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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, research project on research ethics aimed groups of active researchers, and
social and technological changes in at examining the actual research record- inspection of university policies on
academic research groups have keeping practices of active academic research record-keeping. The authors
challenged traditional research record- scientists and their impact on research believe these best practices constitute a
keeping practices, making them either misconduct inquiries. snapshot of the current normative
insufficient or obsolete. New practices standards for research records within the
have developed but standards (best The best practices differentiate and academic research community. They are
practices) are still evolving. Based on the provide separate standards for three offered as ethical and practical guidelines
authors review and analysis of a number different levels within the university: the subject to continuing evolution and not
of sources, they present a set of individual researcher, the research group as absolute rules. They may be especially
systematically compiled best practices for leader, and the department/institution. useful in training the next generation of
research record-keeping for academic They were developed using a researchers.
research groups. These best practices combination of literature reviews, surveys
were developed as an adjunct to a of university integrity officials, focus Acad Med. 2006; 81:4247.

G ood record-keeping is central to the regulatory uses of research records have Given the importance of good research
scientific process.1 4 Good research become prominent. Research records records, it is somewhat surprising that
records encompass much more that just have long been used to resolve formal standards for such records are the
research data. They include but are not intellectual property disputes.2 However, exception rather than the rule in
limited to planning and protocol research misconduct scandals in the academic research laboratories. Although
descriptions, data manipulations and 1980s and 1990s involving falsification governments have mandated standards
analysis procedures, personal and group and fabrication of research records for good research records for certain
interpretations of the results, and provoked the federal government to segments of the research community
important communications and group require universities to implement most notably in the area of human health
decisions among collaborators. Data research misconduct policies.2 and safety research through the stringent
management is a subset of the broader Examination of research records is a regulations of the U.S. Food and Drug
concept of research record-keeping. central feature of inquiries and Administration (FDA) and the
Research records are important for investigations under such university Environmental Protection Agency
managing and planning research, for policies. (EPA)7,8the majority of academic
replicating results, for documenting researchers are not constrained by any
collaborations, for publishing and peer external set of record-keeping guidelines.
We recently conducted a survey of 96
review, and for complying with In fact, most academic scientists find the
university officials who are responsible
governmental and institutional rules and mandated FDA record-keeping practices
for such inquiries and investigations as
regulations. In recent decades, legal and both onerous and unnecessary. Academic
part of a research project on the impact
researchers prefer informal guidelines
of research records in research
rather than formal standards for record-
Dr. Schreier is director of new program misconduct cases.5 We found that over keeping.
development and coordinator of university half of the officials who reported
compliance, Division of Research and Graduate experience with misconduct cases at their
Studies, East Carolina University, Greenville, North During the last half of the 20th century,
Carolina. institutions also reported that they had technological changes in how records are
been hampered in their produced, collected, analyzed and stored,
Dr. Wilson is associate professor, Department of
Sociology, East Carolina University, Greenville, North
inquires/investigations by inadequate coupled with social changes in the nature
Carolina. research records. Also, another recent of research groups, have created new
Dr. Resnik is institute bioethicist, Division of
survey of investigators who had been challenges for research record-keeping.9
Intramural Research, National Institute of funded by the National Institutes of Traditional practices for such record-
Environmental Health Sciences, National Institutes of Health (NIH) on the prevalence of keeping are either no longer sufficient or,
Health, Research Triangle Park, North Carolina.
questionable research practices noted at worse, obsolete for the modern
Correspondence should be addressed to Dr. Schreier, that 27% of the 3,247 respondents researcher. New record-keeping practices
Division of Research and Graduate Studies, East
Carolina University, Greenville, NC 27858; e-mail: admitted to inadequate record-keeping have arisen to meet these challenges;
schreiera@mail.ecu.edu. related to research projects.6 however, very little research has been

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Institutional Issues

done on defining in a systematic way the instruments and methods that self- research groups abandoned the
best practices* for research record-keeping recorded data either on paper printouts traditional bound notebook in favor of
in the 21st century academy. The or photographically (e.g., X-ray films, loose-leaf binders or manila folders for
literature is replete with descriptions of slides, and photographs); and (3) the rise both the collection of data output
record-keeping practices, but they are of computers in the laboratory. (instrument and photographic data) and
usually personal assessments. In this for the planning of experiments. Soon,
article, we will discuss the modern The current environment for research the processing and analysis of data was
challenges to traditional research record- training, where a graduate student or a also placed into loose-leaf binders or
keeping practices. We will then articulate postdoctoral fellow is usually a part of the manila folders, thus contributing to the
best practices (principles and specific large research group, encourages the physical fragmentation of research
practices) for keeping research records teaching of record-keeping practices to records.
that have emanated from our research new researchers by peers rather than by
and which, we believe, can help the senior group leader. Oversight of The rise of computers in the laboratory
researchers respond to these challenges. research is often focused only on the was another major technical advance.
Because these principles and practices results of a young researchers project; it They made possible the collection and
were developed in a systematic way, we appears to be rare for a researchers processing of monumental amounts of
believe that they represent current norms primary research records to be examined data that were critical for the
within the scientific community by a senior research group leader. If there advancement of many fields (e.g., X-ray
(excluding FDA- or EPA-regulated are no standards imposed by the research crystallography, genomics, and
research). We offer these best practices as group leader, the actual record-keeping proteomics). However, the computer also
ethical guidelines for researchers, practices within the laboratory group promoted the fragmentation of the
research group leaders, and research may deviate from accepted norms. The research records in academic laboratories
institutions, not as absolute rules or legal practices actually in use will depend on and made oversight more difficult.
requirements. an individual researchers own attitude Researchers routinely use many different
toward record-keeping and on the computer applications in the course of
attitudes and practices of peers. An their work and produce a variety of
Modern Challenges to Traditional extreme example of this occurs when research records (e.g., word processing
Record-Keeping Practices foreign students and postdocs keep their files, spreadsheets, instrument data
During the 19th and early 20th centuries, research records in their native languages output files, etc.). For a single research
a tradition for research record-keeping if there is no requirement to keep records project, relevant computer files can be
developed in the academic physical and in a common language. There are many scattered among several computers
biological sciences that focused on the anecdotal cases of this practice because within a research group, depending on
research notebook as the primary tool for international students and postdocs are the number of individuals working on
organizing research projects, planning prevalent in academic research groups. the project. Within each computer, the
experiments, recording data, analyzing Kanare10 describes a case where a pertinent files may be scattered among
the results, and storing these records for research group leader discovered, after apparently unrelated folders on the hard
future reference. Research groups were his Japanese postdoc had returned to drive. In addition, the rapid obsolescence
small, allowing group leaders to Japan, that the postdoc had written his of computer software and hardware
personally train young researchers and to notebooks in Japanese. (often only three to five years per
regularly examine primary research generation) has made the long-term
records; this process ensured the The introduction of self-recording electronic retrieval of research records
transmission of the record-keeping research instruments and new problematic, if not impossible.
tradition to the next generation. During photography-based techniques were a
the last half of the 20th century, a major technical advance for science, but
number of trends in research have they have had the unfortunate byproduct Technological Solutions to
complicated the traditional record- of reducing the utility of the traditional Modern Record-Keeping
keeping process and interfered with the bound research notebook, and more Challenges: Different Responses
training of new researchers in record- important, of beginning the of Academia and Industry
keeping practices.9 Chief among these fragmentation of the research record that Computer technology has also been
trends were (1) the rise of large research is so common today. The first self- called upon to provide solutions to these
groups; (2) the introduction of research recording instruments in the 1940s and modern record-keeping challenges.
1950s produced paper-based output Laboratory information management
(they now produce digital files). systems (LIMS) and electronic laboratory
*Best practices and good practices are terms of art Photographic recording techniques also notebooks (ELNs) are the two major
common in the literature on ethical and regulatory appeared at about this time, such as types of tools that have been
aspects of clinical trials and laboratory science. For imaging radiolabels on paper developed.1113 Industry has embraced
example, the Food and Drug Administration10 has
good clinical practices (GCPs) and good laboratory
chromatographs. These types of records these systems due, in part, to intellectual
practices (GLPs) for the conduct of clinical trials, and were difficult to incorporate into property concerns and stringent FDA
the Environmental Protection Agency11 has good traditional bound laboratory notebooks regulations. LIMS systems in particular
laboratory practices (GLPs) for laboratory research.
due to the cumbersome need to glue or have been extremely helpful in managing
Our best practices are intended to supplement but
not supplant GCPs, GLPs, and other best practices tape such output into notebooks and the laboratories that generate a great deal of
for research. sheer volume of such records. Many data and use standardized procedures,

Academic Medicine, Vol. 81, No. 1 / January 2006 43


Institutional Issues

research record-keeping. We derived


List 1 these best practices from four sources:
Best Practice Principles for Individual Researchers* (1) the research training and ethics
Useful (good) research records explain literature; (2) institutional policies and
guidelines; (3) interviews with university
what you did,
officials responsible for investigating
when you did it,
why you did it, allegations of scientific misconduct; and
how you did it, (4) focus groups composed of faculty
who you are (the person creating the record), members from both medical and
what project(s) it was a part of, nonmedical faculties of Duke University,
who thought of it if not you,
what special materials and instruments you used, East Carolina University, North Carolina
where you obtained the materials and instruments, State University, and the University of
what happened and what did not happen (data), North Carolina at Chapel Hill.
how you manipulated and analyzed the results,
your interpretation (and the interpretations of others if important), and
The research training and ethics literature
what will be the next steps in the project based on these results.
was our primary source of record-
In addition, good research records keeping practices. The regular research
are legible if handwritten, literature (e.g., journal articles,
are recorded using reliable materials and tools, monographs, conference proceedings,
are well organized (e.g., well labeled, indexed, catalogued, etc.), etc.) was not excluded from our review;
are accurate and complete; they include (1) all original data and important study details
however, this literature usually does not
(meta-data) and (2) successful and unsuccessful studies and activities,
describe and date all alterations and changes in records, discuss research record-keeping practices.
allow repetition of your procedures and studies by yourself and others, The ethics and research training literature
are accessible (physically and/or electronically) to others both short term and long term, is large and often included detailed and
are stored and backed-up properly for the short and long term (archiving), discipline specific recommendations for
are witnessed where needed to protect intellectual property rights,
are in compliance with departmental, institutional, and federal regulatory requirements, with record-keeping. Many of the references
special care given to human and animal research, and for record-keeping practices were in
are the research diaries of the researchers work and thoughts. textbooks or primers for students
*Researchers may be at any level from student and staff to senior faculty if they are personally performing
learning laboratory techniques for the
hands-on research. Research records are defined briefly as recorded information, regardless of media, that is first time. They usually focused on the
necessary for the reconstruction and evaluation of the research. An individual record element may not need all proper construction of a research
the above attributes, but the whole record probably does. notebook and more, recently, its
Source: This list adopted from Table 11.1 from Scientific Integrity: An Introduction with Case Studies, by Francis electronic counterparts. The monograph
L. Macrina, ASM Press (2000), with permission.
Writing the Laboratory Notebook by
Kanare10 is the acknowledged classic in
which is often the case in industrial and be used to guide the development of this field. The practices described in this
clinical labs and pharmaceutical quality future generations of LIMS and ELNs. book and the other references are the
control facilities. However, in academic We believe that these principles practices that an individual researcher
(discovery-type) research, protocols and transcend the mechanism for their should follow when he or she is planning,
methods can change frequently, and the implementation, whether they be paper- collecting, recording, and analyzing
amount of data collected tends to be or computer-based. research. We named these specific
relatively limited. Because LIMS systems practices individual best practices. Only
need to be customized for each process recently have references appeared that
Genesis of the Best Practices speak to higher-level best practices, such as
they handle, such systems are therefore
viewed as being too inflexible for the We developed the best practices those that research group leaders,
typical academic laboratory.12 The described below as an adjunct to our departments and institutions could
exceptions here are areas like genomics research-on-research-ethics project emulate to promote good record-
and proteomics, whose procedures have entitled Scientific Record Keeping and keeping. Selected primary documents
become highly standardized with a need Responsible Research Conduct funded used in our compilation of our best
to process high amounts of data. ELNs by a grant from the National Science practices are listed in the references at the
supposedly mimic the bound paper Foundation (NSF).5 We carried out the end of this article.2 4,9,10,14 25
notebook, but again due to flexibility research to determine the actual record-
issues, anecdotal evidence suggests that keeping practices of active NSF- and Institutional policies and guidelines that
such tools are not commonly used in NIH-funded scientists and how these deal with research records from many
academic laboratories.12 influence the adjudication of research research universities were reviewed.
misconduct investigations. To help Although our review was far from
These technological solutions themselves prepare a national survey of active NSF inclusive, we found that such policies and
are limited by the basic assumptions used and NIH scientists on their record- guidelines usually spoke to issues of
in their design about what constitutes keeping practices and to aid in the retention, ownership, access and transfer
good records and good record-keeping. analysis of the responses, it was necessary of research records. Only rarely did a
The best practice principles that we to have a set of generally recognized best policy or guideline (e.g., those of the
developed and have described below can practices, that is, normative standards for University of California, San Francisco)18

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


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set specific standards for record-keeping


beyond these administrative issues. List 2
Sources that contained representative Best Practice Principles for Leaders of Research Groups
policies and guidelines that were useful Research group leaders should
are noted in the reference list.18 25
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
Our research ethics project included other documentation),
interviews with university officials from (2) labeling and cataloging of experimental samples, tangible products of research, etc.,
96 research universities.5 These officials (3) communications with collaborating researchers, such as letters, e-mails, minutes of
provided us with a number of positive meetings (face-to-face or teleconference), etc.,
provide/assure that group members receive training in record-keeping practices,
practices for good record-keeping based provide motivation by emphasizing the benefits of good records and the problems associated
on their experiences. In almost every with poor records,
case, however, these practices reiterate provide examples of well-maintained records and good record-keeping practices,
those that appeared in the literature. clarify data and research record ownership and access rights,
perform periodic reviews of the records of the members of your group,
Thus, the university officials provided
delegate, as needed, oversight and training duties for group records to senior members of your
anecdotal evidence for the value of these group and perform periodic checks on the performance of these duties and modify/reassign
practices. duties as needed,
provide the tools (paper-based notebooks or electronic hardware/software),
As the number of specific best practices establish temporary storage areas for records in use (both paper and electronic) and
appropriate backup facilities/methods,
grew, they became too unwieldy to be a require adherence to group record-keeping standards by group members,
useful guide if compiled into a single list. promote communication of research information within the group,
An organizational structure was needed. have a plan to assure the transmission of important research information (accessible and
We divided the best practices into three understandable records/notebooks) from departing group members,
require adherence to departmental, institutional, and legal requirements,
hierarchical groups: best practices for
seek to assure the long-term accessibility of records for a set period of time (archiving) after
individual researchers, best practices for completion of the research, and
research group leaders, and best practices update records standards as needed.
for departments and institutions. We also
developed summaries essentially
statements of principles for the best
practices for each group (see Lists 1, 2,
records have greatly increased in traditional and modern practices from a
and 3)and compiled the detailed best
importance due to the highly variety of sources. They emphasize
practices separately. The resulting
collaborative nature of modern research, principles over detailed practices, which
document, containing both principles
where the collaborating scientists and are subject to obsolescence and
and specific practices, was provided to
their research groups can be physically disciplinary restrictions. They also
the focus groups for their review and
quite distant from each other. Records emphasize the critical role of the research
suggested revisions.
of communications about research group leader in setting standards and in
results, plans for future research, and the training of new researchers. In
The focus groups were particularly
decisions regarding results or future addition, they explicitly acknowledge the
helpful in refining the best practices. The
plans need to be documented to role of departments and institutions in
focus-group members totaled 48 active
prevent misunderstandings and setting the organizational context within
senior scientists (12 on each campus),
miscommunications. Another area of which the research groups operate. Our
who have NSF or NIH funding in a
extreme importance to all focus groups focus-group members felt that these two
variety of research fields (from basic
was the concern that any set of best higher-level sets of practice principles
sciences like physics and chemistry
practices resulting from our work would were applicable to any research discipline
through clinical fields to social and
be adopted as mandated requirements by or institution. These principles address
behavioral sciences). Focus-group
federal agencies, resulting in inflexible the effective management of scientific
sessions of four hours in length were held
and onerous regulation of their research. laboratories and work groups, and are
in the spring and summer of 2004.
Interestingly, the members of the groups aimed at promoting good
directed most of their comments toward The Best Practices communication between current research
best practices for research group leaders participants and future participants
Description (through stored records).
and departments and institutions, the
areas that were least discussed in the Lists 1, 2, and 3 summarize the best practice
literature. They stressed the pivotal role principles for research record-keeping at all It is our opinion that a breakdown in the
of the research group leader in setting three levels described above. A complete training and supervision of new
standards and procedures for his or her document with detailed best practices is researchers has contributed to the decline
group. The focus-group members available at http://www.research2.ecu.edu/ of research record-keeping. The
identified some new types of research BestPractices_Sep04.doc. fragmented and still-evolving nature of
records that had previously not been modern research records has contributed
mentioned in the literature, such as Reflections to this breakdown by making many of the
records of e-mails and teleconference The best practices described above and in old record-keeping practices obsolete,
transcripts and minutes. These types of the three lists are a synthesis of with no generally accepted replacements

Academic Medicine, Vol. 81, No. 1 / January 2006 45


Institutional Issues

the Research Process http://books.nap.edu/


List 3 books/0309047315/html/index.html.
Accessed 2 October 2005 .
Departmental and Institutional Best Practices for Research Record-keeping
5 Wilson K, Brantley A, Schreier A, Resnik D.
Department/School Level Scientific record-keeping and responsible
Make available training/mentoring to faculty (especially new faculty) on research group/lab research conduct [manuscript in
management skills and practices. Include best practices in scientific record-keeping. preparation].
Encourage faculty members to have a strategy/plan (preferably written) for research record- 6 Martinson BC, Anderson MS, deVries R.
keeping. The strategy should adopt individual best practices to the research groups Scientists behaving badly. Nature. 2005;435:
circumstances and include active mentoring and oversight of trainees and staff. 73738.
Provide record-keeping materials and resources if possible (e.g., research journals, lab
notebooks, specialized software, bar-coding equipment, dedicated servers [computers] for 7 U.S. Food and Drug Administration. Good
storing electronic records. Clinical Practice in FDA-Regulated Clinical
Trials http://www.fda.gov/oc/gcp/
default.htm. Accessed 2 October 2005.
University Level
8 Environmental Protection Agency. Good
Provide clear policies on research record ownership, access, retention, transfer, and Laboratory Practices http://www.epa.gov/
destruction. What constitutes research records should be clearly defined and should include Compliance/monitoring/programs/fifra/
paper, electronic, and tangible forms of research information. glp.html. Accessed 2 October 2005.
Provide Institutional facilities for archiving records (all media). Many institutions already have
this service through their university libraries. 9 Wright DE. Data management: recording,
To help assert university ownership of research records, provide record-keeping materials for access, retention, ownership. In: Davis T (ed).
the departments/units to distribute (e.g., research journals, lab notebooks, specialized Management of the Biomedical Research
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(eds). Making the Right Moves http://www.
hhmi.org/grants/office/graduate/
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new research group leaders may find it employed in the NSF project. Dr. Resnik, a 2005. Chevy Chase, MD: Howard Hughes
bioethicist formerly on the faculty of East Medical Institutes, 2004.
difficult to understand the linkages
Carolina University, provided the initial ideas for 12 Bonneta L. Toward a Paperless Lab? Scientist.
between the specific, detailed processes the NSF project as well as critical review of all 2003;17:4042.
they follow in their research and the steps in the project.
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Automat Inform Manage. 1996;32:15.
By identifying a separate set of The authors would like to thank Dr. Robert P.
responsibilities assigned to the research Lowman (Chapel Hill), Dr. Albert Collier 14 Gollub JP. Haverford College Astrophysics
(Chapel Hill), Dr. Joseph M. Corless (Duke Lab Documentation Policy http://www.
group leader, they may be able to more haverford.edu/physics-astro/Gollub/Lab_
University), and Mr. Mathew K. Ronning
clearly understand how to manage their Doc_Policy_0512rev3_ok.pdf. Accessed 2
(NCSU) for their assistance with the focus groups
groups and train their students more and Ms. Angel Griffin (ECU) for her technical October 2005.
effectively. assistance. This project was supported by a grant 15 Grant GF. Digital Authentication of Research
# SES-0322752 from the National Science Notebooks, In: Abstracts: 2002 Research
We present this new synthesis of best Foundation and the intramural research program Conference on Research Integrity http://
practices to the research community as a of the National Institute of Environmental ori.dhhs.gov/documents/rri_conference_
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Health (NIH). The ideas and opinions in this 2005. Rockville, MD: Office of Research
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project do not represent the views of the NSF,
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www.cctec.cornell.edu/labnotebooks.html. www.nih.gov/campus/irnews/guidelines.htm. 24 University of California, San Francisco. Office


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Cover Note
University of New Mexico School of Medicine
Nestled in the southwest enclave of This institution furthers its educational In coming years, the UNM School of
Albuquerque, the University of New mission by fostering strong Medicine will continue to focus on
Mexico (UNM) Health Sciences Center associations with civic, academic and those areas resulting in the greatest
boasts cutting-edge facilities and community organizations and impact on New Mexicos health care
world-class faculty. leadership. Students at the UNM needs, while growing our infectious
School of Medicine are supported disease, cancer, pulmonary, and
The UNM School of Medicine was throughout their academic careers neurosciences research programs. In
established in 1961, and in 1964 with effective mentoring programs, addition to the traditional NIH-
admitted its first class of medical popular community health events, supported individual-investigator
students. It remains the only medical active student organizations, and initiatives and program projects, the
school in New Mexico, and has exceptional faculty. UNM School of Medicine will
graduated more than 2,300 physicians, undertake further interdisciplinary
In the fall of 2006, the School of
many of whom have remained to translational and clinical scientific
Medicine will begin a combined-
practice in the state. inquiry to move forward scientific
degree program implemented in
partnership with UNMs College of knowledge and potential new clinical
Over the years, the UNM School of therapies in these areas.
Arts and Sciences. The program will
Medicine has developed into a
enhance recruitment of highly
nationally recognized educational Through partnerships with our
accomplished and motivated New
institution, consistently ranked among colleagues in the UNM colleges of
Mexico high school students into a
the top 10 in Family Medicine and Pharmacy and Nursing, School of
seven-year program culminating in
Rural Medicine education, and this Engineering, and College of Arts and
both a bachelors degree and an MD
year was named one of the top 10
degree. Sciences, as well as with Los Alamos
medical schools for Hispanics by
and Sandia national laboratories, the
Hispanic Business Magazine. The Medical research in our institution has UNM School of Medicine will expand
organ-system problem-based grown more than 250% in the past its research efforts, particularly in
curriculum at UNM School of Medicine five years and nearly 400% in the past bioengineering and biocomputing.
distinguishes the institution, and our ten. Consistent with that pace is the These partnerships will also allow UNM
subspecialty clinical expertise has pivotal emergence of the NCI-
School of Medicine to develop novel
earned regional recognition. designated Cancer Research and
graduate programs in various
Treatment Center, the MIND Institute
More recently, the UNM School of disciplines to produce the next
and Imaging Center, a 29,000-square-
Medicine is developing a national generation of scientists.
foot Research Incubator Building, a
reputation for its research in the nationally integrated Center for Luke Frank
biological mechanisms and clinical Infectious Diseases, a vital University Senior Public Affairs Representative
treatments in cancer, neurosciences, Teaching Hospital system, the Center HSC Public Affairs
pulmonary disorders and infectious for Native American Health, and the University of New Mexico School of Medicine
diseases. Oral Health Institute. Albuquerque, New Mexico

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

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