Promoting Integrity in the Next Generation of Researchers
A Curriculum for Responsible Conduct of Research
In Occupational Therapy (2005)Funded by the Office of Research Integrity through the
American Association of Medical Colleges
Data Management
Objectives Discuss why data management is an issue of
both scientific rigor and ethics. Describe what constitutes data. Discuss who is responsible for the accuracy of
data collection, recording, and storage. Discuss the policies that determine how long
data must be kept, who may access data, and in what contexts data may or must be withheld.
Research Relies on Trust Principal Investigators are rarely supervised Even data collectors are rarely line-of-sight
supervised Research relies on a researchers to:
Develop and employ unbiased research methods Honestly and accurately report a study’s methods,
data handling, and analyses
Data Management Includes:
Data Collection Recordkeeping Data Analysis Data Ownership Data Storage/Retention Sharing Data
(Magnus & Kalichman, 2002)
Examples of Data Recorded by an observer
Physical characteristics or behaviors Live or recorded
Self-report by participant Questionnaires,
Checklists, Surveys
Records of research decisions
Records of research protocols
Interaction between participants & researcher Tapes/notes: Focus Groups,
Interviews
Recordings by computer Digitized images Instrument measures
Institutional files Medical or School Records
Researchers Share Responsibility for Data
Principal Investigator Creates system that
collects, records, and stores data
Trains data collectors Supervises data
collection, recording, and storage
Data Collector Collects data Records data Stores data while
study is in process
Responsible Data Collection
It is unethical to: Knowingly collect data in a manner that is
biased Falsify or fabricate data Tailor or change a protocol to alter findings Change or remove non-conforming data to
bend findings
Your Policy on Data Collection Insert your University /Department data
collection policy here
Or ask students to develop same
Responsible Record Keeping
Records must be thorough, complete, and organized.
Keep Outcome data Meeting notes and other records that show
history of work, “what was done, by whom, and when”
(Magnus & Kalichman, 2002)
Responsible Record Keeping (continued)
In quantitative studies, deviations from protocol should be avoided Record all actions, incidents, and
variations from protocol in a lab notebook
(University of Minnesota, n.d.)
Responsible Record Keeping (continued)
In qualitative studies, protocols may be intentionally altered during a study Confirm changes with advisor &
collaborators Record changes, actions, incidents, and
variations in a lab notebook Record reasoning for above as well
Responsible Record Keeping (continued)
In both qualitative and quantitative studies, a research notebook should Be used only for the research study Have continuous pages Be written in ink
Responsible Record Keeping (continued) When correcting errors on data forms or
lab notebook Strike through, date, and initial all errors or
corrections.
Note reasons for changes if they are not obvious.
Never erase.
(University of Minnesota, n.d.)
Your University’s or Department’s Policy on Record Keeping
Insert your University /Department record keeping policy here
Responsible Data Analysis It is unethical to change, add, or exclude data
to bias findings or produce a desired result.
In quantitative research: Decisions to exclude data from analysis must be
based on objective rules, preferably established before the ‘cleaning’
Excluded data should be described in any report made of the study
Reduce likelihood of biased interpretation by using blind analysis
Responsible Data Analysis (continued) In qualitative research:
Divergent, conflicting, or disconfirming subject themes should be reflected in the findings
Ensure that findings accurately reflect data through triangulation, peer review, and member checking
Responsible Data Analysis (continued) If any qualitative or quantitative data are
excluded or changed, researchers must inform audience or reader How data were reviewed How data were selected for exclusion or change Which data were excluded from analysis How exclusion or alteration changed findings
Responsible Data Ownership Regardless of funding source, study data
belong to the institution (University or College), not the individual researcher or collaborative group
Institutions may choose not to exert their ownership
Individual researchers (students and faculty) are generally permitted to have a copy of the study data after subject identifiers are removed
Your University’s Data Ownership Policy
Insert your University /Department ownership policy here
Responsible Data Storage Data should be stored in a manner that
protects them from loss, theft, or damage
Store historical records of decision making, draft work, and other documents detailing processes with the same care as outcome data
Responsible Data Storage (continued) Store signed consent forms separate from
data forms
Store master-code connecting names to participant numbers, separate from data forms
Destroy master-code as soon as possible.
Keep a ‘back-up copy’ of database stripped of identifiers
Responsible Data Retention Ensure that data are retrievable regardless of
technological changes in Devices used to collect data Software or hardware used to store data
Responsible Data Retention (continued)
Data should be kept after study ends Federally funded data must be kept for at
least 3 years after a final report(Columbia University, 2003–2004)
American Psychological Association recommends that data be kept for 5 years post-publication
(American Psychological Association, 2001)
Responsible Data Sharing Data sharing refers to one researcher
allowing another to use another’s raw data or database
Federal guidelines encourage data sharing of NIH-supported studies
(National Institutes of Health, 2003)
Unless proprietary agreements prohibit sharing, all interested parties may access data gathered using public funding
Responsible Data Sharing (continued) Before sharing:
Protect rights and privacy of participants (e.g., IRB, HIPAA) by stripping all identifiers or variables that could identify individual subjects
Responsible Data Sharing (continued) Data cannot be shared if:
It is impossible to strip identifiers or otherwise protect confidentiality and anonymity of subjects.
Sharing compromises proprietary information and there are temporary restrictions specified by contractual agreement with sponsors
Resources American Psychological Association. (2001).
Publication manual of the American Psychological Association (5th ed.). Washington, DC: Author.
Columbia University. (2003–2004). Responsible conduct of research: Courses portal. Course 6: Data acquisition and management. Retrieved August 20, 2005, from http://www.ccnmtl.columbia.edu/projects/rcr/rcr_data/foundation/index.html.
Resources (continued) Magnus, P. D., & Kalichman, M. (2002, September).
Data management. Retrieved August 20, 2005, from RCR Education Resources, Online Resource for RCR Instructors: http://rcrec.org/r/index.php?module=ContentExpress&func=display&meid=29&ceid=2.
Martinson, B. C., Anderson, M. S., & deVries, R. (2005). Scientists behaving badly. Nature, 435, 737–738.
Resources (continued) National Institutes of Health. (2003, February 26).
Final NIH statement on sharing research data. Retrieved August 20, 2005, from http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
University of Minnesota. (n.d.). Guidelines for maintaining laboratory notebooks. Retrieved August 20, 2005, from http://www.ptm.umn.edu/v3/documents/labnotes.pdf.
This completes the presentation on Data Management
THANK YOU!