Professional Documents
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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
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,
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