academic research record-keeping

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Institutional Issues Academic Research Record-Keeping: Best Practices for Individuals, Group Leaders, and Institutions Alan A. Schreier, PhD, Kenneth Wilson, PhD, and David Resnik, PhD, JD Abstract During the last half of the 20th century, social and technological changes in academic research groups have challenged traditional research record- keeping practices, making them either insufficient or obsolete. New practices have developed but standards (best practices) are still evolving. Based on the authors’ review and analysis of a number of sources, they present a set of systematically compiled best practices for research record-keeping for academic research groups. These best practices were developed as an adjunct to a research project on research ethics aimed at examining the actual research record- keeping practices of active academic scientists and their impact on research misconduct inquiries. The best practices differentiate and provide separate standards for three different levels within the university: the individual researcher, the research group leader, and the department/institution. They were developed using a combination of literature reviews, surveys of university integrity officials, focus groups of active researchers, and inspection of university policies on research record-keeping. The authors believe these best practices constitute a snapshot of the current normative standards for research records within the academic research community. They are offered as ethical and practical guidelines subject to continuing evolution and not as absolute rules. They may be especially useful in training the next generation of researchers. Acad Med. 2006; 81:42–47. Good record-keeping is central to the scientific process. 1–4 Good research records encompass much more that just research data. They include but are not limited to planning and protocol descriptions, data manipulations and analysis procedures, personal and group interpretations of the results, and important communications and group decisions among collaborators. Data management is a subset of the broader concept of research record-keeping. Research records are important for managing and planning research, for replicating results, for documenting collaborations, for publishing and peer review, and for complying with governmental and institutional rules and regulations. In recent decades, legal and regulatory uses of research records have become prominent. Research records have long been used to resolve intellectual property disputes. 2 However, research misconduct scandals in the 1980s and 1990s involving falsification and fabrication of research records provoked the federal government to require universities to implement research misconduct policies. 2 Examination of research records is a central feature of inquiries and investigations under such university policies. We recently conducted a survey of 96 university officials who are responsible for such inquiries and investigations as part of a research project on the impact of research records in research misconduct cases. 5 We found that over half of the officials who reported experience with misconduct cases at their institutions also reported that they had been hampered in their inquires/investigations by inadequate research records. Also, another recent survey of investigators who had been funded by the National Institutes of Health (NIH) on the prevalence of questionable research practices noted that 27% of the 3,247 respondents admitted to “inadequate record-keeping related to research projects.” 6 Given the importance of good research records, it is somewhat surprising that formal standards for such records are the exception rather than the rule in academic research laboratories. Although governments have mandated standards for good research records for certain segments of the research community— most notably in the area of human health and safety research through the stringent regulations of the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) 7,8 —the majority of academic researchers are not constrained by any external set of record-keeping guidelines. In fact, most academic scientists find the mandated FDA record-keeping practices both onerous and unnecessary. Academic researchers prefer informal guidelines rather than formal standards for record- keeping. During the last half of the 20th century, technological changes in how records are produced, collected, analyzed and stored, coupled with social changes in the nature of research groups, have created new challenges for research record-keeping. 9 Traditional practices for such record- keeping are either no longer sufficient or, at worse, obsolete for the modern researcher. New record-keeping practices have arisen to meet these challenges; however, very little research has been Dr. Schreier is director of new program development and coordinator of university compliance, Division of Research and Graduate Studies, East Carolina University, Greenville, North Carolina. Dr. Wilson is associate professor, Department of Sociology, East Carolina University, Greenville, North Carolina. Dr. Resnik is institute bioethicist, Division of Intramural Research, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina. Correspondence should be addressed to Dr. Schreier, Division of Research and Graduate Studies, East Carolina University, Greenville, NC 27858; e-mail: [email protected]. Academic Medicine, Vol. 81, No. 1 / January 2006 42

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Page 1: Academic Research Record-keeping

Institutional Issues

Academic Research Record-Keeping:Best Practices for Individuals, Group Leaders, andInstitutionsAlan A. Schreier, PhD, Kenneth Wilson, PhD, and David Resnik, PhD, JD

AbstractDuring the last half of the 20th century,social and technological changes inacademic research groups havechallenged traditional research record-keeping practices, making them eitherinsufficient or obsolete. New practiceshave developed but standards (bestpractices) are still evolving. Based on theauthors’ review and analysis of a numberof sources, they present a set ofsystematically compiled best practices forresearch record-keeping for academicresearch groups. These best practiceswere developed as an adjunct to a

research project on research ethics aimedat examining the actual research record-keeping practices of active academicscientists and their impact on researchmisconduct inquiries.

The best practices differentiate andprovide separate standards for threedifferent levels within the university: theindividual researcher, the research groupleader, and the department/institution.They were developed using acombination of literature reviews, surveysof university integrity officials, focus

groups of active researchers, andinspection of university policies onresearch record-keeping. The authorsbelieve these best practices constitute a!snapshot! of the current normativestandards for research records within theacademic research community. They areoffered as ethical and practical guidelinessubject to continuing evolution and notas absolute rules. They may be especiallyuseful in training the next generation ofresearchers.

Acad Med. 2006; 81:42–47.

Good record-keeping is central to thescientific process.1– 4 Good researchrecords encompass much more that justresearch data. They include but are notlimited to planning and protocoldescriptions, data manipulations andanalysis procedures, personal and groupinterpretations of the results, andimportant communications and groupdecisions among collaborators. Datamanagement is a subset of the broaderconcept of research record-keeping.Research records are important formanaging and planning research, forreplicating results, for documentingcollaborations, for publishing and peerreview, and for complying withgovernmental and institutional rules andregulations. In recent decades, legal and

regulatory uses of research records havebecome prominent. Research recordshave long been used to resolveintellectual property disputes.2 However,research misconduct scandals in the1980s and 1990s involving falsificationand fabrication of research recordsprovoked the federal government torequire universities to implementresearch misconduct policies.2

Examination of research records is acentral feature of inquiries andinvestigations under such universitypolicies.

We recently conducted a survey of 96university officials who are responsiblefor such inquiries and investigations aspart of a research project on the impactof research records in researchmisconduct cases.5 We found that overhalf of the officials who reportedexperience with misconduct cases at theirinstitutions also reported that they hadbeen hampered in theirinquires/investigations by inadequateresearch records. Also, another recentsurvey of investigators who had beenfunded by the National Institutes ofHealth (NIH) on the prevalence ofquestionable research practices notedthat 27% of the 3,247 respondentsadmitted to “inadequate record-keepingrelated to research projects.”6

Given the importance of good researchrecords, it is somewhat surprising thatformal standards for such records are theexception rather than the rule inacademic research laboratories. Althoughgovernments have mandated standardsfor good research records for certainsegments of the research community—most notably in the area of human healthand safety research through the stringentregulations of the U.S. Food and DrugAdministration (FDA) and theEnvironmental Protection Agency(EPA)7,8—the majority of academicresearchers are not constrained by anyexternal set of record-keeping guidelines.In fact, most academic scientists find themandated FDA record-keeping practicesboth onerous and unnecessary. Academicresearchers prefer informal guidelinesrather than formal standards for record-keeping.

During the last half of the 20th century,technological changes in how records areproduced, collected, analyzed and stored,coupled with social changes in the natureof research groups, have created newchallenges for research record-keeping.9

Traditional practices for such record-keeping are either no longer sufficient or,at worse, obsolete for the modernresearcher. New record-keeping practiceshave arisen to meet these challenges;however, very little research has been

Dr. Schreier is director of new programdevelopment and coordinator of universitycompliance, Division of Research and GraduateStudies, East Carolina University, Greenville, NorthCarolina.

Dr. Wilson is associate professor, Department ofSociology, East Carolina University, Greenville, NorthCarolina.

Dr. Resnik is institute bioethicist, Division ofIntramural Research, National Institute ofEnvironmental Health Sciences, National Institutes ofHealth, Research Triangle Park, North Carolina.

Correspondence should be addressed to Dr. Schreier,Division of Research and Graduate Studies, EastCarolina University, Greenville, NC 27858; e-mail:"[email protected]#.

Academic Medicine, Vol. 81, No. 1 / January 200642

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done on defining in a systematic way thebest practices* for research record-keepingin the 21st century academy. Theliterature is replete with descriptions ofrecord-keeping practices, but they areusually personal assessments. In thisarticle, we will discuss the modernchallenges to traditional research record-keeping practices. We will then articulatebest practices (principles and specificpractices) for keeping research recordsthat have emanated from our researchand which, we believe, can helpresearchers respond to these challenges.Because these principles and practiceswere developed in a systematic way, webelieve that they represent current normswithin the scientific community(excluding FDA- or EPA-regulatedresearch). We offer these best practices asethical guidelines for researchers,research group leaders, and researchinstitutions, not as absolute rules or legalrequirements.

Modern Challenges to TraditionalRecord-Keeping Practices

During the 19th and early 20th centuries,a tradition for research record-keepingdeveloped in the academic physical andbiological sciences that focused on theresearch notebook as the primary tool fororganizing research projects, planningexperiments, recording data, analyzingthe results, and storing these records forfuture reference. Research groups weresmall, allowing group leaders topersonally train young researchers and toregularly examine primary researchrecords; this process ensured thetransmission of the record-keepingtradition to the next generation. Duringthe last half of the 20th century, anumber of trends in research havecomplicated the traditional record-keeping process and interfered with thetraining of new researchers in record-keeping practices.9 Chief among thesetrends were (1) the rise of large researchgroups; (2) the introduction of research

instruments and methods that self-recorded data either on paper printoutsor photographically (e.g., X-ray films,slides, and photographs); and (3) the riseof computers in the laboratory.

The current environment for researchtraining, where a graduate student or apostdoctoral fellow is usually a part of thelarge research group, encourages theteaching of record-keeping practices tonew researchers by peers rather than bythe senior group leader. Oversight ofresearch is often focused only on theresults of a young researcher’s project; itappears to be rare for a researcher’sprimary research records to be examinedby a senior research group leader. If thereare no standards imposed by the researchgroup leader, the actual record-keepingpractices within the laboratory groupmay deviate from accepted norms. Thepractices actually in use will depend onan individual researcher’s own attitudetoward record-keeping and on theattitudes and practices of peers. Anextreme example of this occurs whenforeign students and postdocs keep theirresearch records in their native languagesif there is no requirement to keep recordsin a common language. There are manyanecdotal cases of this practice becauseinternational students and postdocs areprevalent in academic research groups.Kanare10 describes a case where aresearch group leader discovered, afterhis Japanese postdoc had returned toJapan, that the postdoc had written hisnotebooks in Japanese.

The introduction of self-recordingresearch instruments and newphotography-based techniques were amajor technical advance for science, butthey have had the unfortunate byproductof reducing the utility of the traditionalbound research notebook, and moreimportant, of beginning thefragmentation of the research record thatis so common today. The first self-recording instruments in the 1940s and1950s produced paper-based output(they now produce digital files).Photographic recording techniques alsoappeared at about this time, such asimaging radiolabels on paperchromatographs. These types of recordswere difficult to incorporate intotraditional bound laboratory notebooksdue to the cumbersome need to glue ortape such output into notebooks and thesheer volume of such records. Many

research groups abandoned thetraditional bound notebook in favor ofloose-leaf binders or manila folders forboth the collection of data output(instrument and photographic data) andfor the planning of experiments. Soon,the processing and analysis of data wasalso placed into loose-leaf binders ormanila folders, thus contributing to thephysical fragmentation of researchrecords.

The rise of computers in the laboratorywas another major technical advance.They made possible the collection andprocessing of monumental amounts ofdata that were critical for theadvancement of many fields (e.g., X-raycrystallography, genomics, andproteomics). However, the computer alsopromoted the fragmentation of theresearch records in academic laboratoriesand made oversight more difficult.Researchers routinely use many differentcomputer applications in the course oftheir work and produce a variety ofresearch records (e.g., word processingfiles, spreadsheets, instrument dataoutput files, etc.). For a single researchproject, relevant computer files can bescattered among several computerswithin a research group, depending onthe number of individuals working onthe project. Within each computer, thepertinent files may be scattered amongapparently unrelated folders on the harddrive. In addition, the rapid obsolescenceof computer software and hardware(often only three to five years pergeneration) has made the long-termelectronic retrieval of research recordsproblematic, if not impossible.

Technological Solutions toModern Record-KeepingChallenges: Different Responsesof Academia and Industry

Computer technology has also beencalled upon to provide solutions to thesemodern record-keeping challenges.Laboratory information managementsystems (LIMS) and electronic laboratorynotebooks (ELNs) are the two majortypes of tools that have beendeveloped.11–13 Industry has embracedthese systems due, in part, to intellectualproperty concerns and stringent FDAregulations. LIMS systems in particularhave been extremely helpful in managinglaboratories that generate a great deal ofdata and use standardized procedures,

*Best practices and good practices are terms of artcommon in the literature on ethical and regulatoryaspects of clinical trials and laboratory science. Forexample, the Food and Drug Administration10 hasgood clinical practices (GCPs) and good laboratorypractices (GLPs) for the conduct of clinical trials, andthe Environmental Protection Agency11 has goodlaboratory practices (GLPs) for laboratory research.Our best practices are intended to supplement butnot supplant GCPs, GLPs, and other best practicesfor research.

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which is often the case in industrial andclinical labs and pharmaceutical qualitycontrol facilities. However, in academic(discovery-type) research, protocols andmethods can change frequently, and theamount of data collected tends to berelatively limited. Because LIMS systemsneed to be customized for each processthey handle, such systems are thereforeviewed as being too inflexible for thetypical academic laboratory.12 Theexceptions here are areas like genomicsand proteomics, whose procedures havebecome highly standardized with a needto process high amounts of data. ELNssupposedly mimic the bound papernotebook, but again due to flexibilityissues, anecdotal evidence suggests thatsuch tools are not commonly used inacademic laboratories.12

These technological solutions themselvesare limited by the basic assumptions usedin their design about what constitutesgood records and good record-keeping.The best practice principles that wedeveloped and have described below can

be used to guide the development offuture generations of LIMS and ELNs.We believe that these principlestranscend the mechanism for theirimplementation, whether they be paper-or computer-based.

Genesis of the Best Practices

We developed the best practicesdescribed below as an adjunct to ourresearch-on-research-ethics projectentitled “Scientific Record Keeping andResponsible Research Conduct” fundedby a grant from the National ScienceFoundation (NSF).5 We carried out theresearch to determine the actual record-keeping practices of active NSF- andNIH-funded scientists and how theseinfluence the adjudication of researchmisconduct investigations. To helpprepare a national survey of active NSFand NIH scientists on their record-keeping practices and to aid in theanalysis of the responses, it was necessaryto have a set of generally recognized bestpractices, that is, normative standards for

research record-keeping. We derivedthese best practices from four sources:(1) the research training and ethicsliterature; (2) institutional policies andguidelines; (3) interviews with universityofficials responsible for investigatingallegations of scientific misconduct; and(4) focus groups composed of facultymembers from both medical andnonmedical faculties of Duke University,East Carolina University, North CarolinaState University, and the University ofNorth Carolina at Chapel Hill.

The research training and ethics literaturewas our primary source of record-keeping practices. The regular researchliterature (e.g., journal articles,monographs, conference proceedings,etc.) was not excluded from our review;however, this literature usually does notdiscuss research record-keeping practices.The ethics and research training literatureis large and often included detailed anddiscipline specific recommendations forrecord-keeping. Many of the referencesfor record-keeping practices were intextbooks or primers for studentslearning laboratory techniques for thefirst time. They usually focused on theproper construction of a researchnotebook and more, recently, itselectronic counterparts. The monographWriting the Laboratory Notebook byKanare10 is the acknowledged classic inthis field. The practices described in thisbook and the other references are thepractices that an individual researchershould follow when he or she is planning,collecting, recording, and analyzingresearch. We named these specificpractices individual best practices. Onlyrecently have references appeared thatspeak to higher-level best practices, such asthose that research group leaders,departments and institutions couldemulate to promote good record-keeping. Selected primary documentsused in our compilation of our bestpractices are listed in the references at theend of this article.2– 4,9,10,14 –25

Institutional policies and guidelines thatdeal with research records from manyresearch universities were reviewed.Although our review was far frominclusive, we found that such policies andguidelines usually spoke to issues ofretention, ownership, access and transferof research records. Only rarely did apolicy or guideline (e.g., those of theUniversity of California, San Francisco)18

List 1Best Practice Principles for Individual Researchers*

Useful (good) research records explain

• what you did,• when you did it,• why you did it,• how you did it,• who you are (the person creating the record),• what project(s) it was a part of,• who thought of it if not you,• what special materials and instruments you used,• where you obtained the materials and instruments,• what happened and what did not happen (data),• how you manipulated and analyzed the results,• your interpretation (and the interpretations of others if important), and• what will be the next steps in the project based on these results.

In addition, good research records

• are legible if handwritten,• are recorded using reliable materials and tools,• are well organized (e.g., well labeled, indexed, catalogued, etc.),• are accurate and complete; they include (1) all original data and important study details

(meta-data) and (2) successful and unsuccessful studies and activities,• describe and date all alterations and changes in records,• allow repetition of your procedures and studies by yourself and others,• are accessible (physically and/or electronically) to others both short term and long term,• are stored and backed-up properly for the short and long term (archiving),• are witnessed where needed to protect intellectual property rights,• are in compliance with departmental, institutional, and federal regulatory requirements, with

special care given to human and animal research, and• are the research diaries of the researcher’s work and thoughts.

*Researchers may be at any level from student and staff to senior faculty if they are personally performinghands-on research. Research records are defined briefly as recorded information, regardless of media, that isnecessary for the reconstruction and evaluation of the research. An individual record element may not need allthe above attributes, but the whole record probably does.

Source: This list adopted from Table 11.1 from Scientific Integrity: An Introduction with Case Studies, by FrancisL. Macrina, ASM Press (2000), with permission.

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set specific standards for record-keepingbeyond these administrative issues.Sources that contained representativepolicies and guidelines that were usefulare noted in the reference list.18 –25

Our research ethics project includedinterviews with university officials from96 research universities.5 These officialsprovided us with a number of positivepractices for good record-keeping basedon their experiences. In almost everycase, however, these practices reiteratethose that appeared in the literature.Thus, the university officials providedanecdotal evidence for the value of thesepractices.

As the number of specific best practicesgrew, they became too unwieldy to be auseful guide if compiled into a single list.An organizational structure was needed.We divided the best practices into threehierarchical groups: best practices forindividual researchers, best practices forresearch group leaders, and best practicesfor departments and institutions. We alsodeveloped summaries— essentiallystatements of principles for the bestpractices for each group (see Lists 1, 2,and 3)—and compiled the detailed bestpractices separately. The resultingdocument, containing both principlesand specific practices, was provided tothe focus groups for their review andsuggested revisions.

The focus groups were particularlyhelpful in refining the best practices. Thefocus-group members totaled 48 activesenior scientists (12 on each campus),who have NSF or NIH funding in avariety of research fields (from basicsciences like physics and chemistrythrough clinical fields to social andbehavioral sciences). Focus-groupsessions of four hours in length were heldin the spring and summer of 2004.Interestingly, the members of the groupsdirected most of their comments towardbest practices for research group leadersand departments and institutions, theareas that were least discussed in theliterature. They stressed the pivotal roleof the research group leader in settingstandards and procedures for his or hergroup. The focus-group membersidentified some new types of researchrecords that had previously not beenmentioned in the literature, such asrecords of e-mails and teleconferencetranscripts and minutes. These types of

records have greatly increased inimportance due to the highlycollaborative nature of modern research,where the collaborating scientists andtheir research groups can be physicallyquite distant from each other. Recordsof communications about researchresults, plans for future research, anddecisions regarding results or futureplans need to be documented toprevent misunderstandings andmiscommunications. Another area ofextreme importance to all focus groupswas the concern that any set of bestpractices resulting from our work wouldbe adopted as mandated requirements byfederal agencies, resulting in inflexibleand onerous regulation of their research.

The Best Practices

Description

Lists 1, 2, and 3 summarize the best practiceprinciples for research record-keeping at allthree levels described above. A completedocument with detailed best practices isavailable at "http://www.research2.ecu.edu/BestPractices_Sep04.doc#.

Reflections

The best practices described above and inthe three lists are a synthesis of

traditional and modern practices from avariety of sources. They emphasizeprinciples over detailed practices, whichare subject to obsolescence anddisciplinary restrictions. They alsoemphasize the critical role of the researchgroup leader in setting standards and inthe training of new researchers. Inaddition, they explicitly acknowledge therole of departments and institutions insetting the organizational context withinwhich the research groups operate. Ourfocus-group members felt that these twohigher-level sets of practice principleswere applicable to any research disciplineor institution. These principles addressthe effective management of scientificlaboratories and work groups, and areaimed at promoting goodcommunication between current researchparticipants and future participants(through stored records).

It is our opinion that a breakdown in thetraining and supervision of newresearchers has contributed to the declineof research record-keeping. Thefragmented and still-evolving nature ofmodern research records has contributedto this breakdown by making many of theold record-keeping practices obsolete,with no generally accepted replacements

List 2Best Practice Principles for Leaders of Research Groups

Research group leaders should

• set standards for record-keeping practices for individuals in their group in areas such as(1) research studies/activities within the group (handwritten and electronic notes, data, and

other documentation),(2) labeling and cataloging of experimental samples, tangible products of research, etc.,(3) communications with collaborating researchers, such as letters, e-mails, minutes of

meetings (face-to-face or teleconference), etc.,• provide/assure that group members receive training in record-keeping practices,• provide motivation by emphasizing the benefits of good records and the problems associated

with poor records,• provide examples of well-maintained records and good record-keeping practices,• clarify data and research record ownership and access rights,• perform periodic reviews of the records of the members of your group,• delegate, as needed, oversight and training duties for group records to senior members of your

group and perform periodic checks on the performance of these duties and modify/reassignduties as needed,

• provide the tools (paper-based notebooks or electronic hardware/software),• establish temporary storage areas for records in use (both paper and electronic) and

appropriate backup facilities/methods,• require adherence to group record-keeping standards by group members,• promote communication of research information within the group,• have a plan to assure the transmission of important research information (accessible and

understandable records/notebooks) from departing group members,• require adherence to departmental, institutional, and legal requirements,• seek to assure the long-term accessibility of records for a set period of time (archiving) after

completion of the research, and• update records standards as needed.

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in sight. Young scientists in training andnew research group leaders may find itdifficult to understand the linkagesbetween the specific, detailed processesthey follow in their research and thegeneral norms of scientific research.By identifying a separate set ofresponsibilities assigned to the researchgroup leader, they may be able to moreclearly understand how to manage theirgroups and train their students moreeffectively.

We present this new synthesis of bestpractices to the research community as apotential aid in thinking about thechallenges of record-keeping in the firstdecades of the 21st century. We hope thatit will guide the development of betterpractices among research group leaders,as well as encourage departments andinstitutions to adopt practices andpolicies that will aid research groupleaders in their responsibility to keepgood records of their research.

Dr. Schreier is a university administrator chargedwith coordinating university research complianceactivities including the review of allegations ofresearch misconduct. He is primarily responsiblefor the development of the best practicesdocument described in the present article. Dr.Wilson, the principal investigator of the NSFgrant, is an experienced survey sociologist who isprimarily responsible for the development and

execution of the surveys and focus groupsemployed in the NSF project. Dr. Resnik, abioethicist formerly on the faculty of EastCarolina University, provided the initial ideas forthe NSF project as well as critical review of allsteps in the project.

The authors would like to thank Dr. Robert P.Lowman (Chapel Hill), Dr. Albert Collier(Chapel Hill), Dr. Joseph M. Corless (DukeUniversity), and Mr. Mathew K. Ronning(NCSU) for their assistance with the focus groupsand Ms. Angel Griffin (ECU) for her technicalassistance. This project was supported by a grant# SES-0322752 from the National ScienceFoundation and the intramural research programof the National Institute of EnvironmentalHealth Sciences (NIEHS), National Institutes ofHealth (NIH). The ideas and opinions in thisproject do not represent the views of the NSF,NIEHS, or NIH.

References1 Steneck N. Introduction to the Responsible

Conduct of Research "http://ori.dhhs.gov/publications/ori_intro_text.shtml#. Accessed2 October 2005. Washington, DC: Office ofResearch Integrity, DHHS, 2004.

2 Shamoo A, Resnik D. Responsible Conduct ofResearch. New York: Oxford University Press,2003.

3 Macrina F. Scientific Integrity: AnIntroduction with Case Studies, 2nd ed.Washington, DC: American Society ofMicrobiology Press, 2000.

4 National Academies Press. ResponsibleScience, Volume I: Ensuring the Integrity of

the Research Process "http://books.nap.edu/books/0309047315/html/index.html#.Accessed 2 October 2005 .

5 Wilson K, Brantley A, Schreier A, Resnik D.Scientific record-keeping and responsibleresearch conduct [manuscript inpreparation].

6 Martinson BC, Anderson MS, deVries R.Scientists behaving badly. Nature. 2005;435:737–38.

7 U.S. Food and Drug Administration. GoodClinical Practice in FDA-Regulated ClinicalTrials "http://www.fda.gov/oc/gcp/default.htm#. Accessed 2 October 2005.

8 Environmental Protection Agency. GoodLaboratory Practices "http://www.epa.gov/Compliance/monitoring/programs/fifra/glp.html#. Accessed 2 October 2005.

9 Wright DE. Data management: recording,access, retention, ownership. In: Davis T (ed).Management of the Biomedical ResearchLaboratories: Proceedings of a NationalConference. Washington DC: Office ofResearch Integrity, 1998.

10 Kanare H. Writing the Laboratory Notebook.Washington, DC: American Chemical SocietyPress, 1985.

11 Data Management and LaboratoryNotebooks. In: Bonneta L, Davenport P(eds). Making the Right Moves "http://www.hhmi.org/grants/office/graduate/labmanagement.html#. Accessed 2 October2005. Chevy Chase, MD: Howard HughesMedical Institutes, 2004.

12 Bonneta L. Toward a Paperless Lab? Scientist.2003;17:40–42.

13 Gibbon G. A Brief History of LIMS. LabAutomat Inform Manage. 1996;32:1–5.

14 Gollub JP. Haverford College AstrophysicsLab Documentation Policy "http://www.haverford.edu/physics-astro/Gollub/Lab_Doc_Policy_0512rev3_ok.pdf#. Accessed 2October 2005.

15 Grant GF. Digital Authentication of ResearchNotebooks, In: Abstracts: 2002 ResearchConference on Research Integrity "http://ori.dhhs.gov/documents/rri_conference_abstracts_2002.pdf#. Accessed 2 October2005. Rockville, MD: Office of ResearchIntegrity.

16 Struble CA. Laboratory Notebooks forComputer Sciences "http://www.mscs.mu.edu/cstruble/class/general/labnotebook.pdf#.Accessed 2 October 2005. Milwaukee:Marquette University, 2003.

17 Walter C, Edwards RP. Standards forScientific Record Keeping. IEEE Engineeringin Medicine and Biology Magazine. 1992;2:88. "http://biotech.law.lsu.edu/IEEE/ieee09.htm#. Accessed 2 October 2005.

18 Responsibilities of a Group Leader. In:Advancement and Promotion at UCSF: AFaculty Handbook for Success "http://www.ucsf.edu/senate/facultyhandbook/index.html#.Accessed 2 October 2005. San Francisco:University of California, 1995.

19 Cornell University Guidelines forMaintaining Laboratory Notebooks "http://

List 3Departmental and Institutional Best Practices for Research Record-keeping

Department/School Level

• Make available training/mentoring to faculty (especially new faculty) on research group/labmanagement skills and practices. Include best practices in scientific record-keeping.

• Encourage faculty members to have a strategy/plan (preferably written) for research record-keeping. The strategy should adopt “individual best practices” to the research group’scircumstances and include active mentoring and oversight of trainees and staff.

• Provide record-keeping materials and resources if possible (e.g., research journals, labnotebooks, specialized software, bar-coding equipment, dedicated servers [computers] forstoring electronic records.

University Level

• Provide clear policies on research record ownership, access, retention, transfer, anddestruction. What constitutes research records should be clearly defined and should includepaper, electronic, and tangible forms of research information.

• Provide Institutional facilities for archiving records (all media). Many institutions already havethis service through their university libraries.

• To help assert university ownership of research records, provide record-keeping materials forthe departments/units to distribute (e.g., research journals, lab notebooks, specializedsoftware, dedicated servers [computers] for storing electronic records).

• Provide resources to help departments/units provide training in research record-keeping (e.g.,training materials, examples of good records and practices, a Web-based tutorial in record-keeping practices).

• Provide resources to help assure the long-term accessibility of electronic records (i.e., helpprotect against hardware/software obsolescence and availability issues for older data andrecords).

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www.cctec.cornell.edu/labnotebooks.html#.Accessed 2 October 2005.

20 Data Management: Research Records. In:New Investigators: A Quick Guide ToStarting Your Research at UCSF. "http://www.research.ucsf.edu/QG/orQgDm.asp#.Accessed 2 October 2005. San Francisco:University of California.

21 National Institutes of Health. Guidelines onthe Conduct of Research at the NIH "http://

www.nih.gov/campus/irnews/guidelines.htm#.Accessed 2 October 2005.

22 University of California, San Francisco.Guidelines on Research Data and Reports"http://neurosurgery.medschool.ucsf.edu/academics/guidelines.html#. Accessed 2October 2005.

23 University of Minnesota. Guidelines forMaintaining Laboratory Notebooks "http://www.ptm.umn.edu/v3/documents/labnotes.pdf#.Accessed 2 October 2005.

24 University of California, San Francisco. Officeof Research Guidelines for LaboratoryNotebooks. In: New Investigators: A QuickGuide to Starting Your Research at UCSF "http://www.research.ucsf.edu/QG/orQgNb.asp#.Accessed 2 October 2005.

25 North Carolina State University. Policy onLab Notebook Maintenance for PatentPurposes "http://www.ncsu.edu/sparcs/lab_management/ncsu_patent.html#.Accessed 2 October 2005.

Cover NoteUniversity of New Mexico School of MedicineNestled in the southwest enclave ofAlbuquerque, the University of NewMexico (UNM) Health Sciences Centerboasts cutting-edge facilities andworld-class faculty.

The UNM School of Medicine wasestablished in 1961, and in 1964admitted its first class of medicalstudents. It remains the only medicalschool in New Mexico, and hasgraduated more than 2,300 physicians,many of whom have remained topractice in the state.

Over the years, the UNM School ofMedicine has developed into anationally recognized educationalinstitution, consistently ranked amongthe top 10 in Family Medicine andRural Medicine education, and thisyear was named one of the top 10medical schools for Hispanics byHispanic Business Magazine. Theorgan-system problem-basedcurriculum at UNM School of Medicinedistinguishes the institution, and oursubspecialty clinical expertise hasearned regional recognition.

More recently, the UNM School ofMedicine is developing a nationalreputation for its research in thebiological mechanisms and clinicaltreatments in cancer, neurosciences,pulmonary disorders and infectiousdiseases.

This institution furthers its educationalmission by fostering strongassociations with civic, academic andcommunity organizations andleadership. Students at the UNMSchool of Medicine are supportedthroughout their academic careerswith effective mentoring programs,popular community health events,active student organizations, andexceptional faculty.

In the fall of 2006, the School ofMedicine will begin a combined-degree program implemented inpartnership with UNM’s College ofArts and Sciences. The program willenhance recruitment of highlyaccomplished and motivated NewMexico high school students into aseven-year program culminating inboth a bachelor’s degree and an MDdegree.

Medical research in our institution hasgrown more than 250% in the pastfive years and nearly 400% in the pastten. Consistent with that pace is thepivotal emergence of the NCI-designated Cancer Research andTreatment Center, the MIND Instituteand Imaging Center, a 29,000-square-foot Research Incubator Building, anationally integrated Center forInfectious Diseases, a vital UniversityTeaching Hospital system, the Centerfor Native American Health, and theOral Health Institute.

In coming years, the UNM School ofMedicine will continue to focus onthose areas resulting in the greatestimpact on New Mexico’s health careneeds, while growing our infectiousdisease, cancer, pulmonary, andneurosciences research programs. Inaddition to the traditional NIH-supported individual-investigatorinitiatives and program projects, theUNM School of Medicine willundertake further interdisciplinarytranslational and clinical scientificinquiry to move forward scientificknowledge and potential new clinicaltherapies in these areas.

Through partnerships with ourcolleagues in the UNM colleges ofPharmacy and Nursing, School ofEngineering, and College of Arts andSciences, as well as with Los Alamosand Sandia national laboratories, theUNM School of Medicine will expandits research efforts, particularly inbioengineering and biocomputing.These partnerships will also allow UNMSchool of Medicine to develop novelgraduate programs in variousdisciplines to produce the nextgeneration of scientists.

Luke FrankSenior Public Affairs RepresentativeHSC Public AffairsUniversity of New Mexico School of MedicineAlbuquerque, New Mexico

Institutional Issues

Academic Medicine, Vol. 81, No. 1 / January 2006 47