Data Management
This module is modeled after
and reproduces with permission parts of the University of Minnesota curriculum
in RCR (http://www.research.umn.edu/ethics/modResearch2.html)
Name the federal,
University, and disciplinary guidelines that govern (a) ownership of data, (b)
access to data, and (c) how long data should be retained with respect to data
generated in your research.
Given brief descriptions of
cases involving (a) accuracy and reliability of data, (b) data ownership, (c)
access to data, (d) decisions on the use of data, and (e) data retention,
distinguish better from worse choices and better from worse justifications to
support the decisions.
Prepare a set of guidelines
for the management of data generated in your research.
Code of Conduct -
http://www1.umn.edu/regents/policies/academic/Conduct.pdf
(or .html)
Academic Misconduct -
http://www1.umn.edu/regents/policies/humanresources/AcademicMisconduct.pdf
(or html)
Research Secrecy
http://policies.memphis.edu/Policies/12b_Academic_Policies/12b0101.html
Acquisition, processing, and
communication of research data are the basis for scientific research, and
responsible data management must be an integral part of it. Research data are generated for the benefit
of individuals, the University, specific sponsors, or society as a whole. Data management has to consider who derives
benefit from the data. In many cases,
intellectual property is based on research data, and data management needs to
be tied to the University's Intellectual Property Policy. Some data contain private and/or proprietary
information, and access has to be limited according to established laws or
contractual obligations.
Research data is recorded
quantitative information generated through research or, more generally,
recorded information, including qualitative information, generated through
systematic inquiry.
Raw data. Any
quantifiable information contained in laboratory notebooks, computer files,
etc., pertaining to a specific research project.
Processed data. Graphs and
equations displaying analyses, descriptions, and conclusions in reports or
papers.
Published data. Information
distributed to people beyond those involved in data acquisition and
administration.
Data can be further
classified according to access restrictions as follows:
Temporary restrictions to
preserve intellectual property/copyright claims.
Restrictions due to privacy
considerations of human subjects.
Restrictions due to
proprietary considerations of research sponsors.
An additional distinction in
the way data are treated is made according to the type of benefit they provide,
e.g., medical/pharmaceutical, historical, etc.
The following issues are
relevant to responsible data management and form the basis for effective data
management guidelines.
Accuracy and reliability of
data and the need for verification (ethical conduct of research)
Data ownership and
management responsibility
Potential benefits or
potential damage from the data and decision on use of the data (i.e.,
publication, commercialization, reporting of negative results)
Control of access to data
Data retention and time
limit for storage
Note that the issues may be
different for different classes of data.
For example, raw data will be treated differently than processed data,
and issues for data containing private information may be different from those
without privacy concerns.
Research
and Data Management Case Studies
These cases are taken from
the University of Minnesota website for Responsible Conduct of Research and
have been adapted for application to University of Memphis. Materials are used with permission of the
University of Minnesota.
A principal investigator
(PI) outlines her theory for a certain effect to her graduate student who is
involved in acquiring data to confirm or refute the theory. The PI explains her anticipation of finding
experimental data having these values.
The graduate student generates the experimental data with approximately
the anticipated values. The data are
published, the PI garners recognition, her grant is renewed, and the graduate
student receives his Ph.D.
The next student working on
this project, however, has difficulties reproducing the data. After further investigation, it is found
that the first graduate student chose in cases of ambiguity of the data those
values that came closer to the expected values, emphasizing a trend in the data
that was not present in general. In
other words, the original data were altered in favor of the PI’s hypothesis.
Should the PI have
restrained herself from mentioning her anticipations? Should the PI have more closely supervised the acquisition of the
data to verify the accuracy? Should the
PI have insisted on a more thorough check of data reproducibility? What should the PI do now about the
situation?
A student enters a
laboratory in which the record-keeping procedures and practices have not been
formally reviewed, and each member of the lab appears to use his/her own
style. The new student often works late
in the evening and sometimes writes data down on paper towels or yellow pads.
After several exciting
months of results, the student writes up several tables and graphs for a
manuscript. While the faculty advisor
is reviewing these materials, he raises a question about the details of the
protocol used for one of the experiments.
To the student's horror, he can no longer find the particular piece of
paper on which those data were written.
Can the data be used? What should the student have done? How should records be kept? How important are duplicates? All along?
Toward the end? At the end? What if a student works on a project and
then leaves the lab? Can the student
continue the project? The faculty
advisor? Both, in competition with each
other?
How much detail should there
be in the lab book? How should it be
organized? By date? By experiment? What kind of primary data should be
kept? Scintillation counter tapes?
Autoradiagrams? Pictures of gels? What should be noted about reagents? Should protocols and data always be written
directly into the lab book or jotted down first and then transcribed neatly at
a later time? What if a mistake is made
in the lab book? Should the researcher
erase? White out? Cross out?
Comment: Briefly, some
recommendations are "to err on the side of thoroughness and
completeness," not to erase any entry, and to glue in hard copies of
electronic data. The notebooks must
remain with the laboratory.
A graduate research
assistant works on a sponsored project that financially supports 50 percent of
her time while pursuing a Ph.D. degree. Her advisor, the principal investigator
(PI), developed the original idea and has predicted some correlations. An undergraduate research assistant is
involved in a crucial part of the data acquisition.
The research turns out to be
scientifically successful, resulting in a new process that promises commercial
revenue through licensing. The graduate
student finishes her Ph.D. degree and obtains a copyright for her thesis in
which the relevant correlations are reported.
The University decides to file a patent application. The graduate student objects, however,
because she wants to file a patent application herself, found a company, and
commercially exploit the idea. The
graduate student argues that she conceived the idea while working on her own
time and that she holds the copyright for an important part of the idea.
Is the graduate student
entitled to pursue the commercial interests of results derived from her thesis
research? How is the ownership divided
between the PI, the graduate research assistant, the undergraduate research
assistant, and the University? Can the
graduate research assistant obtain a copyright for a thesis that contains
material generated by her advisor? Does
copyright ownership include the right to commercial exploitation?
Comment: According to the
University of Memphis Intellectual Property Policy, the results of all research
performed at the University belong to the University unless stated otherwise in
a specific contract. All people working
at the University, including graduate students working on an advanced degree,
are covered by this policy regardless of whether or not they receive
remuneration. Owning the copyright for
a certain presentation of the data does not include data ownership.
A student who is in her
third year as a Ph.D. student is working with Professor Smith in a very active
laboratory. One evening when she
returns to the laboratory to stop an incubation, she finds Professor Smith and
one of the postdocs reading her lab notebook. She is instantly angry and
defensive.
Would this be a reasonable
reaction? Should graduate students keep
their lab notebooks locked up? Should
lab notebooks be returned to the professor after a graduate student finishes
his/her degree?
Comment: While the reaction
is understandable because expended effort usually generates a sense of
proprietorship, the lab notebook and its contents belong to the
University.
Certain results of a
sponsored research project are of high scientific value as well as potential
commercial value. The University
decides to file a patent application and requests that the principal
investigator (PI) refrain from publishing the data for several months. Unfortunately, the PI is attending an
important conference next month and would like to present the results,
particularly since the project director of the agency supporting his research
will be present.
Does the potential
commercial benefit outweigh the personal benefit of peer recognition?
Comment: It is the
University's right and responsibility to make the final decision.
In a famous case, a
pharmaceutical company sponsored a university research project in which one of
the company's high-priced prescription drugs was to be compared with a generic
substitute. The research contract
specified review of any potential publication resulting from this research by
company officials before submission to a journal.
The research showed the
generic drugs to be equivalent in their effectiveness to the high-priced
brand-name drug. The company
successfully blocked publication of the research results for several years
until involvement of one of its board members resulted in permission to publish
the results. (Rennie, D. "Thyroid Storm" (Editorial), JAMA. Vol.
277(15) (April 16, 1997) pp. 1238-1243.)
In this case, the
significant benefits to the public are connected to damage to the research
sponsor. Do the benefits to the public
override contractual obligations to the sponsor? Can the University accept contracts that limit access to the data
generated by the research?
Comment: The University of
Memphis Policy states that the University may only in exceptional cases accept
contracts in which research results cannot be published. It is the principal investigator's
responsibility to avoid incompatibility between the sponsor's requests and
University regulations.
A graduate research
assistant is involved in a company-sponsored research project while working on
his thesis. For scientific reasons, he
would like to expand data acquisition into another area — one that could also
contribute to his thesis. The sponsor,
however, is not interested in this research and would rather complete the
project quickly.
The principal investigator
(PI) is caught in the middle. While she
agrees with the graduate student on the value of the additional data, she would
like to remain on good terms with the company in the hope of receiving future
funding. There are usually ways to
accommodate all interests, but situations may exist where this is not possible.
Is the PI's primary
responsibility to her graduate student or to her research sponsor?
Comment: The PI has the obligation to fulfill the
contractual requirements. Note, this
faculty member has a certain conflict between the obligation to follow a legal
contract and the ethical obligation to advance science and a student’s education. Contracts need to be followed, but the
faculty member can negotiate different arrangements for the future.
In a behavioral study,
questionnaires from a well identified section of the population are evaluated
(e.g., children of immigrants from Norway coming to Minnesota in the 1920s and
1930s). Some questions deal with
private issues (e.g., marital fidelity and abortion). Because of the relatively small group of people involved and the
personal nature of the questions, it's possible that someone reading the data
could identify a respondent if the two previously knew each other.
The usual procedure for
compiling data of this kind is to have an undergraduate research assistant
enter the data into a computer and a graduate student evaluate the data to
arrive at correlations. In this case,
the undergraduate research assistant entering the data recognizes one of the
respondents as a friend of the family and learns some compromising information.
How much effort should be
spent to ensure that human subjects of a study are unrecognizable? Should the PI have entered the data him or
herself? Should any person having
access to these data for further processing be made fully aware of the privacy
issues involved?
After 10 years of research,
results obtained led to the filing of a patent application and the subsequent
granting of a patent for a new drug.
Further research, clinical trials, and government approval, however,
delayed the marketing of the drug, and the first royalty check arrived 11 years
after the filing of the application.
None of the original researchers who started the project 21 years before
were still with the University, and no primary data still existed.
Is it reasonable to ask for
retention of the primary data for 20 years and beyond to support a potential
patent infringement suit? Who becomes
responsible for the data when the principal investigator for the research
leaves the University?
Comment: No universal policy on data retention exists
for universities, and decisions regarding retention are usually made on a
case-by-case basis. Public Health
Services and other government agencies specify, however, that complete and
original records be kept for a minimum of three years after closing of the
grant. Some professional societies
require that data be retained up to five years after publication of the data by
a society journal. Industry policies on
research data have changed dramatically from indefinite retention some time
ago, to very limited retention now.
A predoctoral student
working in the laboratory of his mentor is gathering data for a federally
funded project on which the mentor serves as principal investigator. The student is, of course, going to use the
data for her dissertation work. The
student and mentor have a terrible falling out. The student leaves the lab and finds a new advisor. The original mentor notices that data and
materials related to the student's project are missing. The student readily admits to removing the
databooks, tissue sections, gels, and computer disks but asserts that they are
"hers"- the product of her sweat and blood.
What issues of data
ownership apply here and what should be done?
(c) ASM Press
This case is from Francis L.
Macrina (2000): Scientific Integrity, 2nd edition, published by ASM Press. Used
with permission.
Ronald Wu had just completed
all the requirements for his Ph.D., and his thesis defense had gone extremely
well. Dr. Christine Morris, his mentor, wrote in a letter of reference:
Ron is the best graduate
student I ever had. He should be justly proud of what he has accomplished
during the five years he has spent in this lab, having nursed a very important
problem in transcriptional regulation from conceptualization to the purification
of several key transcription factors and the cloning of their genes.
Furthermore, one of the materials he prepared has the potential of being an
important therapeutic agent.
On the basis of his
performance and recommendations, Ron was accepted for a prestigious and
comparatively well-paying postdoctoral fellowship in a productive, highly
regarded laboratory in his area of interest. This situation was particularly
attractive since it held the promise of a faculty position in two years. During
his recruitment visit, the lab chief, Dr. John Link, suggested that the more
materials Ron could bring from his current laboratory, the more productive Ron
could be, avoiding the time and expense of preparing the materials anew.
Up until this point, Ron and
Dr. Morris had not discussed the disposition of the products of his research.
One day, Ron met with Dr. Morris to thank her for all her years of support and
friendship, and for helping him obtain the fellowship. When Ron raised the
topic of research materials, Dr. Morris restated her affection for him and her
appreciation of his promise as a scientist. Dr. Morris then stated somewhat
apologetically, "Of course, you understand that the materials associated
with your research project belong to the lab. I really can't allow you to take
your notebooks, probes, or other materials with you. I'm sorry Ron, but that's
just the way it is."
What do you think of the
suggestion by Dr. Link? Who has
ownership rights to the following materials:
Ron's original lab
notebooks?
the cell lines on which Ron
worked, including the mutant lines he prepared?
clones of the transcription
factor genes?
the limited supply of
antibodies that he prepared to the transcription factors?
the software Ron developed
to carry out some of the studies?
unpatented software Ron
utilized, which was developed by others in the lab? Is Ron entitled: to carry with him a photocopy of his lab
notebooks?
to write a research grant
for funds to continue exactly along the lines of his Ph.D. thesis?
What measures should a
prudent and responsible laboratory take to protect its valued and unique
materials? At what point should lab
personnel, including students, learn about the institution's policies
concerning the ownership or research materials and data? Is it the institution's or the individual's
responsibility to be sure that there is a clear understanding of the policy?
Further Discussion:
Suppose that Ron's response
to Dr. Morris's assertion is,
There is ample precedent in
other areas to support the notion that I should have access to these materials.
For example, Cell and Science explicitly state that materials must be made
available to qualified investigators. Since I did the work, I must be a
qualified investigator. Also, NIH requires that materials developed under NIH
grants be shared. Ethically, you cannot deny me the materials. Furthermore, as
a graduate student I'm as entitled to a share in the profits derived from my
research as you are.
Discuss the validity of
Ron's statement.
The lack of availability to
Ron of the materials he has developed will slow Ron's progress on his next job,
and possibly in a larger sense, the progress of science. On the other hand, Dr.
Morris has an interest in ensuring that her project not be "scooped"
by another lab, and the institution regards materials developed with its
resources as its own. Which of these conflicting interests do you believe
should prevail? Why?
From Teaching the
Responsible Conduct of Research Through a Case Study Approach,
a handbook prepared by the
Association of American Medical Colleges (Korenman SG and Shipp AC, 1994)
This case was contributed by
Allan Shipp (acshipp@aamc.org)
of the Association of
American Medical Colleges. ©1994
Fields, K. L., & Price,
A. R. (1993). Problems in research
integrity arising from misconceptions about the ownership of research, Academic Medicine. 68/9, S60-S64, 1993.
National Institutes of
Health. (1990). Guidelines for the Conduct of Research at
the National Institutes of Health. Bethesda, MD: Author.
Institute of Medicine,
Division of Health Sciences Policy (1989).
The responsible conduct of
research in the health sciences. Washington, D.C.: National Academy Press.
Rennie, D. (1997). Thyroid storm (Editorial). Journal
of the American Medical Association, 277(15), 1238-1243.
Council on Government
Relations (1996): Access to and retention of data. This essay from COGR summarizes policy issues relevant to the
access and retention of data.
Department of Health and
Human Services (1990). Data Management
in Biomedical Research, Report of a Workshop, April 1990 Chevy Chase, Maryland.
"...forum for
scientists, science administrators, and policy makers to identify areas of
agreement and areas for further discussion on the topics of data ownership,
access, sharing, and retention." Single copies are available from the
Office of Research Integrity (http://ori.dhhs.gov/html/publications/conference.asp)
National Academy of Sciences
/ National Academy of Engineering (1992): Data Handling.
In: Chapter 2: Scientific
Principles and Research Practices. In: Responsible Science--Ensuring the
Integrity of the Research Process, vol. I. Washington, D.C., pp. 47-51. http://books.nap.edu/books/0309047315/html/47.html#pagetop
Online Ethics Center for
Engineering and Science Research Ethics
http://www.onlineethics.org/text/reseth/research.html
Online Ethics Center for
Engineering and Science National Society of Professional Engineers Code of
Ethics for Engineers
http://www.onlineethics.org/text/codes/NSPEcode.html
American Statistical
Association (1998): Ethical guidelines for statistical practice.
http://amstat.org/profession/ethicalstatistics.html
Food and Drug
Administration: Electronic Records; Electronic Signatures. 21 CFR Part 11
http://www.fda.gov/ora/compliance_ref/part11
Food and Drug
Administration: Good laboratory practice for nonclinical laboratory studies. 21
CFR Part 58
http://vm.cfsan.fda.gov/~lrd/cfr58.html
Good Laboratory Practices
Online
Links to regulations
relevant to meeting FDA guidelines for Good Laboratory Practices.
http://www.glpguru.com:80/links.shtml
Guidelines for Good
Epidemiology Practicies
"The Guidelines for
Good Epidemiology Practices address those issues -- data quality, study design,
and study conduct -- that are under the control of the investigator."
http://www.hsph.harvard.edu/Organizations/DDIL/gep.html
Kanare, H. M. (1985).
Writing the laboratory notebook.
American Chemical Society. Washington,
D.C.
Summarizes recommendations
for keeping an effective laboratory notebook.
Macrina, F. L. (2000). Chapter 11: Scientific record
keeping. In F. L. Macrina, (Ed.), Scientific integrity: An introductory text
with cases. ASM Press, Washington,
DC, pp. 231-256.
Council on Governmental
Relations (1999): A Tutorial on Technology Transfer in U.S. Colleges and
Universities
http://www.cogr.edu/techtransfertutorial.htm
Mays, T. D. (2000). Chapter 9: Ownership of data and intellectual property. In F. L. Macrina, (Ed.), Scientific integrity: An introductory text with cases. ASM Press, Washington, DC, pp. 179-210.
U.S. Patent and Trademark
Office
U.S. Copyright Office
Council on Governmental
Relations (1998): Materials Transfer in Academia
Council on Governmental
Relations (2000): Guidance to campuses on NIH "Principles and Guidelines
for Recipients of NIH Research Grants and Contracts on Obtaining and
Disseminating Biomedical Research Resources"
http://www.cogr.edu/finalnih.htm
Office of Management and
Budget Circular A-110: Uniform Administrative Requirements for Grants Revised
Sept. 1999 [see section Intangible Property]
http://www.whitehouse.gov/OMB/circulars/a110/a110.html#36
Office of Management and
Budget (1999): Section 53: Retention and access requirements for records. In Circular No. A-110
http://www.whitehouse.gov/OMB/circulars/a110/a110.html#53
National Institutes of
Health (1998): Working Group Report on Research Tools Working Group Report,
submitted June 4, 1998
http://www.nih.gov/news/researchtools
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