data acquisition, management, sharing, and ownership madhu purewal, ph. d, j.d. senior compliance...
TRANSCRIPT
Data Acquisition, Management, Sharing, and Ownership
Madhu Purewal, Ph. D, J.D.Senior Compliance AttorneyResearch Compliance, Institutional Compliance Office
RCR Lecture SeriesOctober 29, 2014
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Topics
• Compliance considerations• Good practices
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About dataCompliance considerations
• Integrity• Retention• Confidentiality• Ownership• Sharing
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Roadmap
Activity Compliance considerations Governing authority/body
Acquisition Integrity, confidentiality, retention Federal
Management Integrity, confidentiality, retention Federal
Sharing Access; confidentiality Federal
Ownership Intellectual property University of Texas
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Research record defined42 C.F.R. § 93.224 (Research Misconduct regulations)
Record of data or results that embody the facts resulting from scientific inquiry.
Includes:– Research proposals– laboratory records, both physical and electronic– progress reports– abstracts– theses– oral presentations– internal reports– journal articles– any documents and materials provided to HHS or an institutional official
by a respondent in the course of the research misconduct proceeding
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Raw Data defined
21 C.F.R. § 58.3(k) (Good Laboratory Practices regulations)• Any laboratory worksheets, records, memoranda, notes,
or exact copies• That are the result of original observations and activities
of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study– An exact copy or exact transcript may be substituted for the
original source as raw data– Including photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data from automated instruments
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About dataCompliance considerations: Integrity
• Objectivity- lack of investigator bias
• Research misconduct proceedings– The destruction, absence of, or respondent's failure to provide
research records adequately documenting the questioned research is evidence of research misconduct where the institution or HHS establishes by a preponderance of the evidence that the respondent intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the respondent's conduct constitutes a significant departure from accepted practices of the relevant research community. 42 C.F.R. § 93.106 (Emphasis added)
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About dataCompliance considerations: Retention
• Federal record retention requirements–Grants management regulations– Food and Drug administration regulations
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About DataGrants requirements: Retention
Grants management regulations (45 C.F.R. §74.53)• Retention period– Three years from the date of submission of the final
expenditure report– For awards that are renewed quarterly or annually,
three years from the date of the submission of the quarterly or annual financial report
– Applies to paper and electronic records
Note: Litigation or Audit Exception until all litigation, claims or audit findings involving the records have been resolved and final action taken.
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About dataCompliance considerations: Retention
• Food and Drug Administration– Specific requirements by activity (includes
retention requirement for specimens and test articles)–Pre-clinical and clinical investigation data• Relative to date of research or marketing application
submission or approval • Sponsor obligations• Investigator obligations• IRB obligations
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About dataOther considerations: Retention
• Intellectual property rights– Life of patent
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About dataCompliance considerations: Retention
• Leaving MDACC– Institutional obligations unchanged• Integrity• Retention• Confidentiality• Sharing
– Institutional interests unchanged• Intellectual property rights
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About dataCompliance considerations: Confidentiality
• Protected Health Information– Use and disclosure restrictions– Security requirements
• Sensitive and classified information• Export-controlled technology– License required for disclosure– Prohibitions on disclosure to certain
individuals/countries
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About dataOther considerations: Confidentiality
• Contractual obligations
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About dataCompliance considerations: Ownership
• Federal regulations– Owner = Grantee (Institution) = MDACC
• UT Board of Regents Rules– Owner = University of Texas= MDACC
• In practice– Investigator = custodian
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About dataCompliance considerations: Sharing
• NIH requirements– Public access– Clinicaltrials.gov reporting
• National Science Foundation– Research.gov
• Freedom of Information Act (Federal)• Public Information Act (Texas)
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Quiz
Which one of the following statements is false?1. Grants management record-keeping
requirements do not apply to the individual researcher
2. Poor record keeping can affect an individual’s ability to:
a. Obtain a patent for his/her inventionb. Defend against research misconduct
allegations
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Quiz
Which one of the following statements is false?1. Grants management record-keeping
requirements do not apply to the individual researcher
2. Poor record keeping can affect an individual’s ability to:
a. Obtain a patent for his/her inventionb. Defend against research misconduct
allegations
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About dataGood practices
• Have a plan– Data management– Responsible parties
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About dataGood practices
• Your laboratory notebooks (electronic or paper)– Objective(s)– Experiment Design– Materials, methods, procedures– Observations and results• Tables• Photographs, slides, films
– Conclusion(s)
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About dataGood practices
• Bound notebooks with a Table of Contents, sequential page numbers, from/to information on each page, footer with signature blocks for “performed by” and “reviewed or read & understood by.”
• Neat, Legible, Verifiable. Pen entries (no pencil entries).
• All raw data identified and raw data locations noted including electronic data (archived & backed up).
• Calculations; Pictures; Print-Outs.
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About dataGood practices
• Who conceived the work, planned the work, and did the work. Your contributions to all of the foregoing.
• All entries dated Month/Day/Year.• Record all results contemporaneously (within the same
period of time over which the work was performed).• Do NOT omit results such as experiment failures,
suspected artifacts, errors, unexpected results, abnormal data. The foregoing should be analyzed and assessed in your notebook.
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About dataGood practices
• Authors should make every attempt to reduce the amount of post acquisition processing of data.
• Some degree of processing may be unavoidable in certain instances, and is permitted provided that the final data accurately reflects that of the original.
• In the case of image processing, alterations must be applied to the entire image (e.g. brightness, contrast, color balance).
• In rare instances where this is not possible (e.g. alterations to a single color channel on a microscopy image) any alterations must be clearly stated in the figure legend and in the methods section.
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About dataGood practices
• Groupings and consolidation of data (e.g. cropping of images or removal of lanes from gels and blots) must be made apparent and should be explicitly indicated in the appropriate figure legends.
• Data comparisons should only be made from comparative experiments, and individual data should not be utilized across multiple figures.
• In cases where data are used multiple times (e.g. multiple experiments were performed simultaneously with a single control experiment) this must be clearly stated within each figure legend.
• In the event that it is deemed necessary for proper evaluation of the manuscript, authors will be required to make the original unprocessed data available to the editors of the journal.
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Reporting compliance concernsIt is every Workforce Member’s responsibility to report a violation or potential violation.
To discuss or report compliance concerns, contact:The Chief Compliance Officer via the page operator at:
713-792-7090The Institutional Compliance Office at:
713-745-6636The Fraud & Abuse Hotline at:
800-789-4448The Privacy Hotline at:
888-337-7497
Institutional Compliance Office e-mail:[email protected]
To report suspected fraud, waste, and abuse involving state resources, call the State Auditor’s Office Hotline at: 1-800-892-8348.
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Relevant authorities
• Grants management: 45 C.F.R. §74.53 • Research misconduct: 42 C.F.R. Part 93• FDA– Electronic records and signatures: 21 C.F.R. Part 11– Good laboratory practices: 21 C.F.R. Part 58– Investigational new drug application: 21 C.F.R. Part 312– Investigational device exemptions: 21 C.F.R. Part 812
• Privacy and Security: 45 C.F.R. Parts 160, 162, and 164• NIH Grants Policy Statement
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Relevant institutional policies
• Principles for Ethical Scientific Research Policy• Research Misconduct Policy• Confidentiality Policy• Essential Documents for the Conduct of Clinica
l Research• Source Documents and Documentation Guidel
ines in the Conduct of Clinical Research• Intellectual Property Policy