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!