? pick lists are being loaded into the database to We're still very early in the implementation ensure that the PI and their staff can easily select process at this time. PI's will be given lots of no- procedures, drugs, housing and work locations tice when the transition to eSirius is scheduled to when completing their protocol. Active personnel take place. lists are being compiled for inclusion in the data tables so that the PI has the bulk of their staff Who do I contact if I have questions con- listed in eSirius prior to going live. Principal cerning eSirius? Investigators will be mailed a report of all current Andi Mitchell staff listed on their protocols to approve and UAC eSirius Program Coordinator assign eSirius access rights (protocols, animal mitchela@u.arizona.edu orders, invoices/account management or no or esirius@email.arizona.edu access). Additional staff not currently listed on a 307-2560 protocol (ex. � fund accountant or Business Man- Susan E. Wilson-Sanders, D.V.M., M.S. ager) can be identified and added during this Director, University Animal Care initial phase of access rights assignment. After (520) 626-1066 Fax: (520) 626-4079 this initial loading of personnel into eSirius, the PI wilson-s@u.arizona.edu will need to complete an eSirius Access Request HUMAN SUBJECTS form and return it to the eSirius office to give access to additional personnel. A PDF form will PROTECTION PROGRAM be available in the future on the UAC web page in the forms section Highlights . What's next? Family Educational Rights and A review and comment session with the Privacy Act of 1974 (FERPA)* IACUC staff and interested IACUC members will One of the laws that protects private identi- occur after the initial customization has been fiable information is the Family Educational completed. Any changes identified during the Rights and Privacy Act of 1974 (FERPA). This IACUC session will be addressed and then a test law focuses on student records and is overseen by period will take place with a few PI's entering the Department of Education. The following are protocols into eSirius for review by the IACUC. major concepts found in FERPA: Further changes resulting from the protocol test Student records are considered "education will be implemented and reviewed by the records." An educational record includes any IACUC. Concurrent with the protocol testing information or data recorded in any medium, phase, the animal requisition screens and pro- including but not limited to handwriting, cesses will begin to undergo customization. After print, tapes, film, e-mail, microfilm, and the protocol portion of eSirius has been tested and microfiche which is directly related to a updated as necessary, the testing process will student and maintained by the "institution" or move on to animal ordering. by a person acting for the "institution." What about training sessions for eSirius? All education records are confidential in most After eSirius has been configured and cases (except directory information) and thoroughly tested, individualized training sessions cannot be disclosed unless the student (or will be offered to UAC, IACUC and PI staff in parent if the individual is under 18 years of both group and one-on-one sessions. Training age) consents to the disclosure. Directory will be offered monthly or on an "as needed" information does not generally require a basis to accommodate the needs of new staff written consent from the student or student's members after eSirius has been implemented. parent and may be viewed and released to 5   the public unless the student or parent has You may also view the conference web site at: placed an affirmative "restriction" on its release. http://www.irpa12.org.ar/index.php. Directory information can include the following Registration and fees: and may vary from institution to institution: http://www.irpa12.org.ar/index.php. For more information, please use the following Students' name, date of birth, local ad- email address: secretariat@irpa12.org.ar. dress/telephone number, electronic mail address, college, class standing, academic program, dates of attendance, status (full or Upcoming Conferences/Workshops part-time registration), degrees received, July 23, 2008 honors and awards received, participation in Public Service, Public Trust: Deepening the Experience of officially recognized activities, and weight Research Integrity for Medical Scientists and Clinicians and height of members of athletic teams. Bethesda, MD Co-Sponsor: Uniformed Services University A general rule to remember is that if the infor- September 17, 2008 mation is personally identifiable, you need to A Research Integrity Education Conference for the Federal obtain written consent from the student or from Nursing Community the parent. Personally identifiable means the Bethesda, MD information would make the student's identity Co-Sponsor: Uniformed Services University easily traceable. If you are obtaining written October 2-3, 2008 consent, it must include the following: Fostering International Research Collaborations Co-Sponsor: University of Minnesota o The precise records to be disclosed Minneapolis, MN o The purpose of the disclosure October 19-14, 2008 IRPA 12 � Buenos Aires, Argentina o To whom the disclosure will be made October 19-24, 2008 The form must be signed and dated by the 13th Annual Congress of the International Radiation student or the student's parent. Protection Agency (IRPA) http://www.irpa12.org.ar/index.php Faculty and staff generally may not see a student's education records without first May 15-17, 2009 identifying a legitimate educational interest or one Fifth Biennial Research Conference on Research Integrity Niagara Falls, NY of the other exceptions under which records may Co-Sponsor: University of Minnesota be reviewed. University of Arizona Program in Access to student records carries with it a bond of trust which requires close attention and Research Integrity Education staff: compliance with FERPA. In other words, access Ruth K. Daniels, Program Coordinator and Editor should only be obtained when information is of the P.R.I.E. Newsletter rhk@u.arizona.edu needed to perform a specific task and com- Program telephone number: (520) 626-6282 munication to other parties should only occur when the communication is authorized under Words of Wisdom: FERPA law. "When an American says that he *http://www.registrar.Arizona.edu/ferpacourse/Maj orconcepts.htm loves his country, he means not only Rebecca Dahl, Ph.D. Director, Human Subject Protection Program that he loves the New England hills, Office of the Vice President for Research the prairies glistening in the sun, the rdahl@email.arizona.edu wide and rising plains, the great Radiation Control mountains, and the sea. He means that he loves an inner air, an inner IRPA Conference Information light in which freedom lives and in IRPA 12 � Buenos Aires, Argentina October 19-24, 2008 which a man can draw the breath of 13th Annual Congress of the International self-respect." Radiation Protection Agency (IRPA) The Congress motto is: ~Adlai Stevenson "Strengthening radiation protection worldwide." 6 Document Outline |
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